A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD) (NCT06764615) | Clinical Trial Compass
RecruitingPhase 2
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
United States, China, Czechia192 participantsStarted 2025-05-28
Plain-language summary
Crohn's Disease and Ulcerative Colitis are two types of inflammatory bowel disease (IBD), which is a serious, long-term condition in the gut (intestine) that can cause pain and swelling (inflammation) in the bowel. TAK-279 is a medicine which helps to block inflammation.
This study is an extension of the parent studies, TAK-279-CD-2001 (NCT06233461), TAK-279-UC-2001 (NCT06254950) and TAK-279-CD-2003 (NCT07403968). This means that participants who responded to treatment with TAK-279 in either of the parent studies may be able to continue to benefit from the treatment in this study.
The main aim of this study is to find out how safe TAK-279 is for long term use and to check if it reduces bowel inflammation and symptoms when used for a longer period of time in adults with moderately to severely active UC or CD.
The participants will be treated with TAK-279 for up to 3 years (156 weeks).
During the study, participants will visit their study clinic around 15 times.
Who can participate
Age range
18 Years – 75 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. The participant is willing and able to understand and fully comply with trial procedures and requirements (including digital tools and applications), in the opinion of the investigator.
. Completion of Week 52 in the parent trials (phase 2b CD and phase 2 UC) with valid electronic (e) Diary data for Week 52 (TAK-279-CD-2001 and TAK-279-UC-2001).
. Clinical or symptomatic responder at parent trial Week 52 as defined below:
. TAK-279-CD-2001: Clinical response at Week 52 of the parent trial based on PRO2, assessed as \>=30% decrease in average daily very soft or liquid stools and/ or \>=30% decrease in average AP from parent trial baseline.
. TAK-279-UC-2001: Symptomatic response at Week 52 of the parent trial, assessed as a reduction in partial modified Mayo score (pmMS) of \>=1 points and \>=30% from parent trial baseline; and a decrease from parent trial baseline in the rectal bleeding sub-score of \>=1 point or an absolute rectal bleeding sub-score of \<=1 point.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
All Cohorts: Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interest (AESIs)
Timeframe: From start of study drug administration up to Week 160 (current study)
2
All Cohorts: Number of Participants With Clinically Significant Changes in Vital Sign Values
Timeframe: From start of study drug administration up to Week 160 (current study)
3
All Cohorts: Number of Participants With Clinically Significant Changes in Clinical Laboratory Values
Timeframe: From start of study drug administration up to Week 160 (current study)
4
Cohorts 1 and 2: Number of Participants With Clinically Significant Changes in 12-lead Electrocardiogram (ECG) Values
. TAK-279-CD-2003: Endoscopic response at Week 12 of the parent trial, assessed as a participant achieving decrease in SES-CD \>50% from baseline (or for participants with isolated ileal disease, SES-CD \<=4 or at least a 2-point reduction from baseline).
. Participants must meet the contraception recommendations.
Exclusion criteria
. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns.
. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE.
. Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol.
. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.