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.
Age ≥18 years to ≤75 years, regardless of gender;
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;
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 period, with a Simplified Endoscopic Score for Crohn's Disease (SES-CD) ≥6 for ileocolonic or colonic disease (SES-CD ≥4 for isolated ileal disease);
Inadequate response, loss of response, or intolerance to one or more of the following treatments (including corticosteroids, immunosuppressants [azathioprine, 6-mercaptopurine, methotrexate], and advanced therapies such as anti-TNF, anti-integrin, anti-IL-23 or anti-IL-12/23, JAK inhibitors) (failure to 5-aminosalicylic acid [5-ASA] alone does not meet the study inclusion requirements) (it will be determined by the investigator based on the assessment criteria; see Appendix 13.1 for details);
History of allergy to any component of the investigational product (including the investigational drug and placebo);
Study participants who have previously received treatment that upregulates microRNA-124 (miR-124) (e.g., ABX464);
Study participants who have failed more than three advanced therapies for CD, or who have failed two advanced therapies for CD with different mechanisms of action;
Treatment with cyclosporine, tacrolimus, sirolimus, mycophenolate mofetil, or thalidomide within 4 weeks prior to screening endoscopy;
Parallel
H021 Enteric-coated Tablets Low-dose Group
DrugH021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 1 tablet
H021 Enteric-coated Tablets High-dose Group
DrugH021 Enteric-coated Tablets(Specification: 12.5 mg/tablet) 2 tablet
Placebo Group
DrugPlacebo(Specification: 0 mg/tablet)
Proportion of study participants achieving clinical response based on CDAI score at Week 12
Proportion of study participants achieving clinical remission based on CDAI score at Week 12
Proportion of study participants achieving endoscopic response at Week 12
Proportion of study participants achieving endoscopic remission at Week 12
Proportion of study participants achieving clinical remission based on CDAI score at Week 52
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