A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease

Sponsor
Takeda
Study ID
NCT07403968
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 75 Years
Healthy Volunteers
Not accepted

Interventions

Study Details

Crohn's disease (CD) is a serious, long-term condition that can cause swelling (inflammation) and painful ulcers anywhere in the gut. This study will investigate whether zasocitinib can improve CD biology at the cellular and molecular level in adults. The main aims of this study are to better understand zasocitinib's mechanism of action in CD and evaluate how safe this treatment is. The participants will be treated with zasocitinib for 3 months (12 weeks) and will need to undergo a test where a doctor uses a thin, flexible tube with a tiny camera to look inside the large bowel (colon) and the end of the small bowel (ileum); this test is called ileocolonoscopy. During the study, participants will visit the study clinic several times.

Key Dates

First listed
Feb 11, 2026
Start date
Aug 13, 2026
Status verified
Aug 2026
Primary completion
Mar 30, 2028
Completion
Mar 30, 2028

Study Design

Enrollment
20 participants (estimated)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Experimental: Zasocitinib Dose
    Participants will receive zasocitinib dose orally, once daily (QD) for 12 week treatment period (Week 0 to 12).

Primary Outcome Measure

Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interests (AESIs) [ Time Frame: From start of study drug administration up to follow-up (up to Week 16) ]

Central Contacts

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