Once-Daily Oral Ozanimod for Japanese Patients With Ulcerative Colitis: Results From the Phase 2/3 J-True North Study.

ABSTRACT:

Background and aims

Ozanimod is a once-daily, oral, selective sphingosine 1-phosphate receptor 1 and 5 modulator. The objective of the randomized, phase 2/3 J-True North study (NCT03915769) was to assess the efficacy and safety of ozanimod in Japanese patients with moderately to severely active ulcerative colitis.

Methods

In the 12-week induction period (IP), patients were randomized 1:1:1 to receive placebo, ozanimod 0.46 mg, or ozanimod 0.92 mg. Patients who completed the IP with a clinical response at week (w) 12 were eligible to enter a 40-week maintenance period where they received the same treatment as they did in the IP. The primary endpoint was clinical response (complete Mayo score) at w12; clinical and mucosal secondary endpoints were assessed at w12 and w52.

Re

SUBMITTER: Nakase H 

PROVIDER: S-EPMC12630022 | biostudies-literature | 2026

REPOSITORIES: biostudies-literature