Clinical trials: Moderate-to-severe Ulcerative Colitis
Ulcerative Colitis
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Ulcerative Colitis (LIBERTY-UC)
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Ulcerative Colitis
- Trial name
- NCT04205643
- Testing
- CT-P13 SC (Infliximab)
- Where
- Poland
- Volunteers
- 548 people
- Sponsor
- Celltrion
Ulcerative Colitis
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis…
- Trial name
- FIGARO UC 302 (NCT03259308)
- Testing
- Ontamalimab
- Where
- 207 sites in United States, Argentina and 20 more
- Volunteers
- 279 people
- Sponsor
- Shire
Ulcerative Colitis, Crohn's Disease
A Phase I Study of Etrolizumab Followed by Open-Label Extension and Safety Monitoring in Pediatric Patients With Moderate to Severe Ulcerative Colitis or Moderate to Severe Crohn's Disease
This study will evaluate pharmacokinetics, pharmacodynamics and safety of etrolizumab in pediatric patients of 4 to <18 years of age with moderate to severe ulcerative colitis (UC) or with moderate to severe Crohn's disease (CD).
- Trial name
- FENNEL (NCT03478956)
- Testing
- Etrolizumab
- Where
- 5 sites in Belgium, Poland and 2 more
- Volunteers
- 24 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
Etrasimod Dose-Ranging Versus Placebo as Induction Therapy Study in Adult Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this Japan-only study is to assess the safety and efficacy of etrasimod at 2 doses in Japanese subjects with moderately to severely active ulcerative colitis (UC) when administered for 12 weeks.
- Trial name
- NCT05061446
- Testing
- Etrasimod
- Where
- 80 sites in Japan
- Volunteers
- 54 people
- Sponsor
- Pfizer
Ulcerative Colitis
Study of Vedolizumab (MLN0002) in Patients With Moderate to Severe Ulcerative Colitis
The primary purpose of this study was to determine the effect of vedolizumab induction treatment on clinical response at 6 weeks and to determine the effect of vedolizumab maintenance treatment on clinical remission at 52 weeks.
- Trial name
- GEMINI I (NCT00783718)
- Testing
- vedolizumab
- Where
- 105 sites in United States, Canada and 1 more
- Volunteers
- 895 people
- Sponsor
- Millennium Pharmaceuticals, Inc.
Ulcerative Colitis
An Efficacy and Safety Study of Ontamalimab as Maintenance Therapy in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of ontamalimab as maintenance therapy treatment of remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate…
- Trial name
- FIGARO UC 303 (NCT03290781)
- Testing
- Ontamalimab
- Where
- 401 sites in United States, Argentina and 35 more
- Volunteers
- 366 people
- Sponsor
- Shire
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
Ulcerative Colitis
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02895100
- Testing
- PTG-100
- Where
- 98 sites in United States, Australia and 15 more
- Volunteers
- 98 people
- Sponsor
- Protagonist Therapeutics, Inc.
Pyoderma Gangrenosum, Crohn's Disease
Open Label Study for Adults With Pyoderma Gangrenosum and Inflammatory Bowel Disease
Subjects must be 18- 75 years old and have a history of both inflammatory bowels disease (Crohn's or ulcerative colitis) and pyoderma gangrenosum. This is a 6 month open label study of an intravenous (IV) medication.
- Conditions
- Pyoderma Gangrenosum, Crohn's Disease, Ulcerative Colitis, Inflammatory Bowel Disease
- Trial name
- NCT00791557
- Testing
- Infliximab
- Where
- United States
- Volunteers
- 2 people
- Sponsor
- University Hospitals Cleveland Medical Center
Pediatric Ulcerative Colitis
Clinical Study of TA-650 in Pediatric Patients With Ulcerative Colitis
The purpose of this study is to evaluate the the efficacy of TA-650 using Clinical activity index (CAI) score and other evaluation indicators in pediatric patients with moderate to severe ulcerative colitis after TA-650…
- Trial name
- NCT01585155
- Testing
- TA-650
- Where
- 7 sites in Japan
- Volunteers
- 21 people
- Sponsor
- Tanabe Pharma Corporation
Colitis, Ulcerative
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ASTRO (NCT05528510)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 236 sites in United States, Argentina and 23 more
- Volunteers
- 418 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis, IBD
Placebo-Controlled Study of Brazikumab in Participants With Moderately to Severely Active Ulcerative Colitis
The present study (D5272C00001/Legacy #3151-201-008) aims to evaluate the efficacy and safety of brazikumab in patients with moderately to severely active UC and will include assessments of clinical responses as demonstrated by…
- Trial name
- Expedition (NCT03616821)
- Testing
- Brazikumab
- Where
- 125 sites in United States, Canada and 17 more
- Volunteers
- 242 people
- Sponsor
- AstraZeneca
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT00385736
- Testing
- adalimumab
- Where
- 80 sites in United States, Austria and 11 more
- Volunteers
- 576 people
- Sponsor
- Abbott
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.
Ulcerative Colitis
Etrasimod Versus Placebo as Induction Therapy in Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy of etrasimod on clinical remission in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ELEVATE UC 12 (NCT03996369)
- Testing
- Etrasimod
- Where
- 407 sites in United States, Argentina and 39 more
- Volunteers
- 354 people
- Sponsor
- Arena Pharmaceuticals
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
Crohn Disease, Ulcerative Colitis
A Study to Evaluate the Long-term Safety and Efficacy of Deucravacitinib in Participants With Crohn's Disease or Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of Deucravacitinib in participants who have previously been enrolled in a Deucravacitinib Phase 2 study for moderate to severe Crohn's disease or moderate…
- Trial name
- NCT04877990
- Testing
- Deucravacitinib
- Where
- 43 sites in United States, Australia and 14 more
- Volunteers
- 67 people
- Sponsor
- Bristol-Myers Squibb
Ulcerative Colitis
Phase 2 Dose-finding IMU-838 for Ulcerative Colitis
This is a phase 2, multicenter, randomized, double-blind, placebo-controlled, dose-finding study to evaluate the efficacy and safety of IMU-838 for induction and maintenance therapy with an option for open-label treatment…
- Trial name
- CALDOSE-1 (NCT03341962)
- Testing
- IMU-838
- Where
- 131 sites in United States, Albania and 17 more
- Volunteers
- 263 people
- Sponsor
- Immunic AG
Ulcerative Colitis
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and…
- Trial name
- SELECTION (NCT02914522)
- Testing
- Filgotinib, PTM filgotinib
- Where
- 343 sites in United States, Argentina and 38 more
- Volunteers
- 1,351 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of…
- Trial name
- NCT06137183
- Testing
- Vixarelimab
- Where
- 65 sites in United States, Brazil and 10 more
- Volunteers
- 79 people
- Sponsor
- Genentech, Inc.