98. 好酸球性消化管疾患 Eosinophilic gastrointestinal disease Clinical trials / Disease details
臨床試験数 : 171 / 薬物数 : 184 - (DrugBank : 47) / 標的遺伝子数 : 42 - 標的パスウェイ数 : 141
| No. | TrialID | Date_ enrollment | Date_ registration | Public_title | Scientific_title | Condition | Intervention | Primary_ sponsor | Secondary_ sponsor | Recruitment_ Status | Inclusion_ agemin | Inclusion_ agemax | Inclusion_ gender | Target_ size | Phase | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 1 | JPRN-jRCT2021210067 | 07/03/2022 | 02/02/2022 | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITIS | A PHASE 3, MULTICENTER, RANDOMIZED, DOUBLEBLIND,PLACEBO-CONTROLLED INDUCTION AND MAINTENANCE STUDY TO EVALUATE THE EFFICACY AND SAFETY OF CC-93538 IN ADULT AND ADOLESCENT JAPANESE SUBJECTS WITH EOSINOPHILIC GASTROENTERITIS | Eosinophilic gastroenteritis | CC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescents of 12 years of age or older.After 16 weeks after the initial administration,a dose of 360 mg is administered subcutaneously weekly or bi-weekly.During the OLE phase,360 mg will be administered subcutaneously weekly. | Zhang Changliang | NULL | Pending | >= 12age old | <= 75age old | Both | 45 | Phase 3 | Japan |
| 2 | NCT05246085 (ClinicalTrials.gov) | March 1, 2022 | 1/2/2022 | Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical Steroids | Evaluating Adrenal Insufficiency in Adults With Eosinophilic Esophagitis on Chronic Swallowed Topical Steroids | Eosinophilic Esophagitis | Diagnostic Test: Cortisol level | University of Colorado, Denver | NULL | Not yet recruiting | 18 Years | 85 Years | All | 300 | NULL | |
| 3 | NCT05247866 (ClinicalTrials.gov) | March 2022 | 21/12/2021 | Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis | Efficacy of Dupilumab on Facilitated Food Introduction in Eosinophilic Esophagitis | Eosinophilic Esophagitis | Dietary Supplement: EoE food introduction-1st;Dietary Supplement: E0E food introduction-2nd;Dietary Supplement: EoE Food introduction-3rd dose;Drug: Dupilumab | Children's Hospital of Philadelphia | Regeneron Pharmaceuticals;Genzyme, a Sanofi Company | Not yet recruiting | 6 Years | 25 Years | All | 30 | Phase 4 | United States |
| 4 | EUCTR2020-004335-24-PT (EUCTR) | 24/02/2022 | 03/12/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 5 | JPRN-jRCT2031210574 | 10/02/2022 | 22/01/2022 | A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS | A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS | eosinophilic esophagitis | All subjects will be administered CC-93538 at a dose of 360 mg SC once weekly. | Zhang Changliang | NULL | Pending | >= 12age old | <= 75age old | Both | 22 | Phase 3 | United States of America;Canada;United Kingdom;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan |
| 6 | EUCTR2020-004335-24-IT (EUCTR) | 08/02/2022 | 29/10/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multicenter, Multinational, Open-Label Extension Study to evaluate the Long-Term Safety of CC-93538 in adult and adolescent subjects with Eosinophilic Esophagitis - - | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Trade Name: Cendakimab Product Name: Cendakimab Product Code: [CC-93538] INN or Proposed INN: Cendakimab | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 7 | NCT04835168 (ClinicalTrials.gov) | January 30, 2022 | 10/3/2021 | Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis | A Randomized, Placebo-Controlled, Double-Blind, Multicenter Study to Evaluate Safety and Pharmacokinetics of Orodispersible BT-11 in Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: BT-11 500mg;Drug: BT-11 1000mg;Drug: BT-11 Placebo | Landos Biopharma Inc. | NULL | Not yet recruiting | 18 Years | 65 Years | All | 36 | Phase 1 | NULL |
| 8 | NCT05251909 (ClinicalTrials.gov) | January 18, 2022 | 6/8/2021 | Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) | A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients With Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) | Eosinophilic Gastritis;Eosinophilic Gastroenteritis | Biological: Benralizumab;Biological: Placebo | AstraZeneca | NULL | Recruiting | 12 Years | 130 Years | All | 230 | Phase 3 | United States;Australia;Brazil;Canada;France;Germany;Italy;Japan;Netherlands;Poland;Spain;Ukraine;Vietnam |
| 9 | JPRN-jRCT2031210500 | 14/01/2022 | 18/12/2021 | Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (HUDSON GI) | A Multi-center, Randomized, Double-blind, Parallel-group, Placebo-controlled 3-Part Phase 3 Study to Demonstrate the Efficacy and Safety of Benralizumab in Patients with Eosinophilic Gastritis and/or Gastroenteritis (The HUDSON GI Study) - HUDSON GI | Eosinophilic gastritis, Eosinophilic gastroenteritis | The patients are planned to be randomly assigned to receive either a fixed SC dose of Benralizumab or placebo once monthly in a 24 week double-blind period followed by assessments during an open-label Benralizumab treatment period. | Hibi Kazushige | NULL | Recruiting | >= 12age old | <= 130age old | Both | 230 | Phase 3 | Australia;China;Vietnam;Italy;France;Poland;Spain;Brazil;Canada;America;Netherlands;Ukraine;Israel;Japan |
| 10 | EUCTR2020-004335-24-DE (EUCTR) | 14/01/2022 | 30/07/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | ||
| 11 | EUCTR2020-004336-16-ES (EUCTR) | 12/01/2022 | 12/01/2022 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 12 | EUCTR2020-001314-37-PT (EUCTR) | 26/11/2021 | 12/02/2021 | Clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus | Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis - Once daily versus twice daily budesonide orodispersible tablets for induction of remission in EoE | eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg) INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 1 mg orodispersible tablets INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 242 | Phase 3 | Portugal;Spain;Austria;Germany;Switzerland | ||
| 13 | NCT05084963 (ClinicalTrials.gov) | October 29, 2021 | 30/9/2021 | A Study to Assess the Efficacy, Safety and Tolerability of IRL201104 in Adults With Active Eosinophilic Esophagitis | A Phase 2a, Double-blind, Placebo-Controlled, Multi-Center Study to Assess the Efficacy, Safety, and Tolerability of IRL201104 in Adult Participants With Active Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis | Drug: IRL201104;Drug: Placebo | Revolo Biotherapeutics | NULL | Recruiting | 18 Years | 75 Years | All | 36 | Phase 2 | United States |
| 14 | NCT05083312 (ClinicalTrials.gov) | September 30, 2021 | 6/10/2021 | Efficacy and Safety APT-1011 in Adolescent Subjects With Eosinophilic Esophagitis (EoE) - A Sub-Study of the FLUTE-2 Trial | An Adolescent Sub-study Within FLUTE-2: A Randomized, Double-blind, Placebo-Controlled Study of APT-1011 (Fluticasone Propionate Oral Dispersible Tablet Formulation), With an Open-label Extension, in Adolescent Subjects With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo oral tablet | Ellodi Pharmaceuticals, LP | NULL | Recruiting | 12 Years | 17 Years | All | 30 | Phase 3 | United States;Australia |
| 15 | EUCTR2020-004336-16-DE (EUCTR) | 29/09/2021 | 01/02/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 16 | EUCTR2020-004336-16-PT (EUCTR) | 24/09/2021 | 01/04/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 17 | NCT04991935 (ClinicalTrials.gov) | September 14, 2021 | 28/7/2021 | Safety Study of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis | A Phase 3, Multi-Center, Multi-National, Open-Label Extension Study to Evaluate the Long Term Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Active Eosinophilic Esophagitis. | Eosinophilic Esophagitis | Drug: CC-93538 | Celgene | NULL | Recruiting | 12 Years | 75 Years | All | 259 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom |
| 18 | EUCTR2021-002288-24-NL (EUCTR) | 10/08/2021 | 27/07/2021 | Effect of citalopram on chest pain in patients with chest pain of unkown origin | Effect of citalopram on chest pain in patients with functional chest pain - Ci-FCP | Chest pain can be divided in cardiac or non-cardiac chest pain (NCCP). To establish the diagnosis NCCP, acute coronary disease has to be ruled out first. NCCP can be caused by functional chest pain (FCP). NCCP in the absence of musculoskeletal abnormalities, major esophageal motor disorders, gastroesophageal reflux or eosinophilic esophagitis is called FCP.;Therapeutic area: Diseases [C] - Symptoms and general pathology [C23] | Trade Name: Citalopram Product Name: Citalopram | Amsterdam UMC | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 52 | Phase 4 | Netherlands | ||
| 19 | EUCTR2017-003516-39-ES (EUCTR) | 22/07/2021 | 14/06/2021 | A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission | Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Jorveza 1 mg orodispersible tablets Product Name: Budesonide 1 mg orodispersible tablets Product Code: BUL 1 mg INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 0.5 mg orodispersible tablets Product Name: Budesonide 0.5 mg orodispersible tablets Product Code: BUL 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Switzerland;Italy | ||
| 20 | EUCTR2020-004336-16-PL (EUCTR) | 21/07/2021 | 12/05/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Poland;Belgium;Australia;Germany;Japan;New Zealand | ||
| 21 | EUCTR2017-003516-39-IT (EUCTR) | 09/07/2021 | 17/08/2021 | A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission | Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission - Episodic and continuous treatment with budesonide orodispersible tablets versus placebo for maintena | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Jorveza 1 mg compresse orodispersibili Product Name: Budesonide 1 mg compresse orodispersibili Product Code: [BUL 1 mg] INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 0.5 mg compresse orodispersibili Product Name: Budesonide 0.5 mg compresse orodispersibili Product Code: [BUL 0.5 mg] INN or Proposed INN: BUDESONIDE | DR. FALK PHARMA GMBH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Switzerland;Italy | ||
| 22 | JPRN-jRCT2051200140 | 01/07/2021 | 19/02/2021 | A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | Eosinophilic esophagitis | CC-93538 is administered subcutaneously at a dose of 360 mg weekly in adults and adolescent 12 years of age or older. After 24 weeks after the initial dose, a dose of 360 mg is administered subcutaneously weekly or biweekly. | Hatano Ben | NULL | Recruiting | >= 12age old | <= 75age old | Both | 33 | Phase 3 | United States of America;Canada;UK;Italy;Israel;Portugal;Germany;Switzerland;Poland;Spain;Austria;Belgium;Australia;Argentina;Japan |
| 23 | NCT04849390 (ClinicalTrials.gov) | June 29, 2021 | 2/4/2021 | A Study to Investigate the Efficacy and Tolerability of ESO-101 in Patients With Eosinophilic Esophagitis | A Randomized, Placebo-controlled, Double-blind Trial Evaluating the Efficacy, Tolerability and Safety of ESO-101 in Adult Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: ESO-101;Drug: Placebo | EsoCap AG | FGK Clinical Research GmbH;FGK Representative Service B.V. | Recruiting | 18 Years | 70 Years | All | 42 | Phase 2 | Germany;Netherlands;Spain;Switzerland |
| 24 | EUCTR2020-004336-16-IT (EUCTR) | 17/06/2021 | 08/06/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A phase 3, multicenter, multinational, randomized, double-blind, placebo-controlled induction and maintenance study to evaluate the efficacy and safety of CC-93538 in adult and adolescent subjects with eosinophilic esophagitis - - | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: [CC-93538] INN or Proposed INN: Cendakimab | CELGENE INTERNATIONAL II SàRL | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | ||
| 25 | NCT04856891 (ClinicalTrials.gov) | May 20, 2021 | 20/4/2021 | A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Duodenitis | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Duodenitis Who Have an Inadequate Response With, Lost Response to, or Were Intolerant to Standard Therapies | Eosinophilic Duodenitis;Eosinophilic Gastroenteritis | Drug: AK002;Other: Placebo | Allakos, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 94 | Phase 3 | United States |
| 26 | NCT03678545 (ClinicalTrials.gov) | May 14, 2021 | 6/8/2018 | Dupilumab in Eosinophilic Gastritis | A Randomized, Double-blind, Placebo-controlled Clinical Trial to Evaluate the Efficacy of Dupilumab (Anti-IL4a) in Subjects With Eosinophilic Gastritis | Eosinophilic Gastritis;Eosinophilic Gastroenteritis | Drug: Dupilumab (blinded);Drug: Placebo (blinded);Drug: Dupilumab (open-label) | Children's Hospital Medical Center, Cincinnati | Regeneron Pharmaceuticals;National Institutes of Health (NIH) | Recruiting | 12 Years | 70 Years | All | 40 | Phase 2 | United States |
| 27 | EUCTR2020-001314-37-AT (EUCTR) | 06/05/2021 | 01/03/2021 | clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus | Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis | eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg) INN or Proposed INN: BUDESONIDE Trade Name: Jorveza Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 242 | Phase 3 | Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland | ||
| 28 | EUCTR2020-003226-23-DE (EUCTR) | 05/05/2021 | 21/12/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis - VOYAGE | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;France;Spain;Belgium;Australia;Netherlands;Germany;Switzerland | ||
| 29 | EUCTR2017-003516-39-DE (EUCTR) | 28/04/2021 | 21/12/2020 | A phase III clinical study in adult and adolescent patients with eosinophilic inflammation of the gullet to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining remission | Double-blind, randomized phase III trial in adult and adolescent patients with eosinophilic esophagitis to prove superiority compared to placebo of an episodic and/or a continuous 48-week treatment with budesonide orodispersible tablets for maintaining clinico-histological remission | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Trade Name: Jorveza 1 mg orodispersible tablets Product Name: Budesonide 1 mg orodispersible tablets Product Code: BUL 1 mg INN or Proposed INN: BUDESONIDE Trade Name: Jorveza 0.5 mg orodispersible tablets Product Name: Budesonide 0.5 mg orodispersible tablets Product Code: BUL 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 110 | Phase 3 | Spain;Germany;Switzerland;Italy | ||
| 30 | EUCTR2020-001314-37-DE (EUCTR) | 26/04/2021 | 27/11/2020 | clinical study to show equal clinical efficacy of two dosing regimen of budesonid orodispersible tablets (twice daily vs. once daily) for treatment of inflammation of the esophagus | Double-blind, double-dummy, randomized, parallel-group, non-inferiority phase III trial on the efficacy and tolerability of 2 mg once daily vs. 1 mg twice daily budesonide orodispersible tablets for induction of histological remission in adults with eosinophilic esophagitis | eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide 2 mg orodispersible tablets (BUL 2 mg) INN or Proposed INN: BUDESONIDE Trade Name: Jorveza Product Name: Budesonide 1 mg orodispersible tablets (BUL 1 mg) INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 242 | Phase 3 | Portugal;Canada;Spain;Austria;Russian Federation;Germany;Switzerland | ||
| 31 | NCT02873468 (ClinicalTrials.gov) | April 2021 | 16/8/2016 | Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis | Randomized, Double-blind, Multicentric, Parallel, National, Phase II Clinical Trial to Evaluate the Efficacy and Safety of Three Doses of Florence Oral Suspension in Adults With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Florence 30 µg/mL;Drug: Florence 60 µg/mL;Drug: Florence 90 µg/mL;Other: Placebo | EMS | NULL | Not yet recruiting | 18 Years | N/A | All | 116 | Phase 2 | NULL |
| 32 | NCT04776694 (ClinicalTrials.gov) | March 29, 2021 | 25/2/2021 | Compassionate Use of Dupilumab | Bullous Pemphigoid;Eosinophilic Esophagitis (EoE);Pediatric Asthma;Pediatric and Adolescent Chronic Rhinosinusitis With Nasal Polyps (CRSwNP);Pediatric Atopic Dermatitis | Drug: Dupilumab | Regeneron Pharmaceuticals | NULL | Available | NULL | ||||||
| 33 | NCT04682639 (ClinicalTrials.gov) | February 23, 2021 | 19/12/2020 | A Study to Assess the Safety and Efficacy of Oral Etrasimod in Adult Participants With Eosinophilic Esophagitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Etrasimod;Drug: Placebo | Arena Pharmaceuticals | NULL | Recruiting | 18 Years | 65 Years | All | 96 | Phase 2 | United States;Australia;Belgium;Netherlands;Spain;Switzerland |
| 34 | EUCTR2020-003226-23-NL (EUCTR) | 22/02/2021 | 26/11/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis - VOYAGE | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;Spain;Belgium;Australia;Germany;Netherlands;Switzerland | ||
| 35 | NCT04753697 (ClinicalTrials.gov) | February 22, 2021 | 5/2/2021 | A Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Participants With Eosinophilic Esophagitis | A Phase 3, Multicenter, Multinational, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: CC-93538;Other: Placebo | Celgene | NULL | Recruiting | 12 Years | 75 Years | All | 399 | Phase 3 | United States;Argentina;Australia;Austria;Belgium;Canada;Germany;Israel;Italy;Japan;Poland;Portugal;Spain;Switzerland;United Kingdom;Puerto Rico |
| 36 | EUCTR2020-003226-23-BE (EUCTR) | 02/02/2021 | 23/11/2020 | A study evaluating the efficacy and safety of Etrasimod in the treatment of patients with eosinophilic esophagitis | A Phase 2 Randomized, Double-Blind, Placebo-Controlled Study to Assess the Safety and Efficacy of Etrasimod in Adult Subjects with Eosinophilic Esophagitis - VOYAGE | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine Product Name: Etrasimod Product Code: APD334 INN or Proposed INN: etrasimod L-arginine Other descriptive name: AR401959 L-arginine | Arena Pharmaceuticals Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 96 | Phase 2 | United States;France;Spain;Belgium;Australia;Netherlands;Germany;Switzerland | ||
| 37 | EUCTR2020-000082-16-DE (EUCTR) | 21/01/2021 | 29/07/2020 | A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagus | A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis | Active eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ESO-101 Product Code: ESO-101 INN or Proposed INN: mometasone Other descriptive name: MOMETASONE FUROATE | EsoCap AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | Spain;Netherlands;Germany;Switzerland | ||
| 38 | NCT04620811 (ClinicalTrials.gov) | December 3, 2020 | 3/11/2020 | An Extension Study of Lirentelimab in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | A Phase 3, Multicenter, Open-Label, Extension Study to Evaluate the Efficacy and Safety of AK002 in Patients That Were Previously Enrolled in AK002-016 or AK002-012 Studies and Have Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | Eosinophilic Gastritis;Eosinophilic Duodenitis | Drug: lirentelimab | Allakos, Inc. | NULL | Enrolling by invitation | 18 Years | 80 Years | All | 170 | Phase 3 | United States |
| 39 | EUCTR2020-000082-16-NL (EUCTR) | 29/10/2020 | 03/09/2020 | A study to investigate the efficacy and tolerability of the drug ESO-101 in adult patients with inflammation of the esophagus | A randomized, placebo-controlled, double-blind trial evaluating the efficacy, tolerability and safety of ESO-101 in adult patients with active eosinophilic esophagitis | Active eosinophilic esophagitis MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: ESO-101 Product Code: ESO-101 INN or Proposed INN: mometasone Other descriptive name: MOMETASONE FUROATE | EsoCap AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 42 | Phase 2 | Spain;Germany;Netherlands;Switzerland | ||
| 40 | NCT04149470 (ClinicalTrials.gov) | October 7, 2020 | 30/10/2019 | Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) | Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis Assessed by Transnasal Endoscopy (TNE) | Eosinophilic Esophagitis | Drug: Omeprazole 20mg BID | University of Colorado, Denver | Children's Hospital Colorado | Recruiting | 8 Years | 22 Years | All | 90 | Phase 4 | United States |
| 41 | NCT04593251 (ClinicalTrials.gov) | September 28, 2020 | 13/10/2020 | Dose Escalation Study to Evaluate an Experimental New Treatment (CALY-002) in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis | A Multicentre, SAD, and MAD Clinical Trial to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of IV Treatment of CALY-002 in Healthy Subjects and Subjects With Celiac Disease and Eosinophilic Esophagitis | Eosinophilic Esophagitis;Celiac Disease | Biological: CALY-002;Biological: Placebo | Calypso Biotech BV | NULL | Recruiting | 18 Years | N/A | All | 95 | Phase 1 | Belgium;Germany;Netherlands |
| 42 | JPRN-jRCT2061200026 | 22/09/2020 | 04/11/2020 | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis | The aim of this Phase 3 study is to investigate the use of benralizumab as a treatment for patients with EoE. The effect of doses of benralizumab on EoE histologic signs and symptoms will be assessed over a 52-week treatment period (including a 24-week double-blind placebo-controlled treatment period and a 28-week open-label treatment period). It is proposed that benralizumab will deplete eosinophils from GI tissue(s), improve the symptoms of dysphagia, and improve endoscopy scores as well as other markers of disease activity. Upon completion of the initial 52-week treatment period, patients will be offered an additional Open Label Extension period of at least 1 year, with benralizumab treatment and ongoing study assessments. - MESSINA | Eosinophilic Esophagitis D3255C00001 | Biological: Benralizumab Solution for injection in a single accessorized prefilled syringe (APFS) will be administered subcutaneously (SC), 1 mL fill volume. Biological: Matching placebo Matching placebo solution for injection in APFS, 1 mL fill volume. Placebo solution will be administered subcutaneously (SC), 1 mL fill volume | Hibi Kazushige | NULL | Recruiting | >= 12age old | <= 65age old | Both | 170 | Phase 3 | Canada;France;Germany;Israel;Italy;Netherlands;Poland;Russia;Spain;UK;US;Japan |
| 43 | NCT04543409 (ClinicalTrials.gov) | September 22, 2020 | 18/8/2020 | A Study of Benralizumab in Patients With Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo Controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis | Eosinophilic Esophagitis | Biological: Benralizumab;Biological: Matching placebo | AstraZeneca | NULL | Recruiting | 12 Years | 65 Years | All | 170 | Phase 3 | United States;Canada;France;Germany;Israel;Italy;Japan;Netherlands;Poland;Russian Federation;Spain;United Kingdom |
| 44 | NCT04394351 (ClinicalTrials.gov) | September 1, 2020 | 7/5/2020 | Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis (EoE) | A Randomized, Double-Blind, Placebo-Controlled Study to Investigate the Efficacy and Safety of Dupilumab in Pediatric Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis (EoE) | Drug: Dupilumab;Drug: Matching Placebo | Regeneron Pharmaceuticals | Sanofi | Active, not recruiting | 1 Year | 11 Years | All | 102 | Phase 3 | United States;Canada |
| 45 | EUCTR2019-001521-27-DE (EUCTR) | 03/08/2020 | 10/02/2020 | Study with Eosinophilic Esophagitis subjects | Fluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 | Eosinophilic Esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APT-1011 Product Code: APT-1011 - 3 mg INN or Proposed INN: Fluticasone Propionate, USP Other descriptive name: FLUTICASONE PROPIONATE | Adare Pharmaceuticals US, LP | NULL | Not Recruiting | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Australia;Germany | ||
| 46 | EUCTR2019-004391-19-NL (EUCTR) | 30/07/2020 | 13/05/2020 | Study to Evaluate the Efficacy and Safety of AK002 in Subjects with Active Eosinophilic Esophagitis | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Efficacy and Safetyof AK002 in Adult and Adolescent Subjects with Active Eosinophilic Esophagitis | Active Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Code: AK002 INN or Proposed INN: not available | Allakos Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 300 | Phase 2;Phase 3 | United States;Australia;Netherlands | ||
| 47 | NCT04248712 (ClinicalTrials.gov) | July 10, 2020 | 28/1/2020 | Antihistamines in Eosinophilic Esophagitis | A Phase II, Randomized, Placebo-controlled Study Evaluating the Efficacy of Antihistamines in the Treatment of Eosinophilic Esophagitis (the ATEE Study) | Eosinophilic Esophagitis | Drug: Famotidine;Drug: Loratadine;Drug: Placebo | Mayo Clinic | NULL | Recruiting | 18 Years | N/A | All | 50 | Phase 2 | United States |
| 48 | EUCTR2019-002871-32-FR (EUCTR) | 06/07/2020 | 11/05/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 49 | NCT04322708 (ClinicalTrials.gov) | July 6, 2020 | 24/3/2020 | A Study of Lirentelimab (AK002) in Patients With Active Eosinophilic Esophagitis | A Phase 2/3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Lirentelimab (AK002) in Adult and Adolescent Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Other: Placebo;Drug: lirentelimab (AK002) | Allakos, Inc. | NULL | Active, not recruiting | 12 Years | 80 Years | All | 277 | Phase 2/Phase 3 | United States;Australia;Netherlands |
| 50 | NCT04322604 (ClinicalTrials.gov) | June 18, 2020 | 24/3/2020 | A Study to Assess AK002 in Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | A Phase 3, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate Efficacy and Safety of AK002 in Patients With Moderately to Severely Active Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | Eosinophilic Gastritis;Eosinophilic Duodenitis | Drug: lirentelimab (AK002);Other: Placebo | Allakos, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 180 | Phase 3 | United States |
| 51 | EUCTR2019-002871-32-IT (EUCTR) | 11/05/2020 | 31/08/2021 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebocontrolled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: benralizumab Product Code: [MEDI-563] INN or Proposed INN: benralizumab | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 52 | EUCTR2019-002871-32-DE (EUCTR) | 09/04/2020 | 27/01/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan | ||
| 53 | EUCTR2019-001521-27-ES (EUCTR) | 04/04/2020 | 28/02/2020 | Study with Eosinophilic Esophagitis subjects | Fluticasone propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 in Adult and Adolescent Subjects with Eosinophilic Esophagitis - FLUTE-2 | Eosinophilic Esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APT-1011 Product Code: APT-1011 - 3 mg INN or Proposed INN: Fluticasone Propionate, USP Other descriptive name: FLUTICASONE PROPIONATE | Adare Pharmaceuticals US, LP | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 120 | Phase 3 | United States;Spain;Australia;Germany;Switzerland | ||
| 54 | EUCTR2017-003737-29-NL (EUCTR) | 01/04/2020 | 09/04/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Germany;Netherlands;United Kingdom | ||
| 55 | EUCTR2019-002871-32-NL (EUCTR) | 02/03/2020 | 08/01/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Trade Name: Fasenra Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Germany;Netherlands;United Kingdom;Italy;Japan | ||
| 56 | EUCTR2019-002871-32-GB (EUCTR) | 24/02/2020 | 18/03/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United Kingdom;Italy;Japan;Germany;Netherlands;Israel;Russian Federation;Poland;Spain;Canada;France;United States | ||
| 57 | EUCTR2019-002871-32-ES (EUCTR) | 05/02/2020 | 20/12/2019 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 170 | Phase 3 | United States;France;Canada;Poland;Spain;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy | ||
| 58 | NCT04281108 (ClinicalTrials.gov) | January 30, 2020 | 20/2/2020 | Efficacy and Safety APT-1011 in Adult Subjects With Eosinophilic Esophagitis (EoE) (FLUTE-2) | Fluticasone Propionate Oral Dispersible Tablet Formulation in Eosinophilic Esophagitis: A Two-Part, Randomized, Double-blind, Placebo-Controlled Study of APT-1011 With an Open-label Extension, in Adult Subjects With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo oral tablet | Ellodi Pharmaceuticals, LP | NULL | Active, not recruiting | 18 Years | N/A | All | 143 | Phase 3 | Germany;United States;Spain;Australia |
| 59 | EUCTR2019-002691-14-IT (EUCTR) | 30/10/2019 | 24/05/2021 | Oral viscous budesonide administration for 3 months in a population of patients affected by esophageal atresia and eosinophilic esophagitis. | VISCOUS BUDESONIDE IN PATIENTS AFFECTED BY EOSINOPHILIC ESOPHAGITIS, OPERATED FOR ESOPHAGEAL ATRESIA - na | Eosinophilicesophagitis (EoE) in Esophageal atresia (EA). MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide Product Code: [na] INN or Proposed INN: Budesonide Product Name: Budesonide Product Code: [na] INN or Proposed INN: Budesonide Product Name: Budesonide Product Code: [na] INN or Proposed INN: Budesonide | IRCCS, OSPEDALE PEDIATRICO BAMBINO GESÙ DI ROMA | NULL | Not Recruiting | Female: yes Male: yes | 9 | Phase 2 | Italy | ||
| 60 | EUCTR2018-000844-25-DE (EUCTR) | 21/10/2019 | 13/11/2018 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 61 | EUCTR2018-000844-25-SE (EUCTR) | 09/10/2019 | 15/11/2018 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 290 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 62 | NCT03615950 (ClinicalTrials.gov) | October 1, 2019 | 24/7/2018 | Effects of Swallowed Steroids on Bone Density and Growth in Pediatric Eosinophilic Esophagitis | Effects of Swallowed Corticosteroids on Bone Mineral Density and Growth Velocity in Children With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Diagnostic Test: Bone Mineral Density (DEXA) scan;Diagnostic Test: Vitamin D Measurement;Diagnostic Test: Height measurement;Other: Assessment of medication compliance | Arkansas Children's Hospital Research Institute | University of Arkansas | Recruiting | 5 Years | 12 Years | All | 60 | United States | |
| 63 | EUCTR2017-003737-29-GR (EUCTR) | 18/09/2019 | 03/09/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 64 | EUCTR2017-003737-29-GB (EUCTR) | 01/08/2019 | 24/10/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 65 | EUCTR2018-000844-25-GB (EUCTR) | 12/07/2019 | 20/11/2018 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 3 | United States;Portugal;Spain;United Kingdom;Italy;Switzerland;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 66 | EUCTR2018-000844-25-PT (EUCTR) | 08/07/2019 | 26/12/2018 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Not Recruiting | Female: yes Male: yes | 425 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 67 | EUCTR2018-000844-25-NL (EUCTR) | 03/07/2019 | 11/12/2018 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Netherlands;Germany;Sweden | ||
| 68 | EUCTR2018-000844-25-BE (EUCTR) | 14/06/2019 | 14/03/2019 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 290 | Phase 3 | Canada;United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Belgium;Australia;Germany;Netherlands;Sweden | ||
| 69 | EUCTR2017-003737-29-PT (EUCTR) | 24/05/2019 | 29/01/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Phase 2;Phase 3 | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 70 | EUCTR2017-003737-29-ES (EUCTR) | 11/04/2019 | 18/01/2019 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | ||
| 71 | EUCTR2018-000844-25-ES (EUCTR) | 05/04/2019 | 17/05/2019 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 72 | NCT03656380 (ClinicalTrials.gov) | March 20, 2019 | 30/8/2018 | Mepo for EoE Study | A Multi-center, Randomized, Double Blind, Parallel-arm, Placebo Controlled Trial of Mepolizumab for Treatment of Adults and Adolescents With Active Eosinophilic Esophagitis and Dysphagia-predominant Symptoms | EoE;Eosinophilic Esophagitis | Drug: Mepolizumab 300 mg;Drug: Mepolizumab 100 mg;Other: Placebo | University of North Carolina, Chapel Hill | GlaxoSmithKline;University of Utah;Northwestern University;MNGI Digestive Health, P.A. | Recruiting | 16 Years | 75 Years | All | 72 | Phase 2 | United States |
| 73 | EUCTR2018-000844-25-FR (EUCTR) | 05/03/2019 | 14/11/2018 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): no Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 74 | EUCTR2018-000844-25-IT (EUCTR) | 05/02/2019 | 28/03/2019 | A study to determine the efficacy and safety of dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients with Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: PT;Classification code 10064212;Term: Eosinophilic oesophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Immune System Diseases [C20] | Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB Trade Name: Dupixent Product Name: dupilumab INN or Proposed INN: dupilumab Other descriptive name: DUPILUMAB | Regeneron Pharmaceuticals, Inc. | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 425 | Phase 3 | United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden | ||
| 75 | NCT03664960 (ClinicalTrials.gov) | November 14, 2018 | 6/9/2018 | An Extension Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis | A Phase 2, Multicenter, Open-Label, Extension Study to Evaluate the Safety and Tolerability of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Duodenitis (Formerly Referred to as Eosinophilic Gastroenteritis) | Eosinophilic Gastritis;Eosinophilic Gastroenteritis;Eosinophilic Duodenitis | Drug: AK002 | Allakos, Inc. | NULL | Active, not recruiting | 18 Years | 80 Years | All | 58 | Phase 2 | United States |
| 76 | NCT03781596 (ClinicalTrials.gov) | October 2, 2018 | 11/11/2018 | EoE RCT Fluticasone and Omeprazole vs Fluticasone Alone | Randomized Controlled Trial Comparing Fluticasone Plus Omeprazole With Fluticasone Alone for Eosinophilic Esophagitis | Eosinophilic Esophagitis | Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug;Other: Symptom Survey;Other: Medication Compliance Phone Call;Diagnostic Test: Endoscopy while on study drug;Drug: Fluticasone;Drug: Omeprazole;Drug: Placebo oral capsule | Claire Daniels | NULL | Recruiting | 6 Years | 60 Years | All | 100 | Phase 4 | United States |
| 77 | NCT03633617 (ClinicalTrials.gov) | September 24, 2018 | 14/8/2018 | Study to Determine the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) | A Phase 3, Randomized, 3-Part Study to Investigate the Efficacy and Safety of Dupilumab in Adult and Adolescent Patients With Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis | Drug: Dupilumab;Drug: Placebo | Regeneron Pharmaceuticals | Sanofi | Active, not recruiting | 12 Years | N/A | All | 321 | Phase 3 | United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;Switzerland;United Kingdom |
| 78 | NCT03496571 (ClinicalTrials.gov) | July 18, 2018 | 6/4/2018 | A Study of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis | A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy, Safety, Tolerability, and Pharmacodynamic Effect of AK002 in Patients With Eosinophilic Gastritis and/or Eosinophilic Gastroenteritis | Eosinophilic Gastritis;Eosinophilic Gastroenteritis | Drug: AK002;Other: Placebo | Allakos, Inc. | NULL | Completed | 18 Years | 80 Years | All | 65 | Phase 2 | United States |
| 79 | EUCTR2016-004749-10-DE (EUCTR) | 15/11/2017 | 26/07/2017 | study in subjects with Eosinophilic Esophagitis | FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. | Eosinophilic Esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APT-1011 INN or Proposed INN: FLUTICASONE PROPIONATE Other descriptive name: FLUTICASONE PROPIONATE Product Name: APT-1011 Other descriptive name: FLUTICASONE PROPIONATE Product Name: APT-1011 Other descriptive name: FLUTICASONE PROPIONATE | Adare Pharmaceutical | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Spain;Belgium;Germany;Switzerland | ||
| 80 | NCT04803162 (ClinicalTrials.gov) | November 14, 2017 | 14/3/2021 | The Role of HRM and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected EoE | The Role of High-resolution Esophageal Manometry and Specific Biomarkers of Inflammation in the Diagnosis of Patients With Dysphagia and Suspected Eosinophilic Esophagitis | Eosinophilic Esophagitis | Diagnostic Test: High-resolution manometry;Diagnostic Test: Serum biomarkers;Diagnostic Test: Gastrointestinal Quality of Life index;Drug: Omeprazole 20 MG Oral Tablet | Wroclaw Medical University | NULL | Active, not recruiting | 18 Years | N/A | All | 58 | Poland | |
| 81 | EUCTR2014-001485-99-DK (EUCTR) | 27/10/2017 | 06/07/2017 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | Spain;Belgium;Denmark;Netherlands;United Kingdom;Switzerland | ||
| 82 | EUCTR2016-004749-10-BE (EUCTR) | 06/10/2017 | 07/07/2017 | study in subjects with Eosinophilic Esophagitis | FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. | Eosinophilic Esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APT-1011 INN or Proposed INN: FLUTICASONE PROPIONATE Other descriptive name: FLUTICASONE PROPIONATE Product Name: APT-1011 Other descriptive name: FLUTICASONE PROPIONATE Product Name: APT-1011 Other descriptive name: FLUTICASONE PROPIONATE | Adare Pharmaceutical | NULL | Not Recruiting | Female: yes Male: yes | 100 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United States;Canada;Spain;Belgium;Germany;Switzerland | ||
| 83 | NCT03245840 (ClinicalTrials.gov) | October 5, 2017 | 8/8/2017 | Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Participants With Eosinophilic Esophagitis (EoE) | A Phase 3, Multicenter, Open-label Continuation Study With Budesonide Oral Suspension (BOS) for Adolescent and Adult Subjects With Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) | Drug: Budesonide oral suspension | Shire | Takeda Development Center Americas, Inc. | Active, not recruiting | 11 Years | 55 Years | All | 133 | Phase 3 | United States |
| 84 | EUCTR2014-001485-99-IT (EUCTR) | 29/09/2017 | 20/01/2021 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo formaintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinicopathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Compressa effervescente 1 mg di budesonide per uso orodispersibile Product Code: BUET 1 mg INN or Proposed INN: BUDESONIDE Product Name: Compressa effervescente 0,5 mg di budesonide per uso orodispersibile Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | DR. FALK PHARMA GMBH | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland;Italy;Eswatini;Spain | ||
| 85 | EUCTR2016-004749-10-ES (EUCTR) | 20/09/2017 | 20/09/2017 | study in subjects with Eosinophilic Esophagitis | FLUTicasone in Eosinophilic esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose ranging, and Maintenance Study of APT-1011 in Subjects with Eosinophilic Esophagitis. | Eosinophilic Esophagitis MedDRA version: 20.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000013492;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: APT-1011 INN or Proposed INN: Fluticasone Propionate Other descriptive name: FLUTICASONE PROPIONATE Product Name: APT-1011 INN or Proposed INN: Fluticasone Propionate Other descriptive name: FLUTICASONE PROPIONATE Product Name: APT-1011 INN or Proposed INN: Fluticasone Propionate Other descriptive name: FLUTICASONE PROPIONATE | Adare Pharmaceutical | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 100 | Phase 2 | United States;Canada;Belgium;Spain;Germany | ||
| 86 | NCT03191864 (ClinicalTrials.gov) | June 22, 2017 | 15/6/2017 | Efficacy, Safety, and Pharmacokinetics of APT-1011 in Subjects With Eosinophilic Esophagitis (EoE) | FLUTicasone in Eosinophilic Esophagitis (FLUTE): A Randomized, Double-blind, Placebo-controlled, Dose-ranging, and Maintenance Study of APT-1011 in Subjects With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: APT-1011;Drug: Placebo | Adare Pharmaceuticals, Inc. | NULL | Completed | 18 Years | 75 Years | All | 106 | Phase 2 | United States;Belgium;Canada;Germany;Spain;Switzerland |
| 87 | NCT03290482 (ClinicalTrials.gov) | June 19, 2017 | 24/8/2017 | Natural History of Eosinophilic Esophagitis | Natural History of Eosinophilic Esophagitis: A Longitudinal Follow-up Over 10 Years | Eosinophilic Esophagitis | Diagnostic Test: Barium Esophagram;Device: EsophaCap;Diagnostic Test: Physical Examination and Questionnaires | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 65 | United States | |
| 88 | NCT03029091 (ClinicalTrials.gov) | May 23, 2017 | 20/1/2017 | An Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) | A Preliminary Open-Label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder | Eosinophilic Esophagitis | Drug: Losartan Potassium | Children's Hospital Medical Center, Cincinnati | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institute of Allergy and Infectious Diseases (NIAID);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS) | Completed | 5 Years | 25 Years | All | 15 | Phase 2 | United States |
| 89 | EUCTR2014-001485-99-NL (EUCTR) | 24/08/2016 | 02/05/2016 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | Spain;Belgium;Denmark;Germany;Netherlands;United Kingdom;Switzerland | ||
| 90 | ChiCTR-DOD-16009003 | 2016-08-04 | 2016-08-10 | Perspective Study On Eosinophilic Gastroenteritis | Perspective Study On Eosinophilic Gastroenteritis | Eosinophilic Gastroenteritis | Gold Standard:;Index test:; | Endoscopy Center, Department of Gastroenterology, The Third Affiliated Hospital of Sun Yat-sen University. | NULL | Recruiting | Both | Target condition:0;Difficult condition:0 | China | |||
| 91 | NCT04069429 (ClinicalTrials.gov) | July 2016 | 27/7/2019 | Radiation Dose in Humans From Orally Administered Tc99m-Heparin | Radiation Dose in Humans From Orally Administered Tc99m-Heparin | Eosinophilic Esophagitis | Radiation: Computerized Tomography scan;Radiation: Single Photon Emission Computed Tomography scans;Drug: Technetium Tc 99M;Radiation: Planar Images;Procedure: Esophagogastroduodenoscopy | University of Utah | NULL | Completed | 18 Years | 70 Years | All | 8 | Early Phase 1 | United States |
| 92 | NCT02778867 (ClinicalTrials.gov) | May 20, 2016 | 12/10/2015 | SOFEED: Six Food vs. One Food Eosinophilic Esophagitis Diet Study | Six Food vs One Food Eosinophilic Esophagitis Elimination Diet (SOFEED) Followed by Swallowed Glucocorticoid Trial | Eosinophilic Gastrointestinal Disorders (EGIDs);Eosinophilic Esophagitis (EoE) | Other: 1 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet Therapy;Other: 6 Food Elimination Diet (after 1FED failure);Drug: Fluticasone Propionate, 880 mcg twice daily (after 6FED failure) | Children's Hospital Medical Center, Cincinnati | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK);National Institute of Allergy and Infectious Diseases (NIAID);Office of Rare Diseases (ORD);National Center for Advancing Translational Science (NCATS) | Completed | 18 Years | 60 Years | All | 129 | Phase 2/Phase 3 | United States |
| 93 | NCT02736409 (ClinicalTrials.gov) | April 29, 2016 | 22/3/2016 | An Extension Study to Evaluate Maintenance of Efficacy and Long-term Treatment Effect of Oral Budesonide Suspension (OBS) in Adults and Adolescents With Eosinophilic Esophagitis (EoE) | A Phase 3, Multicenter, Double-blind Extension Study to Evaluate Maintenance of Efficacy of Oral Budesonide Suspension (OBS) and Long-term Treatment Effect of OBS in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (OBS);Drug: Placebo | Shire | NULL | Completed | 11 Years | 55 Years | All | 200 | Phase 3 | United States;United Kingdom |
| 94 | NCT02722148 (ClinicalTrials.gov) | April 21, 2016 | 24/3/2016 | Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET) | Application of a Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy in Patients With Eosinophilic Esophagitis (IDiET) | Eosinophilic Esophagitis | Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy | University of North Carolina, Chapel Hill | National Institutes of Health (NIH) | Completed | 16 Years | 80 Years | All | 24 | N/A | United States |
| 95 | NCT02610816 (ClinicalTrials.gov) | March 21, 2016 | 12/10/2015 | Eosinophilic Esophagitis Intervention Trial-1 Food vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids | Eosinophilic Esophagitis (EoE) Intervention Trial-Randomized 1 Food Elimination vs. 4 Food Elimination Diet Followed by Swallowed Glucocorticoids | Eosinophilic Esophagitis;Eosinophilic Gastrointestinal Disorders (EGIDs) | Other: 1 Food Elimination Diet;Other: 4 Food Elimination Diet;Other: 4 Food Elimination Diet (post 1FED failure);Drug: Fluticasone Propionate, 800 mcg twice daily (post 4FED failure) | Children's Hospital Medical Center, Cincinnati | Patient-Centered Outcomes Research Institute | Completed | 6 Years | 17 Years | All | 67 | Phase 2/Phase 3 | United States |
| 96 | JPRN-UMIN000021041 | 2016/02/15 | 15/02/2016 | A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis | A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis - A study investigating the therapeutic effect of vonoprazan on the patients with proton pump inhibitor resistant eosinophilic esophagitis | Eosinophilic esophagitis | administration of Vonoprazan (20mg/day for 2 months) | Second department of Internal Medicine, Shimane University Faculty of Medicine | NULL | Complete: follow-up complete | 20years-old | Not applicable | Male and Female | 5 | Not selected | Japan |
| 97 | EUCTR2014-001485-99-BE (EUCTR) | 22/01/2016 | 23/07/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 204 | Phase 3 | Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland | ||
| 98 | EUCTR2014-001485-99-ES (EUCTR) | 22/01/2016 | 17/11/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 18.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 204 | Phase 3 | Spain;Switzerland | ||
| 99 | NCT02493335 (ClinicalTrials.gov) | January 15, 2016 | 7/7/2015 | Maintenance of Remission With Budesonide Orodispersible Tablets vs. Placebo in Eosinophilic Esophagitis | Double-blind, Randomized, Placebo-controlled, Phase III Study on the Efficacy and Tolerability of a 48-week Treatment With Two Different Doses of Budesonide Effervescent Tablets vs. Placebo for Maintenance of Clinico-pathological Remission in Adult Patients With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Budesonide 0.5mg orodispersible tablet twice daily;Drug: Budesonide 1mg orodispersible tablet twice daily;Drug: Placebo orodispersible tablet twice daily | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | All | 204 | Phase 3 | Germany |
| 100 | EUCTR2014-001484-12-NL (EUCTR) | 23/12/2015 | 12/10/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis | Active eosinophilic esophagitis MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Spain;Belgium;Germany;Netherlands;Switzerland | ||
| 101 | EUCTR2014-001485-99-GB (EUCTR) | 23/12/2015 | 23/10/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 204 | Phase 3 | Belgium;Spain;Denmark;Netherlands;Germany;Switzerland;United Kingdom | ||
| 102 | EUCTR2014-001485-99-DE (EUCTR) | 08/12/2015 | 29/06/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets in comparison with placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III study on the efficacy and tolerability of a 48-week treatment with two different doses of budesonide effervescent tablets vs. placebo for maintenance of clinico-pathological remission in adult patients with eosinophilic esophagitis - Maintenance of remission with budesonide effervescent tabl. vs. placebo in eosinophilic esophagitis | Maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 0.5 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 0.5 mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 204 | Phase 3 | Spain;Belgium;Denmark;Netherlands;Germany;United Kingdom;Switzerland | ||
| 103 | NCT02605837 (ClinicalTrials.gov) | December 7, 2015 | 4/11/2015 | A Study in Adolescents and Adults With Eosinophilic Esophagitis (EoE) Measuring Histologic Response and Determine if Reduction in Dysphagia is Achieved | Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11 to 55 Years of Age, Inclusive) With Eosinophilic Esophagitis: A Phase 3 Randomized, Double-blind, Placebo-controlled Study | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (OBS);Drug: Placebo | Shire | NULL | Completed | 11 Years | 55 Years | All | 318 | Phase 3 | United States |
| 104 | NCT02434029 (ClinicalTrials.gov) | November 11, 2015 | 30/4/2015 | Budesonide Orodispersible Tablet vs. Placebo in Active Eosinophilic Esophagitis | Double-blind, Randomized, Placebo-controlled, Phase III Trial on the Efficacy and Tolerability of a 6-week Treatment With Budesonide Effervescent Tablets vs. Placebo for Induction of Clinico-pathological Remission in Adult Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Budesonide 1mg orodispersible tablet twice daily;Drug: Placebo orodispersible tablet twice daily | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | All | 88 | Phase 3 | Germany |
| 105 | EUCTR2014-001484-12-BE (EUCTR) | 09/10/2015 | 19/05/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis | Active eosinophilic esophagitis MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Spain;Belgium;Netherlands;Germany;Switzerland | ||
| 106 | NCT02579876 (ClinicalTrials.gov) | October 2015 | 14/10/2015 | Milk Patch for Eosinophilic Esophagitis | A Double, Blind Placebo-controlled, Randomized Trial to Study Efficacy and Safety of the Viaskin Milk for Treating Milk Induced Eosinophilic Esophagitis in Children | Eosinophilic Esophagitis;Milk Allergy | Drug: Viaskin Milk 500 mcg;Drug: Viaskin Placebo | Children's Hospital of Philadelphia | DBV Technologies | Completed | 4 Years | 17 Years | All | 20 | Phase 2 | United States |
| 107 | EUCTR2014-001484-12-DE (EUCTR) | 22/09/2015 | 09/04/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis | Active eosinophilic esophagitis MedDRA version: 19.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Spain;Belgium;Netherlands;Germany;Switzerland | ||
| 108 | EUCTR2014-001484-12-ES (EUCTR) | 18/08/2015 | 10/07/2015 | Double-blind (neither physician nor patient knows of the actual treatment which can with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (tested against tablets without active substance), phase III study on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, phase III trial on the efficacy and tolerability of a 6-week treatment with budesonide effervescent tablets vs. placebo for induction of clinico-pathological remission in adult patients with active eosinophilic esophagitis - Induction of remission with budesonide effervescent tablets vs. placebo in eosinophilic esophagitis | Active eosinophilic esophagitis MedDRA version: 18.0;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1 mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 90 | Phase 3 | Belgium;Spain;Netherlands;Germany;Switzerland | ||
| 109 | NCT02379052 (ClinicalTrials.gov) | May 12, 2015 | 27/2/2015 | Study of Dupilumab in Adult Participants With Active Eosinophilic Esophagitis (EoE) | A Randomized, Double-Blind, Parallel, Placebo-Controlled Study of the Efficacy, Safety and Tolerability of Dupilumab in Adult Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Dupilumab;Drug: Placebo | Regeneron Pharmaceuticals | Sanofi | Completed | 18 Years | 65 Years | All | 47 | Phase 2 | United States |
| 110 | NCT02434705 (ClinicalTrials.gov) | April 2015 | 30/4/2015 | Food Antigen in Eosinophilic Esophagitis | Protocol for Food Antigen Staining in Esophageal Mucosa in Patients With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Other: Antigen (wheat base soy sauce) spray | Mayo Clinic | NULL | Active, not recruiting | 18 Years | 80 Years | All | 20 | United States | |
| 111 | NCT02019758 (ClinicalTrials.gov) | January 1, 2015 | 18/12/2013 | Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis | Budesonide Versus Fluticasone for Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Oral Viscous Budesonide;Drug: Fluticasone MDI;Drug: Placebo slurry;Drug: Placebo inhaler | University of North Carolina, Chapel Hill | National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | Completed | 16 Years | 80 Years | All | 129 | Phase 4 | United States |
| 112 | NCT02353078 (ClinicalTrials.gov) | January 2015 | 26/1/2015 | The Effect of Sucralfate Slurry in Patients With Eosinophilic Esophagitis | The Effect of Sucralfate Slurry on Dilated Intercellular Spaces, Tight Junctions, Mucosal Impedance and Mucosal Activity in Patients With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Sucralfate;Procedure: Intraluminal Impedance;Device: Intraluminal Impedance | Mayo Clinic | NULL | Completed | 18 Years | 80 Years | All | 3 | Early Phase 1 | United States |
| 113 | NCT02371941 (ClinicalTrials.gov) | December 2014 | 11/2/2015 | Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis | A Randomized, Double-blind, Placebo-controlled Study of the Use of Oral Cromolyn Sodium for the Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: oral cromolyn sodium;Drug: Placebo | University of Tennessee | NULL | Completed | 2 Years | 18 Years | All | 16 | Phase 4 | United States |
| 114 | NCT02314455 (ClinicalTrials.gov) | September 2014 | 10/11/2014 | Esophageal Absorption in EoE | Esophageal Absorption in Eosinophilic Esophagitis | Eosinophilic Esophagitis | Other: D-xylose | Mayo Clinic | NULL | Terminated | 18 Years | 80 Years | Both | 14 | N/A | United States |
| 115 | NCT02098473 (ClinicalTrials.gov) | August 31, 2014 | 25/3/2014 | Dose Ranging Study of RPC4046 in Eosinophilic Esophagitis | A Phase2, Multi-Center, Multi-national, Randomized, Double-blind, Placebo-controlled Parallel-group Clinical Trial to Evaluate the Efficacy and Safety of RPC4046 in Adult Subjects With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: RPC4046;Drug: Placebo | Celgene | NULL | Completed | 18 Years | 65 Years | All | 100 | Phase 2 | United States;Canada;Switzerland |
| 116 | NCT02113267 (ClinicalTrials.gov) | April 2014 | 10/4/2014 | Mometasone-furoate for Treatment of Eosinophilic Esophagitis - a Randomized Placebo Controlled Study. | Treatment of Eosinophilic Esophagitis With Mometason Furoat Aerosol: a Randomised, Placebo-controled Phase II Study for Evaluation of Treatment Effect on Group Level Including Symtom Questionnaires | Eosinophilic Esophagitis | Drug: Mometasone furoate;Drug: Placebo | Mogens Bove | Vastra Gotaland Region | Terminated | 18 Years | N/A | All | 40 | Phase 2 | Sweden |
| 117 | NCT02058537 (ClinicalTrials.gov) | February 2014 | 4/2/2014 | Bethanechol for Eosinophilic Esophagitis | Bethanechol for Treatment of Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis (EoE) | Drug: Bethanechol | University of Iowa | NULL | Terminated | 18 Years | 75 Years | All | 2 | Phase 2 | United States |
| 118 | NCT02125851 (ClinicalTrials.gov) | January 2014 | 21/2/2014 | Comparison of Esophageal Clearance Times of Oral Budesonide Preparations | Comparison of Esophageal Clearance Times of Oral Budesonide Preparations | Eosinophilic Esophagitis | Other: Xanthan Gum;Other: Honey | Walter Reed National Military Medical Center | NULL | Completed | 18 Years | 75 Years | Both | 24 | N/A | United States |
| 119 | EUCTR2012-005842-39-SE (EUCTR) | 20/12/2013 | 05/11/2013 | Treatment of patients with eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study | Treatment of eosinophilic esophagitis with mometason furoat aerosol: a randomised, placebo-controled phase II study for evaluation of treatment effect on group level including symtom questionnaires | Eosinphilic Esophagitis;Therapeutic area: Diseases [C] - Ear, nose and throat diseases [C09] | Trade Name: Nasonex | NU-sjukvården, Norra Älvsborgs Länssjukhus | NULL | Not Recruiting | Female: yes Male: yes | 60 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Sweden | ||
| 120 | NCT01808196 (ClinicalTrials.gov) | October 10, 2013 | 30/1/2013 | Testing Effectiveness of Losartan in Patients With EoE With or Without a CTD | A Preliminary, Open-label Trial of Losartan Potassium in Participants With Eosinophilic Esophagitis (EoE) With or Without a Connective Tissue Disorder. | Eosinophilic Esophagitis;Connective Tissue Disorders | Drug: Losartan Potassium | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 5 Years | 21 Years | All | 6 | Phase 2 | United States |
| 121 | NCT01929824 (ClinicalTrials.gov) | August 2013 | 14/8/2013 | Nasal Nitric Oxide Levels in Eosinophilic Esophagitis (EoE) | A Pilot Study: Nasal Nitric Oxide Levels in Eosinophilic Esophagitis. | Eosinophilic Esophagitis | Other: Oral Nitric Oxide testing | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 50 | United States | |
| 122 | NCT01821898 (ClinicalTrials.gov) | July 9, 2013 | 27/3/2013 | Eosinophilic Esophagitis Clinical Therapy Comparison Trial | Eosinophilic Esophagitis Clinical Therapy Comparison Trial | Eosinophilic Esophagitis | Drug: Oral Budesonide;Other: Elimination diet | Baylor College of Medicine | NULL | Terminated | 3 Years | 17 Years | All | 5 | Phase 2 | United States |
| 123 | NCT01814059 (ClinicalTrials.gov) | March 7, 2013 | 15/3/2013 | Sirolimus for Eosinophil-Associated Gastrointestinal Disorders | A Phase 1, Open-Label Study of Sirolimus in Eosinophil-Associated Gastrointestinal Disorders | Eosinophilic Gastroenteritis;Eosinophilic Esophagitis | Drug: sirolimus | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Terminated | 18 Years | 65 Years | All | 4 | Phase 1 | United States |
| 124 | NCT01865825 (ClinicalTrials.gov) | March 2013 | 23/5/2013 | Proton Pump Inhibitor (PPI) Responsive Eosinophilic Esophagitis EoE: Gastroesophageal Reflux Disease (GERD) or Eosinophilic Esophagitis (EoE)? | PPI Responsive Esophageal Eosinophilia: GERD or Eosinophilic Esophagitis? | Erosive Esophagitis | Radiation: Esophageal Barium Xray | Mayo Clinic | NULL | Completed | 18 Years | N/A | All | 20 | N/A | United States |
| 125 | NCT01846962 (ClinicalTrials.gov) | November 2012 | 30/4/2013 | Dietetic Versus Topical Steroids for Pediatric Eosinophilic Esophagitis | COMPARISON OF TREATMENT FOR PEDIATRIC EOSINOPHILIC ESOPHAGITIS: A RANDOMIZED CLINICAL TRIAL (DIETETIC Versus TOPICAL STEROIDS) | Eosinophilic Esophagitis | Drug: Budesonide;Drug: Fluticasone;Behavioral: six-foods elimination diet;Drug: Oral Viscous Budesonide (OVB) | Azienda Policlinico Umberto I | NULL | Completed | 6 Months | 18 Years | All | 64 | Phase 4 | Italy |
| 126 | NCT01685034 (ClinicalTrials.gov) | October 2012 | 5/9/2012 | Allergy Immunotherapy in the Management of Eosinophilic Esophagitis | Evaluation of the Clinical, Endoscopic and Histologic Effects of Environmental Allergy Immunotherapy in the Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Biological: Allergy immunotherapy (allergy shots) | United States Naval Medical Center, San Diego | NULL | Withdrawn | 18 Years | N/A | Both | 0 | N/A | NULL |
| 127 | NCT01642212 (ClinicalTrials.gov) | July 23, 2012 | 13/7/2012 | OBS in Adolescent and Adults With EOE: A Phase II, Randomized, Double-Blind, Placebo Controlled, Study With an Open Label Extension | Oral Budesonide Suspension (OBS) in Adolescent and Adult Subjects (11-40 Years of Age)With Eosinophilic Esophagitis: A Phase II, Randomized, Double-Blind, Placebo-Controlled Study With an Open Label Extension | Eosinophilic Esophagitis (EoE) | Drug: Oral Budesonide Suspension (MB-9);Drug: Placebo | Shire | NULL | Completed | 11 Years | 40 Years | All | 93 | Phase 2 | United States |
| 128 | NCT01479231 (ClinicalTrials.gov) | March 2012 | 22/11/2011 | Predictors of Proton Pump Inhibitor (PPI) Response in Eosinophilic Esophagitis | Predictors of PPI Response in Eosinophilic Esophagitis | Gastroesophageal Reflux Disease;Eosinophilic Esophagitis;Dysphagia | Drug: dexlansoprazole | Mayo Clinic | NULL | Withdrawn | 18 Years | 80 Years | Both | 0 | Phase 1/Phase 2 | United States |
| 129 | EUCTR2009-016692-29-BE (EUCTR) | 20/02/2012 | 24/11/2011 | A study to investigate the efficacy and tolerance of budesonide tablets and suspension in patients suffering from esophagitis over a 14 day period | Double-blind, double-dummy, randomized, placebo-controlled, phase IIa study on the efficacy and tolerability of a 14-day treatment with budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in patients with eosinophilic esophagitis - Budesonide effervescent tablets vs. viscous budesonide suspension vs. placebo in EE | Active eosinophilic esophagitis MedDRA version: 14.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: 1mg budesonide effervescent tablet for orodispersible use Product Code: BUET 1mg INN or Proposed INN: BUDESONIDE Product Name: 2mg budesonide effervescent tablet for orodispersible use Product Code: BUET 2mg INN or Proposed INN: BUDESONIDE Product Name: Budesonide [0.4mg/ml] viscous suspension Product Code: BUU 0.4mg/ml INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Not Recruiting | Female: yes Male: yes | 100 | Phase 2 | Belgium;Germany;Switzerland | ||
| 130 | NCT01498497 (ClinicalTrials.gov) | January 2012 | 16/12/2011 | A Six Month, Safety Follow-up Study in Eosinophilic Esophagitis Subjects Who Completed Study PR-021 | Six Month Safety Follow-up Study for PR-021 [Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Eosinophilic Esophagitis Subjects] | Eosinophilic Esophagitis | Drug: EUR-1100;Drug: Placebo | Forest Laboratories | NULL | Completed | 12 Years | 55 Years | All | 14 | Phase 1/2 | United States |
| 131 | NCT01702701 (ClinicalTrials.gov) | January 2012 | 4/10/2012 | Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone | Eosinophilic Esophagitis Treatment: Montelukast vs Fluticasone | Eosinophilic Esophagitis;Dysphagia | Drug: Montelukast;Drug: Fluticasone | Medical College of Wisconsin | NULL | Withdrawn | 18 Years | N/A | All | 0 | Phase 3 | United States |
| 132 | NCT01458418 (ClinicalTrials.gov) | December 2011 | 18/10/2011 | A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children | A Trial of Montelukast for Maintenance Therapy of Eosinophilic Esophagitis in Children | Eosinophilic Esophagitis | Drug: Montelukast;Other: placebo;Drug: 5 mg Montelukast | Children's Mercy Hospital Kansas City | NULL | Terminated | 2 Years | 17 Years | All | 4 | N/A | United States |
| 133 | NCT01386112 (ClinicalTrials.gov) | September 2011 | 28/6/2011 | Safety and Tolerability Study of Oral EUR-1100 to Treat Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Placebo-controlled, Safety and Tolerability Phase 1/2a Study of Two Dosing Regimens of EUR-1100 for Oral Use, in Subjects With Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis | Drug: EUR-1100;Drug: placebo | Aptalis Pharma | NULL | Completed | 12 Years | 55 Years | Both | 24 | Phase 1/Phase 2 | United States |
| 134 | NCT02280616 (ClinicalTrials.gov) | June 2011 | 29/10/2014 | Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Eosinophilic Esophagitis | Double-blind, Double-dummy, Randomized, Placebo-controlled, Phase IIa Study on the Efficacy and Tolerability of a 14-day Treatment With Budesonide Effervescent Tablets vs. Viscous Budesonide Suspension vs. Placebo in Patients With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: low dose budesonide tablet;Drug: high dose budesonide tablet;Drug: high dose budesonide suspension;Drug: Placebo | Dr. Falk Pharma GmbH | NULL | Completed | 18 Years | 75 Years | Both | 76 | Phase 2 | Germany |
| 135 | NCT01624129 (ClinicalTrials.gov) | January 2011 | 8/2/2011 | New Serological Markers for Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Fluticasone | Technische Universität München | NULL | Recruiting | 18 Years | 80 Years | Both | 20 | N/A | Germany | |
| 136 | NCT01170234 (ClinicalTrials.gov) | August 2010 | 23/7/2010 | Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis | Exhaled Nitric Oxide as a Biomarker of Disease Activity in Eosinophilic Esophagitis | Eosinophilic Esophagitis | Device: NIOX MINO® Airway Inflammation Monitor | Tufts Medical Center | NULL | Completed | 7 Years | 65 Years | All | 14 | United States | |
| 137 | NCT01056783 (ClinicalTrials.gov) | August 2010 | 25/1/2010 | Proof of Concept Study of OC000459 in Eosinophilic Esophagitis | A Randomized, Placebo-controlled, Double-blind, Single-centre Proof-of-concept Study of OC000459 in Adult Patients With Active Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: OC000459;Drug: Placebo | Oxagen Ltd | NULL | Completed | 18 Years | 75 Years | Both | 26 | Phase 2 | Switzerland |
| 138 | NCT01016223 (ClinicalTrials.gov) | March 2010 | 18/11/2009 | A Randomized Double Blind Placebo Controlled Study of the Effect of Swallowed Beclomethasone Dipropionate on Inflammatory Markers in Adult Patients With Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Beclomethasone dipropionate;Drug: placebo | Penn State University | NULL | Completed | 18 Years | 65 Years | Both | 20 | Phase 1 | United States | |
| 139 | NCT02038894 (ClinicalTrials.gov) | December 2009 | 1/5/2013 | Comparing Anesthetic Techniques in Children Having Esophagogastroduodenoscopies | Comparison Of Different Anesthetic Techniques In Children Undergoing Esophagogastroduodenoscopies | Eosinophilic Esophagitis | Drug: Intubated with Sevoflurane (IS);Drug: Intubated with Propofol (IP);Drug: Zofran - no intubation;Drug: Propofol | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 1 Year | 12 Years | All | 179 | N/A | United States |
| 140 | NCT01022970 (ClinicalTrials.gov) | November 2009 | 25/11/2009 | Efficacy and Safety of QAX576 in Patients With Eosinophilic Esophagitis | A Double Blinded Randomized Placebo-controlled Trial of Intravenous QAX576 in the Treatment of Eosinophilic Esophagitis (EoE) | Eosinophilic Esophagitis | Drug: QAX576 placebo;Drug: QAX576 | Novartis Pharmaceuticals | NULL | Completed | 18 Years | 50 Years | All | 25 | Phase 2 | United States |
| 141 | NCT00961233 (ClinicalTrials.gov) | October 2009 | 14/8/2009 | Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE) | Topical Budesonide Treatment for Eosinophilic Esophagitis (EoE): Esophageal Medication Distribution, Treatment Response, and Effect on the Adrenal Axis. | Eosinophilic Esophagitis | Drug: inhaled/swallowed budesonide;Drug: viscous/swallowed budesonide | University of North Carolina, Chapel Hill | AstraZeneca | Completed | 18 Years | N/A | All | 25 | N/A | United States |
| 142 | NCT01040598 (ClinicalTrials.gov) | June 2009 | 27/12/2009 | Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model | Identifying Responders to Xolair (Omalizumab) Using Eosinophilic Esophagitis as a Disease Model | Eosinophilic Esophagitis | Biological: Omalizumab | O & O Alpan LLC | Genentech, Inc. | Completed | 12 Years | 76 Years | Both | 19 | Phase 1 | United States |
| 143 | NCT00762073 (ClinicalTrials.gov) | January 8, 2009 | 29/9/2008 | Dose-Ranging Study of Oral Viscous Budesonide in Pediatrics With Eosinophilic Esophagitis | Oral Viscous Budesonide Suspension (MB-7) in Subjects With Eosinophilic Esophagitis: A Randomized, Placebo-Controlled, Dose-Ranging Study in Children and Adolescents | Eosinophilic Esophagitis (EoE) | Drug: budesonide;Drug: placebo | Shire | NULL | Completed | 2 Years | 18 Years | All | 82 | Phase 2 | United States |
| 144 | NCT00880906 (ClinicalTrials.gov) | August 2008 | 25/8/2008 | Study of the Efficiency of Esophageal Dilation on Patient With Eosinophilic Esophagitis | Prospective, Single-Blinded, Randomized Controlled Trial With Sham Comparing Standard Therapy With or Without Esophageal Dilatation in Patients With Eosinophilic Esophagitis | Suspected Eosinophilic Esophagitis | Procedure: Esophageal dilation;Drug: Steroid and Proton Pump Inhibitor Therapy | Vanderbilt University | Takeda | Completed | 18 Years | 75 Years | All | 50 | N/A | United States |
| 145 | NCT00635089 (ClinicalTrials.gov) | July 2008 | 6/3/2008 | Open-Label Extension Study of Reslizumab in Pediatric Subjects With Eosinophilic Esophagitis | An Open-Label Safety and Efficacy Study of Reslizumab (CTx55700) for the Treatment of Pediatric Subjects With Eosinophilic Esophagitis Who Completed Study Res-5-0002 | Eosinophilic Esophagitis | Drug: reslizumab | Ception Therapeutics | Cephalon | Completed | 5 Years | N/A | All | 190 | Phase 3 | United States;Canada |
| 146 | NCT00728481 (ClinicalTrials.gov) | May 2008 | 15/7/2008 | The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis | The Role Of Gastroesophageal Reflux Disease (GERD) in Eosinophilic Esophagitis | Eosinophilic Esophagitis;Gastroesophageal Reflux Disease;EE;GERD | Drug: Esomeprazole;Drug: Budesonide | Mayo Clinic | AstraZeneca | Completed | 18 Years | 80 Years | All | 51 | Phase 2/Phase 3 | United States |
| 147 | NCT00895817 (ClinicalTrials.gov) | April 2008 | 6/5/2009 | Fluticasone Versus Esomeprazole to Treat Eosinophilic Esophagitis | Comparison of Aerosolized Swallowed Fluticasone to Esomeprazole for the Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Swallowed fluticasone;Drug: Esomeprazole | Walter Reed Army Medical Center | NULL | Completed | 18 Years | N/A | All | 42 | N/A | United States |
| 148 | NCT00538434 (ClinicalTrials.gov) | March 2008 | 1/10/2007 | Efficacy and Safety Study of Reslizumab to Treat Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years | An Efficacy and Safety Study of Reslizumab (CTx55700) in the Treatment of Eosinophilic Esophagitis in Subjects Aged 5 to 18 Years | Eosinophilic Esophagitis | Biological: Reslizumab;Other: Saline | Ception Therapeutics | NULL | Completed | 5 Years | 18 Years | All | 227 | Phase 2/Phase 3 | United States;Canada |
| 149 | NCT00638456 (ClinicalTrials.gov) | February 2008 | 12/3/2008 | Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis | Use of Topical Budesonide in the Treatment of Eosinophilic Esophagitis, a Randomized Clinical Trial | Eosinophilic Esophagitis | Drug: Budesonide plus Prevacid;Drug: placebo plus Prevacid | Ranjan Dohil | Meritage Pharma, Inc. | Completed | 1 Year | N/A | All | 32 | Phase 2 | United States |
| 150 | NCT01404832 (ClinicalTrials.gov) | October 2007 | 27/7/2011 | The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors | The Frequency of Eosinophilic Esophagitis in Patients With Heartburn That is Refractory to Proton Pump Inhibitors | Gastroesophageal Reflux Disease;Eosinophilic Esophagitis | Drug: Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms | Dallas VA Medical Center | TAP Pharmaceutical Products Inc. | Terminated | 18 Years | N/A | All | 102 | Phase 4 | United States |
| 151 | NCT00523354 (ClinicalTrials.gov) | August 2007 | 30/8/2007 | Off Label Use of Infliximab in Adult Patients With Severe Eosinophilic Esophagitis | Phase 2 Proof-of-Concept Study to Analyze the Efficacy of in TNF-Alpha Blockade in Adult Patients With Severe, Corticosteroid-Dependent Eosinophilic Esophagitis | Esophagitis | Drug: Infliximab | Swiss EE Study Group | NULL | Completed | 18 Years | 70 Years | Both | Phase 2 | Switzerland | |
| 152 | NCT00511316 (ClinicalTrials.gov) | August 2007 | 1/8/2007 | Trial of Montelukast in Eosinophilic Esophagitis | A Randomized Placebo-Controlled Trial of Montelukast in Maintenance Therapy of Asymptomatic Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Montelukast/ Singulair;Drug: Placebo | Mayo Clinic | Merck Sharp & Dohme Corp.;Merck Sharp & Dohme Corp. | Completed | 18 Years | 100 Years | Both | 41 | Phase 1 | United States |
| 153 | NCT00426283 (ClinicalTrials.gov) | January 2007 | 22/1/2007 | A Study of Flovent in Patients With Eosinophilic Esophagitis | A Double Blinded, Randomized Trial of Swallowed 1760mcg Fluticasone Propionate Versus Placebo in the Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Flovent;Other: Placebo | Marc Rothenberg, MD | NULL | Completed | 3 Years | 30 Years | All | 42 | Phase 2 | United States |
| 154 | NCT00358449 (ClinicalTrials.gov) | September 11, 2006 | 27/7/2006 | Intravenous Mepolizumab In Children With Eosinophilic Esophagitis | A Randomized, Double-blind, Parallel Group Clinical Trial to Assess Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of Intravenous Mepolizumab (SB240563)(0.55mg/kg, 2.5mg/kg or 10mg/kg) in Pediatric Subjects With Eosinophilic Esophagitis, Aged 2 to 17 Years (Study MEE103219) | Oesophagitis, Eosinophilic | Drug: mepolizumab | GlaxoSmithKline | NULL | Completed | 2 Years | 17 Years | All | 84 | Phase 2 | United States;Australia;Canada;United Kingdom |
| 155 | EUCTR2005-006074-10-GB (EUCTR) | 15/06/2006 | 07/02/2006 | A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis | A randomized, double-blind, parallel group clinical trial to assess safety, tolerability, pharmacokinetics, and pharmacodynamics of intravenous mepolizumab (SB240563) (0.55mg/kg, 2.5mg/kg or 10mg/kg) in pediatric subjects with eosinophilic esophagitis, aged 2 to 17 years - Mepolizumab in paediatric eosinophilic oesophagitis | Eosinophilic oesophagitis | Product Name: Mepolizumab Product Code: SB-240563 INN or Proposed INN: Mepolizumab | GlaxoSmithKline Research & Development Ltd. | NULL | Not Recruiting | Female: yes Male: yes | 72 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | United Kingdom | ||
| 156 | NCT00271349 (ClinicalTrials.gov) | December 2005 | 29/12/2005 | Budesonide for Eosinophilic Esophagitis | Budesonide for Eosinophilic Esophagitis: a Randomized, Placebo-controlled, Double-blind Treatment Study | Eosinophilic Esophagitis | Drug: Budesonide | Swiss EE Study Group | NULL | Completed | 14 Years | 70 Years | Both | 28 | Phase 2 | Switzerland |
| 157 | NCT00275561 (ClinicalTrials.gov) | November 2005 | 10/1/2006 | Topical Steroid Treatment for Eosinophilic Esophagitis | A Randomized Placebo-controlled Trial of Swallowed Fluticasone in Treatment of Eosinophilic Esophagitis | Eosinophilic Esophagitis | Drug: Fluticasone;Drug: Placebo | Mayo Clinic | NULL | Completed | 18 Years | 60 Years | All | 42 | Phase 2 | United States |
| 158 | NCT00123630 (ClinicalTrials.gov) | November 2005 | 21/7/2005 | A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab | A Pilot Study of the Treatment of Eosinophilic Esophagitis With Omalizumab | Esophagitis | Drug: omalizumab;Drug: Placebo | University of Utah | Novartis Pharmaceuticals | Completed | 12 Years | 60 Years | All | 30 | Phase 2 | United States |
| 159 | NCT00148603 (ClinicalTrials.gov) | September 2005 | 6/9/2005 | Montelukast in the Treatment of Duodenal Eosinophilia | Montelukast in the Treatment of Duodenal Eosinophilia in Children With Dyspepsia: Effect on Eosinophil Density and Activation in Relation to Pharmacokinetics | Eosinophilic Gastroenteritis;Dyspepsia | Drug: montelukast | Children's Mercy Hospital Kansas City | Merck Sharp & Dohme Corp. | Completed | 8 Years | 17 Years | Both | 24 | N/A | United States |
| 160 | NCT00123656 (ClinicalTrials.gov) | August 2004 | 21/7/2005 | Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis | Comparison of Esomeprazole to Aerosolized, Swallowed Fluticasone for Eosinophilic Esophagitis | Esophagitis | Drug: esomeprazole;Drug: fluticasone | University of Utah | American Society for Gastrointestinal Endoscopy | Completed | 18 Years | 80 Years | Both | 30 | Phase 2 | United States |
| 161 | NCT00084097 (ClinicalTrials.gov) | June 2, 2004 | 5/6/2004 | Omalizumab to Treat Eosinophilic Gastroenteritis | Pilot Study of Omalizumab in Eosinophilic Gastroenteritis | Gastroenteritis | Drug: Omalizumab | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | 12 Years | 76 Years | All | 30 | Phase 2 | United States |
| 162 | NCT00266578 (ClinicalTrials.gov) | October 2002 | 15/12/2005 | A Study Comparing Swallowed Flovent and Placebo in Patients With Eosinophilic Disorders | Effect of Swallowed Fluticasone Propionate on Eosinophilic Esophagitis; A Prospective, Randomized, Placebo-Controlled Trial | Eosinophilic Esophagitis | Drug: Fluticasone Propionate | Marc Rothenberg | NULL | Completed | 3 Years | 30 Years | Both | 30 | Phase 3 | United States |
| 163 | NCT00266565 (ClinicalTrials.gov) | December 2001 | 15/12/2005 | Anti-Interleukin-5 (IL-5) Study for Hypereosinophilic Syndrome | A Phase I/II Study of the Effect of Intravenous Anti-IL-5 (Mepolizumab) SB 240563 on the Outcome and Management of Hypereosinophilic Syndromes | Hypereosinophilic Syndromes;Eosinophilic Gastroenteritis;Churg-Strauss Syndrome;Eosinophilic Esophagitis | Drug: Mepolizumab | Children's Hospital Medical Center, Cincinnati | NULL | Completed | 18 Years | 65 Years | All | 24 | Phase 1/Phase 2 | United States |
| 164 | NCT00017862 (ClinicalTrials.gov) | June 2001 | 15/6/2001 | Anti-Interleukin-5 Antibody to Treat Hypereosinophilic Syndrome | A Pilot Phase II Study of the Efficacy of Humanized Anti-IL5 Antibody (SCH55700) in Reducing Eosinophilia in Patients With Hypereosinophilic Syndrome or Eosinophilic Gastroenteritis Refractory to or Intolerant of Conventional Therapy | Hypereosinophilic Syndrome | Drug: SCH55700 | National Institute of Allergy and Infectious Diseases (NIAID) | NULL | Completed | N/A | N/A | Both | 10 | Phase 2 | United States |
| 165 | EUCTR2014-002465-30-IT (EUCTR) | 24/06/2014 | Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis. | Spontaneous study on the efficacy and safety of an oral viscous suspension of budesonide administered to children affected by eosinophilic esophagitis. | Eosinophilic Esophagitis;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide Product Code: Budesonide INN or Proposed INN: BUDESONIDE | Dip. Pediatria UOC Gastroenterologia ed Epatologia Pediatrica | NULL | NA | Female: yes Male: yes | Phase 2 | Italy | ||||
| 166 | EUCTR2020-004336-16-BE (EUCTR) | 07/05/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | NA | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | |||
| 167 | EUCTR2017-003737-29-DE (EUCTR) | 17/12/2018 | Double-blind (neither physician nor patient knows of the actual treatment which can be with or without active substance), randomized (patient will be allocated to a certain treatment group by chance), placebo-controlled (one of the treatment groups receives medication without active substance), phase II/III study on the efficacy and tolerability of oral budesonide suspension in comparison with placebo in children and adolescents with eosinophilic esophagitis | Double-blind, randomized, placebo-controlled, Phase II/III trial on the efficacy and tolerability of treatment with budesonide oral suspension vs. placebo in children and adolescents with eosinophilic esophagitis - Budesonide oral suspension vs. placebo in pediatric eosinophilic esophagitis | Active eosinophilic esophagitis and maintenance of remission in eosinophilic esophagitis MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856 ;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Budesonide oral suspension [0.2 mg/ml] INN or Proposed INN: BUDESONIDE | Dr. Falk Pharma GmbH | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 75 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): yes Therapeutic use (Phase 4): no | Portugal;Greece;Spain;Israel;Netherlands;Germany;United Kingdom | |||
| 168 | EUCTR2020-004336-16-AT (EUCTR) | 22/03/2021 | A study to evaluate the efficacy and safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A Phase 3, Multi-Center, Multi-National, Randomized, Double-Blind, Placebo-Controlled Induction and Maintenance Study to Evaluate the Efficacy and Safety of CC-93538 in Adult and Adolescent Subjects with Eosinophilic Esophagitis | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | NA | Female: yes Male: yes | 399 | Phase 3 | United States;Portugal;Czechia;Spain;Austria;Israel;United Kingdom;Switzerland;Italy;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan;New Zealand | |||
| 169 | EUCTR2020-004335-24-AT (EUCTR) | 18/11/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | NA | Female: yes Male: yes | 259 | Phase 3 | United States;Portugal;Spain;Austria;Israel;United Kingdom;Italy;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | |||
| 170 | EUCTR2020-004335-24-BE (EUCTR) | 24/12/2021 | A study to evaluate the long-term safety of CC-93538 in adult and adolescent patients who have eosinophilic esophagitis | A PHASE 3, MULTICENTER, MULTINATIONAL, OPEN-LABEL EXTENSION STUDY TO EVALUATE THE LONG-TERM SAFETY OF CC-93538 IN ADULT AND ADOLESCENT SUBJECTS WITH EOSINOPHILIC ESOPHAGITIS | EOSINOPHILIC ESOPHAGITIS MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: Cendakimab Product Code: CC-93538 INN or Proposed INN: Cendakimab | Celgene International II Sàrl | NULL | NA | Female: yes Male: yes | 259 | Phase 3 | Portugal;Spain;Austria;Israel;United Kingdom;Italy;United States;Switzerland;Canada;Argentina;Belgium;Poland;Australia;Germany;Japan | |||
| 171 | EUCTR2019-002871-32-PL (EUCTR) | 15/01/2020 | A Study of Benralizumab in Patients with Eosinophilic Esophagitis | A Multicenter, Randomized, Double-blind, Parallel-group, Placebo-controlled Study to Investigate the Use of Benralizumab for Eosinophilic Esophagitis (MESSINA) - MESSINA | Eosinophilic Esophagitis (EoE) MedDRA version: 20.1;Level: LLT;Classification code 10064220;Term: Eosinophilic esophagitis;System Organ Class: 100000004856;Therapeutic area: Not possible to specify | Product Name: benralizumab Product Code: MEDI-563 INN or Proposed INN: benralizumab Other descriptive name: benralizumab | AstraZeneca AB | NULL | NA | Female: yes Male: yes | 170 | Phase 3 | France;United States;Canada;Spain;Poland;Russian Federation;Israel;Netherlands;Germany;United Kingdom;Italy;Japan |