Clinical trials: Moderate Ulcerative Colitis
Ulcerative Colitis
(CB-01-02/02) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
This will be a multicentre, randomised, double-blind, double-dummy, parallel group comparative study in patients with mild or moderate, active ulcerative colitis.
- Trial name
- NCT00679380
- Testing
- Blood sampling, endoscopy, Budesonide MMX® 6 mg, Budesonide MMX® 9 mg
- Where
- 71 sites in Australia, Belgium and 13 more
- Volunteers
- 514 people
- Sponsor
- Bausch Health Americas, Inc.
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
Ulcerative Colitis
Randomized Placebo-Controlled Trial of Budesonide Multi-Matrix System (MMX®) 9 Milligrams (mg) in Participants With Ulcerative Colitis Currently on a 5-Aminosalicylic Acid (5-ASA)
This study is to compare the efficacy and safety of budesonide MMX 9 mg versus placebo as add-on therapy to an existing oral 5-ASA regimen for the induction of remission in participants with active mild or moderate ulcerative…
- Trial name
- NCT01532648
- Testing
- Budesonide MMX®, 5-ASA
- Where
- 114 sites in United States, Bulgaria and 9 more
- Volunteers
- 510 people
- Sponsor
- Bausch Health Americas, Inc.
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
Colitis, Ulcerative
BI655130 (SPESOLIMAB) Induction Treatment in Patients With Moderate-to-severe Ulcerative Colitis
This trial has two sequentially enrolling parts with different objectives. The primary objectives of this trial are to prove the concept of clinical activity of BI655130 (SPESOLIMAB) in patients with moderate-to-severely active…
- Trial name
- NCT03482635
- Testing
- Spesolimab
- Where
- 54 sites in United States, Austria and 10 more
- Volunteers
- 98 people
- Sponsor
- Boehringer Ingelheim
Ulcerative Colitis
A Study of Mirikizumab (LY3074828) in Children and Teenagers With Ulcerative Colitis (UC)
This study was designed to evaluate how the body processes and removes mirikizumab. The study also evaluated safety and disease response in pediatric participants with UC taking mirikizumab.
- Trial name
- SHINE-1 (NCT04004611)
- Testing
- Mirikizumab
- Where
- 37 sites in United States, Canada and 3 more
- Volunteers
- 26 people
- Sponsor
- Eli Lilly and Company
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
Crohn Disease, Colitis, Ulcerative
A Study to Evaluate Disease Control, Treatment Patterns, Burden of Disease and Quality of Life in Participants With Moderate to Severe Inflammatory Bowel Disease (IBD)
The purpose of this study is to evaluate the percentage of moderate to severe IBD participants with active disease at Day 1.
- Conditions
- Crohn Disease, Colitis, Ulcerative, Inflammatory Bowel Disease
- Trial name
- RISE AR (NCT03488030)
- Where
- 7 sites in Argentina
- Volunteers
- 246 people
- Sponsor
- Takeda
Inflammatory Bowel Diseases
Shingrix Vaccine in Patients With Moderate to Severe Ulcerative Colitis on Tofacitinib
Patients with ulcerative colitis (UC), a chronic inflammatory bowel disease (IBD), have been shown to be at increased risk of developing certain infections, such as shingles from the Herpes Zoster (HZ) virus, as a result of their…
- Trial name
- NCT03591770
- Testing
- SHINGRIX
- Where
- United States
- Volunteers
- 15 people
- Sponsor
- Boston Medical Center
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.
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 (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
Ulcerative Colitis, Digestive System Diseases
Study of a Monoclonal Antibody KHK4083 in Moderate Ulcerative Colitis
The purpose of this study is to determine the safety and tolerability of administration of multiple ascending doses of KHK4083 and to select the highest dose tolerated by subjects with moderately active Ulcerative Colitis (UC)…
- Conditions
- Ulcerative Colitis, Digestive System Diseases, Colitis, Ulcerative, Colitis
- Trial name
- NCT02647866
- Testing
- KHK4083
- Where
- 23 sites in United States, Czechia and 5 more
- Volunteers
- 66 people
- Sponsor
- Kyowa Kirin, Inc.
Ulcerative Colitis, Ulcerative Colitis Chronic
A Study of Mirikizumab (LY3074828) in Participants With Moderately to Severely Active Ulcerative Colitis
A study to investigate bowel urgency in adults with moderately to severely active ulcerative colitis (UC) treated with mirikizumab. The study will have 4 periods and will last for 36 weeks.
- Trial name
- LUCENT-URGE (NCT05767021)
- Testing
- Mirikizumab
- Where
- 120 sites in United States, Belgium and 8 more
- Volunteers
- 172 people
- Sponsor
- Eli Lilly and Company
Ulcerative Colitis
Safety and Efficacy of Deucravacitinib in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety and efficacy of oral deucravacitinib in participants with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT03934216
- Testing
- BMS-986165
- Where
- 107 sites in United States, Australia and 11 more
- Volunteers
- 131 people
- Sponsor
- Bristol-Myers Squibb
Colitis, Ulcerative
Conventional Step-Up Versus Infliximab Monotherapy in Patients With Ulcerative Colitis (P05553)
This study will be performed to compare the efficacy and safety of the classical "Step-Up" approach for treatment of moderate-to-severe active ulcerative colitis using oral prednisolone + oral 5-aminosalicylic acid (5-ASA) or…
- Trial name
- MUNIX (NCT00984568)
- Testing
- Infliximab, Prednisolone, 5-aminosalicylic acid
- Volunteers
- 28 people
- Sponsor
- Merck Sharp & Dohme LLC
Ulcerative Colitis
An Extension Study of RPC1063 as Therapy for Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the long-term safety and efficacy of RPC1063 in participants with moderately to severely active ulcerative colitis.
- Trial name
- NCT02531126
- Testing
- RPC1063
- Where
- 41 sites in United States, Australia and 18 more
- Volunteers
- 877 people
- Sponsor
- Celgene
Ulcerative Colitis
(CB-01-02/01) Randomized Placebo Controlled Trial of Budesonide-multi-matrix System (MMX™) 6 mg and 9 mg in Patients With Ulcerative Colitis
The purpose of this study is to compare Budesonide MMX™ 6 mg and Budesonide MMX™ 9 mg tablets to placebo and to Asacol 6x 400 mg tablets over an 8-week treatment period to determine if Budesonide MMX™ is effective in the…
- Trial name
- NCT00679432
- Testing
- Blood sampling, endoscopy, budesonide-MMX® 6 mg, budesonide-MMX® 9 mg
- Where
- 105 sites in United States, Canada and 2 more
- Volunteers
- 510 people
- Sponsor
- Bausch Health Americas, Inc.
Colitis, Ulcerative
A Study of Ustekinumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis (UC)
The purpose of this study is to evaluate: a) the efficacy of ustekinumab dosing in inducing clinical remission, b) safety profile of ustekinumab, and c) ustekinumab exposure (pharmacokinetics [PK]) in pediatric participants with…
- Trial name
- UNIFI Jr (NCT04630028)
- Testing
- Ustekinumab Dose Based on BSA and Body Weight
- Where
- 58 sites in United States, Belgium and 7 more
- Volunteers
- 112 people
- Sponsor
- Janssen Research & Development, LLC
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.