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 | Recruiting Phase 2

• 1 other identifier: GenSci120-201
• Study Type: interventional
• Target: 450
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Rheumatoid Arthritis

Keywords

rheumatoid arthritis; GenSci120; inadequate response to at least one DMARD; Programmed death receptor-1 (PD-1); Regulatory T cells

Outcome Measures

Primary Outcomes (1)

• 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

  from baseline after 14 weeks of administration

Secondary Outcomes (2)

• Proportion of participants who meet the improvement criteria for ACR20, ACR50, and ACR70 at each visit (excluding the primary endpoint) after baseline

  at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38

• Changes from baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) at each post-baseline visit.

  at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38

Other Outcomes (32)

• Changes from baseline in DAS28-erythrocyte sedimentation rate (ESR) at each post-baseline visit

  at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38

• Changes from baseline in Clinical Disease Activity Index (CDAI) at each post-baseline visit

  at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38

• Changes from baseline in Simplified Disease Activity Index (SDAI) scores at each post-baseline visit

  at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38

Study Arms (5)

GenSci120 150 mg

EXPERIMENTAL

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

Drug: GenSci120 150 mg

GenSci120 600 mg

EXPERIMENTAL

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

Drug: GenSci120 600 mg

GenSci120 1000 mg

EXPERIMENTAL

Starting from Day 1 (Week 0), GenSci120 1000 mg Q4W until Week 24. Starting from Week 2, adalimumab simulant until Week 26

Drug: GenSci120 1000 mg

adalimumab injection 40 mg

ACTIVE COMPARATOR

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)

Drug: adalimumab injection 40 mg

Placebo

PLACEBO COMPARATOR

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

Drug: GenSci120 600 mg; Drug: Placebo

Interventions

GenSci120 150 mg DRUG

subcutaneous injection

GenSci120 150 mg

GenSci120 600 mg DRUG

subcutaneous injection

GenSci120 600 mg; Placebo

GenSci120 1000 mg DRUG

subcutaneous injection

GenSci120 1000 mg

adalimumab injection 40 mg DRUG

subcutaneous injection

adalimumab injection 40 mg

Placebo DRUG

subcutaneous injection

Placebo

Eligibility Criteria

• Age: 18 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants who voluntarily sign an informed consent form before the start of activities related to this study, understand the procedures and methods of this study, and are willing to strictly follow the clinical study protocol to complete this study;
• Male or female participants aged 18- 70 years (inclusive) when signing the informed consent form;
• Participants diagnosed with RA according to the 2010 RA classification criteria of the American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR), with ACR functional classification Class I-III at screening;
• Moderately to severely active RA is defined as TJC ≥ 6 and SJC ≥ 6 at screening and baseline based on 68/66 joint counts, and ESR or C-reactive protein (CRP)/hsCRP exceeding the upper limit of normal at screening. Joints with major surgery history will not be included in TJC and SJC;

You may not qualify if:

• Known allergy to any component in the GenSci120 formulation, or a history of allergic reactions to any drugs, compounds, foods, or other substances, or a history of hypersensitivity.
• Any autoinflammatory disease or autoimmune disease (excluding secondary Sjogren's syndrome) other than RA, including but not limited to psoriatic arthritis, inflammatory bowel disease, ankylosing spondylitis, systemic lupus erythematosus, systemic sclerosis or idiopathic inflammatory myopathy, multiple sclerosis or other central demyelinating diseases, primary Sjogren's syndrome, immunodeficiency syndrome, etc;
• Other joint disorders which could interfere with the assessment of joint disease activity according to the investigators' judgement, such as severe osteoarthritis;
• History of lymphoproliferative disorders, such as lymphoma, or presence of signs or symptoms of lymphoproliferative disorders, including abnormal lymph node enlargement or hepatosplenomegaly;
• Those with malignant disease or with a history of malignant disease;

Sponsors & Collaborators

• Changchun GeneScience Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

RECRUITING

MeSH Terms

Conditions

Arthritis, Rheumatoid

Interventions

Adalimumab

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Study Officials

• Zhanguo LI, Doctor

  Peking University People's Hospital

  STUDY CHAIR

Central Study Contacts

Wei WANG

CONTACT

+86 18201085833; wangwei13@genscigroup.com

Xi DENG

CONTACT

+86 18201085833; dengxi@genscigroup.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2026
• First Posted: February 20, 2026
• Study Start: April 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028
• Last Updated: May 22, 2026

Record last verified: 2026-02

Locations

CN (1)