Clinical trials: Moderate-to-severe Ulcerative Colitis
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 participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative…
- Trial name
- FIGARO UC 301 (NCT03259334)
- Testing
- Ontamalimab
- Where
- 207 sites in United States, Australia and 16 more
- Volunteers
- 380 people
- Sponsor
- Shire
Ulcerative Colitis
Abrilumab (AMG 181) in Adults With Moderate to Severe Ulcerative Colitis
The primary objective of this study is to evaluate the effect of abrilumab on induction of remission in adults with moderate to severe ulcerative colitis after 8 weeks of treatment as assessed by a total Mayo Score ≤ 2 points…
- Trial name
- NCT01694485
- Testing
- Abrilumab
- Where
- 123 sites in United States, Australia and 18 more
- Volunteers
- 359 people
- Sponsor
- Amgen
Ulcerative Colitis
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- ARTEMIS-UC (NCT04996797)
- Testing
- Tulisokibart, Companion Diagnostic (CDx) Testing
- Where
- 88 sites in United States, Australia and 10 more
- Volunteers
- 178 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
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
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
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with…
- Trial name
- HICKORY (NCT02100696)
- Testing
- Etrozulimab
- Where
- 184 sites in United States, Argentina and 22 more
- Volunteers
- 609 people
- Sponsor
- Hoffmann-La Roche
Colitis, Ulcerative
A Study of Vedolizumab in Children and Teenagers With Moderate to Severe Ulcerative Colitis (UC)
Vedolizumab is a medicine that helps to reduce inflammation and pain in the digestive system. In this study, children and teenagers with moderate to severe ulcerative colitis will be treated with vedolizumab.
- Trial name
- NCT04779307
- Testing
- Vedolizumab
- Where
- 65 sites in United States, Australia and 12 more
- Volunteers
- 121 people
- Sponsor
- Takeda
Colitis, Ulcerative, Inflammatory Bowel Diseases
A Study to Evaluate the Safety and Efficacy of Ustekinumab Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of ustekinumab as intravenous (IV: into the vein) infusion in induction study in participants with moderately to severely active Ulcerative Colitis (UC) and as…
- Trial name
- UNIFI (NCT02407236)
- Testing
- Ustekinumab IV, Ustekinumab SC
- Where
- 247 sites in United States, Australia and 21 more
- Volunteers
- 961 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
Vedolizumab Intravenous (IV) Dose Optimization in Ulcerative Colitis
The purpose of this study is to investigate the efficacy and safety of vedolizumab intravenous (IV) dose optimization on mucosal healing compared with the standard vedolizumab IV dosing regimen over a 30 week treatment period in…
- Trial name
- ENTERPRET (NCT03029143)
- Testing
- Vedolizumab IV
- Where
- 49 sites in United States, Canada
- Volunteers
- 278 people
- Sponsor
- Takeda
Moderate to Severe Ulcerative Colitis
A Study Assessing the Efficacy and Safety of CBP-307 in Subjects With Moderate to Severe Ulcerative Colitis (UC)
This study will evaluate the efficacy and safety of CBP-307 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT04700449
- Testing
- Double-Blind 0.2mg CBP-307, Open-label CBP-307, Double-Blind 0.1mg CBP-307
- Where
- 66 sites in United States, China and 2 more
- Volunteers
- 145 people
- Sponsor
- Connect Biopharm LLC
Ulcerative Colitis
Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment for moderately to severely active ulcerative colitis.
- Trial name
- ELEVATE UC 52 (NCT03945188)
- Testing
- Etrasimod
- Where
- 315 sites in United States, Argentina and 38 more
- Volunteers
- 433 people
- Sponsor
- Arena Pharmaceuticals
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
Efficacy and Safety Study of ABX464 as Maintenance Therapy in Patients With Moderate to Severe Ulcerative Colitis
A phase 2b study to evaluate the long-term efficacy and safety study of ABX464 50mg as maintenance therapy in patients with moderate to severe Ulcerative Colitis.
- Trial name
- NCT04023396
- Testing
- ABX464
- Where
- 120 sites in Austria, Belarus and 14 more
- Volunteers
- 217 people
- Sponsor
- Abivax S.A.
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, Crohn's Disease
A Study of Intravenous Vedolizumab Administered Every 4 Weeks in Japanese Participants With Moderate to Severe Ulcerative Colitis or Crohn's Disease
The main aim of the study is to learn if 4-weekly vedolizumab improves symptoms of Japanese participants with moderate to severe ulcerative colitis (UC) or Crohn's disease (CD).
- Trial name
- NCT04738942
- Testing
- Vedolizumab
- Where
- 20 sites in Japan
- Volunteers
- 56 people
- Sponsor
- Takeda
Ulcerative Colitis
Preference for a Prefilled Syringe or Smartject™ Device for Delivering Golimumab in Participants Suffering From Moderate-to-severe Ulcerative Colitis (MK-8259-027)
This study is designed to determine whether ulcerative colitis participants prefer delivery of golimumab via a prefilled syringe or the Smartject™ device.
- Trial name
- SMART (NCT02155335)
- Testing
- Prefilled Syringe delivery of Golimumab, Smartject Device delivery of Golimumab
- Volunteers
- 100 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis (UC)
A Study to Investigate How Well Ravagalimab (ABBV-323) Works and How Safe it is in Participants With Moderate to Severe Ulcerative Colitis Who Failed Prior Therapy
Study M15-722 is a Phase 2a study to investigate the efficacy and safety of Ravagalimab (ABBV-323) in participants with moderate to severe UC who failed prior therapy.
- Trial name
- NCT03695185
- Testing
- Ravagalimab 600 mg, Ravagalimab 300 mg
- Where
- 34 sites in United States, Canada and 8 more
- Volunteers
- 42 people
- Sponsor
- AbbVie
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
Colitis, Ulcerative
BI 655130 Long-term Treatment in Patients With moderate-to Severe Ulcerative Colitis
To evaluate the long-term safety of BI 655130 (SPESOLIMAB) in patients with moderate to severely active ulcerative colitis, who have completed treatment in previous trials To evaluate the long-term efficacy of BI 655130…
- Trial name
- NCT03648541
- Testing
- Spesolimab
- Where
- 38 sites in United States, Austria and 10 more
- Volunteers
- 79 people
- Sponsor
- Boehringer Ingelheim
Colitis, Ulcerative
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker…
- Trial name
- EVOLUTION (NCT02318667)
- Testing
- Golimumab
- Volunteers
- 38 people
- Sponsor
- Merck Sharp & Dohme LLC