Jiangsu Carephar Pharmaceutical Co., Ltd.
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.
Inclusion Criteria: 1. Age ≥18 years to ≤75 years, regardless of gender; 2. Diagnosis of Crohn's disease (CD) ≥12 weeks prior to screening, with endoscopic and histopathological evidence required for CD confirmation. If no histological results are available at screening, biopsy results from the screening period may be used; 3. Have active moderately to severely active CD, defined as: CDAI score between 220 and 450 (inclusive), and evidence of active mucosal inflammation (involving at least the ileum and/or colon) confirmed by ileocolonoscopy (central reading) performed during the screening pe…
H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 1 tablet
H021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet
Placebo(Specification: 0 mg/tablet)