Clinical trials: Moderately to Severely Active Ulcerative Colitis
Ulcerative Colitis
Safety and Efficacy of Etrasimod (APD334) in Patients With Ulcerative Colitis
The purpose of this study is to determine whether etrasimod is a safe and effective treatment for ulcerative colitis.
- Trial name
- NCT02447302
- Testing
- Etrasimod
- Where
- 134 sites in United States, Australia and 19 more
- Volunteers
- 156 people
- Sponsor
- Arena Pharmaceuticals
Ulcerative Colitis
A Study of Guselkumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of guselkumab in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- QUASAR (NCT04033445)
- Testing
- Guselkumab
- Where
- 392 sites in United States, Argentina and 32 more
- Volunteers
- 1,064 people
- Sponsor
- Janssen Research & Development, LLC
Colitis, Ulcerative
A Study of Guselkumab Therapy in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy, including clinical remission of guselkumab subcutaneous (SC) induction compared to placebo in participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- ASTRO (NCT05528510)
- Testing
- Guselkumab Dose 1, Guselkumab Dose 2, Guselkumab Dose 3
- Where
- 236 sites in United States, Argentina and 23 more
- Volunteers
- 418 people
- Sponsor
- Janssen Research & Development, LLC
Ulcerative Colitis
Study to Evaluate the Efficacy and Safety of Tilpisertib in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objective of this study is to demonstrate the efficacy of tilpisertib (formerly GS-4875) compared with placebo control in achieving clinical remission per modified Mayo Clinic Score (MCS) in adults with moderately to…
- Trial name
- Falcon (NCT04130919)
- Testing
- Tilpisertib
- Where
- 49 sites in United States, Australia and 7 more
- Volunteers
- 19 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis
The Efficacy of Cobitolimod in Patients With Moderate to Severe Active Ulcerative Colitis
The purpose of this study was to evaluate efficacy of cobitolimod treatment at different dose levels and frequencies compared to placebo in patients with moderate to severe left-sided ulcerative colitis.
- Trial name
- CONDUCT (NCT03178669)
- Testing
- cobitolimod
- Where
- 64 sites in Czechia, France and 8 more
- Volunteers
- 213 people
- Sponsor
- InDex Pharmaceuticals
Ulcerative Colitis
A Study to Evaluate the Efficacy, Safety, and Pharmacokinetics of Vixarelimab in Participants With Moderate to Severe Ulcerative Colitis (UC)
The purpose of this study is to evaluate the efficacy, safety, and pharmacokinetics (PK) of vixarelimab compared with placebo in participants with moderate to severe UC who have demonstrated inadequate response to, loss of…
- Trial name
- NCT06137183
- Testing
- Vixarelimab
- Where
- 65 sites in United States, Brazil and 10 more
- Volunteers
- 79 people
- Sponsor
- Genentech, Inc.
Inflammatory Bowel Diseases, Colitis, Ulcerative
A Study to Evaluate MORF-057 in Adults With Moderately to Severely Active UC
This is a Phase 2b randomized, double-blind, placebo-controlled study to evaluate the safety and efficacy of three active dose regimens of MORF-057 in adult patients with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- EMERALD-2 (NCT05611671)
- Testing
- MORF-057
- Where
- 102 sites in United States, Australia and 19 more
- Volunteers
- 280 people
- Sponsor
- Morphic Therapeutic, Inc. (A Wholly Owned Subsidiary of Eli Lilly and Company)
Ulcerative Colitis
A Phase 2 Safety and Efficacy Study of Tulisokibart (MK-7240/PRA023) in Subjects With Moderately to Severely Active Ulcerative Colitis (MK-7240-005)
The purpose of this study is to assess the safety and efficacy of tulisokibart in participants with moderately to severely active Ulcerative Colitis (UC).
- Trial name
- ARTEMIS-UC (NCT04996797)
- Testing
- Tulisokibart, Companion Diagnostic (CDx) Testing
- Where
- 88 sites in United States, Australia and 10 more
- Volunteers
- 178 people
- Sponsor
- Prometheus Biosciences, Inc., a subsidiary of Merck & Co., Inc. (Rahway, New Jersey USA)
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Acute Ulcerative Colitis
The objective of this study is to assess the efficacy and safety of adalimumab for the induction of clinical remission in subjects with moderately to severely active ulcerative colitis.
- Trial name
- NCT00385736
- Testing
- adalimumab
- Where
- 80 sites in United States, Austria and 11 more
- Volunteers
- 576 people
- Sponsor
- Abbott
Colitis, Ulcerative
An Efficacy and Safety Study of Golimumab in Participants With Ulcerative Colitis
The purpose of this study is to assess the effects (good and bad) of golimumab (CNTO 148) therapy in participants with active ulcerative colitis (UC) (sores in the colon).
- Trial name
- NCT00488774
- Testing
- Golimumab 1 mg per kg, Golimumab 2 mg per kg, Golimumab 4 mg per kg
- Where
- 108 sites in United States, Australia and 20 more
- Volunteers
- 291 people
- Sponsor
- Janssen Research & Development, LLC
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
Extension Study of APD334-003 in Patients With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to determine whether etrasimod (APD334) is a safe and effective treatment for ulcerative colitis after 52 weeks of treatment.
- Trial name
- NCT02536404
- Testing
- Etrasimod
- Where
- 127 sites in United States, Australia and 19 more
- Volunteers
- 118 people
- Sponsor
- Arena Pharmaceuticals
Colitis, Ulcerative
Correlation of Soluble Suppression of Tumorigenicity 2 (ST2) With Golimumab (MK-8259) Response in Participants With Ulcerative Colitis (UC) (MK-8529-022).
The purpose of this study is to evaluate serum soluble human ST2 protein, the receptor for Interleukin-33 (IL-33) and a member of the proinflammatory Interleukin-1 (IL-1) receptor superfamily, as a surrogate biological marker…
- Trial name
- EVOLUTION (NCT02318667)
- Testing
- Golimumab
- Volunteers
- 38 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
Efficacy&Safety of ALTB-168 in Patients With Moderate to Severe Active,Anti-TNF Alpha and/or Anti-integrin Refractory UC
To evaluate the efficacy and safety of Neihulizumab (ALTB-168) administered intravenously in patients with moderate to severe active ulcerative colitis who are refractory or intolerant to anti-Tumor Necrosis Factor α and/or…
- Trial name
- TNF (NCT03298022)
- Testing
- ALTB-168
- Where
- 12 sites in United States, Puerto Rico
- Volunteers
- 24 people
- Sponsor
- AltruBio Inc.
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Subjects With Moderately to Severely Active Ulcerative Colitis
This was a Phase 3, multicenter, randomized, double-blind, placebo-controlled trial designed to evaluate the efficacy and safety of the human anti-tumor necrosis factor (TNF) monoclonal antibody adalimumab (ADA) in patients with…
- Trial name
- NCT00408629
- Testing
- adalimumab
- Where
- 108 sites in United States, Argentina and 16 more
- Volunteers
- 518 people
- Sponsor
- Abbott
Ulcerative Colitis
Oral Etrasimod Versus Placebo for the Treatment of Moderately to Severely Active Ulcerative Colitis in Adult Japanese Participants (ELEVATE UC 40 JAPAN)
The purpose of this study is to determine whether oral etrasimod is a safe and effective treatment in adult Japanese participants with moderately to severely active ulcerative colitis (UC).
- Trial name
- NCT04706793
- Testing
- Etrasimod
- Where
- 38 sites in Japan
- Volunteers
- 42 people
- Sponsor
- Pfizer
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
Efficacy & Safety of Infliximab Monotherapy Vs Combination Therapy Vs AZA Monotherapy in Ulcerative Colitis (Part 1) Maintenance Vs Intermittent Therapy for Maintaining Remission (Part 2)(Study P04807)
Part 1 of this study is a 3-arm, randomized, active-controlled, parallel-group, multicenter, double-blind, double-dummy, 16-week study to compare the efficacy and safety of infliximab (IFX), as monotherapy or in combination with…
- Trial name
- NCT00537316
- Testing
- Infliximab (IFX), Azathioprine (AZA)
- Volunteers
- 242 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
Safety and Efficacy of Andecaliximab (GS-5745) in Adults With Moderately to Severely Active Ulcerative Colitis
The primary objectives of this study are as follows: 1) To evaluate the efficacy of andecaliximab to induce endoscopy, rectal bleeding, and stool frequency (EBS) clinical remission at Week 8 (Cohort 1); 2) To evaluate the…
- Trial name
- NCT02520284
- Testing
- Andecaliximab
- Where
- 87 sites in United States, Australia and 21 more
- Volunteers
- 165 people
- Sponsor
- Gilead Sciences
Ulcerative Colitis
A Maintenance Study of Mirikizumab in Participants With Moderately to Severely Active Ulcerative Colitis
The purpose of this study is to evaluate the efficacy and safety of mirikizumab as maintenance therapy in participants who completed as clinical responders in the prior 12-week induction study LUCENT-1 (NCT03518086).
- Trial name
- LUCENT 2 (NCT03524092)
- Testing
- Mirikizumab SC, Mirikizumab IV
- Where
- 385 sites in United States, Argentina and 32 more
- Volunteers
- 1,328 people
- Sponsor
- Eli Lilly and Company