Clinical trials: Moderate-to-severe Ulcerative Colitis
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
A Study to Evaluate Etrasimod Treatment in Adolescents With 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 adolescents (≥ 12 years up to < 18 years of age).
- Trial name
- NCT05287126
- Testing
- Etrasimod
- Where
- 47 sites in United States, Japan and 3 more
- Volunteers
- 36 people
- Sponsor
- Pfizer
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
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.
Crohn's Disease, Ulcerative Colitis
Expanded Access to Vedolizumab for Children and Teenagers With Ulcerative Colitis or Crohn's Disease in the USA
The expanded access program (EAP) allows people to gain access to an unlicensed treatment on compassionate grounds. This EAP provides children and teenagers with Ulcerative Colitis (UC) or Crohn's Disease (CD) who completed the…
- Trial name
- NCT06856135
- Testing
- Vedolizumab IV
- Where
- 3 sites in United States
- Sponsor
- Takeda
Ulcerative Colitis
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multicenter, randomized, double-blind, placebo-controlled Phase 3 maintenance study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- SUNSCAPE-2 (NCT07185009)
- Testing
- Duvakitug
- Where
- 171 sites in United States, Argentina and 29 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
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
A Study of the Safety and Efficacy of Infliximab(REMICADE ) in Pediatric Patients With Moderately to SeverelyActive Ulcerative Colitis
The purpose of the study is to evaluate the effectiveness and safety of infliximab (Remicade) in children with moderately to severely active ulcerative colitis.
- Trial name
- NCT00336492
- Testing
- infliximab
- Where
- 27 sites in United States, Belgium and 3 more
- Volunteers
- 60 people
- Sponsor
- Centocor, Inc.
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
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
Inflammatory Bowel Disease (IBD), CD - Crohn's Disease
Prophylactic Dexamethasone Before Infliximab in Moderate-to-Severe IBD
This comparative observational cohort clinical study aims to investigate the necessity of premedication for allergy prevention prior to infliximab injection, and is designed to evaluate whether non-routine administration of…
- Conditions
- Inflammatory Bowel Disease (IBD), CD - Crohn's Disease, UC - Ulcerative Colitis
- Trial name
- PA (NCT07385131)
- Testing
- Dexamethasone (IV)
- Where
- China
- Volunteers
- 300 people
- Sponsor
- Second Affiliated Hospital, Zhejiang University, School of Medicine
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
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
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
Ulcerative Colitis (UC)
A Study to Evaluate the Safety and Efficacy of Upadacitinib (ABT-494) for Induction and Maintenance Therapy in Participants With Moderately to Severely Active Ulcerative Colitis (UC)
This study was comprised of three substudies. The objective of Substudy 1 was to characterize the dose-response, efficacy, and safety of upadacitinib compared to placebo in inducing clinical remission to identify the induction…
- Trial name
- NCT02819635
- Testing
- Upadacitinib
- Where
- 496 sites in United States, Argentina and 44 more
- Volunteers
- 1,302 people
- Sponsor
- AbbVie
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
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.
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, 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
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