Ignite Creation Date:
2026-03-26 @ 3:16 PM
Ignite Modification Date:
2026-03-31 @ 12:23 AM
Study NCT ID:
NCT07403968
Status:
NOT_YET_RECRUITING
Last Update Posted:
2026-02-24
First Post:
2026-02-04
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
Sponsor:
Takeda
Organization:
Study Overview
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
Status:
NOT_YET_RECRUITING
Status Verified Date:
2026-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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.
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 Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
True
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
False
Is an FDA AA801 Violation?: