NCT03845517已完成2 期
A PHASE 2B, DOUBLE-BLIND, RANDOMIZED, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06700841 IN PARTICIPANTS WITH ACTIVE SYSTEMIC LUPUS ERYTHEMATOSUS (SLE)
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Pfizer
- 入组人数
- 350
- 试验地点
- 157
- 主要终点
- Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
研究概览
简要总结
Assessment of PF-06700841 in participants with moderate to severe active, generalized Systemic Lupus Erythematosus (SLE) that have inadequate response to standard of care.
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
- •Male and/or female subjects between ≥18 and ≤75 years of age inclusive.
- •Diagnosis of moderate to severe active Lupus.
- •Receiving a stable dose of methotrexate, azathioprine, leflunomide, mizoribine, mycophenolate/mycophenolic acid, anti-malarials or corticosteroids.
排除标准
- •Active renal lupus
- •Severe active central nervous system (CNS) lupus
- •Have cancer or a history of cancer within 5 years of screening.
- •Have a history of thrombosis (venous or arterial) or other vascular complications within the last 6 months, or any history of either recurrent thrombosis or a pulmonary embolus.
- •Active bacterial, viral, fungal, mycobacterial or other infections
- •Psychiatric condition including recent or active suicidal ideation or behavior
- •Have active fibromyalgia/myofascial/chronic pain.
- •Pregnant female subjects; breastfeeding female subjects; females subjects planning to become pregnant during the study; fertile male subjects and WOCBP who are unwilling or unable to use a highly effective method of contraception.
研究组 & 干预措施
Placebo
Placebo Comparator
Placebo
干预措施: Placebo (Drug)
PF-06700841 15 mg
Experimental
PF-06700841 15 mg
干预措施: PF-06700841 15 mg (Drug)
PF-06700841 30 mg
Experimental
PF-06700841 30 mg
干预措施: PF-06700841 30 mg (Drug)
PF-06700841 45 mg
Experimental
PF-06700841 45 mg
干预措施: PF-06700841 45 mg (Drug)
结局指标
主要结局
Percentage of Participants Achieving SLE Responder Index (SRI) Change of 4 (SRI-4) at Week 52
时间窗: Week 52
SRI-4 components included Systemic Lupus Erythematosus Disease Activity Index 2000 (SLEDAI-2K), British Isles Lupus Assessment Group (BILAG) 2004 and Physician's Global Assessment (PhGA). Participants were classified as SRI-4 responders, if they met all of the following criteria compared with baseline: 1) greater than or equal to (\>=) 4 point reduction in SLEDAI-2K score; 2) no new BILAG A organ domain score or 2 new BILAG B organ domain scores; 3) no worsening (less than \[\<\] 0.3 point increase) in PhGA score. SLEDAI-2K: assesses improvement in disease activity (range: 0 to 105; higher score = higher severity). BILAG: assesses disease extent, severity in individual organ system (range: A \[severe\] to E \[no disease\]; higher score = less severity). PhGA: assesses worsening in participant's general health status (range: 0 \[none\] to 3 \[severe\]; higher score = higher severity).
次要结局
- Percentage of Participants Achieving British Isles Lupus Assessment Group-Based Composite Lupus Assessment (BICLA) at Week 52(Week 52)
- Percentage of Participants Achieving a SRI-4 Response With Prednisone Dose Reduced to <=7.5 mg/Day and Sustained for 12 Weeks at Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline(12 Weeks prior at Week 52 (Week 40 to Week 52))
- Percentage of Participants Achieving Lupus Low Disease Activity State (LLDAS) at Week 52(Week 52)
- Percentage of Participants Achieving a Reduction in Prednisone (or Equivalent) Dose to <=7.5 mg/Day and Sustained for 12 Weeks Prior to Week 52 in Participants on Prednisone >7.5 mg/Day (or Equivalent) at Baseline(Week 52 for achieving reduction in dose along with Week 40 to Week 52 for sustained dosing)
- Percentage of Participants With >= 50% Reduction in Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity (CLASI-A) Score at Week 52 in Participants With Baseline CLASI-A Score >=10(Week 52)
- Change From Baseline in Planning Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Change From Baseline in Fatigue Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Change From Baseline in Intimate Relationship Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Change From Baseline in Burden to Others Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Incidence Rate of Severe Flare Event(Week 52)
- Change From Baseline in Total Scores of Functional Assessment of Chronic Illness Therapy-Fatigue (FACIT-F) at Week 52(Baseline, Week 52)
- Change From Baseline in Physical Health Domain Scores of Lupus Quality of Life (LupusQoL) at Week 52(Baseline, Week 52)
- Change From Baseline in Pain Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Change From Baseline in Emotional Health Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Change From Baseline in Body Image Domain Scores of LupusQoL at Week 52(Baseline, Week 52)
- Number of Participants With Treatment-Emergent Adverse Events (AE)(Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks))
- Number of Participants With Serious Adverse Events (SAEs)(Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks))
- Number of Participants With Adverse Events Leading to Discontinuation From Study(Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks))
- Number of Participants With Clinically Significant Vital Signs Abnormalities(Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks))
- Number of Participants With Clinically Significant Electrocardiogram (ECG) Abnormalities(Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks))
- Number of Participants With Laboratory Test Abnormalities(Day 1 of dosing up to 4 weeks after last dose of study drug (maximum treatment was up to 52 weeks, follow-up up to 56 weeks))
研究者
研究点 (157)
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