A Phase 1 Study of Afimkibart Effects on Cytochrome P450-Mediated Drug Metabolism in Patients With Active Ulcerative Colitis

The primary objective is to evaluate the effect of afimkibart on the body’s processing of medicines that rely on cytochrome P450 enzymes in patients with active ulcerative colitis. This is clinically relevant for assessing the potential for drug–drug interactions and for informing concomitant medication use. No secondary objectives are specified.

The trial population comprised patients with ulcerative colitis, including both female and male participants, and included vulnerable individuals. The total number of participants was 6. The age range was specified only by code 3. No information was provided on general health status beyond active disease, and no details were provided regarding how the trial population was selected, lifestyle considerations, or additional inclusion or exclusion criteria.

This is a randomized, controlled, early-stage phase 3 clinical trial in patients with ulcerative colitis. The overall trial duration is estimated from 2026-05-01 to 2030-12-31. The plan includes a screening visit to assess eligibility, followed by study participation with scheduled follow-up visits and an end-of-study visit. The study visits are intended to monitor trial procedures and the effects of afimkibart on the body’s processing of medicines that rely on cytochrome P450 enzymes. Participant involvement is expected to continue for the duration required by the protocol. Early termination may occur if a participant no longer meets eligibility criteria, withdraws consent, or is discontinued for other protocol-defined reasons.

No investigational medicinal product or comparator treatment was specified in the source data. No information was provided on pharmaceutical form, dosage, route, frequency of administration, dosing schedule, or compliance monitoring.

Efficacy will be assessed in a clinical trial involving ulcerative colitis using the parameters and methods specified in the trial protocol.