A Phase 3b Multicenter, Randomized, Double-Blind, Double-Dummy, Active Controlled Study Comparing the Safety and Efficacy of Upadacitinib to Dupilumab in Adult Subjects With Moderate to Severe Atopic Dermatitis
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 673
- 试验地点
- 159
- 主要终点
- Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16
研究概览
简要总结
This study will evaluate upadacitinib compared to dupilumab (Dupixent®) in adults with moderate to severe atopic dermatitis (AD) who are candidates for systemic therapy.
详细描述
The study is comprised of a 35-day screening period, a 24-week double-blinded treatment period, and a follow-up visit 12 weeks after the last dose. Participants who complete Week 24 have the option to enroll into an open-label study (Study M19-850; NCT04195698) of upadacitinib 30 mg once daily and receive treatment with upadacitinib for an additional 52 weeks.
Participants who meet eligibility criteria will be randomized in a 1:1 ratio to receive either upadacitinib or dupilumab. Randomization will be stratified by Baseline disease severity (Validated Investigator Global Assessment scale for Atopic Dermatitis [vIGA-AD] score of moderate [3] versus severe [4]) and age (<40, ≥ 40 to < 65, ≥ 65 years).
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 76 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participant has active moderate to severe atopic dermatitis (AD) defined by Eczema Area and Severity Index (EASI) ≥ 16, Investigator's Global Assessment (IGA) ≥ 3, ≥ 10% body surface area (BSA) of AD involvement at the Screening and Baseline Visits, and Baseline weekly average of daily Worst Pruritus NRS ≥
- •Participant is a candidate for systemic therapy or have recently required systemic therapy for AD.
排除标准
- •Participant has prior exposure to Janus Kinase (JAK) inhibitor.
- •Participant has prior exposure to dupilumab.
- •Participant is unable or unwilling to discontinue current AD treatments prior to the study.
- •Participant has requirement of prohibited medications during the study.
- •Participant has other active skin diseases or skin infections requiring systemic treatment or would interfere with appropriate assessment of AD lesions.
- •Female participant who is pregnant, breastfeeding, or considering pregnancy during the study.
研究组 & 干预措施
Upadacitinib 30 mg QD
Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
干预措施: Upadacitinib (Biological)
Upadacitinib 30 mg QD
Participants will receive 30 mg upadacitinib orally once a day (QD) up to Week 24 and placebo to dupilumab by subcutaneous injection every other week from Baseline to Week 22.
干预措施: Placebo to dupilumab (Drug)
Dupilumab 300 mg EOW
Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.
干预措施: Dupilumab (Biological)
Dupilumab 300 mg EOW
Participants will receive a loading dose of 600 mg dupilumab by subcutaneous (SC) injection on Day 1 followed by 300 mg dupilumab SC every other week (EOW) until Week 22 and placebo to upadacitinib orally QD up to Week 24.
干预措施: Placebo to upadacitinib (Drug)
结局指标
主要结局
Percentage of Participants Achieving a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75) at Week 16
时间窗: Baseline and Week 16
EASI is a tool used to measure the extent (area) and severity of atopic eczema based on assessments of the head/neck, trunk, upper limbs and lower limbs. For each region the area score is recorded as the percentage of skin affected by eczema. For each region, the severity score is calculated as the sum of the intensity scores (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for redness (erythema, inflammation), thickness (induration, papulation, swelling - acute eczema), scratching (excoriation), and lichenification (lined skin, prurigo nodules - chronic eczema). The total EASI score for each region is calculated by multiplying the severity score by the area score, with adjustment for the proportion of the body region to the whole body. The final EASI score is the sum of the 4 region scores and ranges from 0 to 72 where higher scores represent worse disease.
次要结局
- Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 16(Baseline (Week 0) to Week 16)
- Percentage of Participants Achieving a 90% Reduction From Baseline in EASI Score (EASI 90) at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving a 100% Reduction From Baseline in EASI Score (EASI 100) at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 1(Baseline (Week 0) to Week 1)
- Percent Change From Baseline in Worst Pruritus Numerical Rating Scale (NRS) Score at Week 4(Baseline (Week 0) to Week 4)
- Percentage of Participants Achieving a Reduction of ≥ 4 Points From Baseline in Worst Pruritus NRS at Week 16(Baseline and Week 16)
- Percentage of Participants Achieving a 75% Reduction From Baseline in EASI Score at Week 2(Baseline and Week 2)