Clinical trials: Moderate-to-severe Inflammatory Bowel Disease
Crohn's Disease
A Study to Assess Adverse Events, Change in Disease Activity, and How Intravenous and Subcutaneous Risankizumab Moves Through the Body of Pediatric Participants With Moderately to Severely Active Crohn's Disease
Crohn's Disease (CD) is a gastrointestinal disease that can cause chronic diarrhea with or without gross bleeding, abdominal pain, weight loss, and fever.
- Trial name
- RISE (NCT05995353)
- Testing
- Risankizumab
- Where
- 85 sites in United States, Belgium and 19 more
- Volunteers
- 110 people
- Sponsor
- AbbVie
Ulcerative Colitis
A Study to Learn More About How Risankizumab Works in Young Participants With Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- MIGHTY (NCT07071519)
- Testing
- Risankizumab
- Where
- 73 sites in United States, Belgium and 14 more
- Volunteers
- 120 people
- Sponsor
- AbbVie
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- EMERALD-2 (NCT05611671)
- Testing
- MORF-057
- Where
- 102 sites in United States, Australia and 19 more
- Volunteers
- 280 people
- Sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Crohn's Disease
An Open-Label, Proof of Consent Study of Vorinostat for the Treatment of Mdoerate-to-Severe Crohn s Disease and Maintenance Therapy With Ustekinumab
Background: Crohn s disease (CD) is an inflammatory bowel disease. It causes inflammation of the gut. Symptoms may include diarrhea, abdominal pain, fatigue, weight loss and malnutrition.
- Trial name
- NCT03167437
- Testing
- Vorinostat, Ustekinumab
- Where
- United States
- Volunteers
- 35 people
- Sponsor
- National Institute of Allergy and Infectious Diseases (NIAID)
Colitis, Ulcerative
A Safety and Effectiveness Study of Golimumab in Japanese Patients With Moderately to Severely Active Ulcerative Colitis.
The purpose of this study is to evaluate safety and effectiveness of golimumab in Japanese participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT01863771
- Testing
- Golimumab
- Where
- 38 sites in Japan
- Volunteers
- 144 people
- Sponsor
- Janssen Pharmaceutical K.K.
Crohn's Disease
An Observational Study to Assess Change in Disease Activity and Adverse Events In Adult Participants With Moderate to Severe Active Crohn's Disease (CD)
Crohn's disease (CD) is an incurable chronic inflammatory disorder of the gastrointestinal tract. This study will assess how safe and effective risankizumab is in treating moderately to severely active CD in real world.
- Trial name
- APPRISE (NCT05841537)
- Where
- 154 sites in Austria, Canada and 9 more
- Volunteers
- 1,019 people
- Sponsor
- AbbVie
Ulcerative Colitis
A Study Comparing the Efficacy and Safety of Etrolizumab to Infliximab in Participants With Moderate to Severe Ulcerative Colitis Who Are Naïve to Tumor Necrosis Factor (TNF) Inhibitors
This is a multicenter, Phase III, randomized, double-blind, double-dummy, parallel-group study to evaluate the safety, efficacy, and tolerability of etrolizumab compared with infliximab in treating participants with moderate to…
- Trial name
- GARDENIA (NCT02136069)
- Testing
- Etrolizumab, Infliximab
- Where
- 119 sites in Austria, Belgium and 18 more
- Volunteers
- 397 people
- Sponsor
- Hoffmann-La Roche
Inflammatory Bowel Diseases
Correlation Between RISANKIZUMAB's Trough Levels, Clinical and Biological Remission in Moderate to Severe Crohn's Disease: a Retrospective Multicentric Study
The goal of this observational study is to determine if, as with other therapeutics such as anti-TNF, trough levels of Risankizumab are correlated with clinical and biological remission in patients with moderate to severe Crohn's…
- Trial name
- RISE-CD (NCT06589895)
- Where
- France
- Volunteers
- 40 people
- Sponsor
- Centre Hospitalier Universitaire de Nīmes
Ulcerative Colitis
Evaluation of Efficacy and Safety of Tralokinumab in Patients With Active, Moderate-to-severe Ulcerative Colitis
The study is designed to evaluate the clinical efficacy and safety of tralokinumab as compared to placebo. Investigational product will be administered as subcutaneous injection.
- Trial name
- NCT01482884
- Testing
- tralokinumab
- Where
- 28 sites in Czechia, France and 4 more
- Volunteers
- 147 people
- Sponsor
- AstraZeneca
Colitis Ulcerative
Dose-finding Study of SAR443122 in Adult Participants With Ulcerative Colitis
This is a randomized, double-blind, placebo controlled, dose-ranging Phase 2 study. The primary objective is to evaluate the efficacy and safety of SAR443122 compared to placebo in participants with moderate to severe UC.
- Trial name
- RESOLUTE (NCT05588843)
- Testing
- SAR443122
- Where
- 106 sites in United States, Argentina and 17 more
- Volunteers
- 187 people
- Sponsor
- Sanofi
Inflammatory Disease, Disease Crohn
InDuctIon TREatment with SubCuTaneous Infliximab for Crohn's Disease
Study Design: A Prospective Multicenter Randomized Controlled, Open-label Non-inferiority Study to Investigate the Efficacy of Subcutaneous (SC) Infliximab (IFX) with and without Immunomodulators during Induction treatment in…
- Conditions
- Inflammatory Disease, Disease Crohn, Bowel Disease
- Trial name
- DIRECTCD (NCT06059989)
- Testing
- Infliximab subcutaneous, Immunosuppressive Agents
- Where
- Netherlands
- Volunteers
- 158 people
- Sponsor
- Academisch Medisch Centrum - Universiteit van Amsterdam (AMC-UvA)
Colitis, Ulcerative
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial…
- Trial name
- DUET-UC (NCT05242484)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 403 sites in United States, Argentina and 35 more
- Volunteers
- 577 people
- Sponsor
- Janssen Research & Development, LLC
Crohn's Disease
Treatment of Chinese Adult Subjects With Moderate to Severe Crohn's Disease With Tabellvi®
This is a post-marketing real-world study designed to evaluate the efficacy and safety of Tabellvi® (Adalimumab Injection) in Chinese adult subjects with moderate to severe active Crohn's disease via a single-arm trial.
- Trial name
- NCT07663526
- Testing
- TyboWe® Adalimumab Injection
- Where
- 7 sites in China
- Volunteers
- 50 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Crohn Disease
Study to Evaluate Efficacy and Safety of Certolizumab Pegol for Induction of Remission in Patients With Crohn's Disease
The primary objective of the study is to evaluate efficacy of certolizumab pegol in inducing clinical remission in patients with moderate to severe Crohn's disease as compared with placebo based on Crohn's Disease Activity Index…
- Trial name
- NCT00552058
- Testing
- certolizumab pegol (CDP870, CZP)
- Where
- 116 sites in United States, Australia and 18 more
- Volunteers
- 439 people
- Sponsor
- UCB Pharma
Crohn's Disease
CP-461 for the Treatment of Crohn's Disease
Patients with moderately to severely active Crohn's disease will be treated with oral CP-461 200 mg (2 x 100 mg capsules) twice-daily for 8 weeks.
- Trial name
- NCT00042055
- Testing
- CP-461
- Where
- 10 sites in United States
- Volunteers
- 30 people
- Sponsor
- Astellas Pharma Inc
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
Colitis, Ulcerative
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active…
- Trial name
- NCT03482635
- Testing
- Spesolimab
- Where
- 54 sites in United States, Austria and 10 more
- Volunteers
- 98 people
- Sponsor
- Boehringer Ingelheim
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.
Ulcerative Colitis
An Observational Study to Assess Change in Disease Activity and Adverse Events of Upadacitinib in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Real-World Practice
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon.
- Trial name
- PROFUNDUS (NCT05494606)
- Where
- 153 sites in Argentina, Australia and 15 more
- Volunteers
- 785 people
- Sponsor
- AbbVie
Moderate-to-severe Ulcerative Colitis, Crohn's Disease (CD)
Universal CAR-T Cell Injection Targeting CD19/BCMA in Patients With Inflammatory Bowel Disease
This is an open-label, Phase I, investigator-initiated trial (IIT) designed to evaluate the safety, tolerability, pharmacokinetics, pharmacodynamics, and efficacy of RD06-05 in patients with moderate-to-severe ulcerative colitis…
- Trial name
- NCT07309744
- Testing
- RD06-05 CART Cell Infusion
- Where
- China
- Volunteers
- 30 people
- Sponsor
- Union Hospital, Tongji Medical College, Huazhong University of Science and Technology