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New RA pill shows promise in early trial

NCT ID NCT07377773

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 180 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Mar 2026

An estimate. Start dates often move.

Expected to finish

Jun 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 75 years

Sex

Anyone

Healthy volunteers

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

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.

  1. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  2. A doctor treating you

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More trials for these conditions

Other studies related to the condition(s) this trial covers.