Clinical trials: Colitis
Ulcerative Colitis
Safety and Efficacy of Asacol 4.8 g/Day Versus Asacol 2.4 g/Day (ASCEND I)
The purpose of this study is to evaluate the safety and efficacy of Asacol 4.8 g/day (800 mg tablet) versus Asacol 2.4 g/day (400 mg tablet
- Trial name
- ASCEND I (NCT00577473)
- Testing
- mesalamine
- Where
- 44 sites in United States
- Volunteers
- 301 people
- Sponsor
- Warner Chilcott
Ulcerative Colitis
Research Study in Patients With Severe Ulcerative Colitis
The purpose of the study is to evaluate an intravenous (by injection) investigational medication to treat severe ulcerative colitis refractory to steroid therapy.
- Trial name
- NCT00032305
- Testing
- Visilizumab
- Where
- 7 sites in United States
- Volunteers
- 20 people
- Sponsor
- Facet Biotech
Ulcerative Colitis
Trial on Profermin and Fresubin in Ulcerative Colitis
This study aim to investigate the effect of Profermin versus Fresubin in the dietetic treatment of active ulcerative colitis.
- Trial name
- CUPE2 (NCT01193894)
- Testing
- Profermin, Fresubin
- Where
- Denmark
- Volunteers
- 73 people
- Sponsor
- Nordisk Rebalance A/S
Inflammatory Bowel Disease, Colitis, Ulcerative
LMT503 First-in-human SAD, MAD, and FE Study
This is a double-blind, randomized, placebo-controlled study, consisting of a single ascending dose (SAD) part with integrated food effect (FE) arm, and a multiple ascending dose (MAD) part to assess the safety, tolerability, and…
- Conditions
- Inflammatory Bowel Disease, Colitis, Ulcerative, Crohn Disease
- Trial name
- NCT05659953
- Testing
- LMT503
- Where
- Netherlands
- Volunteers
- 72 people, healthy volunteers welcome
- Sponsor
- Lmito Therapeutics Inc.
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
Ulcerative Colitis, Crohn's Disease
A Study of Vedolizumab SC Given to Adults With Moderate to Severe Ulcerative Colitis or Crohn's Disease in South Korea
The main aim of the study is to observe adult participants in South Korea that are being treated with vedolizumab injected just under the skin (subcutaneous or SC) to treat ulcerative colitis (UC) or Crohn's disease (CD) who have…
- Conditions
- Ulcerative Colitis, Crohn's Disease, Inflammatory Bowel Disease (IBD)
- Trial name
- NCT05428345
- Where
- South Korea
- Volunteers
- 600 people
- Sponsor
- Takeda
Colitis, Ulcerative
Study of Efficacy, Safety, and Tolerability of LYS006, in Patients With Mild to Moderate Ulcerative Colitis
The purpose of the study was to assess preliminary efficacy, safety, and tolerability of LYS006 in adult patients with mild to moderate ulcerative colitis and to determine if LYS006 has an adequate clinical profile for further…
- Trial name
- NCT04074590
- Testing
- LYS006
- Where
- 9 sites in Bulgaria, Czechia and 4 more
- Volunteers
- 23 people
- Sponsor
- Novartis Pharmaceuticals
Ulcerative Colitis
Prospective Multicenter Trial to Determine the Efficacy and Outcome of the UCRI Biomarker Panel and Algorithm to Detect Mucosal Healing in Moderate to Severe Ulcerative Colitis Patients.
The purpose of this research study is to determine the efficacy and outcome of the UCRI (an in-vitro diagnostics device in the form of a blood test and an algorithm) as a tool to detect mucosal healing (level of inflammation in…
- Trial name
- NCT04897282
- Testing
- UCRI
- Where
- United States
- Volunteers
- 100 people
- Sponsor
- Glycominds, LLC
Ulcerative Colitis
Tacrolimus (FK506) Study in Moderate to Severe Refractory Ulcerative Colitis Patients
This study consists of a 2-week placebo-controlled double-blind inter-group efficacy study in moderate to severe refractory ulcerative colitis (UC) patients followed by a maximum of 12-week open-label efficacy and safety study in…
- Trial name
- NCT00347048
- Testing
- tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 62 people
- Sponsor
- Astellas Pharma Inc
Ulcerative Colitis
A Study of the Efficacy and Safety of Etrolizumab in Participants With Ulcerative Colitis Who Have Been Previously Exposed to Tumor Necrosis Factor (TNF) Inhibitors
This Phase III, double-blind, placebo-controlled, multicenter study will investigate the efficacy and safety of etrolizumab during induction and maintenance of remission compared with placebo in the treatment of participants with…
- Trial name
- HICKORY (NCT02100696)
- Testing
- Etrozulimab
- Where
- 184 sites in United States, Argentina and 22 more
- Volunteers
- 609 people
- Sponsor
- Hoffmann-La Roche
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
A Long Term Safety Study of Infliximab (Remicade) in in Ulcerative Colitis Patients
The purpose of this study is to evaluate long-term safety information of infliximab in patients who have participated in infliximab clinical studies in ulcerative colitis.
- Trial name
- NCT00207688
- Testing
- Infliximab 5 mg/kg, Infliximab 10 mg/kg
- Where
- 102 sites in United States, Argentina and 13 more
- Volunteers
- 505 people
- Sponsor
- Janssen Research & Development, LLC
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
ABX464 in Subjects With Moderate to Severe Active Ulcerative Colitis
This Phase IIa study is an 8-week, double-blind, placebo-controlled, randomized study aiming at evaluating the safety and the efficacy of ABX464 given once a day (o.d) at 50 mg in subjects with moderate to severe Active…
- Trial name
- NCT03093259
- Testing
- ABX464
- Where
- 19 sites in Austria, Belgium and 6 more
- Volunteers
- 32 people
- Sponsor
- Abivax S.A.
Ulcerative Colitis
Efficacy and Safety Study of SHP647 as Induction Therapy in Participants With Moderate to Severe Ulcerative Colitis
The purpose of this study is to evaluate the efficacy of SHP647 in inducing remission, based on composite score of patient-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative colitis…
- Trial name
- FIGARO UC 302 (NCT03259308)
- Testing
- Ontamalimab
- Where
- 207 sites in United States, Argentina and 20 more
- Volunteers
- 279 people
- Sponsor
- Shire
Colitis, Ulcerative, Crohn Disease
Phase 4, Vedolizumab-4002 Post-marketing, Disease-Drug-Drug Interaction Study
The purpose of this study is to evaluate in a step-wise approach the disease drug-drug interaction (DDI) potential for vedolizumab to indirectly affect the exposure of cytochrome P-450 (CYP) substrate drugs by modulating…
- Trial name
- NCT02760615
- Testing
- Caffeine, Losartan, Omeprazole
- Where
- 2 sites in United States
- Volunteers
- healthy volunteers welcome
- Sponsor
- Takeda
Inflammatory Bowel Diseases, Crohn Disease
Safety and Effectiveness Study of Remsima® in the Treatment of Inflammatory Bowel Diseases Among Saudi Arabia Patients
The purpose of this observational study is to assess the safety and effectiveness of biosimilar Infliximab in patients with inflammatory bowel disease (IBD) in Saudi Arabia where no visits or intervention(s) additional to the…
- Conditions
- Inflammatory Bowel Diseases, Crohn Disease, Fistulizing Crohn's Disease, Ulcerative Colitis
- Trial name
- NCT03452501
- Testing
- Infliximab
- Where
- 4 sites in Saudi Arabia
- Volunteers
- 157 people
- Sponsor
- Hikma Pharmaceuticals LLC
Ulcerative Colitis
Efficacy and Safety of Orally Administered BBT-401-1S in Subjects With Ulcerative Colitis
This is a randomised, double-blind, placebo-controlled, proof of clinical principle study to explore the efficacy and safety of orally administered BBT-401-1S in subjects with ulcerative colitis.
- Trial name
- NCT04596293
- Where
- 30 sites in United States, Poland and 2 more
- Volunteers
- 38 people
- Sponsor
- Bridge Biotherapeutics, Inc.
Inflammatory Bowel Diseases
An Efficacy and Safety Study of Infliximab Dose Escalation in Pediatric Participants With Inflammatory Bowel Disease
The purpose of this study is to evaluate whether trough serum infliximab concentrations at the time of loss of clinical response will identify pediatric participants with inflammatory bowel disease (IBD) who would benefit (regain…
- Trial name
- ADAPT (NCT02566889)
- Testing
- Infliximab
- Where
- 36 sites in United States, Canada
- Volunteers
- 53 people
- Sponsor
- Janssen Scientific Affairs, LLC
Ulcerative Colitis (UC)
A Study to Assess Adverse Events and Change in Disease Condition of Mesalamine Capsules in Children Aged 5 to 17 Years With Ulcerative Colitis
Ulcerative colitis (UC) is a type of inflammatory bowel disease (IBD) characterized by diffuse, continuous inflammation of the colon.
- Trial name
- NCT05316220
- Testing
- Mesalamine
- Where
- 10 sites in United States, Puerto Rico
- Sponsor
- AbbVie