Rheumatoid ArthritisPhase 2NCT07423533
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
A Phase 2 study testing GenSci120 150 mg, GenSci120 600 mg and GenSci120 1000 mg in people with Rheumatoid Arthritis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Rheumatoid Arthritis
- What is being tested?
- GenSci120 150 mg, GenSci120 600 mg and GenSci120 1000 mg
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 450 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2026to Dec 2028
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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;
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
Zhanguo LI, Doctor, 010-88378021, li99@bjmu.edu.cn
About this study
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
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.
Read the 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
- Being tested
- GenSci120 150 mg, GenSci120 600 mg, GenSci120 1000 mg, adalimumab injection 40 mg, Placebo
- Keywords
- rheumatoid arthritis, GenSci120, inadequate response to at least one DMARD, Programmed death receptor-1 (PD-1), Regulatory T cells
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GenSci120 150 mgDrug
subcutaneous injection
GenSci120 600 mgDrug
subcutaneous injection
GenSci120 1000 mgDrug
subcutaneous injection
adalimumab injection 40 mgDrug
subcutaneous injection
PlaceboDrug
subcutaneous injection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: 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 Receives: 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) Receives: 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 Receives: Drug: GenSci120 600 mg; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: 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.
Measured: at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Feb 2026
- Study start30 Apr 2026
- Primary completionSep 2027 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid ArthritisStudies of the same condition, open and under way.
- More trials run by Changchun GeneScience Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 450 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Zhanguo LI, Doctor, Study chair, Peking University People's Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07423533
- Sponsor's protocol ID
- GenSci120-201
- Status last verified
- Feb 2026
- First submitted
- 4 Feb 2026
- Last updated
- 22 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 22 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07423533
- Acronym / sponsor ID
- GenSci120-201
- Conditions
- Rheumatoid Arthritis
- Keywords
- rheumatoid arthritis, GenSci120, inadequate response to at least one DMARD, Programmed death receptor-1 (PD-1), Regulatory T cells
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 450 participants (estimated)
- Lead sponsor
- Changchun GeneScience Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 30 Apr 2026 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 20 Feb 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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%.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| GenSci120 150 mg | Experimental | Drug: GenSci120 150 mgStarting 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 |
| GenSci120 600 mg | Experimental | Drug: GenSci120 600 mgStarting 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 |
| GenSci120 1000 mg | Experimental | Drug: GenSci120 1000 mgStarting from Day 1 (Week 0), GenSci120 1000 mg Q4W until Week 24. Starting from Week 2, adalimumab simulant until Week 26 |
| adalimumab injection 40 mg | Active comparator | Drug: adalimumab injection 40 mgStarting 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 | Placebo comparator | Drug: GenSci120 600 mg, Drug: PlaceboPlacebo-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 |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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;
Key exclusion criteria (5 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GenSci120 150 mgsubcutaneous injection | Drug | GenSci120 150 mg |
| GenSci120 600 mgsubcutaneous injection | Drug | GenSci120 600 mg, Placebo |
| GenSci120 1000 mgsubcutaneous injection | Drug | GenSci120 1000 mg |
| adalimumab injection 40 mgsubcutaneous injection | Drug | adalimumab injection 40 mg |
| Placebosubcutaneous injection | Drug | Placebo |
Primary outcome
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
2 secondary outcomes
Proportion of participants who meet the improvement criteria for ACR20, ACR50, and ACR70 at each visit (excluding the primary endpoint) after baseline
Time frame: 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.
Time frame: at Week 2，4，6，8，10，12，14，16，18，20，22，24，26，28，38
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 May 2026.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Zhanguo LI, Doctor study chair
Peking University People's Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GenSci120 150 mg, GenSci120 600 mg and GenSci120 1000 mg in people with Rheumatoid Arthritis, run by Changchun GeneScience Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 22 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Wei WANG (+86 18201085833, wangwei13@genscigroup.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 May 2026.