NCT07403968 A Study of Zasocitinib (TAK-279) in Adults With Active Crohn's Disease
| NCT ID | NCT07403968 |
| Status | Recruiting |
| Phase | Phase 2 |
| Sponsor | Takeda |
| Condition | Crohn's Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 20 participants |
| Start Date | 2026-08-13 |
| Primary Completion | 2028-03-30 |
Eligibility & Interventions
Eligibility Fast-Check
Enter your details for a quick preliminary check. This does not replace medical advice.
What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
In Phase 2, researchers evaluate early signs of effectiveness. You may be randomized to receive the active treatment or a comparator. Monitoring continues closely.
This trial targets 20 participants in total. It began in 2026-08-13 with a primary completion date of 2028-03-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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.
Eligibility Criteria
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.
Contact & Investigator
Study Director
STUDY DIRECTOR
Takeda
Frequently Asked Questions
Who can join the NCT07403968 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 75 Years, studying Crohn's Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07403968 trial and what does that mean for participants?
Phase 2 trials evaluate whether the treatment shows signs of effectiveness while continuing to monitor safety. More participants are enrolled than in Phase 1 to help refine the treatment protocol.
Is NCT07403968 currently recruiting?
Yes, NCT07403968 is actively recruiting participants. Contact the research team at medinfoUS@takeda.com for enrollment information.
Where is the NCT07403968 trial being conducted?
This trial is being conducted at Oxford, United Kingdom.
Who is sponsoring the NCT07403968 clinical trial?
NCT07403968 is sponsored by Takeda. The principal investigator is Study Director at Takeda. The trial plans to enroll 20 participants.
Related Trials
Related Intelligence Guides
In-depth guides covering this condition's trials, eligibility, and what to expect.