A PHASE 2, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF RITLECITINIB (PF-06651600) IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
试验速览
- 阶段
- 2 期
- 状态
- 进行中（未招募）
- 发起方
- Pfizer
- 入组人数
- 128
- 试验地点
- 142
- 主要终点
- Difference in proportion of responders based on Hidradenitis Suppurativa Clinical Response achieving at least 50% reduction from baseline (Hidradenitis Suppurativa Clinical Response HiSCR50) in patients with HS treated with ritlecitinib versus placebo.
研究概览
简要总结
The purpose of this study is to learn about the safety and effects of the study medicine (called Ritlecitinib) for the possible treatment of hidradenitis suppurativa (HS). HS is a disease causing long lasting painful red skin lumps.
This study is seeking participants who:
- have moderate or severe HS
- have previously received antibiotics for HS that did not help, or could not tolerate antibiotics Participants will be randomly (like a flip of coin) assigned to receive either the study medicine or a placebo (a pill that looks like the study medicine but does not contain any medicine). The study medicine or placebo will be taken by mouth once daily at home. For the first part of the study, participants will receive a loading (starting) dose. For the next part of the study, participants will receive a maintenance (ongoing) dose.
Participants will take part in the study for about 24 weeks (about 6 months). There will be about 10 study clinic visits: a screening visit, Day 1, and then every 1, 2, or 4 weeks until week 16. At each visit, participants will report on their health and have tests such as physical exams, blood and urine tests, vital signs, chest X-rays, ECGs, hearing tests, and questionnaires. Participants will record when they take the study medicine and their HS symptoms every day in an eDiary on a mobile phone.
The experiences of participants receiving the study medicine will be compared to those receiving placebo to help see if the study medicine is safe and effective.
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, Care Provider, Investigator)
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
- •Key Eligibility Criteria:
- •Inclusion Criteria:
- •Male or female participants ≥18 to ≤75 years of age.
- •Participants with a diagnosis (based on clinical history and physical examination) of moderate to severe HS for at least 6 months prior to Screening Visit and inadequate response to at least 4-week (28 days) treatment with oral antibiotics for the treatment of HS.
排除标准
- •Presence of ≥20 draining fistulae at Screening or BL visit
- •Evidence of other active skin disease or condition at screening
- •Have a known immunodeficiency disorder
- •Having a history of systemic infection requiring hospitalization or parenteral therapy, including history of infection with Mycobacterium TB
- •Specific Viral Infection History (incl. history of herpes zoster, HBV or HCV Infection
- •Current or recent history of clinically significant severe, progressive, or uncontrolled other medical conditions
- •Any medical or psychiatric condition including any active suicidal ideation in the past year or suicidal behavior in the past 5 years
研究组 & 干预措施
Placebo
Participants will receive matching placebo.
干预措施: Placebo (Drug)
Study Intervention
Participants will receive one oral dose once daily (QD), starting with a loading dose of ritlecitinib for 8 weeks, followed by maintenance for 8 weeks.
干预措施: Ritlecitinib (Drug)
结局指标
主要结局
Difference in proportion of responders based on Hidradenitis Suppurativa Clinical Response achieving at least 50% reduction from baseline (Hidradenitis Suppurativa Clinical Response HiSCR50) in patients with HS treated with ritlecitinib versus placebo.
时间窗: Week 16
The difference in proportion of responders based on HiSCR50 response at Week 16 in patients with HS treated with ritlecitinib versus placebo.
次要结局
- Proportion of participants achieving HiSCR50 response(at Weeks 1, 2, 4, 6, 8 and Week 12.)
- Proportion of participants achieving HiSCR75 response(at Weeks 1, 2, 4, 6, 8, 12 and Week 16.)
- Proportion of participants achieving HiSCR90 response(at Weeks 1, 2, 4, 6, 8, 12 and Week 16)
- Response based on a on total abscess and inflammatory nodule count (AN Count) of 0 or 1(Week 16)
- Response based on a total AN count of 0, 1, or 2(At week 16)
- Percent change from Baseline(CFB) in total AN count(Weeks 1, 2, 4, 6, 8, 12 and 16.)
- Absolute score in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)(at Weeks 1, 2, 4, 6, 8, 12 and 16)
- CFB in Hidradenitis Suppurativa Symptom Daily Diary (HSSDD)(Weeks 1, 2, 4, 6, 8, 12 and 16)
- Skin pain NRS50 response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3.(at Weeks 1, 2, 4, 6, 8, 12, and 16)
- CFB in Hidradenitis Suppurativa Investigator Global Assessment (HS-IGA)(at Weeks 1, 2, 4, 6, 8, 12 and 16)
- Proportion of participants achieving a HS-IGA=0 or 1(Weeks 1, 2, 4, 6, 8, 12 and 16)
- Percent CFB in skin pain NRS, at worst and on average, respectively, in participants with baseline skin pain NRS ≥3(Weeks 1, 2, 4, 6, 8, 12, and 16)
- CFB in skin pain NRS, at worst and on average, respectively(at Weeks 1, 2, 4, 6, 8, 12, and 16)
- Participants who experience an HS flare, defined as at least a 25% increase in total AN count with a minimum increase of 2 relative to Baseline(Weeks 4, 8, 12 and 16.)
- Skin pain NRS30 (numeric rating scale) response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3(Weeks 1, 2, 4, 6, 8, 12, and 16)
- Skin pain NRS70 response, at worst and on average, respectively among participants with baseline skin pain NRS ≥3(at Weeks 1, 2, 4, 6, 8, 12, and 16,)
- Incidence of clinically significant laboratory abnormalities over time(up to 24 Weeks)
- Incidence of treatment emergent adverse events (TEAE), adverse events (AE) and serious adverse events (SAE) leading to discontinuation(up to 24 Weeks)
- Absolute score and % CFB in International Hidradenitis Suppurativa Severity Score System (IHS4)(Weeks 1, 2, 4, 6, 8, 12 and 16.)
- Absolute score and CFB in Hidradenitis Suppurativa Quality of Life (HiSQOL)(at Weeks 1, 2, 4, 6, 8, 12 and 16.)