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;
Jiangsu Carephar Pharmaceutical Co., Ltd.
Lead sponsor