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

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.

Study Overview

• Status: Recruiting
• Conditions: Rheumatoid Arthritis
• Intervention / Treatment: Drug: Placebo; Drug: GenSci120 150 mg; Drug: GenSci120 600 mg; Drug: GenSci120 1000 mg; Drug: adalimumab injection 40 mg

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%.

• Study Type: Interventional
• Enrollment (Estimated): 450
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Wei WANG; Phone Number: +86 18201085833; Email: wangwei13@genscigroup.com
• Study Contact Backup: Name: Xi DENG; Phone Number: +86 18201085833; Email: dengxi@genscigroup.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100044
      • Recruiting
      • Peking University People's Hospital
      • Contact: Zhanguo LI, Doctor; Phone Number: 010-88378021; Email: li99@bjmu.edu.cn

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. 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;
2. Male or female participants aged 18- 70 years (inclusive) when signing the informed consent form;
3. 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;
4. 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;

Exclusion Criteria:

1. 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.
2. 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;
3. Other joint disorders which could interfere with the assessment of joint disease activity according to the investigators' judgement, such as severe osteoarthritis;
4. History of lymphoproliferative disorders, such as lymphoma, or presence of signs or symptoms of lymphoproliferative disorders, including abnormal lymph node enlargement or hepatosplenomegaly;
5. Those with malignant disease or with a history of malignant disease;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

5

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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	Drug: GenSci120 150 mg; subcutaneous injection
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	Drug: GenSci120 600 mg; subcutaneous injection
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	Drug: GenSci120 1000 mg; subcutaneous injection
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)	Drug: adalimumab injection 40 mg; subcutaneous injection
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	Drug: Placebo; subcutaneous injection; Drug: GenSci120 600 mg; subcutaneous injection

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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 Outcome Measures

Outcome Measure	Time Frame
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
Changes from baseline in hsCRP levels/ESR at each post-baseline visit	at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Proportion of participants achieving DAS28-CRP ≤ 3.2/ DAS28-ESR≤3.2/ CDAI≤10/ SDAI≤11/ DAS28-CRP<2.6/ DAS28-ESR<2.6/ CDAI≤2.8/ SDAI≤3.3/ who meet the Boolean remission criteria at baseline and each subsequent visit	at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Changes from baseline in SJC/TJC/HAQ-DI 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 Patient global assessment of disease activity（PGA）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 Evaluator global assessment of disease activity（EGA）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 Patient's assessment of pain（VAS）at each post-baseline visit	at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Proportion of participants with Health Assessment Questionnaire-Disability Index（HAQ-DI）improvement (decrease from baseline of at least 0.22) (at Week 12, 14, 24, 28, and 38)	at Week 12, 14, 24, 28, and 38
Changes from baseline in Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) Scale (at Week 12, 14, 24, 28, and 38)	at Week 12, 14, 24, 28, and 38
Changes from baseline in severity and duration of morning stiffness at baseline and subsequent visits	at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Safety measures such as adverse events and serious adverse events	at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Concentration of GenSci120 in serum samples	Baseline, Day 15, Day 29, Day 57, Day 85, Day 99, Day 197, Day 267
Incidence and the time of anti-drug antibody (ADA) positive and neutralizing antibody (NAb) positive (if applicable) after GenSci120 administration	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Total T cell counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Regulatory T cells (Treg cells) counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Programmed death receptor-1 (PD-1) expressing total T cell counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
High PD-1 expressing total T cell counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Follicular helper T cell (Tfh cell) counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Peripheral helper T cell (Tph cell) counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Total B cell counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Plasma cell counts detected by flow cytometry, as well as the percentage changes from baseline	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of Interferon-γ (IFN-γ)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of interleukin-6 (IL-6)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of tumor necrosis factor-α (TNF-α)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of chemokine CXC ligand-13 (CXCL-13)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of interleukin-21 (IL-21)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of soluble programmed cell death receptor-1 (sPD-1)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of soluble programmed cell death ligand-1 (sPD-L1)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Serum concentration and the percentage changes from baseline of soluble programmed cell death ligand-2 (sPD-L2)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267
Concentration and the percentage changes from baseline of serum amyloid A (SAA)	Baseline, Day 15, Day 29, Day 57, Day 85, Day 197, Day 267

Collaborators and Investigators

• Sponsor: Changchun GeneScience Pharmaceutical Co., Ltd.
• Investigators: Study Chair: Zhanguo LI, Doctor, Peking University People's Hospital

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2026
• Primary Completion (Estimated): September 1, 2027
• Study Completion (Estimated): December 1, 2028

Study Registration Dates

• First Submitted: February 4, 2026
• First Submitted That Met QC Criteria: February 14, 2026
• First Posted (Actual): February 20, 2026

Study Record Updates

• Last Update Posted (Actual): May 22, 2026
• Last Update Submitted That Met QC Criteria: May 21, 2026
• Last Verified: February 1, 2026

More Information

Terms related to this study

• Keywords: rheumatoid arthritis; Regulatory T cells; GenSci120; inadequate response to at least one DMARD; Programmed death receptor-1 (PD-1)
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases; Skin and Connective Tissue Diseases; Arthritis, Rheumatoid; Amino Acids, Peptides, and Proteins; Proteins; Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Serum Globulins; Globulins; Adalimumab
• Other Study ID Numbers: GenSci120-201

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No