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RecruitingPhase 2

A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)

A Phase 2, Open-Label Extension Trial to Evaluate the Long-term Safety and Tolerability of Oral Zasocitinib (TAK-279) in Participants With Moderately to Severely Active Ulcerative Colitis and Moderately to Severely Active Crohn's Disease

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 75 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 3 years

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "The participants will be treated with TAK-279 for up to 3 years (156 weeks)."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests how safe TAK-279 is over time and whether it keeps reducing bowel swelling and symptoms. It is for adults with moderate to severe ulcerative colitis or Crohn’s disease who improved in one of three earlier TAK-279 studies. Treatment lasts up to 3 years, with about 15 clinic visits.

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.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Be able and willing to follow study rules, including using digital tools and apps.
  • Sign a consent form and any required privacy forms before study procedures begin.
  • For TAK-279-CD-2001 or TAK-279-UC-2001: finish Week 52 and have valid electronic diary records for that week.
  • For TAK-279-CD-2001: at Week 52, have at least 30% fewer very soft or liquid stools, at least 30% less belly pain, or both.
  • For TAK-279-UC-2001: at Week 52, have a symptom score drop of at least 1 point and 30%, plus less bleeding from the rectum or a low bleeding score.
  • For TAK-279-CD-2003: at Week 12, have a bowel exam score drop of more than 50%. If disease affects only the last part of the small bowel, the score must be 4 or less or drop by at least 2 points.
  • Follow the study’s birth control recommendations.

Who can't join

  • The study doctor has concerns about your ability to follow study rules or take medicine as directed.
  • A camera exam of the bowel found cancer or abnormal cells that may become cancer during the earlier study or at the start of this study.
  • Have lab test results that meet the study’s rules for exclusion.
  • For TAK-279-CD-2001 or TAK-279-UC-2001: took steroid medicines by mouth for Crohn’s disease or ulcerative colitis at or after Week 48 of the earlier study.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: 1. 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. The participant has provided informed consent (that is, in writing, documented via a signed and dated informed consent form \[ICF\]) and any required privacy authorization prior to the initiation of any trial procedures. 2. 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). 3. Clinical or symptomatic responder at parent trial Week 52 as defined below: 1. 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. 2. 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. 4. 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). Other General Inclusion Criteria: 5. Participants must meet the contraception recommendations. Exclusion Criteria: 1. Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns. 2. Participants with malignancy or dysplasia per endoscopy any time during the parent trial or at the beginning of the OLE. Exclusion Criteria related to Laboratory Investigations: 3. Participants meeting the exclusion criteria related to laboratory investigations as defined in the protocol. Exclusion criteria related to other prohibited concomitant medication for TAK-279-CD-2001 and TAK-279-UC-2001 Cohorts: 4. Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48.

Study sites (2)

MD

TX