NCT05848258已完成2 期
An Adaptive Phase 2a/2b, Randomized, Double-Blind, Placebo-Controlled Study of LY3871801 in Adult Participants With Moderately-to-Severely Active Rheumatoid Arthritis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 164
- 试验地点
- 110
- 主要终点
- Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
研究概览
简要总结
The main purpose of this study is to evaluate the efficacy and safety of LY3871801 in adult participants with active moderately-to-severe rheumatoid arthritis (RA).
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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have a diagnosis of adult-onset RA for at least 3 months prior to screening as defined by the 2010 ACR/European League Against Rheumatism (EULAR) classification criteria.
- •Have moderately-to-severely active RA at screening and baseline, defined by the presence of
- •≥6 swollen joints based on 66 joint count, and
- •≥6 tender joints based on 68 joint count.
- •Have had a history of failure (an inadequate response, intolerance, or loss of response) to at least 1 conventional synthetic disease modifying anti rheumatic drug (csDMARD) and either 1 biologic (bDMARD), or targeted synthetic (tsDMARD) treatment.
排除标准
- •Have Class IV RA according to ACR revised criteria
- •Have presence of 1 or more significant concurrent medical conditions per investigator judgment, including but not limited to
- •poorly controlled diabetes or hypertension
- •chronic kidney disease stage IIIa or IIIb, IV, or V
- •symptomatic heart failure according to New York Heart Association class II, III, or IV
- •myocardial infarction,unstable angina pectoris, stroke, or transient ischemic attack within the past 12 months before randomization
- •severe chronic pulmonary disease, for example, requiring oxygen therapy
- •major chronic inflammatory disease or connective tissue disease other than RA, including but not limited to
- •systemic lupus erythematosus
- •psoriatic arthritis
- •axial spondyloarthritis,including ankylosing spondylitis and non-radiographic axial spondyloarthritis
- •reactive arthritis
- •scleroderma
- •polymyositis
- •dermatomyositis
- •active fibromyalgia, or
- •multiple sclerosis
研究组 & 干预措施
Placebo Phase 2a
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
LY3871801 Dose 1 Phase 2b
Experimental
Participants will receive LY3871801 administered orally.
干预措施: LY3871801 (Drug)
LY3871801 Dose 2 Phase 2b
Experimental
Participants will receive LY3871801 administered orally.
干预措施: LY3871801 (Drug)
Placebo Phase 2b
Placebo Comparator
Participants will receive placebo.
干预措施: Placebo (Drug)
LY3871801 Dose 3 Phase 2b
Experimental
Participants will receive LY3871801 administered orally.
干预措施: LY3871801 (Drug)
LY3871801 Phase 2a
Experimental
Participants will receive LY3871801 administered orally.
干预措施: LY3871801 (Drug)
结局指标
主要结局
Phase 2a: Change from Baseline in Disease Activity Score - high-sensitivity C-reactive protein (DAS28-hsCRP)
时间窗: Baseline, Week 12
Phase 2b: Percentage of Participants Achieving American College of Rheumatology (ACR)50
时间窗: Baseline to Week 12
次要结局
- Phase 2a: Percentage of Participants Achieving ACR20/50/70(Baseline to Week 12)
- Phase 2b: Percentage of Participants Achieving ACR20/70(Week 12)
- Change from Baseline in Simplified Disease Activity Index (SDAI)(Baseline, Week 12)
- Change from Baseline in ACR Core Set Values 68 Tender Joint Counts(Baseline, Week 12)
- Change from Baseline in ACR Core Set Values 66 Swollen Joint Counts(Baseline, Week 12)
- Change from Baseline in ACR Core Set Values Physician's Global Assessment of Disease Activity (PhGADA) Visual Analog Scale (VAS)(Baseline, Week 12)
- Change from Baseline the Duration and Severity of Morning Joint Stiffness(Baseline, Week 12)
- Change from Baseline for Short Form-36 (SF-36) Physical Component Summary Score(Baseline, Week 12)
- Change from Baseline for Participant's Assessment of Arthritis Pain (VAS)(Baseline, Week 12)
- Change from Baseline in Clinical Disease Activity Index (CDAI)(Baseline, Week 12)
- Phase 2b: Change from Baseline in DAS28-hsCRP(Baseline, Week 12)
- Change from Baseline in ACR Core Set Values Patient's Global Assessment of Disease Activity (PaGADA) VAS(Baseline, Week 12)
- Change from Baseline for Participant's Assessment of Physical Function Using Health Assessment Questionnaire-Disability Index (HAQ-DI)(Baseline, Week 12)
- Pharmacokinetics (PK) Trough Plasma Concentrations of LY3871801(Baseline through Week 20)
- Change from Baseline for SF-36 Mental Component Summary Score(Baseline, Week 12)
研究者
研究点 (110)
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