A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Zasocitinib.
- Who it may be relevant to
- Registry conditions: Crohn's Disease. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Center list to be confirmed — check the primary protocol.
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
Official title
An Open-Label, Single-Arm, Phase 2a Trial to Evaluate the Safety, Tolerability, PK, and Mechanism of Action of Zasocitinib (TAK-279) in Participants With Active Crohn's Disease
Overview
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.
Detailed description
Zasocitinib will be tested in this mechanistic study in adult participants with active Crohn's disease (CD). Peripheral blood and affected intestinal biopsy samples will be evaluated at the cellular and molecular levels, before and during zasocitinib treatment. The study will assess therapeutic biology, biomarkers, and the safety of zasocitinib.
The study will enroll approximately 20 participants. This is a single center study. The overall duration is up to approximately 5 months (20 weeks) including a 4-week safety follow-up period.
Interventions
- Drug Zasocitinib
Zasocitinib administered orally.
Primary outcome measures
- 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)]
Eligibility criteria
Inclusion criteria
- Men and women aged 18 to 75 years can participate in the study.
- Must have been diagnosed with Crohn's disease (CD) at least 1 month (30 days) before study start.
- Must have received other treatments for CD earlier but no longer tolerate these treatments or the treatment no longer helps.
Exclusion criteria
- Cannot have another condition that causes swelling (inflammation) in the bowel.
- Cannot have complications of CD which may require surgery.
- Cannot have current abscesses or abscesses that have been treated within 6 weeks before study start.
- Cannot have had a removal of parts of the bowel within half a year (6 months) before study start.
- Cannot have had any surgery inside the belly (intraabdominal) within 3 months before study start.
- Cannot have or had a J-pouch.
- Cannot have had infections up to 2 months (8 weeks) before study start.
- Cannot have given blood or plasma within 1 month (30 days) before study start.
- Cannot tolerate having blood taken with a needle from a vein (venipuncture).
Additional entry criteria will be discussed with the study doctor.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
Center list to be confirmed — check the primary protocol.
Identifiers
NCT: NCT07403968 · TAK-279-CD-2003