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Recruiting Phase 2 NCT06254950

A Study on the Safety of TAK-279 and Whether it Can Reduce Inflammation in the Bowel of Participants With Moderately to Severely Active Ulcerative Colitis

Phase 2 – studying effectiveness and dosage
Conditions: Ulcerative Colitis

Sponsor: Takeda

trial.available_in: БГ
Overview
The main aim of this study is to learn if TAK-279 reduces bowel inflammation and symptoms compared to placebo. Another aim is to compare any medical problems that participants have when they take TAK-279 or placebo and how well the participants tolerate any problems. The participants will take capsules of either TAK-279 or placebo for up to 3 months (12 weeks). Then all the participants will receive TAK-279 for the rest of the treatment part of the study (1 year or 52 weeks). During the study, participants will visit their study clinic several times.
Description
Study TAK-279-UC-2001 is a multicenter, randomized, placebo-controlled, study with a 12-week double-blinded induction treatment period, a 40-week open-label treatment period (52 total weeks of treatment), and a 4-week safety follow-up period. An approximate total of eligible 207 participants will be randomized to one of the three treatment groups - 1. TAK-279 Dose 1 2. TAK-279 Dose 2 3. Placebo The maximum study duration per participant is approximately 60 weeks, including up to 30 days for the screening period, a 12-week randomized and double-blinded induction treatment period, a 40-week open-label treatment period, and a 4-week safety follow-up period.
Who can participate
Inclusion Criteria: 1. Male or female aged 18-75 years old with diagnosis of UC for at least 30 days. In South Korea, the age requirement for adult participants is ≥19 years of age. 2. Confirmed diagnosis of moderately to severely active UC assessed by mMS and ES. 3. Participants with a history of inadequate response to, loss of response to, or intolerance to one or more of conventional, biologic or advance therapies for UC. 4. Participants must meet the contraception recommendations. Exclusion Criteria: 1. Participants with indeterminate/unclassified inflammatory bowel disease (IBD), microscopic colitis, ischemic colitis, infectious colitis, radiation colitis, diverticular disease associated with colitis, and/or clinical/histologic findings suggestive of Crohn's disease (CD). 2. Participants with complications of UC such as strictures, stenoses, fistulas, short gut syndrome, or any other manifestation that might require surgery during the study. 3. Participants with a current ileostomy or colostomy. Participants who had a J-pouch are excluded, as a J-pouch could result in a stoma. 4. Participants who have failed 3 or more classes of advanced therapies.
Locations 21
Australia (1)
Concord Repatriation General Hospital
Sydney , New South Wales
Belgium (1)
Hopital Universitaire de Bruxelles/ Academisch Ziekenhuis Burssel
Brussels , Anderlecht / Region Capitale de Bruxelles/ Brussel
Bulgaria (1)
UMBAL Kaspela
Plovdiv
Canada (1)
Heritage Medical Research Clinic - University Of Calgary
Calgary , Alberta
China (1)
Chongqing General Hospital
Chongqing , Chongqing Sheng
Czech Republic (1)
NH Hospital
Hořovice , Central Bohemia
NOT_YET_RECRUITING
Denmark (1)
Odense Universitetshospital (OUH) (Odense University Hospital)
Odense , Region Syddanmark
France (1)
CHU De Clermont Ferrand - Hopital Estaing
Clermont-Ferrand
Greece (1)
University General Hospital of Patras
Pátrai , Achaia
Hungary (1)
Clinexpert
Budapest
Israel (1)
Assuta Ashdod University Hospital
Ashdod
Site Contact
Italy (1)
IRCCS A.O.U. Policlinico S. Orsola - Malpighi
Bologna
Japan (1)
Toho University Sakura Medical Center
Sakura , Chiba
Norway (1)
Akershus University Hospital
Lorenskog , Akershus
Poland (1)
Centrum Medyczne Melita Medical
Wroclaw , Dolnolskie
Romania (1)
Policlinica Algomed: Centrul De Gastroenterologie Dr. Goldis
Timișoara , Jud Timis
Slovakia (1)
Fakultna nemocnica F. D. Roosevelta
Banská Bystrica
South Korea (1)
Yonsei University Wonju Severance Christian Hospital
Wŏnju , Gangwon-do
Taiwan (1)
Changhua Christian Hospital (CCH)
Changhua , Changhua County
NOT_YET_RECRUITING
United Kingdom (1)
Clinical Research Centre - Barts Health NHS Trust
London , E1 2at
United States (1)
GastroIntestinal BioSciences
Los Angeles , California
Technical details
Status
Recruiting
Phase
Phase 2
Study type
INTERVENTIONAL
Sex
Male and female
Minimum age
18 Years
Maximum age
75 Years
Healthy volunteers
No
Start date
29.03.2024
Completion date
04.08.2027
Registry ID
NCT06254950
Source
anzctr
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