Trial Details
Not RecruitingBasic Information
| Clinical ID | c1987 |
|---|---|
| Identifier | ChiCTR2500098333 |
| Trial Title | A Phase III, Multicenter, Double-Blind, Placebo-Controlled, Treat-Through Study To Assess The Efficacy And Safety Of Induction And Maintenance Therapy With RO7790121 In Patients With Moderately To Severely Active Crohn's Disease |
| Trial URL | Visit Original Page |
Study Information
| Study Results | No results available |
|---|---|
| Conditions | CD is a chronic, progressive inflammatory disease of the gastrointestinal tract, characterized by periods of relapse and remission, which can ultimately lead to bowel damage and disability. Most patients present with an inflammatory phenotype, but over time, uncontrolled inflammation can lead to complications such as fibrotic strictures, fistula formation, or intestinal neoplasia (Torres et al. 2 |
| Interventions | Test group 1:500 mg IV at weeks 0, 2, 6, and 10, followed by 450mg SC every 4 weeks from week 12 to week 52 (Q4W);Test group 2:500 mg IV at weeks 0, 2, 6, and 10, followed by 150 mg SCQ4W from week 12 to week 52;Placebo group:Placebo IV at weeks 0, 2, 6, and 10, followed by placebo SC Q4W from week 12 to week 52; |
Participant Information
| Sponsor | Sir Run Run Shaw Hospital, School of Medicine, Zhejiang University |
|---|---|
| City | - |
| Country/Region | China |
Enrollment Criteria
| Sex Requirement | ALL |
|---|---|
| Age Requirement | ADULT, ELDER, OLDER_ADULT, TEENAGER |
Study Design
| Study Type | Interventional study |
|---|---|
| Phase | Not Available |
Time Information
| Start Date | 2025-04-24 |
|---|---|
| Primary Completion Date | - |
| Completion Date | - |