Phase 2 Study to Assess the Efficacy and Safety of SPY002-072 in Adults With Moderately to Severely Active Rheumatologic Disease
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 入组人数
- 285
- 试验地点
- 92
- 主要终点
- Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)
研究概览
简要总结
This is a multi-center, double-blind, placebo-controlled, Phase 2, proof-of-concept basket study with the goal of assessing the efficacy and safety of SPY072 compared to placebo in adults (aged ≥18 years) with rheumatic disease (RD).
详细描述
The basket study comprises of substudies in rheumatoid arthritis (RA), axial spondyloarthritis (axSpA) and psoriatric arthritis (PsA) as follows:
- RA substudy: Moderately to severely active RA despite treatment with conventional synthetic disease-modifying anti-rheumatic drugs (csDMARDs), biologic disease modifying anti-rheumatic drugs (bDMARDs), or targeted synthetic disease-modifying anti-rheumatic drugs (tsDMARDs)
- axSpA substudy: Moderately to severely active axSpA despite treatment with non-steroidal anti-inflammatory drugs (NSAIDS), bDMARDs, or tsDMARDs
- PsA substudy: Moderately to severely active PsA despite treatment with NSAIDs, csDMARDs, bDMARDs, or tsDMARDs
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •For rheumatoid arthritis:
- •Moderate-to-severely active RA as defined by the presence of ≥4 swollen joints (based on 28 joint count) and ≥4 tender joints (based on 28 joint count) at Screening and Day
- •Documentation of ≥1 of the following:
- •Positive test results for rheumatoid factor or anti-citrullinated peptide antibodies at Screening, OR
- •Radiology report documenting bony erosions in hands or feet consistent with RA on previous radiographs
- •Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
- •≥1 csDMARD treatment; AND/OR
- •≤2 classes of bDMARD/tsDMARD treatment (>2 classes of bDMARDs and/or tsDMARDs is exclusionary)
- •For axial spondyloarthritis:
- •Moderate-to-severely active axSpA defined by BOTH of the following at Screening AND Day 1:
- •BASDAI ≥4, AND
- •Back pain ≥4 (from BASDAI Item 2)
- •hsCRP greater than the ULN per the central laboratory at Screening
- •Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
- •2 different NSAIDs given at the maximum tolerated dose for ≥4 weeks or intolerant to or has a contraindication to NSAID therapy; AND/OR
- •≤2 classes of bDMARD (anti-TNF or anti-IL-17)/tsDMARD at an approved dose for ≥12 weeks (>2 classes of bDMARDs/tsDMARDs is exclusionary)
- •For psoriatic arthritis:
- •Screening and Day 1 TJC ≥3 out of 68 and SJC ≥3 out of 66 (dactylitis counts as 1 joint each)
- •≥1 active plaque psoriasis lesion and/or a documented history of psoriasis
- •Inadequate response (defined as signs and symptoms of persistently active disease, loss of response, or intolerance) to:
- •≥1 NSAID treatment; AND
- •≥1 csDMARD treatment; AND/OR ≤2 classes of bDMARD/tsDMARD treatment (>2 classes of bDMARDs and/or tsDMARDs is exclusionary)
排除标准
- •Inadequate response to >2 classes of bDMARDs/tsDMARDs
- •Other autoimmune, rheumatologic, inflammatory diseases or pain-amplification syndromes that might confound the evaluations of efficacy of SPY072
研究组 & 干预措施
Rheumatoid Arthritis, Dose Regimen 1
Participants will receive double-blind dosing regimen 1 of SPY072
干预措施: SPY002-072 (Drug)
Rhematoid Arthritis Placebo
Participants will receive matching placebo
干预措施: Placebo (Drug)
Psoriatic Arthritis Placebo
Participants will receive matching placebo
干预措施: Placebo (Drug)
Axial Spondyloarthritis Placebo
Participants will receive matching placebo
干预措施: Placebo (Drug)
Psoriatic Arthritis
Participants will receive double-blind dose of SPY072
干预措施: SPY002-072 (Drug)
Rheumatoid Arthritis, Dose Regimen 2
Participants will receive double-blind dosing regimen 2 of SPY072
干预措施: SPY002-072 (Drug)
Axial Spondyloarthritis
Participants will receive double-blind dose of SPY072
干预措施: SPY002-072 (Drug)
结局指标
主要结局
Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)
时间窗: Week 12
The score is calculated based on the number of tender and swollen joints out of 28 assessed (TJC28 and SJC28), a measure of inflammation in the blood (c-reactive protein, CRP), and the subject's overall assessment of their health (patient global assessment). Scores range from 0-10. Higher scores indicate greater disease activity.
Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS)
时间窗: Week 16
The score combines 5 disease activity variables (back pain, duration of morning stiffness, patient global assessment of disease activity, peripheral pain/swelling and measure of inflammation) to measure disease activity. Lowest score is 0.6 and increases as disease worsens. Higher scores indicate greater disease activity.
Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) response
时间窗: Week 16
The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts (TJC and SJC), and at least 20% improvement in 3 out of 5 other disease activity measures (patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire, and measure of inflammation) will be assessed.
Rheumatoid Arthritis: Change from baseline in Disease Activity Score in 28 joints (c-reactive protein) (DAS-CRP)
时间窗: Week 12
The score is calculated based on the number of tender and swollen joints out of 28 assessed (TJC28 and SJC28), a measure of inflammation in the blood (c-reactive protein, CRP), and the subject's overall assessment of their health (patient global assessment). Scores range from 0-10. Higher scores indicate greater disease activity.
Axial Spondyloarthritis: Change from baseline in Ankylosing Spondylitis Disease Activity Score (ADAS)
时间窗: Week 16
The score combines 5 disease activity variables (back pain, duration of morning stiffness, patient global assessment of disease activity, peripheral pain/swelling and measure of inflammation) to measure disease activity. Lowest score is 0.6 and increases as disease worsens. Higher scores indicate greater disease activity.
Psoriatic Arthritis: Proportion of participants who achieve an American College of Rheumatology 20 Response Criteria (ACR20) response
时间窗: Week 16
The proportion of subjects who achieve at least 20% improvement in tender and swollen joint counts (TJC and SJC), and at least 20% improvement in 3 out of 5 other disease activity measures (patient global assessment, physician global assessment, patient pain assessment, health assessment questionnaire, and measure of inflammation) will be assessed.
次要结局
- Rheumatoid Arthritis: Proportion of participants who achieve an ACR20 response(Week 12)
- Axial Spondyloarthritis: Proportion of participants who achieve an Assessment of Spondyloarthritis International Society (40% improvement) (ASAS40) response(Week 16)
- Psoriatic Arthritis: Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)(Week 16)
- Rheumatoid Arthritis: Proportion of participants who achieve an ACR20 response(Week 12)
- Axial Spondyloarthritis: Proportion of participants who achieve an Assessment of Spondyloarthritis International Society (40% improvement) (ASAS40) response(Week 16)
- Psoriatic Arthritis: Change from baseline in Disease Activity Index for Psoriatic Arthritis (DAPSA)(Week 16)