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.
Study ID
NCT07423533
Phase
PHASE2
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - 70 Years
Healthy Volunteers
Not accepted

Interventions

  • GenSci120 150 mg — DRUG
    subcutaneous injection
  • GenSci120 600 mg — DRUG
    subcutaneous injection
  • GenSci120 1000 mg — DRUG
    subcutaneous injection
  • adalimumab injection 40 mg — DRUG
    subcutaneous injection
  • Placebo — DRUG
    subcutaneous injection

Study Details

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.

Key Dates

Start date
Apr 30, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2027
Completion
Dec 31, 2028

Study Design

Enrollment
450 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: GenSci120 150 mg
    Starting from Day 1 (Week 0), GenSci120 150 mg once every 4 weeks (Q4W) until Week 24 (3 injection points are complemented by GenSci120 simulant to maintain blindness). Starting from Week 2, adalimumab simulant until Week 26
  • Experimental: GenSci120 600 mg
    Starting from Day 1 (Week 0), GenSci120 600 mg Q4W until Week 24 (3 injection points are complemented by GenSci120 simulant to maintain blindness). Starting from Week 2, adalimumab simulant until Week 26
  • Experimental: GenSci120 1000 mg
    Starting from Day 1 (Week 0), GenSci120 1000 mg Q4W until Week 24. Starting from Week 2, adalimumab simulant until Week 26
  • Active Comparator: adalimumab injection 40 mg
    Starting from Day 1 (Week 0), adalimumab injection 40 mg Q2W until Week 26 (3 injection points are complemented by GenSci120 simulant at Weeks 0, 4, 8, 12, 16, 20, and 24 to maintain blindness)
  • Placebo Comparator: Placebo
    Placebo-controlled treatment period: Starting from Day 1 (Week 0), GenSci120 simulant (3 injection points) Q4W until Week 12, and starting from Week 2, adalimumab simulant until Week 14. Extension treatment period: Starting from Week 16, all participants in the placebo group will receive GenSci120 600 mg Q4W until Week 24, and starting from Week 18, they will receive adalimumab simulant until Week 26

Primary Outcome Measure

Proportion of participants achieving the American College of Rheumatology 20% improvement criteria (ACR20) for disease activity assessment in RA from baseline after 14 weeks of administration [ Time Frame: from baseline after 14 weeks of administration ]

Central Contacts

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