Crohn's Disease
Conditions
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.
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
DRUGZasocitinib
Zasocitinib administered orally.
Sponsors
Takeda
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants with Treatment-emergent Adverse Events (TEAEs) and Adverse Events of Special Interests (AESIs) | 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. |
Countries
United Kingdom
Contacts
CONTACTTakeda Contact
STUDY_DIRECTORStudy Director
Takeda
Outcome results
None listed