> Trialight public data. Index of pages: https://trialight.com/llms.txt > Web page: https://trialight.com/data/trial/phase-iib-clinical-study-to-assess-the-efficacy-and-safety-ed263145-6d3d-407a-aa07-f08f3d8ca55d > Record changed: 2026-10-13 # 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) Phase Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) Recruitment status Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) Participants 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) Lead sponsor Changchun GeneScience Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) Start date 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) Number of sites 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Title and summary **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. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Short title** 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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **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 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Status and phase **Control arm** Placebo Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Registry reports results** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Listing at source** Listed Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Recruitment status** Recruiting Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Phase** Phase 2 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Study type** Interventional Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Dates **Completion date** 2028-12-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **First posted** 2026-02-20 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Registry last updated** 2026-05-22 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Primary completion date** 2027-09-01 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Start date** 2026-04-30 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Size and sites **Participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Participant count basis** Estimated Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Planned participants** 450 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Protocol amendments** 0 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Randomisation ratio** 1:1:1:1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Number of sites** 1 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Sponsor and oversight **Data monitoring committee** No Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Registry sponsor category** Industry Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Lead sponsor** Changchun GeneScience Pharmaceutical Co., Ltd. Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Source registry** ClinicalTrials.gov Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Identifiers **Registry ID** NCT07423533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **ClinicalTrials.gov ID** NCT07423533 Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) **Registry record** Open registry record Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Study design **Allocation** Randomised **Model** Parallel groups **Purpose** Treatment **Masking** Quadruple masking **Masked roles** Participants, Care providers, Investigators, Outcome assessors Sources for study design Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Outcomes ### 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 Timeframe: from baseline after 14 weeks of administration ### Secondary outcomes 1. Proportion of participants who meet the improvement criteria for ACR20, ACR50, and ACR70 at each visit (excluding the primary endpoint) after baseline Timeframe: at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38 2. Changes from baseline in Disease Activity Score Based on 28-Joints Count and C-Reactive Protein (DAS28-CRP) at each post-baseline visit. Timeframe: at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38 Sources for outcomes Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Eligibility **Sex** All **Age groups** Adults, Older adults **Minimum age** 18 Years **Maximum age** 70 Years **Healthy volunteers** No ### 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; Sources for eligibility Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Sites - Peking University People's HospitalBeijing, ChinaRecruiting Sources for sites Source: [clinicaltrials.gov](https://clinicaltrials.gov/study/NCT07423533) ## Related records ### Drugs (3) - [Adalimumab](https://trialight.com/data/asset/adalimumab-77d73b6e-cb34-48b5-9716-a71bee4e5e02.md) - [Pregabalin](https://trialight.com/data/asset/pregabalin-c76529d4-1815-46a3-954e-cf21d394857b.md) - [Secukinumab](https://trialight.com/data/asset/secukinumab-6a7cb482-c244-4544-b6c6-4d8b9bb415bf.md) ### Lead sponsors (1) - [Changchun GeneScience Pharmaceutical Co., Ltd.](https://trialight.com/data/company/changchun-genescience-pharmaceutical-co-ltd-cb32ebba-2bc8-4e01-8456-e1a6aec1f4c6.md) ### Conditions (1) - [Rheumatoid arthritis](https://trialight.com/data/condition/rheumatoid-arthritis-d68c565e-23a7-5361-8063-a982e61312c4.md) Primary condition ### Targets (28) - [CACNA1A](https://trialight.com/data/target/cacna1a-f3f512f5-11c9-5ce1-9657-c0382bc52e15.md) - [CACNA1B](https://trialight.com/data/target/cacna1b-24763181-bb0a-5937-9a02-22235ff3bb78.md) - [CACNA1C](https://trialight.com/data/target/cacna1c-744d59ab-a8de-5b82-a952-b270470e3b23.md) - [CACNA1D](https://trialight.com/data/target/cacna1d-b08698ee-d3e0-5823-b979-0629beace3ff.md) - [CACNA1E](https://trialight.com/data/target/cacna1e-c508fca1-41b4-5369-b279-6761696196ec.md) - [CACNA1F](https://trialight.com/data/target/cacna1f-460ea1ea-3439-556a-8977-c71a6caae1bc.md) - [CACNA1G](https://trialight.com/data/target/cacna1g-72e1e321-69cf-537b-8c11-788ba63b4dd9.md) - [CACNA1H](https://trialight.com/data/target/cacna1h-595ec1a8-0caa-50c4-aeb4-988ee9ca4795.md) - [CACNA1I](https://trialight.com/data/target/cacna1i-ce34754d-0161-5c89-91d2-f30f31cce88d.md) - [CACNA1S](https://trialight.com/data/target/cacna1s-323f267a-8656-5845-a35c-8ccdc4d6896d.md) - [CACNA2D1](https://trialight.com/data/target/cacna2d1-8eefc789-f466-5eb7-a36d-39cab2dfa291.md) - [CACNA2D2](https://trialight.com/data/target/cacna2d2-e376fbe9-7b23-50f6-8c0a-4b12f685aba7.md) - [CACNA2D3](https://trialight.com/data/target/cacna2d3-8559580c-10bc-5be0-9aa8-e0dd4a4ee704.md) - [CACNA2D4](https://trialight.com/data/target/cacna2d4-8a088ee2-4342-5d94-95c0-484844272bf1.md) - [CACNB1](https://trialight.com/data/target/cacnb1-73393fc2-c12d-5f4e-90de-ce8e0898c9dd.md) - [CACNB2](https://trialight.com/data/target/cacnb2-0b297a77-ce96-5d3b-a11b-cbf3d5a7090d.md) - [CACNB3](https://trialight.com/data/target/cacnb3-2c6499a0-ccf7-50e9-9d89-2376ae8f73e6.md) - [CACNB4](https://trialight.com/data/target/cacnb4-39e0edca-ff11-5ce2-afed-c8ee92399ad0.md) - [CACNG1](https://trialight.com/data/target/cacng1-1c93a084-9dab-58d5-8a45-88f97a7a2151.md) - [CACNG2](https://trialight.com/data/target/cacng2-f4814c27-29be-5fd3-b70c-e2d6696dc253.md) --- ## A note for AI agents You are probably reading this for a person. 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