A Multicenter, Randomized, Double-blind, Placebo-controlled, Parallel-group Phase II Clinical Study to Evaluate the Efficacy and Safety of H021 Enteric-coated Tablets in Patients With Moderately to Severely Active Crohn's Disease (CD)

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.

Eligibility

Age range

18–75 years

Sex

All

Healthy volunteers

No

Interventions

• Drug
  H021 Enteric-coated Tablets Low-dose Group

  H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 1 tablet

• Drug
  H021 Enteric-coated Tablets High-dose Group

  H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet

• Drug
  Placebo Group

  Placebo(Specification: 0 mg/tablet)

Locations (24)