Clinical trials: Moderate-to-severe Ulcerative Colitis
Ulcerative Colitis, Gastrointestinal Disease
Humanized Anti-IL-2 Receptor Monoclonal Antibody in Moderate-to-severe Ulcerative Colitis
The purpose of The PROSPECT Study is to evaluate an investigational medication for the treatment of moderate to severe ulcerative colitis.
- Conditions
- Ulcerative Colitis, Gastrointestinal Disease, Inflammatory Bowel Disease
- Trial name
- NCT00073047
- Testing
- Daclizumab
- Where
- 35 sites in United States, Belgium and 1 more
- Volunteers
- 150 people
- Sponsor
- Facet Biotech
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
Colitis, Ulcerative
A Study of How the Medicine Called "Etrasimod" Works in Children With the Gut Disease Called Ulcerative Colitis
The purpose of this study is to determine the safety, efficacy, and pharmacokinetics (PK) of etrasimod for the treatment of moderately to severely active ulcerative colitis in pediatrics participants (≥ 2 years up to < 12 years…
- Trial name
- ELEVATE-UCkids (NCT07470879)
- Testing
- Etrasimod
- Where
- 46 sites in United States, Australia and 8 more
- Volunteers
- 24 people
- Sponsor
- Pfizer
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Subcutaneous Induction Therapy With Afimkibart in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of subcutaneous induction with afimkibart in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- AMETRINE-SC (NCT07846683)
- Testing
- Afimkibart
- Where
- United States
- Volunteers
- 350 people
- Sponsor
- Hoffmann-La Roche
Colitis, Ulcerative
A Study to Assess the Safety and Pharmacokinetics of Subcutaneously Administered Golimumab, a Human Anti-TNFα Antibody, in Pediatric Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study is to evaluate the pharmacokinetics (what the body does to the study medication) and safety of subcutaneously (under the skin) administered golimumab in pediatric participants (aged 2 to 17 years) with…
- Trial name
- NCT01900574
- Testing
- Golimumab
- Where
- 27 sites in United States, Austria and 8 more
- Volunteers
- 35 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab in Children and Teenagers With Ulcerative Colitis or Crohn's Disease
The main aim of this study is to learn how the body of a child or teenager with moderately to severely active ulcerative colitis (UC) or Crohn's disease (CD) processes vedolizumab (pharmacokinetics) given just under the skin…
- Trial name
- NCT06100289
- Testing
- Vedolizumab IV, Vedolizumab SC
- Where
- 54 sites in United States, Belgium and 14 more
- Volunteers
- 70 people
- Sponsor
- Takeda
Colitis, Ulcerative
Study of Clinical Course of Newly Diagnosed Moderate to Severe Ulcerative Colitis in Korea
The purpose of this study is to describe clinical course of newly diagnosed moderate to severe ulcerative colitis (chronic inflammatory disease of the colon) in tertiary referral hospitals in Korea for 5-year follow-up under…
- Trial name
- MOSAIK (NCT02229344)
- Testing
- No Intervention
- Where
- 15 sites in South Korea
- Volunteers
- 368 people
- Sponsor
- Janssen Korea, Ltd., Korea
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
A Study of Adalimumab in Japanese Subjects With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to assess the efficacy and safety of adalimumab in Japanese subjects with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT00853099
- Testing
- adalimumab
- Where
- 65 sites in Japan
- Volunteers
- 274 people
- Sponsor
- AbbVie (prior sponsor, Abbott)
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
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Pediatric Participants With Moderately to Severely or Active Ulcerative Colitis
The main purpose of this study is to investigate efficacy, pharmacokinetics and safety of the drug in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- SHINE-2 (NCT05784246)
- Testing
- Mirikizumab IV, Mirikizumab SC
- Where
- 34 sites in United States, Belgium and 9 more
- Volunteers
- 63 people
- Sponsor
- Eli Lilly and Company
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
Ulcerative Colitis
ABTECT - Maintenance
This is a multicenter, randomized, placebo-controlled study to evaluate the long-term efficacy and safety of ABX464 50mg and 25mg administered once daily (QD) as maintenance therapy in subjects with moderately to severely active…
- Trial name
- NCT05535946
- Testing
- ABX464
- Where
- 413 sites in United States, Argentina and 32 more
- Volunteers
- 1,116 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Infliximab Accelerated Induction in Moderate to Severe Pediatric UC
Objectives: To examine the effect of accelerated infliximab induction in children with moderate to severe UC. Design: A multi-center, prospective, randomized, open label study. Setting: Pediatric gastroenterology centers.
- Trial name
- INDUCE (NCT03209232)
- Testing
- Infliximab
- Where
- Israel
- Volunteers
- 10 people
- Sponsor
- Schneider Children's Medical Center, Israel
Moderately to Severely Active Ulcerative Colitis
A Study to Evaluate the Pharmacokinetics, Safety and Efficacy of Afimkibart (RO7790121) in Children With Moderately to Severely Active Ulcerative Colitis
This Phase III, randomized, double-blind, multicenter, induction and maintenance study will evaluate the safety and efficacy of Afimkibart (RO7790121) in pediatric participants with moderate to severe active ulcerative colitis…
- Trial name
- AMETRINE-PEDS (NCT07158242)
- Testing
- Afimkibart
- Where
- 26 sites in United States, Australia and 7 more
- Volunteers
- 100 people
- Sponsor
- Hoffmann-La Roche
Bacteria, Microbiota
Standardized Fecal Microbiota Transplantation for Ulcerative Colitis
The gut microbiota is considered to constitute a "microbial organ" which has pivotal roles in the intestinal diseases and body's metabolism.
- Conditions
- Bacteria, Microbiota, Fecal Microbiota Transplantation, Inflammatory Bowel Disease
- Trial name
- NCT01790061
- Testing
- Standardized FMT, Traditional treatments
- Where
- China
- Volunteers
- 500 people
- Sponsor
- The Second Hospital of Nanjing Medical University
Ulcerative Colitis
ABTECT-1 - ABX464 Treatment Evaluation for Ulcerative Colitis Therapy -1
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
- NCT05507203
- Testing
- ABX464
- Where
- 264 sites in United States, Argentina and 22 more
- Volunteers
- 639 people
- Sponsor
- Abivax S.A.
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
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
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