A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
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
1 other identifier
interventional
20
0 countries
N/A
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for phase_2
Started May 2026
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 4, 2026
CompletedFirst Posted
Study publicly available on registry
February 11, 2026
CompletedStudy Start
First participant enrolled
May 29, 2026
ExpectedPrimary Completion
Last participant's last visit for primary outcome
March 30, 2028
Study Completion
Last participant's last visit for all outcomes
March 30, 2028
May 6, 2026
May 1, 2026
1.8 years
February 4, 2026
May 5, 2026
Conditions
Outcome Measures
Primary Outcomes (1)
Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interests (AESIs)
An adverse event (AE) is any untoward medical occurrence in a clinical study participant, temporally associated with the use of the trial intervention, whether or not the occurrence is considered related to the trial intervention. A TEAE is defined as any event emerging or manifesting at or after the initiation of treatment with a trial intervention or medicinal product or any existing event that worsens in either intensity or frequency after exposure to the trial intervention. An AESI is an adverse event of scientific and medical concern specific to the compound or program, for which ongoing monitoring and rapid communication by the investigator may be appropriate.
From start of study drug administration up to follow-up (up to Week 16)
Study Arms (1)
Zasocitinib Dose
EXPERIMENTALParticipants will receive zasocitinib dose orally, once daily (QD) for 12 week treatment period (Week 0 to 12).
Interventions
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Takedalead
Related Links
- Click here for more information about this trial in easy-to-understand language, including a Plain Language Summary of the results if the trial has been completed.
- Click here to ask Takeda's chatbot for comprehensive and easy-to-understand information about clinical trials - even across products and indications - in your local language.
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Study Director
Takeda
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 4, 2026
First Posted
February 11, 2026
Study Start (Estimated)
May 29, 2026
Primary Completion (Estimated)
March 30, 2028
Study Completion (Estimated)
March 30, 2028
Last Updated
May 6, 2026
Record last verified: 2026-05
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP, ICF, CSR
- Access Criteria
- IPD from eligible studies will be shared with qualified researchers according to the criteria and process described on https://vivli.org/ourmember/takeda/. For approved requests, the researchers will be provided access to anonymized data (to respect patient privacy in line with applicable laws and regulations) and with information necessary to address the research objectives under the terms of a data sharing agreement.
Takeda provides access to the de-identified individual participant data (IPD) for eligible studies to aid qualified researchers in addressing legitimate scientific objectives (Takeda's data sharing commitment is available on https://clinicaltrials.takeda.com/takedas-commitment?commitment=5). These IPDs will be provided in a secure research environment following approval of a data sharing request, and under the terms of a data sharing agreement.