Clinical trials: IBD
Crohn's Disease
Phase III Study of D9421-C 9 mg in Patients With Active Crohn's Disease in Japan
The purpose of this study is to evaluate the clinical efficacy of D9421-C 9 mg once daily compared to Mesalazine 1 g three times a day to patients with mild to moderate active Crohn's disease affecting ileum, ileocecal region…
- Trial name
- NCT01514240
- Testing
- D9421-C capsule 3 mg, Mesalazine tablets
- Where
- 25 sites in Japan
- Volunteers
- 123 people
- Sponsor
- AstraZeneca
Crohn Disease, Ulcerative Colitis
National Observational Study On The Use Of Inflectra™ An Infliximab Biosimilar In Real Life
National, prospective, multicentre observational study designed for eligible patients treated with Inflectra. Its objectives are to describe under real conditions of use, the profile of patients treated with Inflectra and the…
- Conditions
- Crohn Disease, Ulcerative Colitis, Rheumatoid Arthritis, Ankylosing Spondylitis
- Trial name
- ReFLECT (NCT02925338)
- Testing
- QOL questionaire
- Where
- 67 sites in France
- Volunteers
- 1,431 people
- Sponsor
- Pfizer
Crohn Disease
A Pharmacokinetic Study of Ustekinumab in Pediatric Subjects With Moderately to Severely Active Crohn's Disease
The purpose of this study is to evaluate the pharmacokinetics (PK) of ustekinumab in subjects from 2 through less than (<) 18 years old in the USA, or 6 through less than (<) 18 years old in other countries and determine if it is…
- Trial name
- STELARA (NCT02968108)
- Testing
- Ustekinumab
- Where
- 26 sites in United States, Belgium and 4 more
- Volunteers
- 45 people
- Sponsor
- Janssen Research & Development, LLC
Crohn Disease
A Study of Efficacy and Safety of Mongersen (GED-0301) for the Treatment of Adult and Adolescent Subjects With Active Crohn's Disease
The purpose of study is to test the effect of an experimental medication GED-0301(mongersen) and evaluate its safety in patients (≥ 12 years of age) with active Crohn's disease.
- Trial name
- NCT02974322
- Testing
- GED-0301
- Where
- 311 sites in United States, Australia and 28 more
- Sponsor
- Celgene
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
Gastrointestinal Disease, Inflammatory Bowel Disease (IBD)
Elemental 028 Extra Case Studies
Elemental 028 Extra is a nutritionally complete ACBS approved amino acid-based (elemental) feed designed to provide adequate daily amounts of both macronutrients and micronutrients when used as a sole source of nutrition and to…
- Conditions
- Gastrointestinal Disease, Inflammatory Bowel Disease (IBD), Short Bowel, Malabsorption
- Trial name
- E028E (NCT06877923)
- Testing
- Elemental 028 Extra
- Where
- United Kingdom
- Volunteers
- 30 people
- Sponsor
- Nutricia UK Ltd
Ulcerative Colitis
A Study of Asacol Absorption, Metabolism and Excretion in Children and Adolescents With Ulcerative Colitis.
The purpose of this randomized, open-label, parallel-group study is to determine how the body absorbs and eliminates mesalamine following administration of either 30 mg/kg/day, 60 mg/kg/day or 90 mg/kg/day as 400 mg…
- Trial name
- NCT00254618
- Testing
- mesalamine
- Where
- 22 sites in United States
- Volunteers
- 34 people
- Sponsor
- Warner Chilcott
Ulcerative Colitis (UC), Crohn Disease (CD)
VedAryo® (Vedolizumab) Effectiveness and Safety Evaluation
The aim of this observational study is to evaluate Effectiveness and safety of VedAryo® (Vedolizumab) in male or female participants with clinical diagnosis of Inflammatory Bowel Disease. The main questions are aim to answer: 1.
- Conditions
- Ulcerative Colitis (UC), Crohn Disease (CD), Inflammatory Bowel Disease (IBD)
- Trial name
- NCT07273760
- Testing
- Vedolizumab
- Where
- 12 sites in Iran
- Volunteers
- 150 people
- Sponsor
- AryoGen Pharmed Co.
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
Tacrolimus (FK506) P-III, Open-label Study in Refractory Ulcerative Colitis Patients
Patients with severe refractory ulcerative colitis (UC) or those who received placebo in study F506-CL-1107 will receive tacrolimus for a maximum of 12 weeks. Safety and efficacy will be evaluated.
- Trial name
- NCT00643071
- Testing
- Tacrolimus
- Where
- 6 sites in Japan
- Volunteers
- 32 people
- Sponsor
- Astellas Pharma Inc
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)
Crohn's Disease
Long-term Safety Study of Brodalumab in Adults With Crohn's Disease
The purpose of this study is to evaluate the safety and efficacy of long-term treatment with brodalumab in adults with Crohn's disease.
- Trial name
- NCT01199302
- Testing
- Brodalumab
- Where
- 34 sites in United States, Australia and 6 more
- Volunteers
- 67 people
- Sponsor
- Amgen
Crohn's Disease
A Study to Evaluate the Efficacy and Safety of Tulisokibart (MK-7240) in Participants With Moderate to Severe Crohn's Disease (MK-7240-008)
The purpose of this protocol is to evaluate the efficacy and safety of tulisokibart in participants with moderately to severely active Crohn's disease.
- Trial name
- NCT06430801
- Testing
- IV Tulisokibart, SC Tulisokibart
- Where
- 499 sites in United States, Australia and 45 more
- Volunteers
- 1,200 people
- Sponsor
- Merck Sharp & Dohme LLC
Crohn's Disease
Phase III Study of MLN0002 (300 mg) in Treatment of Crohn's Disease
This study is a phase 3, multicenter, randomized, double-blinded, placebo-controlled, parallel-group study to examine the efficacy, safety, and pharmacokinetics of vedolizumab (MLN0002) in induction and maintenance therapy in…
- Trial name
- NCT02038920
- Testing
- Vedolizumab
- Where
- 56 sites in Japan
- Volunteers
- 157 people
- Sponsor
- Takeda
Crohn's Disease
A Study of Ustekinumab Treatment in Children With Crohn's Disease
The purpose of this study is to evaluate the effectiveness of ustekinumab in achieving clinical remission in pediatric participants (greater than or equal to [>=] 2 to less than [<] 18 years and weight >= 40 kilograms [kg] at…
- Trial name
- REALITI (NCT05242458)
- Testing
- Ustekinumab
- Where
- United States
- Volunteers
- 545 people
- Sponsor
- Janssen Research & Development, LLC
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 (UC)
An Observational Study to Learn About Velsipity After Long Term Use in Patients With Ulcerative Colitis
A study to assess the safety and effectiveness of Velsipity Tablets 2 mg during long-term treatment (up to a maximum of 52 weeks) in patients with ulcerative colitis under actual medical practice.
- Trial name
- NCT07459686
- Testing
- Velsipity
- Where
- Japan
- Volunteers
- 1 people
- Sponsor
- Pfizer
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 (UC)
A Study of the Efficacy and Safety of Upadacitinib (ABT-494) in Participants With Moderately to Severely Active Ulcerative Colitis
The objective of this study is to evaluate the efficacy and safety of upadacitinib compared to placebo in inducing clinical remission (per Adapted Mayo score) in participants with moderately to severely active ulcerative colitis…
- Trial name
- U-Accomplish (NCT03653026)
- Testing
- Upadacitinib
- Where
- 379 sites in United States, Argentina and 42 more
- Volunteers
- 522 people
- Sponsor
- AbbVie
Ulcerative Colitis (UC)
A Study to Assess the Efficacy and Safety of Risankizumab in Participants With Ulcerative Colitis
The purpose of this study is to evaluate safety and efficacy of risankizumab in participants with ulcerative colitis (UC) in participants who responded to induction treatment with risankizumab in a prior AbbVie study of…
- Trial name
- COMMAND (NCT03398135)
- Testing
- risankizumab
- Where
- 426 sites in United States, Argentina and 41 more
- Volunteers
- 1,242 people
- Sponsor
- AbbVie