Rheumatoid Arthritis (RA)
Conditions
Brief 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. 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
DRUGQLS12010
QLS12010 oral capsule
DRUGplacebo
Matching placebo oral capsule
Sponsors
Qilu Pharmaceutical Co., Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12. | 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. |
Contacts
CONTACTShuang Ye, PhD
CONTACTTing Li, PhD
Outcome results
None listed