drugset / Trial / NCT07423533

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

NCT07423533

Phase 2 Recruiting 450 enrolled Changchun GeneScience Pharmaceutical Co., Ltd.
RandomizedParallel-groupQuadruple-blindTreatment

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.

Timeline

Start
2026-04-30
Primary completion
2027-09
Completion
2028-12

Drugs

EvaluationDrugModalityDoseRoute
Comparator Adalimumab Monoclonal antibody 40 mg Subcutaneous
Subject GenSci120 Unknown 150 mg Subcutaneous
Subject GenSci120 Unknown 600 mg Subcutaneous
Subject GenSci120 Unknown 1000 mg Subcutaneous

Indications