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Not yet recruiting NCT07377773

QLS12010 in Participants With Moderate-to-severe Rheumatoid Arthritis

Phase II Interventional Rheumatoid Arthritis (RA)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: QLS12010, placebo.
Who it may be relevant to
Registry conditions: Rheumatoid Arthritis (RA). Basic parameters: 18 years — 75 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

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

Overview

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.

Interventions

  • Drug QLS12010
    QLS12010 oral capsule
  • Drug placebo
    Matching placebo oral capsule

Primary outcome measures

  • Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12. [Time frame: 12 weeks]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT07377773 · QLS12010-203

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗