Zasocitinib (TAK-279) in adults with active Crohn’s disease

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 2, single-center mechanistic study enrolling about 20 adults with active Crohn’s disease. Participants will receive zasocitinib for 12 weeks and undergo ileocolonoscopy to sample tissue from the colon and ileum, with cellular and molecular analyses of blood and biopsy samples. Researchers will examine therapeutic biology and biomarkers while monitoring safety. End-of-study follow-up extends safety assessments for about one month after treatment. The study aims to understand zasocitinib’s mechanism of action in Crohn’s disease and its safety profile.

Why it matters

Who can join: the full rules

Inclusion Criteria:

1. Men and women aged 18 to 75 years can participate in the study.
2. Must have been diagnosed with Crohn's disease (CD) at least 1 month (30 days) before study start.
3. Must have received other treatments for CD earlier but no longer tolerate these treatments or the treatment no longer helps.

Exclusion Criteria

1. Cannot have another condition that causes swelling (inflammation) in the bowel.
2. Cannot have complications of CD which may require surgery.
3. Cannot have current abscesses or abscesses that have been treated within 6 weeks before study start.
4. Cannot have had a removal of parts of the bowel within half a year (6 months) before study start.
5. Cannot have had any surgery inside the belly (intraabdominal) within 3 months before study start.
6. Cannot have or had a J-pouch.
7. Cannot have had infections up to 2 months (8 weeks) before study start.
8. Cannot have given blood or plasma within 1 month (30 days) before study start.
9. Cannot tolerate having blood taken with a needle from a vein (venipuncture).

Additional entry criteria will be discussed with the study doctor.

Where it's running

• Oxford Experimental Medicine Clinical Research Facility
  Oxford, United Kingdom Recruiting

Study contacts

• Study coordinator: Takeda Contact
• Email: medinfoUS@takeda.com
• Phone: +1-877-825-3327

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.