Clinical trials: Moderately to Severely Active Ulcerative Colitis
- Condition Moderately to Severely Active Ulcerative Colitis
- Funder type Industry (pharma, biotech, devices)
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.
Ulcerative Colitis
Study of Tilpisertib Fosmecarbil in Participants With Moderately to Severely Active Ulcerative Colitis
The goal of this study is to learn if tilpisertib fosmecarbil (formerly known as GS-5290) is effective and safe in treating participants with moderate to severe ulcerative colitis.
- Trial name
- PALEKONA (NCT06029972)
- Testing
- Tilpisertib Fosmecarbil
- Where
- 102 sites in United States, Australia and 12 more
- Volunteers
- 176 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis
Generate Real World Data On Tofacitinib Induction Therapy and Changes In Clinical and Patient Reported Outcomes.
This study is expected to contribute to the body of real-world data of tofacitinib's safety and efficacy profile in ulcerative colitis.
- Trial name
- KIC-START (NCT05069259)
- Testing
- Stool sample collection
- Where
- 5 sites in Switzerland
- Volunteers
- 18 people
- Sponsor
- Pfizer
Colitis, Ulcerative
To Evaluate Efficacy and Long-term Safety of Ozanimod in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
Japanese patients with moderate or severe active ulcerative colitis as a subject when ozanimod 0.46 mg or 0.92 mg is orally administered is evaluated about dose response, efficacy and safety with placebo as a control.
- Trial name
- NCT03915769
- Testing
- Ozanimod
- Where
- 67 sites in Japan
- Volunteers
- 198 people
- Sponsor
- Celgene
Ulcerative Colitis
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis…
- Trial name
- SUNSCAPE-1 (NCT07184996)
- Testing
- Duvakitug
- Where
- 240 sites in United States, Argentina and 23 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Ulcerative Colitis
A Study to Evaluate the Safety of PRV-300 in Adult Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the safety and tolerability of PRV-300 for 12 weeks in subjects with active ulcerative colitis. Subjects will receive either PRV-300 or placebo treatment.
- Trial name
- PULSE (NCT03849599)
- Testing
- PRV-300
- Where
- 3 sites in Georgia, Moldova and 1 more
- Volunteers
- 37 people
- Sponsor
- Provention Bio, Inc.
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, Ulcerative Colitis Chronic
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
- Trial name
- LUCENT-URGE (NCT05767021)
- Testing
- Mirikizumab
- Where
- 120 sites in United States, Belgium and 8 more
- Volunteers
- 172 people
- Sponsor
- Eli Lilly and Company
Inflammatory Bowel Diseases
Clinical Trial of TQH3906 Capsules for the Treatment of Adult Patients With Moderately to Severely Active Ulcerative Colitis or Crohn's Disease
This phase will commence following dose escalation in the 24mg bid group during Phase I. Employing a 1:1:1 randomized, double-blind, placebo-controlled study design, it will evaluate the efficacy, safety, and…
- Trial name
- NCT06754891
- Testing
- 24mg bid TQH3906 capsule, 32mg TQH3906 capsule
- Where
- 30 sites in China
- Volunteers
- 135 people
- Sponsor
- Chia Tai Tianqing Pharmaceutical Group Nanjing Shunxin Pharmaceutical Co., Ltd.
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
Ulcerative Colitis, Crohn's Disease
Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).
- Trial name
- NCT02913508
- Testing
- Vedolizumab intravenous injection, Vedolizumab subcutaneous injection
- Sponsor
- Takeda
Ulcerative Colitis
A Study Evaluating the Effects of GLPG3970 Given as an Oral Treatment for 6 Weeks in Adults With Ulcerative Colitis
The primary objective of this study was to evaluate the effect of GLPG3970 compared to placebo on the signs and symptoms of Ulcerative Colitis (UC) in participants with moderately to severely active UC.
- Trial name
- SEA TURTLE (NCT04577794)
- Testing
- GLPG3970
- Where
- 15 sites in Georgia, Moldova and 2 more
- Volunteers
- 31 people
- Sponsor
- Lakefront Biotherapeutics NV
Colitis, Ulcerative
A Study of Safety and Effectiveness of JNJ-54781532 in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of the study is to evaluate dose response of JNJ-54781532 in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT01959282
- Testing
- JNJ-54781532 25 mg once daily, JNJ-54781532 75 mg once daily, JNJ-54781532 150 mg once daily
- Where
- 97 sites in United States, Australia and 12 more
- Volunteers
- 219 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
LY4268989 (MORF-057) Co-Administered With Mirikizumab in Adults With Moderately to Severely Active Ulcerative Colitis:
The main purpose of the study is to evaluate the effectiveness and safety of LY4268989 when given with mirikizumab compared to mirikizumab alone in adult participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- TOPAZ-UC (NCT07186101)
- Testing
- LY4268989, Mirikizumab
- Where
- 147 sites in United States, Austria and 15 more
- Volunteers
- 252 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis (UC)
A Long-Term Registry of Humira® (Adalimumab) in Patients With Moderately to Severely Active Ulcerative Colitis (UC)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in patients with moderately to severely active UC who are treated as recommended in the product label.
- Trial name
- LEGACY (NCT01848561)
- Where
- 512 sites in United States, Australia and 19 more
- Volunteers
- 8,250 people
- Sponsor
- AbbVie
Ulcerative Colitis (UC)
A Study of AC-101 Tablets in Patients With Ulcerative Colitis
This is a Phase Ⅱb, multicenter, randomized, parallel-group, double-blind, placebo-controlled, dose-finding study of AC-101 tablets in patients with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT07755241
- Testing
- AC-101
- Where
- China
- Volunteers
- 153 people
- Sponsor
- Accro Bioscience (Suzhou) Limited
Ulcerative Colitis (UC)
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT02065622
- Testing
- Adalimumab
- Where
- 173 sites in United States, Austria and 18 more
- Volunteers
- 952 people
- Sponsor
- AbbVie
Ulcerative Colitis
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis.
- Trial name
- NCT07083193
- Testing
- AC-101
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Accro Bioscience (Suzhou) Limited
Ulcerative Colitis, Inflammatory Bowel Diseases
A Study of Long-acting Antibodies Alone and in Combinations for Moderate to Severe Ulcerative Colitis
This is a Phase 2, multicenter, proof-of-concept platform study in adult participants with moderately to severely active ulcerative colitis (UC).
- Conditions
- Ulcerative Colitis, Inflammatory Bowel Diseases, Colitis, Colitis, Ulcerative
- Trial name
- SKYLINE-UC (NCT07012395)
- Testing
- SPY001, SPY002, SPY003
- Where
- 276 sites in United States, Argentina and 33 more
- Volunteers
- 645 people
- Sponsor
- Spyre Therapeutics, Inc.
Ulcerative Colitis
Open-label Extension Study of Brazikumab in Ulcerative Colitis
The purpose of this OLE Study D5272C00002 (Legacy #3151-202-008) is to permit participants who previously enrolled in the double-blind Study D5272C00001 (Legacy #3151-201-008) to receive brazikumab, allowing for long-term…
- Trial name
- Expedition (NCT04277546)
- Testing
- Brazikumab Maintenance Dose, Brazikumab Induction Dose
- Where
- 36 sites in United States, Czechia and 9 more
- Volunteers
- 57 people
- Sponsor
- AstraZeneca