Clinical trials: Moderate to Severe Ulcerative Colitis
Ulcerative Colitis
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to…
- Trial name
- NCT03518086
- Testing
- Mirikizumab
- Where
- 502 sites in United States, Argentina and 33 more
- Volunteers
- 1,281 people
- Sponsor
- Eli Lilly and Company
Colitis, Ulcerative
A Study To Investigate The Safety And Possible Clinical Benefit Of Multistem(r) In Patients With Moderate To Severe Ulcerative Colitis
MultiStem(r) is a new biological product, manufactured from human stem cells obtained from adult bone marrow or other nonembryonic tissue sources.
- Trial name
- NCT01240915
- Testing
- MultiStem low dose, MultiStem high dose
- Where
- 58 sites in United States, Belgium and 6 more
- Volunteers
- 105 people
- Sponsor
- Pfizer
Ulcerative Colitis
Study of the Efficacy and Safety of AMT-101 in Subjects With Ulcerative Colitis (LOMBARD)
Randomized, Placebo-controlled, Double-blind, Parallel-group, Multicenter, Phase 2a Study of the Efficacy and Safety of Oral AMT-101 in Subjects with Moderate to Severe Ulcerative Colitis.
- Trial name
- NCT04583358
- Testing
- AMT-101 (oral)
- Where
- 59 sites in United States, Belarus and 12 more
- Volunteers
- 105 people
- Sponsor
- Applied Molecular Transport
Ulcerative Colitis
Impact of Adalimumab on Patient-reported Outcomes in Ulcerative Colitis
To evaluate the real-life effect after 1 year of adalimumab treatment on psychological distress/depression symptoms in moderate-to-severe Ulcerative Colitis (UC) patients.
- Trial name
- UCanADA (NCT02506179)
- Where
- 23 sites in Canada
- Volunteers
- 100 people
- Sponsor
- AbbVie
Colitis Ulcerative
A Study to Investigate Efficacy and Safety of SAR441566 in Patients With Ulcerative Colitis
This is a Phase 2, multinational, multicenter, randomized, double-blind, placebo-controlled, dose ranging study to evaluate the efficacy and safety of SAR441566 in adults with moderate-to-severe UC.
- Trial name
- SPECIFI-UC (NCT06867094)
- Testing
- SAR441566
- Where
- 117 sites in United States, Argentina and 22 more
- Volunteers
- 170 people
- Sponsor
- Sanofi
Ulcerative Colitis
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.
- Trial name
- GALOCEAN (NCT05817942)
- Testing
- Filgotinib
- Where
- 81 sites in Austria, Belgium and 8 more
- Volunteers
- 509 people
- Sponsor
- Alfasigma S.p.A.
Inflammatory Bowel Diseases
Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their…
- Trial name
- NCT03591770
- Testing
- SHINGRIX
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Medical Center
Ulcerative Colitis
A Study Of PF-00547659 In Patients With Moderate To Severe Ulcerative Colitis
To determine the dose or doses of PF-00547659 that will be the most effective to improve or halt the disease symptoms in patients with moderate to severe ulcerative colitis.
- Trial name
- TURANDOT (NCT01620255)
- Testing
- PF-00547659 SC Injection
- Where
- 190 sites in United States, Australia and 19 more
- Volunteers
- 357 people
- Sponsor
- Shire
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
Ulcerative Colitis
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®
- Trial name
- UCESIVE (NCT05771155)
- Testing
- Intravenous (IV) infusions
- Where
- Georgia
- Volunteers
- 750 people
- Sponsor
- Polpharma Biologics S.A.
Ulcerative Colitis
A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT06281704
- Testing
- AK101 IV, AK101 SC, AK101 IV/AK101 SC
- Where
- 12 sites in China
- Volunteers
- 34 people
- Sponsor
- Akeso
Crohn's Disease, Ulcerative Colitis
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel.
- Trial name
- NCT06764615
- Testing
- Zasocitinib
- Where
- 16 sites in United States, China and 6 more
- Volunteers
- 192 people
- Sponsor
- Takeda
Colitis, Ulcerative
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely…
- Trial name
- LAUREL (NCT02165215)
- Testing
- Etrolizumab
- Where
- 104 sites in United States, Brazil and 13 more
- Volunteers
- 359 people
- Sponsor
- Hoffmann-La Roche
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Afimkibart (Also Known as RO7790121) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
This Phase III, multicenter, double-blind, placebo-controlled, treat-through study will evaluate the efficacy and safety of Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active…
- Trial name
- Ametrine-1 (NCT06589986)
- Testing
- Afimkibart
- Where
- 184 sites in United States, Argentina and 28 more
- Volunteers
- 400 people
- Sponsor
- Hoffmann-La Roche
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
Colitis, Ulcerative
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical…
- Trial name
- NCT01294410
- Testing
- Anti-IP-10 Antibody
- Where
- 75 sites in United States, Australia and 12 more
- Volunteers
- 305 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis
ABTECT-2 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -2
This is a multicenter, randomized, placebo controlled study to evaluate the efficacy and safety of ABX464 given at 25 or 50 mg QD in inducing clinical remission in subjects with moderately to severely active ulcerative colitis…
- Trial name
- NCT05507216
- Testing
- ABX464
- Where
- 262 sites in United States, Argentina and 25 more
- Volunteers
- 636 people
- Sponsor
- Abivax S.A.
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
Moderate-to-severe Inflammatory Bowel Disease
A Study to Evaluate the Safety of SHR-7590 in Chinese Healthy Participants and in Patients With Moderate-to-severe Inflammatory Bowel Disease
This Phase I first-in-human study will evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of SHR-7590 via subcutaneous or intravenous administration in Chinese healthy participants and patients with…
- Trial name
- NCT07758101
- Testing
- SHR-7590
- Where
- China
- Volunteers
- 88 people, healthy volunteers welcome
- Sponsor
- Guangdong Hengrui Pharmaceutical Co., Ltd
Colitis, Ulcerative
Safety, Efficacy, and Tolerability Study of PF-06480605 in Subjects With Moderate to Severe Ulcerative Colitis.
The purpose of this study is to evaluate the safety, tolerability, and efficacy of PF-06480605 in subjects with moderate to severe ulcerative colitis.
- Trial name
- NCT02840721
- Testing
- PF-06480605
- Where
- 28 sites in United States, Belgium and 4 more
- Volunteers
- 50 people
- Sponsor
- Telavant, Inc.