Clinical trials: Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis, Crohn's Disease
Vedolizumab Subcutaneous (SC) Versus Intravenous (IV) in Ulcerative Colitis or Crohn's Disease
The purpose of this study is to assess the bioavailability and pharmacokinetics (PK) of multiple doses of vedolizumab subcutaneous (SC) compared to vedolizumab intravenous (IV).
- Trial name
- NCT02913508
- Testing
- Vedolizumab intravenous injection, Vedolizumab subcutaneous injection
- Sponsor
- Takeda
Colitis, Ulcerative
A Study Evaluating the Efficacy and Safety of ST-0529 in Subjects With Moderately to Severely Active Ulcerative Colitis
Study CYC-202 is a multicenter, randomized, double-blind, placebo-controlled, parallel-group study to evaluate the efficacy and safety of ST-0529 in subjects with moderately to severely active UC, defined as a score of 5 to 9 on…
- Trial name
- NCT03844932
- Testing
- ST-0529
- Where
- 89 sites in United States, Belarus and 15 more
- Volunteers
- 235 people
- Sponsor
- Sublimity Therapeutics Holdco Limited
Ulcerative Colitis (UC)
Study to Evaluate the Efficacy and Safety of Ponesimod (VSP-128) in Patients With Moderately to Severely Active Ulcerative Colitis
A multicenter, randomized, double-blind, placebo-controlled study to evaluate the efficacy and safety of Ponesimod (VSP-128) in patients with moderately to severely active ulcerative colitis
- Trial name
- NCT07686081
- Testing
- Ponesimod
- Where
- 2 sites in United States
- Volunteers
- 150 people
- Sponsor
- Vanda Pharmaceuticals
Ulcerative Colitis
An Induction Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Ulcerative Colitis
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, Phase 3 induction study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Ulcerative Colitis…
- Trial name
- SUNSCAPE-1 (NCT07184996)
- Testing
- Duvakitug
- Where
- 240 sites in United States, Argentina and 23 more
- Volunteers
- 980 people
- Sponsor
- Sanofi
Ulcerative Colitis
Study to Evaluate the Efficacy and Safety of Filgotinib in the Induction and Maintenance of Remission in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objectives of this study are to evaluate the efficacy of filgotinib in the induction and maintenance treatment of moderately to severely active ulcerative colitis (UC) in participants who are biologic-naive and…
- Trial name
- SELECTION (NCT02914522)
- Testing
- Filgotinib, PTM filgotinib
- Where
- 343 sites in United States, Argentina and 38 more
- Volunteers
- 1,351 people
- Sponsor
- Gilead Sciences
Colitis, Ulcerative
Safety and Tolerability Study of GSK2586184 in Patients With Moderate to Severely Active Ulcerative Colitis.
This is an open label exploratory study to investigate the safety of 400 milligram (mg ) twice a day (b.i.d.) GSK2586184 in patients with moderate to severe, active ulcerative colitis (UC).
- Trial name
- NCT02000453
- Testing
- GSK2586184 400mg
- Where
- Netherlands
- Volunteers
- 2 people
- Sponsor
- GlaxoSmithKline
Ulcerative Colitis (UC)
Study to Evaluate the Safety and Efficacy of Two Adalimumab Dosing Regimens in Subjects With Moderate to Severe Ulcerative Colitis
To evaluate safety and efficacy of two adalimumab dosing regimens for induction and maintenance (standard and higher dosing) in achieving clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT02065622
- Testing
- Adalimumab
- Where
- 173 sites in United States, Austria and 18 more
- Volunteers
- 952 people
- Sponsor
- AbbVie
Colitis, Ulcerative, Crohn Disease
A Master Protocol (IIBD): A Study of Multiple Drugs in Adults With Ulcerative Colitis or Crohn's Disease
Study IIBD is a master protocol that will support a collection of individual sub studies that share key design components. Participants will be assigned to the appropriate study prior to randomization to a treatment group.
- Trial name
- NCT07483073
- Testing
- Mirikizumab - Intravenous (IV), Mirikizumab - Subcutaneous (SC), LY4395089
- Where
- 70 sites in United States, Belgium and 8 more
- Volunteers
- 60 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
Efficacy and Safety of LC51-0255 in Subjects With Ulcerative Colitis
This is a Phase 2, multi center, randomized, placebo controlled parallel group study to evaluate the clinical efficacy and safety of LC51 0255 in subjects with moderately to severely active ulcerative colitis
- Trial name
- NCT04096573
- Testing
- LC51-0255
- Sponsor
- LG Chem
Ulcerative Colitis
An Induction Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis (LUCENT 1)
The purpose of this study is to evaluate the safety and efficacy of Mirikizumab in participants with moderately to severely active ulcerative colitis (UC) who have had an inadequate response to, loss of response, or intolerant to…
- Trial name
- NCT03518086
- Testing
- Mirikizumab
- Where
- 502 sites in United States, Argentina and 33 more
- Volunteers
- 1,281 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
Prospective Observational Study of Effectiveness and Safety of Filgotinib in Participants With Ulcerative Colitis (UC)
To describe the effectiveness, treatment patterns, quality of life, and safety of participants with moderately or severely active UC treated with filgotinib in a real-world setting.
- Trial name
- GALOCEAN (NCT05817942)
- Testing
- Filgotinib
- Where
- 81 sites in Austria, Belgium and 8 more
- Volunteers
- 509 people
- Sponsor
- Alfasigma S.p.A.
Colitis, Ulcerative
A Study of Combination Therapy With Guselkumab and Golimumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of JNJ-78934804 as compared to guselkumab and golimumab in participants with moderately to severely active ulcerative colitis who have had an inadequate initial…
- Trial name
- DUET-UC (NCT05242484)
- Testing
- Guselkumab, Golimumab, JNJ-78934804
- Where
- 403 sites in United States, Argentina and 35 more
- Volunteers
- 577 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®
- Trial name
- UCESIVE (NCT05771155)
- Testing
- Intravenous (IV) infusions
- Where
- Georgia
- Volunteers
- 750 people
- Sponsor
- Polpharma Biologics S.A.
Ulcerative Colitis
A Study of AK101 in Subjects With Moderately to Severely Active Ulcerative Colitis
This is a Phase Ib clinical study to evaluate the safety, tolerance, pharmacokinetics and efficacy of AK101 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT06281704
- Testing
- AK101 IV, AK101 SC, AK101 IV/AK101 SC
- Where
- 12 sites in China
- Volunteers
- 34 people
- Sponsor
- Akeso
Crohn's Disease, Ulcerative Colitis
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel.
- Trial name
- NCT06764615
- Testing
- Zasocitinib
- Where
- 16 sites in United States, China and 6 more
- Volunteers
- 192 people
- Sponsor
- Takeda
Colitis, Ulcerative
A Study of the Efficacy and Safety of Etrolizumab Treatment in Maintenance of Disease Remission in Ulcerative Colitis (UC) Participants Who Are Naive to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, randomized, double-blind, parallel-grouped, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab in maintenance of remission in participants with moderately to severely…
- Trial name
- LAUREL (NCT02165215)
- Testing
- Etrolizumab
- Where
- 104 sites in United States, Brazil and 13 more
- Volunteers
- 359 people
- Sponsor
- Hoffmann-La Roche
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
Crohn Disease, Ulcerative Colitis
Evaluation of the Safety, Tolerability, and Efficacy of MDGN-002 in Adults With Moderate to Severe Active Crohn's Disease or Ulcerative Colitis
This is a Phase 1b, open-label, dose-escalation, signal-finding, multi-center study. The study will evaluate the safety, tolerability, pharmacokinetics and short-term efficacy of MDGN-002 in adults with moderate to severe, active…
- Trial name
- NCT03169894
- Testing
- MDGN-002
- Where
- 13 sites in United States
- Volunteers
- 8 people
- Sponsor
- Avalo Therapeutics, Inc.
Colitis, Ulcerative
Induction and Maintenance Study of BMS-936557 Patients With Moderate to Severe Ulcerative Colitis
The purpose of this study is to determine whether BMS-936557 is effective in the treatment of moderate to severely active ulcerative colitis in patients who have had insufficient response and/or intolerance to other medical…
- Trial name
- NCT01294410
- Testing
- Anti-IP-10 Antibody
- Where
- 75 sites in United States, Australia and 12 more
- Volunteers
- 305 people
- Sponsor
- Bristol-Myers Squibb
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.