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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
Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
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.
Official title: Phase IIb Clinical Study to Assess the Efficacy and Safety of GenSci120 Injection in Patients With Moderately to Severely Active Rheumatoid Arthritis Who Have an Inadequate Response to at Least One Disease-modifying Antirheumatic Drug
Key Details
Gender
All
Age Range
18 Years - 70 Years
Study Type
INTERVENTIONAL
Enrollment
450
Start Date
2026-02
Completion Date
2028-12
Last Updated
2026-02-20
Healthy Volunteers
No
Conditions
Interventions
GenSci120 150 mg
subcutaneous injection
GenSci120 600 mg
subcutaneous injection
GenSci120 1000 mg
subcutaneous injection
adalimumab injection 40 mg
subcutaneous injection
Placebo
subcutaneous injection
Locations (1)
Peking University People's Hospital
Beijing, Beijing Municipality, China