Clinical trials: Moderate-to-severe Ulcerative Colitis
Ulcerative Colitis
Study to Investigate Comparative Efficacy, Safety and Immunogenicity Between AVT16 and Entyvio
The study has been designed as a randomised, parallel-group, double-blind, 2 arm study of the comparative efficacy, safety and immunogenicity of AVT16 and Entyvio in male and female subjects with moderate to severe active…
- Trial name
- NCT06570772
- Testing
- AVT16, Vedolizumab
- Where
- 100 sites in Argentina, Bulgaria and 9 more
- Volunteers
- 301 people
- Sponsor
- Alvotech Swiss AG
Inflammatory Bowel Diseases, Crohn Disease
Real Life Remote Monitoring of Mild, Moderate and Severe Infectious Complications in IBD by Patient Reported Assessment
Inflammatory bowel disease (IBD) is a chronic relapsing immune mediated inflammatory disease (IMID) of the gastrointestinal tract. Like all IMIDs (e.g.
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Ulcerative Colitis, IBD
- Trial name
- NCT04151420
- Testing
- Remote monitoring tool (infections questionnaire) validation
- Where
- 2 sites in Netherlands
- Volunteers
- 584 people
- Sponsor
- Maastricht University Medical Center
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
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
Ulcerative Colitis
Long-term Safety and Efficacy of Efavaleukin Alfa in Participants With Moderately to Severely Active Ulcerative Colitis
The primary objective of this study is to evaluate the long-term safety and tolerability of efavaleukin alfa in participants with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT05672199
- Testing
- Efavaleukin alfa
- Where
- 25 sites in United States, Argentina and 11 more
- Volunteers
- 25 people
- Sponsor
- Amgen
Ulcerative Colitis
Efficacy and Safety of Adalimumab for the Induction of Clinical Response in Ulcerative Colitis
The purpose of this study is to assess the clinical benefit and tolerability of adalimumab, a fully human monoclonal antibody to tumor necrosis factor α (TNF- α), in patients with ulcerative colitis (UC) naive to treatment with…
- Trial name
- NCT01494857
- Testing
- Adalimumab
- Where
- 3 sites in Israel
- Volunteers
- 200 people
- Sponsor
- Clalit Health Services
Ulcerative Colitis
A Phase 3 Study to Investigate the Efficacy and Safety of SHR0302 With Moderately to Severely Active Ulcerative Colitis
This is a randomized, double-blind, placebo-controlled, multicenter Phase 3 study that will enroll approximately 368 subjects aged 18 to 75 years old with Moderately to Severely Active Ulcerative Colitis.
- Trial name
- NCT05181137
- Testing
- SHR0302
- Where
- 113 sites in United States, China and 3 more
- Volunteers
- 368 people
- Sponsor
- Reistone Biopharma Company Limited
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
Ulcerative Colitis
Corticosteroids+5-aminosalicylic Acid Compared to Corticosteroids in the Treatment of Moderate-severe Ulcerative Colitis
The role of steroids in the treatment of ulcerative Colitis (UC) is well established, and recommended by professional societies.
- Trial name
- NCT01941589
- Testing
- oral 5-ASA+/-topical 5-ASA+IV corticosteroids / PO Methylprednisolone, corticosteroids only
- Where
- 10 sites in China, France and 5 more
- Volunteers
- 149 people
- Sponsor
- Sheba Medical Center
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 Chronic Moderate, Ulcerative Colitis Chronic Severe
Comparison Between Bowel Ultrasound-based Treat to Target Versus Routine Treat to Target Strategies in Ulcerative Colitis
UC (UC) is a chronic, relapsing and destructive inflammatory disorder of the colon which can lead to organ damage and impair quality of life.
- Trial name
- NCT05735665
- Testing
- bowel ultrasound, colonoscopy
- Where
- Italy
- Volunteers
- 250 people
- Sponsor
- IRCCS San Raffaele
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
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 Evaluating the Long-term Safety and Efficacy of ABX464 in Active Ulcerative Colitis
This study is an open-label study aiming at evaluating the long-term safety and the efficacy profile of ABX464 given once a day (o.d) at 50 mg in subjects who have been previously enrolled in the ABX464-101 clinical study…
- Trial name
- NCT03368118
- Testing
- ABX464
- Where
- Belgium
- Volunteers
- 22 people
- Sponsor
- Abivax S.A.
Moderate to Severe Ulcerative Colitis
Phase II Study of Hemay005 in Patients With Active Ulcerative Colitis
This study is a multicenter, randomized, double-blind study. There are three dosage groups: Hemay005 45 mg BID group, 60 mg BID group or placebo group, with 36 patients in each dosage group.
- Trial name
- NCT05486104
- Testing
- Hemay005 tablets
- Where
- 18 sites in China
- Volunteers
- 92 people
- Sponsor
- Ganzhou Hemay Pharmaceutical Co., Ltd
Ulcerative Colitis (UC)
Study of the Efficacy, Safety, Pharmacokinetics, Pharmacodynamics, and Immunogenicity of BCD-261 in Subjects With Moderate to Severe Active Ulcerative Colitis
The aim of the study is to evaluate the efficacy, safety, pharmacokinetics, pharmacodynamics and immunogenicity of study drug (BCD-261) in comparison with placebo and to characterize the dose-response relationship in patients…
- Trial name
- ULTRAMARINE (NCT07080034)
- Testing
- anti-TL1A monoclonal antibody, low dose, anti-TL1A monoclonal antibody, medium dose, anti-TL1A monoclonal antibody, high dose
- Where
- 20 sites in Russia
- Volunteers
- 198 people
- Sponsor
- Biocad
Ulcerative Colitis (UC)
A Study for HSK47388 in Participants With Ulcerative Colitis
The purpose of this protocol is to evaluate the efficacy and safety of HSK47388 as therapy in participants with moderately to severely active ulcerative colitis .
- Trial name
- NCT07335055
- Testing
- HSK47388
- Where
- China
- Volunteers
- 150 people
- Sponsor
- Haisco Pharmaceutical Group Co., Ltd.
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 (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
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.