A Phase 2 Multicenter, Randomized, Double-Blinded, Placebo-Controlled, Parallel-Group Study to Evaluate the Efficacy and Safety of CC-99677 in Subjects With Active Ankylosing Spondylitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Celgene
- 入组人数
- 167
- 试验地点
- 63
- 主要终点
- Percentage of Participants Who Achieve ASAS 20 at Week 12
研究概览
简要总结
This study is designed to learn about response to CC-99677 treatment by measuring signs and symptoms of Ankylosing Spondylitis (AS), objective measures of disease activity, quality of life assessments, pharmacokinetics, safety, and tolerability over a 12-week double-blind period.
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 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosis of Ankylosing Spondylitis (AS) fulfilling the modified New York criteria
- •Active axial disease at Screening and Baseline defined by a Bath Ankylosing
- •Spondylitis Disease Activity Index (BASDAI) score ≥ 4 and Total Back Pain ≥ 4
- •Failed prior treatment with at least 2 NSAIDs for at least 4 weeks each
- •Participant has never received a biologic therapy eg, tumor necrosis factor (TNF) antagonist or monoclonal antibody [mAb] against IL-17A (biologic naive main study), or have taken more than one biologic therapy (biologic-failure substudy) for the treatment of AS
排除标准
- •Radiographic evidence of total ankylosis of the spine
- •Clinically significant back pain caused by diseases other than AS
- •Concurrent treatment or treatment within the 6 months prior to Baseline with cell depleting biologic agents
- •Participation in any study of an investigational drug, including those for COVID-19
- •History of malignancy
- •Oral corticosteroids (prednisone or equivalent) > 10 mg/day systemically for ≥ 2 weeks prior to Baseline Visit
研究组 & 干预措施
Administration of CC-99677 150 mg QD PO
49 participants will be randomized to CC-99677 150 mg in biologic naive main study
干预措施: CC-99677 (Drug)
Administration of CC-99677 60mg QD PO
49 participants will be randomized to CC-99677 60 mg in biologic naive main study
干预措施: CC-99677 (Drug)
Administration of Placebo QD PO
49 participants will be randomized to placebo in biologic naive main study
干预措施: Placebo (Other)
Administration of CC-99677 150 mg QD PO.
20 participants will be randomized to CC-99677 150 mg in biologic-failure substudy
干预措施: CC-99677 (Drug)
Administration of CC-99677 60mg QD PO.
20 participants will be randomized to CC-99677 60 mg in biologic-failure substudy
干预措施: CC-99677 (Drug)
Placebo additional dose cohort
10 participants will be randomized to placebo in biologic-failure substudy
干预措施: Placebo (Other)
结局指标
主要结局
Percentage of Participants Who Achieve ASAS 20 at Week 12
时间窗: Week 12
Percentage of participants who achieve an improvement in disease activity from baseline of ≥ 20% and ≥ 1 unit in at least 3 of the 4 SpondyloArthritis International Society (ASAS) domains on a scale of 0 to 10, and no worsening from baseline of ≥ 20% and ≥ 1 unit in the remaining domain on a scale of 0 to 10. Baseline is the last non-missing value on or before the date of the first dose of investigational product. The four ASAS Domains are: * Patient Global Assessment of Disease (0 to 10 unit Numerical Rating Scale \[NRS\]); * Total Back Pain NRS; * Function (the Bath Ankylosing Spondylitis Functional Index \[BASFI\] score NRS); * Inflammation (mean of Bath Ankylosing Spondylitis Disease Activity Index \[BASDAI\] NRS Questions #5 and #6 for morning stiffness).
次要结局
- Percentage of Participants Who Achieve ASAS 40 at Week 12(Week 12)
- Change From Baseline in Ankylosing Spondylitis Disease Activity Score With CRP (ASDAS-CRP) at Week 12(Baseline and Week 12)
- Change From Baseline in BASDAI at Week 12(Baseline and Week 12)
- Change From Baseline in BASFI at Week 12(Baseline and Week 12)
- Change From Baseline in the SPARCC SI Joint Score at Week 12(Baseline and Week 12)
- Change From Baseline in the SPARCC Spine Score at Week 12(Baseline and Week 12)
- Percent Change From Baseline in hsCRP at Week 12(Baseline and Week 12)