Rheumatoid Arthritis (RA)Phase 2NCT07377773
QLS12010 in Participants With Moderate-to-severe Rheumatoid Arthritis
A Phase 2 study testing QLS12010 in people with Rheumatoid Arthritis (RA), run by Qilu Pharmaceutical Co., Ltd..
Trial summary
The objective of this randomized, double-blind, placebo-controlled phase II clinical trial is to investigate the safety and efficacy of QLS12010 in subjects with moderate-to-severe rheumatoid arthritis.The main questions it aims to answer are: Efficacy and safety of QLS12010 in participants with rheumatoid arthritis. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Rheumatoid Arthritis (RA)
- What is being tested?
- QLS12010
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 180 participants
- Where
- No sites listed yet
- Study dates
- 5 Mar 2026to 5 Jun 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 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18-75 years old (inclusive).
- Diagnosed with rheumatoid arthritis as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 12 weeks prior to screening; ACR functional class I-III.
- Tender joint count (TJC) ≥ 4/68 and swollen joint count (SJC) ≥ 4/66.
- High Sensitivity C-Reactive Protein (hsCRP) > Upper Limit of Normal (ULN) or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h at screening.
- Inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and one biologic disease-modifying antirheumatic drug (bDMARD)/ targeted synthetic disease-modifying antirheumatic drug (tsDMARD).
- Glucocorticoid dose ≤ 10 mg/day prednisone-equivalent, stable for ≥ 2 weeks pre-screening and ≥ 4 weeks pre-baseline.
- Nonsteroidal Antiinflammatory Drugs (NSAIDs) or acetaminophen, stable for ≥ 1 week pre-screening and ≥ 2 weeks pre-baseline.
Who cannot join
- Participants with other inflammatory arthritis, systemic inflammatory diseases, or Felty syndrome.
- Participants with a history of malignancy within 5 years prior to screening.
- Concurrent conditions predisposing to QT interval prolongation; QTc interval (Fridericia-corrected) > 450 ms; or thyroid-stimulating hormone (TSH) > 5 mIU/L.
- Participants with untreated recurrent migraine.
- Participants with a history of opportunistic infection within 6 months prior to ICF signing; any infection requiring hospitalization or IV anti-infective therapy within 3 months; or any acute systemic infection within 2 weeks prior to baseline.
- Participants with HIV, HBV, HCV, Treponema pallidum, or active tuberculosis (TB).
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- Participants with a history of major surgery performed within 2 months prior to baseline.
- Participants with a history of severe allergic reactions or known allergy to any component of the study drug.
- Prior receipt of cell therapy (e.g., CAR-T) or T-cell engager therapy.
- Participants with a history of strong CYP3A4 inhibitors/inducers, narrow therapeutic index CYP3A substrates, strong P-gp/BCRP inhibitors, P-gp/BCRP substrates, or any QT-prolonging drugs within 4 weeks or 5 half-lives prior to baseline.
- Participants with a history of addictive drug abuse within 1 year prior to ICF signing; or alcohol abuse within 6 months prior to ICF signing.
- Participants with blood pressure > 160/100 mmHg at baseline.
- Pregnant or lactating women.
- Participants with blood donation or total blood loss ≥ 400 mL within 3 months prior to ICF signing.
- Vaccination with or exposure to live/attenuated live vaccines within 4 weeks prior to screening.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Rheumatoid Arthritis
The objective of this randomized, double-blind, placebo-controlled phase II clinical trial is to investigate the safety and efficacy of QLS12010 in subjects with moderate-to-severe rheumatoid arthritis.The main questions it aims to answer are:
- Efficacy and safety of QLS12010 in participants with rheumatoid arthritis.
Participants will be randomly allocated to four treatment groups at a 1:1:1:1 ratio to compare the efficacy and safety of different dosages of QLS12010 Capsules against the placebo.
- Conditions
- Rheumatoid Arthritis (RA)
- Being tested
- QLS12010, placebo
- Medical subject headings
- Arthritis, Rheumatoid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
QLS12010Drug
QLS12010 oral capsule
placeboDrug
Matching placebo oral capsule
| Study group | Role | What they receive |
|---|---|---|
| QLS12010 Capsule Dose 1 Group | Experimental | Not described Receives: Drug: QLS12010 |
| QLS12010 Capsule Dose 2 Group | Experimental | Not described Receives: Drug: QLS12010 |
| QLS12010 Capsule Dose 3 Group | Experimental | Not described Receives: Drug: QLS12010 |
| Placebo Group | Placebo comparator | Not described Receives: Drug: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12.
The DAS28-CRP score measures how active rheumatoid arthritis is. A score of 2.6 or lower indicates disease remission, while a greater score indicates more severe disease.
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2026
- Study start5 Mar 2026 (estimated)
- Primary completion5 Mar 2028 (estimated)
- Study completion5 Jun 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Rheumatoid Arthritis (RA)Studies of the same condition, open and under way.
- More trials run by Qilu 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
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07377773
- Sponsor's protocol ID
- QLS12010-203
- Status last verified
- Jan 2026
- First submitted
- 22 Jan 2026
- Last updated
- 2 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-Blind, Placebo-Controlled Phase II Clinical Trial Evaluating the Efficacy and Safety of QLS12010 Capsules in Adult Participants With Moderate-to-Severe Rheumatoid Arthritis
- ClinicalTrials.gov ID
- NCT07377773
- Acronym / sponsor ID
- QLS12010-203
- Conditions
- Rheumatoid Arthritis (RA)
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Qilu Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 5 Mar 2026 (estimated)
- Primary completion
- 5 Mar 2028 (estimated)
- Study completion
- 5 Jun 2028 (estimated)
- First posted
- 30 Jan 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.
The objective of this randomized, double-blind, placebo-controlled phase II clinical trial is to investigate the safety and efficacy of QLS12010 in subjects with moderate-to-severe rheumatoid arthritis.The main questions it aims to answer are:
- Efficacy and safety of QLS12010 in participants with rheumatoid arthritis.
Participants will be randomly allocated to four treatment groups at a 1:1:1:1 ratio to compare the efficacy and safety of different dosages of QLS12010 Capsules against the placebo.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| QLS12010 Capsule Dose 1 Group | Experimental | Drug: QLS12010 |
| QLS12010 Capsule Dose 2 Group | Experimental | Drug: QLS12010 |
| QLS12010 Capsule Dose 3 Group | Experimental | Drug: QLS12010 |
| Placebo Group | Placebo comparator | Drug: placebo |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 18-75 years old (inclusive).
- Diagnosed with rheumatoid arthritis as defined by the 2010 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria for at least 12 weeks prior to screening; ACR functional class I-III.
- Tender joint count (TJC) ≥ 4/68 and swollen joint count (SJC) ≥ 4/66.
- High Sensitivity C-Reactive Protein (hsCRP) > Upper Limit of Normal (ULN) or erythrocyte sedimentation rate (ESR) ≥ 28 mm/h at screening.
- Inadequate response to at least one conventional synthetic disease-modifying antirheumatic drug (csDMARD) and one biologic disease-modifying antirheumatic drug (bDMARD)/ targeted synthetic disease-modifying antirheumatic drug (tsDMARD).
Key exclusion criteria (15 listed)
- Participants with other inflammatory arthritis, systemic inflammatory diseases, or Felty syndrome.
- Participants with a history of malignancy within 5 years prior to screening.
- Concurrent conditions predisposing to QT interval prolongation; QTc interval (Fridericia-corrected) > 450 ms; or thyroid-stimulating hormone (TSH) > 5 mIU/L.
- Participants with untreated recurrent migraine.
- Participants with a history of opportunistic infection within 6 months prior to ICF signing; any infection requiring hospitalization or IV anti-infective therapy within 3 months; or any acute systemic infection within 2 weeks prior to baseline.
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 |
|---|---|---|
| QLS12010QLS12010 oral capsule | Drug | QLS12010 Capsule Dose 1 Group, QLS12010 Capsule Dose 2 Group, QLS12010 Capsule Dose 3 Group |
| placeboMatching placebo oral capsule | Drug | Placebo Group |
Primary outcome
Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12.
Time frame: 12 weeks
The DAS28-CRP score measures how active rheumatoid arthritis is. A score of 2.6 or lower indicates disease remission, while a greater score indicates more severe disease.
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 2 Feb 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing QLS12010 in people with Rheumatoid Arthritis (RA), run by Qilu Pharmaceutical Co., Ltd..
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 7 inclusion and 15 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: opening soon, as of the sponsor's last update on 2 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
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 Shuang Ye, PhD (021-58752345, Yeshuang@renji.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12. (time frame: 12 weeks). 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 2 Feb 2026.