Clinical Trial

Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active RA Who Have an Inadequate Response to at Least One DMARD

Recruiting Phase 2
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Summary
This is a multicenter, randomized, double-blind, parallel, placebo- and active comparator- controlled clinical study conducted in patients with moderately to severely active RA and an inadequate response to at least one DMARD, designed to assess the efficacy and safety of GenSci120 injection in this patient population. The study consists of a screening period (≤ 4 weeks), a placebo-controlled treatment period (14 weeks), an extension treatment period (14 weeks), and a follow-up period (10 weeks), with a total of 17 scheduled visits.
Protocol Amendment History 1 change
critical Recruitment opened 2026-05-23
Trial Details
NCT Number NCT07423533
Lead Sponsor Changchun GeneScience Pharmaceutical Co., Ltd.
Conditions Rheumatoid Arthritis
Enrollment 450 participants
Start Date 2026-04-30
Primary Completion 2027-09 (estimated)
Study Completion 2028-12 (estimated)
Updated on ClinicalTrials.gov 2026-05-22