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

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

• Status: Not Yet Recruiting
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 450 (estimated)
• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd. · Industry
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

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.

Detailed description

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. Participants who meet the inclusion criteria will be randomized in a 1:1:1:1:1 ratio to the GenSci120 low dose group-150 mg (Group A), GenSci120 medium dose group-600 mg (Group B), GenSci120 high dose group-1000 mg (Group C), adalimumab group (Group D), and placebo group (Group E), with 90 participants in each group, totaling 450 participants. Among them, the proportion of participants who "have treatment experience of at least one bDMARDs or tsDMARDs" is at least 40%.

Conditions

• Rheumatoid Arthritis

Interventions

Type	Name	Description
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

Timeline

• Start date: 2026-02-01
• Primary completion: 2027-09-01
• Completion: 2028-12-01
• First posted: 2026-02-20
• Last updated: 2026-02-20

Locations

1 site across 1 country: China