Clinical trials: Moderate to Severe Ulcerative Colitis
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
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
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
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)
Exclusive Enteral Nutrition, Ulcerative Colitis
Combined Application of EEN in the Induction of Remission in PUC
The role of exclusive enteral nutrition (EEN) in the induction of remission in pediatric patients with Crohn's disease had been well documented. But the role of EEN in children with Ulcerative Colitis (UC) was not clear.
- Conditions
- Exclusive Enteral Nutrition, Ulcerative Colitis, Children
- Trial name
- NCT04999241
- Testing
- exclusive enteral nutrition, regular food
- Volunteers
- 40 people
- Sponsor
- Children's Hospital of Fudan University
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
An Observational Study to Assess Change in Disease Activity and Adverse Events of Rinvoq in Adult Participants With Moderate to Severe Ulcerative Colitis (UC) in Japan
Ulcerative colitis (UC) is an idiopathic, chronic, inflammatory disease affecting the colon. Participants with UC have mucosal inflammation starting in the rectum that can extend continuously to proximal segments of the colon.
- Trial name
- NCT05791526
- Where
- 114 sites in Japan
- Volunteers
- 308 people
- Sponsor
- AbbVie
Ulcerative Colitis
An Extension Study for Treatment of Moderately to Severely Active Ulcerative Colitis
The purpose of this open-label extension (OLE) study is to evaluate the safety and efficacy of etrasimod in participants with moderately to severely active ulcerative colitis (UC) who previously received double-blind treatment…
- Trial name
- ELEVATE UC OLE (NCT03950232)
- Testing
- Etrasimod
- Where
- 472 sites in United States, Argentina and 37 more
- Volunteers
- 896 people
- Sponsor
- Pfizer
Ulcerative Colitis (UC)
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis…
- Trial name
- U-Accomplish (NCT03653026)
- Testing
- Upadacitinib
- Where
- 379 sites in United States, Argentina and 42 more
- Volunteers
- 522 people
- Sponsor
- AbbVie
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
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in…
- Trial name
- NCT00347048
- Testing
- tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Colitis, Ulcerative
A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction…
- Trial name
- QUASAR Jr (NCT06260163)
- Testing
- Guselkumab Subcutaneous, Guselkumab Intravenous
- Where
- 61 sites in United States, Australia and 11 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
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
Ulcerative Colitis
Study to Assess Change in Disease Activity of Risankizumab Treatment in Japanese Participants With Moderate to Severe Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease that causes inflammation and bleeding from the lining of the rectum and colon (large intestine).
- Trial name
- RISE UP (NCT07136116)
- Where
- 29 sites in Japan
- Volunteers
- 200 people
- Sponsor
- AbbVie
Colitis, Ulcerative
A Study to Assess the Efficacy and Safety of Golimumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate efficacy of golimumab in inducing clinical remission as assessed by the Mayo score, in pediatric participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- PURSUIT 2 (NCT03596645)
- Testing
- Golimumab, Infliximab
- Where
- 58 sites in United States, Belgium and 9 more
- Volunteers
- 84 people
- Sponsor
- Janssen Research & Development, LLC
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
Moderately to Severely Active Ulcerative Colitis
A Study to Assess the Efficacy and Safety of Induction Therapy With Afimkibart (Also Known as RO7790121) in Participants With Moderately to Severely Active Ulcerative Colitis
This Phase III, multicenter, double-blind, placebo-controlled study will evaluate the efficacy and safety of induction therapy with Afimkibart (RO7790121) compared with placebo in participants with moderately to severely active…
- Trial name
- Ametrine-2 (NCT06588855)
- Testing
- Afimkibart
- Where
- 168 sites in United States, Argentina and 27 more
- Volunteers
- 350 people
- Sponsor
- Hoffmann-La Roche
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis, Infliximab
Top Down Versus Step up in Pediatric Ulcerative Colitis
Pediatric Ulcerative Colitis (UC) patients with moderate to severe disease activity at high risk of colectomy. Early use of biologic agents will likely be more effective.
- Conditions
- Ulcerative Colitis, Infliximab, Children
- Trial name
- NCT04999228
- Testing
- Infliximab, Corticosteroids
- Where
- China
- Volunteers
- 40 people
- Sponsor
- Children's Hospital of Fudan University
Ulcerative Colitis
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
- Trial name
- NCT02039505
- Testing
- Vedolizumab
- Where
- 59 sites in Japan
- Volunteers
- 292 people
- Sponsor
- Takeda