NCT07377773尚未招募2 期
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
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 尚未招募
- 入组人数
- 180
- 主要终点
- Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12.
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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/
- •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.
排除标准
- •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.
研究组 & 干预措施
QLS12010 Capsule Dose 3 Group
Experimental
干预措施: QLS12010 (Drug)
Placebo Group
Placebo Comparator
干预措施: placebo (Drug)
QLS12010 Capsule Dose 1 Group
Experimental
干预措施: QLS12010 (Drug)
QLS12010 Capsule Dose 2 Group
Experimental
干预措施: QLS12010 (Drug)
结局指标
主要结局
Change in Disease Activity Score-C-Reactive Protein (DAS28-CRP) from Baseline at Week 12.
时间窗: 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.
次要结局
未报告次要终点
研究者
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