Clinical trials: Inflammatory Bowel Diseases (IBD)
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
Inflammatory Bowel Disease (IBD), Crohn's Disease
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Poland
The primary reason of this study is to observe current treatment options in participants receiving Vedolizumab, intravenous (IV) or subcutaneous (SC), for IBD in Poland.
- Conditions
- Inflammatory Bowel Disease (IBD), Crohn's Disease, Ulcerative Colitis
- Trial name
- VARIETY (NCT05384080)
- Where
- 11 sites in Poland
- Volunteers
- 165 people
- Sponsor
- Takeda
Crohn's Disease
A Non-Interventional Clinical Study to Evaluate Long-Term Safety and Effectiveness of HUMIRA (Adalimumab) in Pediatric Patients With Moderately to Severely Active Crohn's Disease (CD)
This is a registry study to evaluate the long-term safety and effectiveness of adalimumab in pediatric patients with moderately to severely active CD who are treated as recommended in the local product label.
- Trial name
- CAPE (NCT02130362)
- Where
- 148 sites in United States, Bosnia and Herzegovina and 20 more
- Volunteers
- 1,446 people
- Sponsor
- AbbVie
Perianal Fistula, Crohn's Disease
A Study of Human TH-SC01 Cell Injection for Treating Perianal Fistulas in Patients With Crohn's Disease
The purpose of this study is to evaluate the safety and tolerability of human TH-SC01 cell injection for the treatment of perianal fistulas in Crohn's Disease
- Trial name
- NCT05626023
- Testing
- Human TH-SC01 cell injection
- Where
- China
- Volunteers
- 9 people
- Sponsor
- Jiangsu Topcel-KH Pharmaceutical Co., Ltd.
Inflammatory Bowel Disease
Safety, Tolerability, Pharmacokinetics and Pharmacodynamics Study of MT-1303 in Subjects With Inflammatory Bowel Disease
The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics and pharmacodynamics of a single oral dose of MT-1303 in subjects with inflammatory bowel disease.
- Trial name
- NCT01666327
- Testing
- MT-1303
- Where
- United Kingdom
- Volunteers
- 18 people
- Sponsor
- Tanabe Pharma Corporation
Crohn's Disease
A Maintenance Study to Investigate the Efficacy and Safety of Duvakitug in Participants With Moderately to Severely Active Crohn's Disease
This is a multicenter, randomized, double-blind, placebo-controlled, maintenance, Phase 3 study to evaluate the efficacy and safety of duvakitug in participants with moderately to severely active Crohn's Disease (CD).
- Trial name
- STARSCAPE-2 (NCT07184944)
- Testing
- Duvakitug
- Where
- 109 sites in United States, Australia and 25 more
- Volunteers
- 751 people
- Sponsor
- Sanofi
Lactation, Inflammatory Bowel Disease
A Study to Measure Mirikizumab Levels in Breast Milk of Lactating Participants Receiving Mirikizumab Therapeutically for an Approved Indication
The main purpose of this study is to assess the amount of mirikizumab in breast milk in women who are breastfeeding who are receiving stable maintenance doses of mirikizumab for an approved indication.
- Trial name
- NCT07612267
- Testing
- Mirikizumab
- Where
- 20 sites in United States, Canada and 5 more
- Volunteers
- 14 people
- Sponsor
- Eli Lilly and Company
Rheumatoid Arthritis, Crohn's Disease
Certolizumab Pegol for the Treatment of Patients With Active Rheumatoid Arthritis (RA) and Crohn's Disease (CD)
This is an observational trial in Rheumatoid Arthritis and Crohn's Disease patients treated with Cimzia aiming to evaluate the risk and incidence of Tuberculosis.
- Trial name
- NCT01577264
- Where
- 45 sites in Russia
- Volunteers
- 199 people
- Sponsor
- UCB Pharma
Ulcerative Colitis
Efficacy and Safety of Adalimumab in Pediatric Subjects With Moderate to Severe Ulcerative Colitis
The purpose of the study is to demonstrate the efficacy and safety, and to assess the pharmacokinetics of adalimumab administered subcutaneously (SC) in pediatric subjects with moderate to severe ulcerative colitis (UC).
- Trial name
- NCT02065557
- Testing
- Adalimumab
- Where
- 60 sites in United States, Australia and 12 more
- Volunteers
- 101 people
- Sponsor
- AbbVie
Inflammatory Bowel Diseases, Crohns Disease
A Study in Adults With Ulcerative Colitis (UC) or Crohn's Disease (CD) Receiving Vedolizumab in Real-World Practice in Switzerland
Vedolizumab is a medicine that helps to reduce sensitivity and pain in the digestive system for participants with UC or CD. In this study, adults with UC or CD will be treated with vedolizumab according to their clinic's standard…
- Conditions
- Inflammatory Bowel Diseases, Crohns Disease, Colitis, Ulcerative
- Trial name
- NCT04989907
- Where
- 6 sites in Switzerland
- Volunteers
- 92 people
- Sponsor
- Takeda
Ulcerative Colitis
Evaluation of PillCam IBD Capsule Endoscopy System in Visualization of Lesions in the Colon Indicative of Ulcerative Colitis Disease
Study Hypothesis UC Disease affects the colon. PillCam IBD may be used for visualization of the colon mucosa in UC Disease patients.
- Trial name
- UC (NCT02025777)
- Testing
- Capsule Endoscopy
- Where
- 2 sites in Israel, Spain
- Volunteers
- 30 people
- Sponsor
- Medtronic - MITG
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 participant-reported symptoms and centrally read endoscopy, in participants with moderate to severe ulcerative…
- Trial name
- FIGARO UC 301 (NCT03259334)
- Testing
- Ontamalimab
- Where
- 207 sites in United States, Australia and 16 more
- Volunteers
- 380 people
- Sponsor
- Shire
Crohn's Disease
CT-P13 (Infliximab) Subcutaneous Administration in Patients With Moderately to Severely Active Crohn's Disease (LIBERTY-CD)
This is Phase 3, Randomized, Placebo-controlled study to demonstrate superiority of CT-P13 SC over Placebo SC in Patients With Moderately to Severely Active Crohn's Disease
- Trial name
- NCT03945019
- Testing
- CT-P13 SC (Infliximab)
- Where
- 29 sites in United States, Belarus and 24 more
- Volunteers
- 396 people
- Sponsor
- Celltrion
Ulcerative Colitis
Basiliximab in Moderate to Severe Ulcerative Colitis
The purpose of this study is to assess the safety, effectiveness and pharmacokinetics of two levels of intravenous basiliximab in ulcerative colitis, compared to placebo.
- Trial name
- NCT00430898
- Testing
- Basiliximab
- Where
- 68 sites in United States, Belgium and 7 more
- Volunteers
- 181 people
- Sponsor
- Cerimon Pharmaceuticals
Colitis, Ulcerative
Efficacy, Pharmacokinetics, Tolerability, Safety of SB012 Intrarectally Applied in Active Ulcerative Colitis Patients
Ulcerative colitis (UC) represents one of the major entities of idiopathic inflammatory bowel diseases which are defined as chronically relapsing inflammations of the gastrointestinal tract not due to specific pathogens.
- Trial name
- SECURE (NCT02129439)
- Testing
- SB012
- Where
- 3 sites in Germany
- Volunteers
- 20 people
- Sponsor
- Sterna Biologicals GmbH & Co. KG
Ulcerative Colitis
Efficacy, Safety and Immunogenicity of the Proposed Biosimilar Vedolizumab PB016 in Comparison With Entyvio®
This is a multi-center, randomized, parallel arm, double-blind study with approximately 750 participants with moderately to severely active Colitis Ulcerosa randomized to receive either PB016 or Entyvio®
- Trial name
- UCESIVE (NCT05771155)
- Testing
- Intravenous (IV) infusions
- Where
- Georgia
- Volunteers
- 750 people
- Sponsor
- Polpharma Biologics S.A.
Inflammatory Bowel Diseases
West Hertfordshire Inflammatory Bowel Disease Technology Study
A retrospective and prospective, observational, non-interventional, cohort study to develop quantitative metrics from tools used as standard of care when diagnosing, assessing and monitoring patients with inflammatory bowel…
- Trial name
- WHITS (NCT05000242)
- Where
- United Kingdom
- Volunteers
- 200 people
- Sponsor
- Perspectum
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
Crohn Disease
A Retrospective Observational Study of Ustekinumab Among Bio-naive Participants With Crohn's Disease in China
Bio-naive participants are defined as the participants who previously have not received any biologics for Crohn's Disease (CD).The purpose of this retrospective study is to describe the endoscopic remission at week 24 among…
- Trial name
- NCT06082986
- Testing
- Ustekinumab
- Where
- 3 sites in China
- Volunteers
- 200 people
- Sponsor
- Xian-Janssen Pharmaceutical Ltd.
Ulcerative Colitis
Phase III Study of MLN0002 (300 mg) in the Treatment of Ulcerative Colitis
The purpose of this study is to evaluate efficacy, safety and pharmacokinetics of the vedolizumab (MLN0002) induction and maintenance therapy in Japanese participants with moderate or severe ulcerative colitis (UC).
- Trial name
- NCT02039505
- Testing
- Vedolizumab
- Where
- 59 sites in Japan
- Volunteers
- 292 people
- Sponsor
- Takeda
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