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

June 2, 2026 updated by: Takeda

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

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Zasocitinib Dose
Participants will receive zasocitinib dose orally, once daily (QD) for 12 week treatment period (Week 0 to 12).
Drug: Zasocitinib
Zasocitinib administered orally.
Other Names:
  • TAK-279

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
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)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Takeda

Investigators

  • Study Director: Study Director, Takeda

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 15, 2026

Primary Completion (Estimated)

March 30, 2028

Study Completion (Estimated)

March 30, 2028

Study Registration Dates

First Submitted

February 4, 2026

First Submitted That Met QC Criteria

February 4, 2026

First Posted (Actual)

February 11, 2026

Study Record Updates

Last Update Posted (Actual)

June 4, 2026

Last Update Submitted That Met QC Criteria

June 2, 2026

Last Verified

June 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • TAK-279-CD-2003

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

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.

IPD Sharing 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.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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