A Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Trial to Evaluate the Efficacy and Safety of ASLAN004 in Adult Patients 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
- 48
- 主要终点
- Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
研究概览
简要总结
Phase 2b study designed to evaluate the efficacy and safety of ASLAN004 in adult patients with moderate-to-severe Atopic Dermatitis (AD) who are candidates for systemic therapy. This study will have 5 treatment arms (4 active and 1 placebo).
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients with a clinical diagnosis of AD for at least 1 year;
- •vIGA score of ≥3 at Screening and Baseline;
- •≥10% BSA of AD involvement at Screening and Baseline;
- •EASI score ≥16 at Screening and Baseline;
- •History of inadequate response to treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI);
- •Twice daily application of a consistent amount of topical emollient for at least 7 days prior to randomization.
排除标准
- •Immunosuppressive/immunomodulating drugs, systemic therapies or phototherapy within 4 weeks prior to randomization;
- •Treatment with leukotriene inhibitors within 4 weeks prior to randomization;
- •Treatment with topical therapies (including TCS, TCI, topical phosphodiesterase inhibitors, topical JAK inhibitors) or prescription moisturizers, within 1 week prior to randomization;
- •Previous treatment at any time prior to randomization with monoclonal antibody / biologic therapeutic agents as follows;
- •Prior exposure to dupilumab (Dupixent®) which was discontinued due to lack of efficacy, loss of response, or adverse event;
- •Investigational or approved agents targeting interleukins IL-4 or IL-13 ligands or receptors of IL-4 or IL-13, including but not limited to lebrikizumab, tralokinumab or ASLAN004;
- •Other investigational or approved biologic drug within 16 weeks or within 5 half-lives (if known), whichever is longer, prior to the Baseline visit;
- •Cell-depleting biologics, including, but not limited to, rituximab within 6 months prior to the Baseline visit;
- •Inadequate organ function, abnormal lab result, uncontrolled blood pressure or other health condition considered clinically significant by the investigator at the Screening visit;
- •History of HIV, Hepatitis B, Hepatitis C or active/latent Tuberculosis infection;
- •History of immunosuppression including history of invasive opportunistic infections;
- •Treatment with live attenuated vaccine within 8 weeks prior to randomization;
- •Parasitic infection within 4 weeks prior to baseline travel within 3 months prior to randomization to areas of high parasitic exposure;
- •Have skin comorbidities that in the opinion of the Investigator may interfere with study assessments;
- •Pregnant or breastfeeding women;
- •Patients unwilling to use adequate birth control.
- •Active COVID infection at baseline.
研究组 & 干预措施
Placebo every two weeks q2w
Placebo q2w - placebo loading dose equivalents at Baseline and Week 1, then placebo dose equivalents every 2 weeks (q2w) from Week 2 to Week 14.
干预措施: Placebo Comparator (Drug)
ASLAN004 300 mg q2w
ASLAN004 300 mg q2w - loading doses at Baseline and Week 1, followed by regular doses of 300mg q2w from Week 2 to Week 14.
干预措施: ASLAN004 (Biological)
ASLAN004 400 mg q2w
ASLAN004 400 mg q2w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg ASLAN004, alternating with placebo dose equivalents, q2W from Week 4 to Week 14.
干预措施: ASLAN004 (Biological)
ASLAN004 400 mg every four weeks q4w
ASLAN004 400 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 400 mg or alternating placebo (q2W) to Week 14.
干预措施: ASLAN004 (Biological)
ASLAN004 600 mg q4w
ASLAN004 600 mg q4w - loading doses at Baseline, Week 1 and Week 2, followed by regular doses of 600 mg ASLAN004, alternating with placebo dose equivalents, q2W from Week 4 to Week 14.
干预措施: ASLAN004 (Biological)
结局指标
主要结局
Percent change from Baseline in Eczema Area and Severity Index (EASI) at Week 16
时间窗: Baseline, Week 16
The EASI score is used to measure the severity and extent of AD and measured erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD
次要结局
- Change in Body Surface Area (BSA) affected with AD(Baseline, Week 16)
- Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16(Baseline, Week 16)
- Proportion of patients achieving a 4-point reduction in P-NRS(Baseline, Week 16)
- Change in Patient-Oriented Eczema Measure (POEM) from Baseline to Week 16(Baseline to Week 16)
- Change in the European Quality of Life-5 Dimensions-5 Levels (EQ-5D-5L) Index Score United States and United Kingdom Algorithm from Baseline to Week 16(Baseline, Week 16)
- Change in Hospital Anxiety Depression Scale (HADS) from Baseline to Week 16(Baseline to Week 16)
- Number of Treatment-Emergent Adverse Events (TEAEs) and Treatment-Emergent Serious Adverse Events (TESAEs) from study drug administration (Day 1) to Week 28(: Baseline to Week 28)
- Proportion of patients achieving validated Investigator's Global Assessment (vIGA) response of 0 (clear) or 1 (almost clear) at Week 16(Week 16)
- Proportion of patients with EASI 50, 75 and 90 at Week 16(Week 16)
- Proportion of patients with EASI <7 at Week 16(Week 16)
- Percent Change in EASI score from Baseline over time(Baseline, Week 16)
- Absolute and percent change in Pruritus Numerical Rating Scale (P-NRS) over time(Baseline, Week 16)
- Change in Dermatology Life Quality Index (DLQI) from Baseline to Week 16(Baseline, Week 16)
- Absolute and percent change in sleep disturbance SD-NRS over time(Baseline to Week 16)
- Proportion of patients achieving a 4-point reduction in SD-NRS from Baseline to at Week 16(Baseline to Week 16)