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NOT YET RECRUITING
NCT07423533
PHASE2

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.

View on ClinicalTrials.gov

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

Interventions

DRUG

GenSci120 150 mg

subcutaneous injection

DRUG

GenSci120 600 mg

subcutaneous injection

DRUG

GenSci120 1000 mg

subcutaneous injection

DRUG

adalimumab injection 40 mg

subcutaneous injection

DRUG

Placebo

subcutaneous injection

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China