A Study of TAK-018 in Preventing the Recurrence of Crohn's Disease After Surgery
Summary
The main aim is to see if TAK-018 reduces the recurrence of intestinal inflammation after abdominal resection surgery in adults with Crohn's disease. Participants will take either TAK-018 or placebo tablets by mouth, 2 times each day for up to 26 weeks after surgery. The placebo looks like TAK-018 but will not have any medicine in it. Participants will have 6 study visits while receiving treatment. Visits 1 and 6 will be conducted at the study clinic. The others can be in the clinic or at the participant's home. Follow-up will occur 4 weeks after final treatment.
Timeline
- Start
- 2020-08-04
- Primary completion
- 2022-08-25
- Completion
- 2022-08-25
Outcome
Missed primary endpoint
Stopped (Enrollment): “Sponsor decision to discontinue study due to inability to recruit the expected number of subjects within the requisite time period.”
registry analysis (superiority test); Placebo vs TAK-018 0.30 g Low Dose; p =0.590; Estimated Difference in ER Rate -0.10 (95% CI -0.44 to 0.23); Fisher Exact NCT03943446 ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Sibofimloc | Small molecule | 0.3 g | Oral |
| Subject | Sibofimloc | Small molecule | 1.5 g | Oral |