Clinical trials: Moderate-to-severe Inflammatory Bowel Disease
Ulcerative Colitis
Second Line Induction Therapy and Healthy Diet for Patients With Ulcerative Colitis
The purpose of this study is to determine whether a diet intervention (the Fasting Mimicking diet) will help induce clinical and biochemical response to an advanced therapy in patients with ulcerative colitis.
- Trial name
- NCT04505410
- Testing
- A plant based high fiber diet that mimics fasting ("FMD") plus advanced therapy, Advanced therapy only without dietary intervention
- Where
- United States
- Volunteers
- 32 people
- Sponsor
- University of Miami
Crohns Disease, Crohn's Disease
Study to Evaluate Safety, Tolerability and Efficacy of GSK2330811 in Crohn's Disease
The study will include participants with moderate to severe Crohn's disease. The aim is to evaluate the safety, tolerability, and efficacy of anti-oncostatin M monoclonal antibody (mAb) GSK2330811.
- Trial name
- COSMIS (NCT04151225)
- Testing
- GSK2330811
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis
Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)
Part 1 of this study is a 3-arm, randomized, active-controlled, parallel-group, multicenter, double-blind, double-dummy, 16-week study to compare the efficacy and safety of infliximab (IFX), as monotherapy or in combination with…
- Trial name
- NCT00537316
- Testing
- Infliximab (IFX), Azathioprine (AZA)
- Volunteers
- 242 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well…
- Trial name
- NCT06254950
- Testing
- TAK-279
- Where
- 141 sites in United States, Australia and 20 more
- Volunteers
- 213 people
- Sponsor
- Takeda
Crohn Disease, Colitis, Ulcerative
A Study to Evaluate the Long-Term Effect of TEV-48574 in Moderate to Severe Ulcerative Colitis or Crohn's Disease
The primary objective of the study is to evaluate the efficacy of 2 different maintenance dose regimens of TEV-48574 subcutaneous (sc) administered every 4 weeks (Q4W) in adult participants with inflammatory bowel disease (IBD).
- Trial name
- NCT05668013
- Testing
- TEV-48574 Dose Regimen A, TEV-48574 Dose Regiment B
- Where
- 93 sites in United States, Austria and 14 more
- Volunteers
- 247 people
- Sponsor
- Teva Branded Pharmaceutical Products R&D LLC
Ulcerative Colitis
A Study to Evaluate Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderately to Severely Active Ulcerative Colitis (MK-7240-001)
The purpose of this protocol is to evaluate the efficacy of tulisokibart in participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT06052059
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 476 sites in United States, Argentina and 43 more
- Volunteers
- 1,109 people
- Sponsor
- Merck Sharp & Dohme LLC
Inflammatory Bowel Disease
Non-interventional Study of Moderate to Severe Inflammatory Bowel Disease in Brazil
The purpose of this study is to gather information regarding the population with moderate to severe inflammatory bowel disease (IBD), the burden of the disease, and understand their treatment patterns, particularly on the use of…
- Trial name
- NCT02822235
- Testing
- No Intervention
- Where
- 13 sites in Brazil
- Volunteers
- 407 people
- Sponsor
- Takeda
Rheumatoid Arthritis, Psoriasis
A Study of Experimental Medication BMS-986251, Taken by Mouth, in Healthy Participants and Patients With Average to Very Serious Psoriasis
The purpose of this study is to investigate experimental medication BMS-986251 taken by mouth in healthy patients and patients with average to very serious Psoriasis (a condition characterized by itchy, dry skin with a scaly…
- Conditions
- Rheumatoid Arthritis, Psoriasis, Ankylosing Spondylitis, Inflammatory Bowel Diseases
- Trial name
- NCT03329885
- Testing
- BMS-986251
- Where
- Netherlands
- Volunteers
- 38 people, healthy volunteers welcome
- Sponsor
- Bristol-Myers Squibb
Crohn's Disease
A Pilot Study of FFP104 in Subjects With Crohn's Disease
This study will be conducted to evaluate the safety, tolerability and efficacy of intravenously administered FFP104 or placebo over 15 days (3 total doses) in subjects with moderate to severely active Crohn's Disease
- Trial name
- NCT02465944
- Testing
- FFP104
- Where
- 2 sites in Belgium, Netherlands
- Volunteers
- 24 people
- Sponsor
- Fast Forward Pharmaceuticals
Crohn Disease
Safety and Efficacy Study of JNJ-64304500 in Participants With Moderately to Severely Active Crohn's Disease
The purpose of the study is to assess the safety and efficacy of JNJ-64304500 in participants with moderately to severely active Crohn's disease.
- Trial name
- TRIDENT (NCT02877134)
- Testing
- JNJ-64304500, Ustekinumab
- Where
- 147 sites in United States, Belgium and 12 more
- Volunteers
- 388 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis (UC)
A First-in-Human Study of BB-TL1A-VIAL-HLE in Healthy Adults and People With Ulcerative Colitis
The goal of this clinical trial is to learn if BB-TL1A-VIAL-HLE is safe in healthy adults and is safe and effective in treating adults with moderate-to-severe ulcerative colitis.
- Trial name
- NCT07029971
- Testing
- BB-TL1A-VIAL-HLE
- Where
- 2 sites in Australia
- Volunteers
- 16 people, healthy volunteers welcome
- Sponsor
- Vial Australia Pty Ltd
Ulcerative Colitis
Hyperbaric Oxygen Therapy for Ulcerative Colitis (HBOT-UC)
Chronic intestinal hypoxia and accompanying mucosal inflammation is a hallmark of ulcerative colitis (UC). Hyperbaric oxygen therapy (HBOT) involves breathing 100% oxygen under increased atmospheric pressure to increase tissue…
- Trial name
- HBOT-UC (NCT05987852)
- Testing
- Hyperbaric Oxygen Therapy
- Where
- 13 sites in United States
- Volunteers
- 126 people
- Sponsor
- Northwestern University
Crohn's Disease
Evaluation of Efficacy and Safety of MEDI2070 in Patients With Active, Moderate-to-severe Crohn's Disease.
The study is designed to evaluate the clinical efficacy and safety of MEDI2070 as compared to placebo. Investigational product will be administered as intravenous infusion in double-blind period, and as a subcutaneous injection…
- Trial name
- NCT01714726
- Testing
- MEDI2070
- Where
- 80 sites in United States, Canada and 7 more
- Volunteers
- 121 people
- Sponsor
- AstraZeneca
Ulcerative Colitis (UC)
A Multicenter, Randomized, Double-Blind, Placebo Controlled Induction Study to Evaluate the Efficacy and Safety of Risankizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The objectives of Sub-Study 1 are to evaluate the efficacy, safety, and pharmacokinetics of risankizumab as induction treatment in subjects with moderately to severely active ulcerative colitis (UC), and to identify the…
- Trial name
- NCT03398148
- Testing
- risankizumab IV, risankizumab SC
- Where
- 430 sites in United States, Argentina and 42 more
- Volunteers
- 1,558 people
- Sponsor
- AbbVie
Colitis, Crohn's Disease
NIH Substudy of AIN457 (Anti-IL-17 Monoclonal Antibody) for Treatment of Moderate to Severe Crohn's Disease
The objective of this NIH-specific substudy is immunologic monitoring of cytokine and immune cell responses in subjects undergoing treatment with AIN457 (human monoclonal anti-human interleukin-17A) for moderate to severe Crohn's…
- Conditions
- Colitis, Crohn's Disease, Inflammatory Bowel Disease
- Trial name
- NCT00936585
- Testing
- Immunologic Monitoring
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- National Institutes of Health Clinical Center (CC)
Crohn Disease
An Extension Study of Oral Ozanimod for Moderately to Severely Active Crohn's Disease
This is an extension study to evaluate safety and efficacy of ozanimod in participants with moderately to severely active Crohn's Disease.
- Trial name
- NCT03467958
- Testing
- Ozanimod
- Where
- 766 sites in United States, Argentina and 47 more
- Volunteers
- 854 people
- Sponsor
- Celgene
Ulcerative Colitis (UC)
Effectiveness and Safety of Mirikizumab in Patients With Moderate-to-severe Ulcerative Colitis: a Real-life Retrospective Multicenter Study
This is a real-life, multicenter, retrospective observational study with the aim to evaluate effectiveness and safety of Mirikizumab in a real life setting from the baseline up to manteinance at 12, 24 and 52 weeks.
- Trial name
- MIRI REAL (NCT07695636)
- Where
- Italy
- Volunteers
- 282 people
- Sponsor
- IRCCS San Raffaele
Crohn Disease
Study to Evaluate the Efficacy and Safety of PF-06480605 in Adult Participants With Moderate to Severe Crohn's Disease
This Phase 2a, multicenter, randomized, double-blind, placebo-controlled study examines subcutaneous dose of PF-06480605 150 mg administered every 4 weeks in participants with moderate to severe active Crohn's Disease to…
- Trial name
- NCT05471492
- Testing
- Investigational Product
- Sponsor
- Telavant, Inc.
Crohn's Disease
Study of the Human Anti-TNF Monoclonal Antibody Adalimumab for the Induction of Clinical Remission in Subjects With Crohn's Disease
The goal of this study is to test whether adalimumab can induce clinical remission in subjects with active Crohn's disease who have been initially treated with infliximab and either lost response or discontinued its use as a…
- Trial name
- NCT00105300
- Testing
- Adalimumab
- Where
- 56 sites in United States, Belgium and 2 more
- Volunteers
- 300 people
- Sponsor
- Abbott
Crohn's Disease
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD).
- Trial name
- STARSCAPE-2 (NCT07184944)
- Testing
- Duvakitug
- Where
- 109 sites in United States, Australia and 25 more
- Volunteers
- 751 people
- Sponsor
- Sanofi