Clinical trials: Moderate-to-severe Inflammatory Bowel Disease
Crohn's Disease
Certolizumab Pegol for Treatment of Adult Greek Patients With Moderate to Severe Crohn's Disease Who Failed Infliximab
An open-label multi-center single-cohort study to assess the safety and efficacy of certolizumab pegol for the treatment of signs and symptoms of active Crohn's disease in Greek patients who have previously responded to…
- Trial name
- NCT00307931
- Testing
- Certolizumab pegol
- Where
- 5 sites in Greece
- Volunteers
- 16 people
- Sponsor
- UCB Pharma
Colitis, Ulcerative
A Study Investigating Oral Ozanimod (RPC1063) in Pediatric Participants With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the effectiveness and safety of ozanimod (RPC1063) in achieving and maintaining clinical remission.
- Trial name
- NCT05076175
- Testing
- Ozanimod
- Where
- 91 sites in United States, Australia and 11 more
- Volunteers
- 120 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with…
- Trial name
- NCT00408629
- Testing
- adalimumab
- Where
- 108 sites in United States, Argentina and 16 more
- Volunteers
- 518 people
- Sponsor
- Abbott
Ulcerative Colitis
Evaluation of Histologic and Endoscopic Remission Induced by Infliximab in Moderate to Severe Ulcerative Colitis
The aim of this study is to assess the relationship between microscopic Geboes index of inflammation and clinical course of ulcerative colitis in patients treated with infliximab.
- Trial name
- HERICA (NCT01408810)
- Testing
- Infliximab
- Where
- Portugal
- Volunteers
- 21 people
- Sponsor
- Grupo de Estudo da Doença Inflamatória Intestinal
Crohn's Disease
Efficacy and Safety Study of Ontamalimab as Induction Therapy in Participants With Moderate to Severe Crohn's Disease (CARMEN CD 306)
The purpose of this study is to evaluate the efficacy and safety of Ontamalimab in inducing clinical remission and endoscopic response in participants with moderate to severe Crohn's Disease.
- Trial name
- CARMEN CD 306 (NCT03566823)
- Testing
- Ontamalimab
- Where
- 145 sites in United States, Argentina and 18 more
- Volunteers
- 34 people
- Sponsor
- Shire
Ulcerative Colitis
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
- Trial name
- GEMINI I (NCT00783718)
- Testing
- vedolizumab
- Where
- 105 sites in United States, Canada and 1 more
- Volunteers
- 895 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Crohn Disease
A Study to Evaluate the Efficacy, Safety, and Drug Levels of Oral Ozanimod in Pediatric Participants With Moderately to Severely Active Crohn's Disease With an Inadequate Response to Conventional Therapy
The purpose of this study is to evaluate the efficacy, safety, drug levels, and drug effects of ozanimod in pediatric participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT05470985
- Testing
- Ozanimod
- Where
- 46 sites in United States, Australia and 7 more
- Volunteers
- 5 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Participants With Ulcerative Colitis
The purpose of this study is to evaluate if study drug mirikizumab is safe and effective compared to vedolizumab and placebo in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- LUCENT-ACT (NCT04469062)
- Testing
- Mirikizumab IV, Mirikizumab SC, Vedolizumab IV
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab With Adalimumab and Placebo in Participants With Moderate to Severe Ulcerative Colitis (UC) in Participants Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo and active-comparator controlled, multicenter study will investigate the efficacy and safety of etrolizumab in induction of remission in participants with moderately to severely active…
- Trial name
- HIBISCUS II (NCT02171429)
- Testing
- Adalimumab, Etrolizumab
- Where
- 90 sites in United States, Argentina and 17 more
- Volunteers
- 358 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis (UC)
A Study to Evaluate IBI112 in the Treatment of Moderate to Severe Active Ulcerative Colitis
To evaluate the efficacy of IBI112 induction therapy in patients with moderate and severe active Ulcerative Colitis (UC) to achieve clinical remission.
- Trial name
- NCT05377580
- Testing
- Period 2 IBI112 dose 3, Period 1 IBI112 dose 1, Period 1 IBI112 dose 2
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Innovent Biologics (Suzhou) Co. Ltd.
Ulcerative Colitis, Active Moderate, Ulcerative Colitis, Active Severe
Evaluation of Safety, Efficacy, Pharmacokinetic and Pharmacodynamic of Bertilimumab in Patients With Active Moderate to Severe Ulcerative Colitis
This is a randomized, double blind, placebo-controlled, parallel group multi-center study in adult participants with active moderate to severe UC.
- Trial name
- NCT01671956
- Testing
- Bertilimumab
- Where
- 6 sites in Israel
- Volunteers
- 32 people
- Sponsor
- Alexion Pharmaceuticals, Inc.
Inflammatory Bowel Disease, Crohn's Disease (CD)
Standardized Fecal Microbiota Transplantation for Crohn&Apos;s Diseases
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism.
- Trial name
- NCT01793831
- Testing
- FMT
- Where
- 2 sites in China
- Volunteers
- 800 people
- Sponsor
- The Second Hospital of Nanjing Medical University
Crohn Disease
A Safety and Efficacy Study of Infliximab (Remicade) in Patients With Moderate to Severe Active Crohn's Disease
This is a study of infliximab (Remicade) in subjects with Crohn's disease
- Trial name
- NCT00207662
- Volunteers
- 580 people
- Sponsor
- Centocor, Inc.
Ulcerative Colitis
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with…
- Trial name
- NCT01494857
- Testing
- Adalimumab
- Where
- 3 sites in Israel
- Volunteers
- 200 people
- Sponsor
- Clalit Health Services
Crohn's Disease
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
- Trial name
- NCT03945019
- Testing
- CT-P13 SC (Infliximab)
- Where
- 29 sites in United States, Belarus and 24 more
- Volunteers
- 396 people
- Sponsor
- Celltrion
Adult Patients With Moderately to Severely Active Ulcerative Colitis
A Phase 2 Clinical Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of HRS-7085 Tablets in Patients With Inflammatory Bowel Disease
This study is a randomized, double-blind, placebo-controlled Phase II clinical trial comprising screening period, treatment period, and follow-up period.
- Trial name
- NCT07229950
- Testing
- HRS-7085
- Where
- China
- Volunteers
- 48 people
- Sponsor
- Shandong Suncadia Medicine Co., Ltd.
Moderate to Severe Crohn's Disease
Rapidity of Response to Adalimumab Treatment in Patients With Crohn´s Disease
The purpose of this study is to evaluate the rapidity of onset of clinical response to adalimumab therapy in patients with luminal Crohn's disease.
- Trial name
- RAPIDA (NCT02148718)
- Testing
- adalimumab
- Volunteers
- 100 people
- Sponsor
- AbbVie
Crohn's Disease
Effect of ITF2357 on Mucosal Healing in Patients With Moderate-to-severe Active Crohn's Disease
Objectives: The primary objective of the study was to determine the ability of ITF2357, administered orally at the dose of 50 mg b.i.d.
- Trial name
- CD (NCT00792740)
- Testing
- ITF2357
- Where
- 10 sites in Belgium, Italy and 1 more
- Volunteers
- 51 people
- Sponsor
- Italfarmaco
Crohn's Disease
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
- Trial name
- NCT06430801
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 499 sites in United States, Australia and 45 more
- Volunteers
- 1,200 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- SUNSCAPE-2 (NCT07185009)
- Testing
- Duvakitug
- Where
- 171 sites in United States, Argentina and 29 more
- Volunteers
- 751 people
- Sponsor
- Sanofi