A Phase II Study of H021 Enteric-coated Tablets for Moderately to Severely Active Crohn's Disease

Summary

This study employs a multicenter, randomized, double-blind, placebo-controlled, parallel-group, continuous treatment design to evaluate the efficacy, safety, PPK characteristics, and PD effects of H021 Enteric-coated Tablets during both the induction and maintenance treatment periods in patients with moderately to severely active CD. This study consists of an up to 4-week screening period, a 12-week double-blind induction treatment period, a 40-week double-blind maintenance treatment period or open-label extension treatment period, and a 4-week safety follow-up period.

Timeline

Start

2026-07-12

Primary completion

2026-10-12

Completion

2027-11-12

Drugs

Indications