New RA pill shows promise in early trial
NCT ID NCT07377773
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an experimental drug called QLS12010 in 180 adults with moderate-to-severe rheumatoid arthritis. Participants are randomly assigned to receive different doses of the drug or a placebo for 12 weeks. The main goal is to see if the drug reduces joint swelling and tenderness better than placebo, and to check for side effects.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 180 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2028
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 75 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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. Exclusion Criteria: * 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). * 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.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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- Can talk therapy plus exercise beat arthritis fatigue?