Clinical trials: Moderate to Severe Crohn's Disease
Ulcerative Colitis, Crohn's Disease
A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD).
- Trial name
- NCT04738942
- Testing
- Vedolizumab
- Where
- 20 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Takeda
Crohn's Disease
Safety and Efficacy of Andecaliximab in Participants With Moderately to Severely Active Crohn's Disease
This study will primarily evaluate the safety and efficacy of andecaliximab in adults with active Crohn's disease. The study will consist of a Double-Blind Phase of 8 weeks followed by an Open-Label Extension.
- Trial name
- NCT02405442
- Testing
- Andecaliximab
- Where
- 74 sites in United States, Australia and 11 more
- Volunteers
- 187 people
- Sponsor
- Gilead Sciences
Crohn's Disease
A Study of Mirikizumab (LY3074828) in Participants With Crohn's Disease
The reason for this study is to see if the study drug mirikizumab is safe and effective in participants with moderately to severely active Crohn's disease.
- Trial name
- VIVID-1 (NCT03926130)
- Testing
- Mirikizumab, Ustekinumab
- Where
- 580 sites in United States, Argentina and 32 more
- Volunteers
- 1,158 people
- Sponsor
- Eli Lilly and Company
Crohn Disease
Induction Study #1 of Oral Ozanimod as Induction Therapy for Moderately to Severely Active Crohn's Disease
This is a study to explore the effect of oral ozanimod as an induction treatment for participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT03440372
- Testing
- Ozanimod
- Where
- 408 sites in United States, Argentina and 33 more
- Volunteers
- 625 people
- Sponsor
- Celgene
Crohn's Disease
Efficacy and Safety Trial of RPC1063 for Moderate to Severe Crohn's Disease
The purpose is to determine whether RPC1063 is effective in the treatment of Crohn's disease.
- Trial name
- NCT02531113
- Testing
- RPC1063
- Where
- 28 sites in United States, Canada and 3 more
- Volunteers
- 69 people
- Sponsor
- Celgene
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
A Study to Investigate the Safety and Efficacy of CP-690,550 in Patients With Moderate to Severe Crohn's Disease
This study investigates safety and efficacy of CP-690,550 in adult patients with moderate to severe Crohn's disease. The study hypothesis is that at least one of the dose levels to be tested will be more effective than placebo…
- Trial name
- NCT00615199
- Testing
- CP-690,550
- Where
- 72 sites in United States, Belgium and 10 more
- Volunteers
- 139 people
- Sponsor
- Pfizer
Crohn Disease
Open-Label Extension and Safety Study for Participants With Crohn's Disease Previously Enrolled in the Etrolizumab Phase III Study GA29144
This open-label extension and safety monitoring study is composed of two parts: Part 1 will evaluate the long-term safety and efficacy of continued etrolizumab treatment in participants with moderately to severely active Crohn's…
- Trial name
- JUNIPER (NCT02403323)
- Testing
- Etrolizumab
- Where
- 287 sites in United States, Argentina and 31 more
- Volunteers
- 790 people
- Sponsor
- Hoffmann-La Roche
Crohn's Disease
Effect of Intravenous (IV) Vedolizumab on Mucosal Healing in Crohn's Disease
The purpose of this study is to evaluate endoscopic remission at Week 26 as assessed by ileocolonoscopy.
- Trial name
- NCT02425111
- Testing
- Vedolizumab
- Where
- 79 sites in United States, Belgium and 6 more
- Volunteers
- 101 people
- Sponsor
- Takeda
Ulcerative Colitis, Crohn's Disease
An Extension Study to Evaluate the Long-Term Safety and Tolerability of UTTR1147A in Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
This study will evaluate the long-term safety and tolerability of UTTR1147A in participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD), enrolling up to 320 participants from the parent studies: Phase…
- Trial name
- NCT03650413
- Testing
- UTTR1147A
- Where
- 57 sites in United States, Bulgaria and 12 more
- Volunteers
- 143 people
- Sponsor
- Genentech, Inc.
Crohn's Disease, Colitis
A Study to Evaluate the Safety and Efficacy of Ustekinumab Maintenance Therapy in Patients With Moderately to Severely Active Crohn's Disease (IM-UNITI)
The primary purpose of this study is to evaluate the efficacy and safety of 2 maintenance regimens of ustekinumab administered subcutaneously to patients with moderately to severely active Crohn's disease who responded to…
- Conditions
- Crohn's Disease, Colitis, IBD, Inflammatory Bowel Disease
- Trial name
- NCT01369355
- Testing
- Ustekinumab 90 mg SC q8w, Ustekinumab 130 mg IV, Ustekinumab 90 mg SC q12w
- Where
- 220 sites in United States, Australia and 24 more
- Volunteers
- 1,282 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Crohn's Disease Who Have Inadequately Responded to or Are Intolerant to Biologic Therapy
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo as induction therapy in participants with moderately and severely active Crohn's disease (CD).
- Trial name
- NCT03345836
- Testing
- Upadacitinib
- Where
- 428 sites in United States, Argentina and 46 more
- Volunteers
- 624 people
- Sponsor
- AbbVie
Crohn's Disease, Inflammatory Bowel Disease
An Open Label Safety and Tolerability Study of AIN457 in Patients With Moderate to Severe Crohn's Disease
This study will assess the safety and tolerability of AIN457 in patients with moderate to severe Crohn's disease who already participated and completed the core trial CAIN457A2202.
- Trial name
- NCT01009281
- Testing
- AIN457
- Where
- 5 sites in United States
- Volunteers
- 7 people
- Sponsor
- Novartis Pharmaceuticals
Crohn's Disease
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
The purpose of this study is to determine Efficacy, Pharmacokinetics, and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Crohn's Disease
- Trial name
- NCT00409682
- Testing
- Adalimumab
- Where
- 45 sites in United States, Belgium and 6 more
- Volunteers
- 192 people
- Sponsor
- Abbott
Crohn's Disease
Effectiveness and Safety in Patients With Crohn´s Disease in Clinical Routine
The purpose of this study was intended to evaluate the long-term safety and effectiveness of adalimumab in participants with Crohn's disease (CD) who are treated as recommended in the product label.
- Trial name
- NCT01083680
- Volunteers
- 4,107 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
Crohn's Disease, Inflammatory Bowel Disease
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction Therapy in Patients With Moderately to Severely Active Crohn's Disease (UNITI-2)
This study (UNITI-2) will compare the effects (both positive and negative) of an initial treatment with ustekinumab to a placebo over 8 weeks in patients with moderately to severely active Crohn's disease.
- Conditions
- Crohn's Disease, Inflammatory Bowel Disease, IBD, Colitis
- Trial name
- NCT01369342
- Testing
- Group 2 ustekinumab 130 mg, Group 3: ustekinumab approximately 6 mg/kg
- Where
- 220 sites in United States, Australia and 20 more
- Volunteers
- 640 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
Brodalumab (AMG 827) in Adults With Moderate to Severe Crohn's Disease
The study will examine the safety and effectiveness of brodalumab for the treatment of moderate to severe Crohn's disease. Participants will randomly assigned to receive either brodalumab or placebo (a lookalike liquid that…
- Trial name
- NCT01150890
- Testing
- Brodalumab
- Where
- 50 sites in United States, Australia and 6 more
- Volunteers
- 130 people
- Sponsor
- Amgen
Crohn's Disease
An Active Treatment Study to Induce Clinical Response and/or Remission With GSK1605786A in Subjects With Crohn's Disease
This is a multi-centre, randomised, double-blind, active treatment, parallel group induction study in subjects with moderately-to-severely active Crohn's disease.
- Trial name
- SHIELD-4 (NCT01536418)
- Testing
- GSK1605786A
- Where
- 227 sites in United States, Australia and 29 more
- Volunteers
- 255 people
- Sponsor
- GlaxoSmithKline
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
Efficacy and Safety of Two Treatment Algorithms in Adults With Moderate to Severe Crohn's Disease
The primary objective of this study was to demonstrate that tight control of disease activity, using stringent criteria based on Crohn's disease activity Index (CDAI), biomarkers (high sensitivity C-reactive protein [hs-CRP] and…
- Trial name
- CALM (NCT01235689)
- Testing
- Adalimumab, Prednisone, Azathioprine
- Volunteers
- 252 people
- Sponsor
- AbbVie (prior sponsor, Abbott)