96. クローン病 Crohn disease Clinical trials / Disease details
臨床試験数 : 2,400 / 薬物数 : 1,391 - (DrugBank : 267) / 標的遺伝子数 : 170 - 標的パスウェイ数 : 215
| 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 | EUCTR2019-001866-14-IT (EUCTR) | 21/12/2021 | 12/10/2021 | Open-label Extension Study of Brazikumab in Crohn's Disease | An Open-label, Long-term Extension Study of Brazikumab in Participants With Moderately to Severely Active Crohn's Disease (INTREPID OLE) - INTREPID OLE | Moderately to Severely Active Crohn's Disease. MedDRA version: 20.0;Level: LLT;Classification code 10011402;Term: Crohn's disease (colon);System Organ Class: 100000004856;Therapeutic area: Diseases [C] - Digestive System Diseases [C06] | Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MED2070 Product Name: Brazikumab Product Code: [MEDI2070] INN or Proposed INN: ( L ) ASCORBATO DI CALCIO Other descriptive name: Anti-Interleukin-23 Immunoglobulin G2 (IgG2) Human Monoclonal Antibody; also referred to as MEDI2070 | ASTRAZENECA AB | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 150 | Phase 3 | United States;Czechia;Taiwan;Slovakia;Spain;Ukraine;Austria;Israel;Russian Federation;United Kingdom;Italy;India;France;Hungary;Canada;Poland;South Africa;Germany;Korea, Republic of | ||
| 2 | EUCTR2018-001895-39-HR (EUCTR) | 21/11/2019 | 20/01/2020 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 3 | EUCTR2018-001895-39-NL (EUCTR) | 27/09/2019 | 03/06/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Netherlands;Germany | ||
| 4 | EUCTR2018-001895-39-BG (EUCTR) | 05/09/2019 | 16/07/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders ;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Human pharmacology (Phase 1): no Therapeutic exploratory (Phase 2): yes Therapeutic confirmatory - (Phase 3): no Therapeutic use (Phase 4): no | Serbia;United States;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 5 | EUCTR2018-001895-39-CZ (EUCTR) | 06/06/2019 | 05/03/2019 | A phase 2 Dose-finding study of IMU-838 in patients with active Crohn’s disease | A phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding trial to evaluate the efficacy and safety of IMU-838 for treatment of patients with active Crohn’s disease with an option for open-label treatment extension (CALDOSE-2) - CALDOSE-2 | Crohn’s disease (CD) MedDRA version: 20.0;Level: PT;Classification code 10011401;Term: Crohn's disease;System Organ Class: 10017947 - Gastrointestinal disorders;Therapeutic area: Body processes [G] - Digestive System and Oral Physiological Phenomena [G10] | Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 Product Name: vidofludimus calcium Product Code: IMU-838 INN or Proposed INN: Vidofludimus calcium Other descriptive name: IM90838 | Immunic AG | NULL | Authorised-recruitment may be ongoing or finished | Female: yes Male: yes | 258 | Phase 2 | United States;Serbia;Slovenia;Spain;Ukraine;Russian Federation;United Kingdom;Czech Republic;Poland;Croatia;Romania;Bulgaria;Germany;Netherlands | ||
| 6 | NCT02704624 (ClinicalTrials.gov) | December 2016 | 24/2/2016 | Effects of Supplementation of Vitamin D in Patients With Crohn's Disease | The Impact of Serum Vitamin D and Calcium Levels on the Body Composition, Bone Mineral Density, Muscle Strength, Exercise Tolerance, Fatigue and Inflammatory Activity in Patients With Crohn's Disease: a Randomized Controlled Trial | Crohn Disease;Vitamin D Deficiency;Fatigue;Sarcopenia;Muscle Weakness;Disorder of Bone Density and Structure, Unspecified | Dietary Supplement: Vitamin D;Other: Placebo | Federal University of Juiz de Fora | Fundação de Amparo à Pesquisa do estado de Minas Gerais | Enrolling by invitation | 18 Years | 50 Years | All | 110 | Phase 4 | Brazil |
| 7 | NCT01735461 (ClinicalTrials.gov) | December 2012 | 22/11/2012 | Calcium Supplements Strategy for Kidney Stones Prevention in Crohn's Patients | Oral Calcium Supplementation, a Strategy to Reduce Kidney Stones in Crohn's Patients Living With a Small Bowel Resection | Kidney Calculi;Crohn's Disease | Dietary Supplement: Calcium Carbonate | University of British Columbia | University of Texas Southwestern Medical Center | Recruiting | 19 Years | N/A | All | 40 | N/A | Canada |
| 8 | NCT01215890 (ClinicalTrials.gov) | September 2010 | 5/10/2010 | Risedronate Therapy in the Treatment of Low Bone Mineral Density in Crohn's Disease | A Randomized, Data Collection Program To Determine the Efficacy and Safety of Risedronate (Actonel) Therapy Plus Calcium and Vitamin D Supplementation Versus Placebo Plus Calcium and Vitamin D Supplementation in the Treatment of Low Bone Mineral Density in Crohn's Disease Patients | Crohn's Disease;Low Bone Mineral Density | Drug: risedronate;Drug: placebo | University of Alberta | NULL | Completed | 18 Years | N/A | Both | Phase 4 | Canada | |
| 9 | NCT00427804 (ClinicalTrials.gov) | January 2007 | 25/1/2007 | Tumor Necrosis Factor Decreases Vitamin D Dependant Calcium Absorption | Tumor Necrosis Factor-a Induces Vitamin D Resistance in Small Intestinal Calcium Absorption | Rheumatoid Arthritis;Crohn's Disease | Drug: calcitriol | Atlanta VA Medical Center | Emory University | Completed | 18 Years | 50 Years | Male | 9 | N/A | United States |