A Randomized, Double-Blind, Placebo-Controlled, Parallel-Group, Dose-Ranging Study Investigating the Efficacy, Safety, and Pharmacokinetic Profile of ANB020 Administered to Adult Subjects With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 302
- 试验地点
- 81
- 主要终点
- Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
研究概览
简要总结
This study is designed to evaluate the efficacy, safety, and pharmacokinetic (PK) profiles of multiple doses of etokimab in adult participants with atopic dermatitis (AD).
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 or female participants must be 18 to 75 years of age, at the time of signing the informed consent.
- •Body mass index (BMI) of 18 to ≤ 35 kilogram per square meter (kg/m^2) at screening.
- •Clinically confirmed diagnosis of AD.
- •Eczema Area and Severity Index (EASI) score ≥ 16, body surface area (BSA) involvement ≥ 10%, and an Investigator's Global Assessment (IGA) score (5-point scale) ≥ 3 at baseline.
- •Participants with a history of inadequate response to topical treatment, use of systemic treatments to treat AD, and/or for whom topical treatments are otherwise medically inadvisable.
- •Daily use of non-medicated emollient for at least 7 days prior to baseline.
排除标准
- •Treatment with topical corticosteroids, topical calcineurin inhibitors, or crisaborole within 2 weeks before dosing.
- •Prior exposure to an anti-interleukin (IL)-33 antibody.
- •Exposure to an investigational or licensed or other anti T-helper 2 (Th2) type cytokine or cytokine receptor antagonist within 16 weeks or 5 half-lives, whichever is longer.
- •History of prior exposure to any investigational or biologic systemic treatment within 5 half lives of the screening or is currently enrolled in another clinical study.
- •Have received systemic treatment for AD (including systemic corticosteroids, immunosuppressants or immunomodulating drugs, or phototherapy or use of a tanning booth) within 4 weeks before screening.
- •History of severe allergic or anaphylactic reactions to human, humanized, chimeric, or murine monoclonal antibodies.
- •Note: Other protocol defined Inclusion/Exclusion criteria may apply.
研究组 & 干预措施
Placebo
Participants received matching placebo to etokimab, administered subcutaneously (SC) every 4 weeks (Q4W) for up to 16 weeks.
干预措施: Placebo (Drug)
Etokimab 20 mg SC Q4W
Participants received etokimab 20 milligrams (mg) administered SC Q4W for up to 16 weeks.
干预措施: Etokimab (Biological)
Etokimab 300 mg load + 150 mg SC Q8W
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.
干预措施: Etokimab (Biological)
Etokimab 300 mg load + 150 mg SC Q8W
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC every 8 weeks (Q8W) for up to 16 weeks. At Weeks 4 and 12 participants received placebo.
干预措施: Placebo (Drug)
Etokimab 300 mg load + 150 mg SC Q4W
Participants received a 300 mg loading dose of etokimab on Day 1 then 150 mg etokimab administered SC Q4W for up to 16 weeks.
干预措施: Etokimab (Biological)
Etokimab 600 mg load + 300 mg SC Q4W
Participants received a 600 mg loading dose of etokimab on Day 1 then 300 mg etokimab administered SC Q4W for up to 16 weeks.
干预措施: Etokimab (Biological)
结局指标
主要结局
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
时间窗: Baseline and Week 16
EASI measures the extent and severity of atopic eczema based on assessments of 4 body regions: head/neck, trunk, upper limbs and lower limbs. For each region the percentage of skin affected and the severity (scored as none \[0\], mild \[1\], moderate \[2\], or severe \[3\]) for symptoms such as redness (erythema), thickness (induration, papulation, and edema), scratching (excoriation), and lichenification (lined skin) are assessed. Total score is calculated by summing the EASI scores of 6 symptoms across 4 body regions. The EASI score ranges from 0 (no disease) to 72 (worse disease).
次要结局
- Number of Participants With a 75% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 75 Response) at Week 16(Baseline and Week 16)
- Number of Participants Who Achieved a Reduction of ≥ 4 Points From Baseline in Weekly Averaged Peak Numerical Rating Scale (NRS) for Pruritus Score at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Peak Weekly Averaged Numerical Rating Scale (NRS) for Pruritus Score at Week 16(Baseline and Week 16)
- Number of Participants Who Achieved a Reduction of ≥ 2 Points From Baseline in the Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) at Week 16(Baseline and Week 16)
- Number of Participants Who Achieved a vIGA-AD Response of 0 (Clear) or 1 (Almost Clear) at Week 16(Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) Score at Week 16(Baseline and Week 16)
- Number of Participants Who Experienced an Adverse Event (AE)(From first dose to Week 24)
- Number of Participants With a 50% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 50 Response) at Week 16(Baseline and Week 16)
- Percent Change From Baseline in Scoring Atopic Dermatitis (SCORAD) Score at Week 16(Baseline and Week 16)
- Number of Participants With a 90% Reduction From Baseline in Eczema Area and Severity Index Score (EASI 90 Response) at Week 16(Baseline and Week 16)