Clinical trials: Moderately Active Ulcerative Colitis
Ulcerative Colitis
New Tablet Formulation and Dosing Regimen of Balsalazide Disodium in Mildly to Moderately Active Ulcerative Colitis
The purpose of this study is to establish the efficacy and safety of a new tablet formulation and dosing regimen of balsalazide disodium dosed twice daily in achieving clinical improvement in subjects with mildly to moderately…
- Trial name
- NCT00269438
- Testing
- 5 ASA, enemas, suppositories, corticosteroids
- Where
- 66 sites in United States
- Volunteers
- 225 people, healthy volunteers welcome
- Sponsor
- Bausch Health Americas, Inc.
Ulcerative Colitis, Inflammatory Bowel Diseases
Comparison of Ustekinumab, Infliximab and Combination Therapy in Moderately to Severely Active Ulcerative Colitis
The goal of this clinical trial is to learn if combined therapy with infliximab and ustekinumab works better than using these drugs alone in adult patients with ulcerative colitis.
- Trial name
- COMBO-UC (NCT06453317)
- Testing
- Infliximab, Ustekinumab
- Where
- Poland
- Volunteers
- 172 people
- Sponsor
- Medical University of Lodz
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
An Investigation of Oral BT051 in Subjects With Moderately to Severely Active Ulcerative Colitis (UC)
This is a randomised, double-blind, placebo-controlled study to assess the safety and tolerability of multiple ascending doses of BT051 in subjects with moderately to severely active ulcerative colitis.
- Trial name
- SCOUT (NCT05084261)
- Testing
- BT051 200 mg, BT051 800 mg, BT051 3200 mg
- Where
- 6 sites in United States, Georgia and 2 more
- Volunteers
- 24 people
- Sponsor
- Adiso Therapeutics
Ulcerative Colitis
A Study With GB004 in Adult Subjects With Active Ulcerative Colitis (UC)
A 2-part study, comprising of a 36-week placebo-controlled period (PCP) and a 24-week open-label extension (OLE) period, to assess the efficacy and safety of 2 dose regimens of GB004 when added to background UC therapy of…
- Trial name
- NCT04556383
- Testing
- GB004
- Where
- 77 sites in United States, Georgia and 7 more
- Volunteers
- 236 people
- Sponsor
- GB004, Inc.
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
Curcumin + Aminosalicylic Acid (5ASA) Versus 5ASA Alone in the Treatment of Mild to Moderate Ulcerative Colitis
Ulcerative colitis (UC) is a chronic inflammatory disease resulting in increased morbidity in patients. The current standard treatment for mild to moderate UC (MTMUC) includes 5-aminosalicylic compounds (5ASA) such as olsalazine…
- Trial name
- 5ASA (NCT01320436)
- Testing
- Curcumin, 5-aminosalicylic acid
- Where
- Israel
- Volunteers
- 50 people
- Sponsor
- Sheba Medical Center
Ulcerative Colitis
A Study of AC-101 Tablets in Participants With Moderate to Severe Active Ulcerative Colitis
The purpose of the study is to evaluate the safety, efficacy, and pharmacokinetics of AC-101 tablets in participants with moderate-to-severe ulcerative colitis.
- Trial name
- NCT07083193
- Testing
- AC-101
- Where
- China
- Volunteers
- 25 people
- Sponsor
- Accro Bioscience (Suzhou) Limited
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
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)
Ulcerative Colitis, Active Moderate
Adacolumn in Refractory UC Patients Trial
The objectives of the study are to observe and document the efficacy and safety of 5 or more Adacolumn treatments, administered once weekly over 5 or more weeks, in a specific subset of ulcerative colitis patients.
- Trial name
- ART (NCT01481142)
- Testing
- (GMA) Adsorptive Apheresis
- Where
- France
- Volunteers
- 100 people
- Sponsor
- Otsuka Pharmaceutical Europe Ltd
Ulcerative Colitis (UC)
LIV001 in Patients with Mild-to-Moderate Active Ulcerative Colitis (UC)
A Phase 1b study to evaluate the safety and tolerability of LIV001 in Patients with Mild-to- Moderate Active Ulcerative Colitis
- Trial name
- NCT06749795
- Testing
- LIV001
- Where
- Poland
- Volunteers
- 15 people
- Sponsor
- Liveome Inc.
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
A Study to Evaluate the Efficacy and Safety of ZYIL1 Oral Capsules for the Treatment of Patients With Mild to Moderately Active Ulcerative Colitis Resistant or Intolerant to Oral Aminosalicylates
The purpose of this study is to evaluate efficacy and safety of ZYIL1 oral capsule twice a day for 12 weeks for treatment of mild to moderate active ulcerative colitis resistant or intolerant to oral aminosalicylates.
- Trial name
- NCT06398808
- Testing
- Arm1, Arm 2
- Where
- India
- Volunteers
- 24 people
- Sponsor
- Zydus Lifesciences Limited
Ulcerative Colitis
The Efficacy and Safety of Cobitolimod in Participants With Moderate to Severe Active Left-Sided Ulcerative Colitis
The purpose of the study is to evaluate the efficacy of cobitolimod treatment compared to placebo in inducing clinical remission, in participants with moderate to severe active left-sided UC and to evaluate the efficacy of…
- Trial name
- CONCLUDE (NCT04985968)
- Testing
- Cobitolimod 250 mg, Cobitolimod 500 mg
- Where
- 203 sites in United States, Australia and 26 more
- Volunteers
- 171 people
- Sponsor
- InDex Pharmaceuticals
Ulcerative Colitis
Safety and Efficacy Study of PTG-100 in the Treatment of Moderate to Severe Ulcerative Colitis
The main objectives of this study are to evaluate the efficacy, safety, and tolerability of daily doses of PTG-100 in subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02895100
- Testing
- PTG-100
- Where
- 98 sites in United States, Australia and 15 more
- Volunteers
- 98 people
- Sponsor
- Protagonist Therapeutics, Inc.
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
Efficacy and Safety Study of Ozanimod in Ulcerative Colitis
The purpose of this study is to determine whether RPC1063 is effective in the treatment of ulcerative colitis (UC).
- Trial name
- Touchstone (NCT01647516)
- Testing
- Ozanimod
- Where
- 88 sites in United States, Australia and 13 more
- Volunteers
- 199 people
- Sponsor
- Celgene
Mild to Moderate Ulcerative Colitis
A BE Study Comparing Mesalamine 400 mg to ASACOL® 400 mg in Patients With Mild To Moderately Active Ulcerative Colitis
The objectives of this bioequivalence study in patients with ulcerative colitis (UC) were: To establish the therapeutic equivalence of mesalamine delayed release tablet (MDRT) and Asacol Delayed Release Tablets 2.4 g per day (800…
- Trial name
- NCT01045018
- Testing
- Mesalamine
- Sponsor
- EMET Pharmaceuticals, LLC
Ulcerative Colitis
Open Label Study to Assess Safety, PK and Explore Efficacy of OPRX-106 in Patients With Active Mild to Moderate Ulcerative Colitis
This is a proof of concept, randomized, open label, 2-arm study of OPRX-106 in subjects with active mild to moderate ulcerative colitis.
- Trial name
- NCT02768974
- Testing
- OPRX-106
- Where
- 7 sites in Israel
- Volunteers
- 20 people
- Sponsor
- Protalix