NCT04092452已完成2 期
A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
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
- 194
- 试验地点
- 75
- 主要终点
- Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
研究概览
简要总结
This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing Period and a 4 week Follow up 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
- Triple (Participant, 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 or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa
排除标准
- •History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
- •Infected with hepatitis B or hepatitis C viruses.
- •Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
研究组 & 干预措施
Cohort 1
Experimental
PF-06650833
干预措施: PF-06650833 (Drug)
Cohort 2
Experimental
PF-6700841
干预措施: PF-06700841 (Drug)
Cohort 3
Experimental
PF-06826647
干预措施: PF-06826647 (Drug)
Cohort placebo
Placebo Comparator
placebo
干预措施: Placebo (Drug)
结局指标
主要结局
Percentage of Participants Achieving Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16- Minimum Risk (MR) [Full Analysis Set (FAS), Non-responder Imputation (NRI)].
时间窗: At week 16
HiSCR response was defined as at least a 50% reduction in total abscess and inflammatory nodule (AN) count relative to baseline, and no increase in abscess count, and no increase in draining fistula count. Confidence interval (CI) was calculated using Blyth-Still-Casella method.
次要结局
- Least Squares Mean of Percent Change From Baseline in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Plasma Concentration Versus Time Summary (Pharmacokinetic Concentration Set)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Percentage of Participants Who Experienced a Hidradenitis Suppurativa (HS) Flare at Weeks 4, 8, 12 and 16 - MR [FAS, Only Observed Data (OBS)].(At weeks 4, 8, 12 and 16)
- Least Squares Mean of Absolute Score in International Hidradenitis Suppurativa Severity Score System (IHS4) at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI).(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Least Squares Mean of Percent Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 -ANCOVA (FAS With Baseline ≥3, MI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Least Squares Mean of Change From Baseline in PGA Skin Pain Numeric Rating Scale, on Average, at Weeks 1, 2, 4, 6, 8, 12 and 16 - ANCOVA (FAS, MI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Percentage of Participants Achieving HiSCR Response at Weeks 1, 2, 4, 6, 8, and 12 - MR (FAS, NRI).(At weeks 1, 2, 4, 6, 8, and 12)
- Percentage of Participants Achieving a Total Abscess and Inflammatory Nodule (AN) Count of 0 or 1; 0, 1 or 2 at Week 16 - MR (FAS, NRI).(At week 16)
- Least Squares (LS) Mean of Percent Change From Baseline in AN Count at Weeks 1, 2, 4, 6, 8, 12 and 16 - Analysis of Covariance (ANCOVA) [FAS, Multiply Imputed (MI)].(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Percentage of Participants Achieving Skin Pain Numeric Rating Scale (NRS30), at Worst, at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS With Baseline ≥3, NRI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Percentage of Participants Achieving Erythema Response Among Participants With Baseline Erythema Score ≥2 in at Least 1 Region at Weeks 1, 2, 4, 6, 8, 12 and 16 - MR (FAS, NRI)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Number of Participants With Treatment-Emergent Adverse Events (All Causalities)(Up to 20 weeks)
- Number of Participants With Treatment-Emergent Adverse Events (Treatment Related)(Up to 20 weeks)
- Number of Participants With Incidence of Post-baseline Vital Signs of Clinical Concern - Increase From Baseline (Safety Analysis Set)(Up to 20 weeks)
- Number of Participants With Incidence of Laboratory Test Abnormalities (Without Regard to Baseline Abnormality) (Safety Analysis Set)(Up to 20 weeks)
- Number of Participants With Incidence of Post-baseline Electrocardiogram (ECG) Values of Clinical Concern (Safety Analysis Set)(Up to 20 weeks)
- Least Squares Mean of Absolute Score in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - Mixed Effect Model Repeated Measurement (MMRM) (FAS, OBS)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Least Squares Mean of Change From Baseline in Hidradenitis Suppurativa (HS) Symptom Items up to Week 16 - MMRM (FAS, OBS)(At weeks 1, 2, 4, 6, 8, 12 and 16)
- Least Squares Mean of Absolute Score in Dermatology Life Quality Index (DLQI) Total Score up to Week 16 - MMRM (FAS, OBS)(At weeks 4, 8, 12 and 16)
- Least Squares Mean of Change From Baseline in DLQI Total Score up to Week 16 - MMRM (FAS, OBS)(At weeks 4, 8, 12 and 16)
- Percentage of Participants Achieving DLQI Total Score of 0 or 1 up to Week 16 - MR (FAS With Baseline >1, NRI)(At weeks 4, 8, 12 and 16)
研究者
研究点 (75)
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