A Phase 2, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled, 52 Week Study to Evaluate the Efficacy and Safety of LY3454738 in the Treatment of Adult Patients With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 234
- 试验地点
- 65
- 主要终点
- Percentage of Biologic and Small Molecule Naive Participants Achieving Eczema Area and Severity Index (EASI) 75 (≥75% Reduction in EASI Score) at Week 16
研究概览
简要总结
The main purpose of this study is to describe the efficacy and safety of LY3454738 in adult participants with moderate-to-severe 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
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Are candidates for systemic therapy.
- •ISA specific:
- •Have moderate-to-severe AD, defined as meeting all of the following criteria, at the first dosing visit:
- •EASI score greater than or equal to (≥)16
- •vIGA-AD score ≥3, and
- •≥10% of BSA involvement (per EASI BSA).
- •Have applied at least 1 emollient every day for at least 2 weeks before the day of the first dose of study intervention in this ISA and agree to daily use of at least 1 emollient continuously throughout the study.
排除标准
- •ISA specific:
- •Have, in the screening period, any of the skin conditions, infections, or medical conditions listed under master IMMB.
- •Are currently being treated with topical or systemic therapy
- •Recent treatment with experimental (biologics and/or small molecules) - doesn't apply for subset of participants who must have been exposed to biologics and/or small molecules.
研究组 & 干预措施
Placebo
Participants received placebo administered subcutaneously (SC) every two weeks (Q2W) from baseline to Week 14. Week 16 responders entered maintenance period and received placebo SC every four weeks (Q4W) until Week 40. Week 16 non-responders entered escape arm and received 800 milligrams (mg) of LY3454738 administered SC Q4W until Week 40.
干预措施: LY3454738 (Drug)
Placebo
Participants received placebo administered subcutaneously (SC) every two weeks (Q2W) from baseline to Week 14. Week 16 responders entered maintenance period and received placebo SC every four weeks (Q4W) until Week 40. Week 16 non-responders entered escape arm and received 800 milligrams (mg) of LY3454738 administered SC Q4W until Week 40.
干预措施: Placebo (Drug)
75 mg LY3454738
Participants received 75 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and received 150 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
干预措施: LY3454738 (Drug)
300 mg LY3454738
Participants received 300 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and continued receiving 300 mg of LY3454738 administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
干预措施: LY3454738 (Drug)
800 mg LY3454738
Participants received 800 mg of LY3454738 administered SC Q2W from baseline until Week 14. Week 16 responders entered maintenance period and were re-randomized to either receive 800 mg of LY3454738 or placebo administered SC Q4W until Week 40. Week 16 non-responders entered escape arm and received 800 mg of LY3454738 administered SC Q4W until Week 40.
干预措施: LY3454738 (Drug)
结局指标
主要结局
Percentage of Biologic and Small Molecule Naive Participants Achieving Eczema Area and Severity Index (EASI) 75 (≥75% Reduction in EASI Score) at Week 16
时间窗: Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent, i.e., percentage of skin affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI-75 score was obtained by weight-averaging these 4 scores and will range from 0 (none) to 72 (severe). The EASI-75 responder is defined as a participant who achieves a ≥ 75% improvement from baseline in the EASI score.
次要结局
- Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-50 (≥ 50% Reduction in EASI Score) at Week 16(Week 16)
- Percentage of Biologic and Small Molecule Naive Participants Achieving EASI-90 (≥ 90% Reduction in EASI Score) at Week 16(Week 16)
- Percentage of Biologic and Small Molecule Naive Participants Achieving SCORing Atopic Dermatitis (SCORAD) 75 at Week 16(Week 16)
- Percentage of Biologic and Small Molecule Naive Participants Achieving SCORAD-90 at Week 16(Week 16)
- Percentage of Biologic and Small Molecule Naive Participants Achieving Validated Investigator's Global Assessment for Atopic Dermatitis (vIGA-AD) of 0 or 1 at Week 16(Week 16)
- Percentage of Biologic and Small Molecule Naive Participants Achieving ≥4-point Improvement From Baseline in Itch Numeric Rating Scale (NRS) in the Subset of Biologic and Small Molecule Naive Participants With ≥4-point Itch NRS at Baseline(Baseline, Week 16)
- Mean Percent Change From Baseline in EASI in Biologic and Small Molecule Naive Participants(Baseline, Week 16)
- Mean Percent Change From Baseline in SCORAD in Biologic and Small Molecule Naive Participants(Baseline, Week 16)
- Percentage of Biologic and Small Molecule Experienced Participants Achieving EASI-75 at Week 16(Week 16)
- Pharmacokinetics (PK): Serum Trough Concentrations of LY3454738 at Week 16(Day 113 post Day 1 Dose)