DDrare: Database of Drug Development for Rare Diseases

Searched query = "Eosinophilic gastrointestinal disease", "Eosinophilic gastroenteritis", "Eosinophilic esophagitis", "Eosinophilic colitis", "Eosinophilic gastro-intestinal disorder", "EGID", "Neonatal food-protein induced enterocolitis", "N-FPIES"
The queries were searched in Public_title, Scientific_title, and Condition. Export date: 03/15/2021. Trials are sorted by Date_enrollment from most recent to oldest in the table.

Drug = 0.5 mg budesonide effervescent tablet for orodispersible use; 1 mg budesonide effervescent tablet for orodispersible use; 1mg budesonide effervescent tablet for orodispersible use; 2mg budesonide effervescent tablet for orodispersible use; 5 mg Montelukast; AK002; APT-1011; APT-1011 - 3 mg; Allergen; Allergy immunotherapy (allergy shots); Antolimab; BUDESONIDE; BUET 0.5 mg; BUET 1mg; BUET 2mg; BUU 0.4mg/ml; Barium; Beclomethasone dipropionate; Behavioral: six-foods elimination diet; Benralizumab; Bethanechol; Budesonide; Budesonide 0.5mg orodispersible tablet twice daily; Budesonide 1mg orodispersible tablet twice daily; Budesonide [0.4mg/ml] viscous suspension; Budesonide oral suspension; Budesonide oral suspension [0.2 mg/ml]; Budesonide plus Prevacid; CALY-002; Cromolyn; DUPILUMAB; Device: EsophaCap; Device: Intraluminal Impedance; Device: NIOX MINO® Airway Inflammation Monitor; Device: Novel Allergen-Specific Immune Signature Directed Approach to Dietary Elimination Therapy; Dexlansoprazole; Diagnostic Test: Barium Esophagram; Diagnostic Test: Bone Mineral Density (DEXA) scan; Diagnostic Test: Endoscopy while on study drug; Diagnostic Test: Height measurement; Diagnostic Test: Physical Examination and Questionnaires; Diagnostic Test: Retrospective evaluation of endoscopy prior to study drug; Diagnostic Test: Vitamin D Measurement; Dupilumab; Dupilumab (blinded); Dupilumab (open-label); Dupixent; ESO-101; EUR-1100; Esomeprazole; FLUTICASONE PROPIONATE; Famotidine; Florence 30 µg/mL; Florence 60 µg/mL; Florence 90 µg/mL; Flovent; Fluticasone; Fluticasone MDI; Fluticasone Propionate; Fluticasone Propionate, 800 mcg twice daily (post 4FED failure); Fluticasone Propionate, 880 mcg twice daily (after 6FED failure); Fluticasone Propionate, USP; Fluticasone propionate; Gold; High dose budesonide suspension; High dose budesonide tablet; Honey; Infliximab; Inhaled/swallowed budesonide; Intubated with Propofol (IP); Intubated with Sevoflurane (IS); Lansoprazole; Lirentelimab; Lirentelimab (AK002); Loratadine; Losartan; Losartan Potassium; Low dose budesonide tablet; MEDI-563; MOMETASONE FUROATE; MONITOR; Mepolizumab; Mepolizumab 100 mg; Mepolizumab 300 mg; Milk; Mometasone; Mometasone furoate; Montelukast; Montelukast/ Singulair; Nasonex; Nitric Oxide; OC000459; Omalizumab; Omeprazole; Omeprazole 20mg BID; Oral Budesonide; Oral Budesonide Suspension (MB-9); Oral Budesonide Suspension (OBS); Oral Viscous Budesonide; Oral Viscous Budesonide (OVB); Oral cromolyn sodium; Other: 1 Food Elimination Diet; Other: 1 Food Elimination Diet Therapy; Other: 4 Food Elimination Diet; Other: 4 Food Elimination Diet (post 1FED failure); Other: 6 Food Elimination Diet (after 1FED failure); Other: 6 Food Elimination Diet Therapy; Other: Antigen (wheat base soy sauce) spray; Other: Assessment of medication compliance; Other: D-xylose; Other: Elimination diet; Other: Honey; Other: Medication Compliance Phone Call; Other: Oral Nitric Oxide testing; Other: Saline; Other: Symptom Survey; Other: Xanthan Gum; Potassium; Procedure: Esophageal dilation; Procedure: Esophagogastroduodenoscopy; Procedure: Intraluminal Impedance; Propofol; QAX576; RPC4046; Radiation: Computerized Tomography scan; Radiation: Esophageal Barium Xray; Radiation: Planar Images; Radiation: Single Photon Emission Computed Tomography scans; Reslizumab; SB-240563; SCH55700; Sevoflurane; Sirolimus; Steroid and Proton Pump Inhibitor Therapy; Sucralfate; Swallowed fluticasone; Technetium Tc 99M; Technetium Tc 99m; Treat with lansoprazole 30 mg BID for 2 weeks, endoscopic examination with esophageal biopsy for patients with persistent symptoms; Viaskin Milk 500 mcg; Viscous/swallowed budesonide; Vitamin D; Vonoprazan; Wheat; Xanthan gum; Xylose; Zofran - no intubation

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	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	Recruiting	1 Year	11 Years	All	60	Phase 3	United States
2	NCT03678545 (ClinicalTrials.gov)	September 1, 2020	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	Not yet recruiting	12 Years	70 Years	All	40	Phase 2	United States
3	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	425	Phase 3	United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
4	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	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;Germany;Netherlands;Sweden
5	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
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
6	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
7	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
8	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	425	Phase 3	United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden
9	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
10	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]		Regeneron Pharmaceuticals, Inc.	NULL	Authorised-recruitment may be ongoing or finished			Female: yes Male: yes	425	Phase 3	Portugal;United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden
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
11	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	Recruiting	12 Years	N/A	All	425	Phase 3	United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom
12	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
13	EUCTR2018-000844-25-IT (EUCTR)		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]		Regeneron Pharmaceuticals, Inc.	NULL	NA			Female: yes Male: yes	425	Phase 3	Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden

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

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

Recruiting

1 Year

11 Years

All

Phase 3

United States

NCT03678545
(ClinicalTrials.gov)

September 1, 2020

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

Not yet recruiting

12 Years

70 Years

All

Phase 2

United States

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

425

Phase 3

United States;Portugal;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Germany;Netherlands;Sweden

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)

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;Germany;Netherlands;Sweden

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)

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

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

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)

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

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)

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

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)

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;Germany;Netherlands;Sweden

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)

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

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]

Regeneron Pharmaceuticals, Inc.

NULL

Authorised-recruitment may be ongoing or finished

Female: yes
Male: yes

425

Phase 3

Portugal;United States;Spain;Switzerland;United Kingdom;Italy;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden

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

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

Recruiting

12 Years

N/A

All

425

Phase 3

United States;Australia;Belgium;Canada;France;Germany;Italy;Netherlands;Spain;Sweden;United Kingdom

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

Phase 2

United States

EUCTR2018-000844-25-IT
(EUCTR)

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]

Regeneron Pharmaceuticals, Inc.

NULL

Female: yes
Male: yes

425

Phase 3

Portugal;United States;Spain;Italy;Switzerland;United Kingdom;France;Canada;Belgium;Australia;Denmark;Germany;Netherlands;Sweden