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Taking people in BulgariaPhase 2

Long-term safety of zasocitinib in ulcerative colitis and Crohn's disease

Tests long-term use of zasocitinib in adults with active ulcerative colitis or Crohn's disease.

Key facts

Who runs it
Takeda
Where
Plovdiv, Sliven, Sofia, and Sofiya, BulgariaSee the 6 sitesAlso in 16 other countries, 91 sites
Trial code
Registry title
A Continuation Study of TAK-279 in Adults With Ulcerative Colitis (UC) and Crohn's Disease (CD)
Status
Recruiting
Phase
Phase 2
People taking part
192 people, planned
Started
28 May 2025
Expected to end
30 Dec 2029
Type of study
Interventional, 3 groups
Treatments tested
  • Zasocitinib
Record updated
22 May 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with ulcerative colitis or Crohn's disease who responded to TAK-279 in one of the earlier parent studies and want to keep taking it.

Age
18 to 75 years
Sex
All sexes can join.
Disease stage
Moderately to severely active ulcerative colitis or Crohn's disease, with a response to treatment in the parent study.
Earlier treatment
Must have finished the parent study (Week 52 in TAK-279-CD-2001 or TAK-279-UC-2001) and responded to TAK-279. For TAK-279-CD-2003, a response seen at Week 12.

Main reasons for not taking part

  • Cancer or dysplasia (abnormal cells) found on endoscopy during the parent study or at the start of this study
  • Doubts about following the trial rules or taking the medicine as directed
  • Lab test results that meet the exclusion rules in the protocol
  • Taking oral corticosteroids for Crohn's disease or ulcerative colitis at or after Week 48 of the parent study (TAK-279-CD-2001 and TAK-279-UC-2001)

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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
  • 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
  • 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:
  • Participants must meet the contraception recommendations

Who cannot take part

  • Participant considered by the investigator to be unsuitable for the OLE trial due to their trial compliance and medication adherence concerns
  • Participants taking oral corticosteroids for CD or UC during parent trial at or after Week 48
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 75 years old?

Where in Bulgaria

Also in 16 other countries, 91 sites

  • University Multiprofile Hospital For Active Treatment Kaspela EOODPlovdiv, BulgariaTaking people
  • Multiprofile Hospital For Active Treatment Hadji Dimitar OODSliven, BulgariaTaking people
  • Acibadem City Clinic University Multiprofile Hospital For Active Treatment EOODSofia, BulgariaTaking people
  • Acibadem City Clinic Tokuda University Hospital EADSofiya, BulgariaTaking people
  • Diagnostic-Consultative Center Alexandrovska EOODSofiya, BulgariaTaking people
  • University Hospital Queen GovannaSofiya, BulgariaTaking people

About the trial

What the trial wants to find out

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.

Read full original descriptionShow less

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.

The 3 groups in the trial

  • Cohort 1: ZasocitinibTreatment being tested

    Participants with CD who completed Week 52 of the parent study, TAK-279-CD-2001 (NCT06233461) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.

    Treatment: Zasocitinib

  • Cohort 2: ZasocitinibTreatment being tested

    Participants with UC who completed Week 52 of the parent study, TAK-279-UC-2001 (NCT06254950) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.

    Treatment: Zasocitinib

  • Cohort 3: ZasocitinibTreatment being tested

    Participants with CD who completed Week 12 of the parent study, TAK-279-CD-2003 (NCT07403968) will be enrolled in this open-label extension trial to receive Zasocitinib, orally for up to 156 weeks.

    Treatment: Zasocitinib

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
Official title
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
Plain-language title
Long-term safety of zasocitinib in ulcerative colitis and Crohn's diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 12 November 2026.
Fit questions
Built from NCT06764615, who can take part
Record updated
22 May 2026