A Phase 2b, Randomized, Double-blind, Placebo-controlled, Multicenter Study to Assess the Efficacy and Safety of 3 Subcutaneous Dose Regimens of Lunsekimig (SAR443765) in Adult Participants With Moderate-to-severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 150
- 试验地点
- 101
- 主要终点
- Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24
研究概览
简要总结
This is a parallel, Phase 2b, randomized, double-blind, placebo-controlled, multicenter study to assess the efficacy, safety, and tolerability of lunsekimig monotherapy in adult participants (aged 18 to 80 years, inclusive) with moderate-to-severe atopic dermatitis (AD).
This study explores the efficacy and safety of 3 subcutaneous (SC) dose regimens of lunsekimig in adult participants with moderate-to-severe AD who have a documented history, within 6 months prior to baseline, of an inadequate response to topical treatments or for whom topical therapies are not advised. The study consists of 6 arms: 3 parallel dosing regimens and matching placebo arms. Additionally, participants have the option of engaging in a dense pharmacokinetic/pharmodynamic (PK/PD) sampling subgroup.
The study duration will be up to approximately 36 weeks, including up to 4 weeks of screening, 24 weeks of treatment period and an 8-week safety follow-up period.
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 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18 to 80 years of age, inclusive, at the time of signing the informed consent.
- •Diagnosis of Atopic Dermatitis (AD) as defined by the American Academy of Dermatology (AAD) clinical guidelines (2023) for 1 year or longer at baseline (Day 1)
- •Documented history within 6 months prior to Screening Visit, of either inadequate response or inadvisability of topical treatments
- •Eczema Area and Severity Index (EASI) score of 16 or higher (range, 0 to 72) at baseline (Day 1)
- •Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 3 or 4 at baseline visit (Day 1) (on the 0 to 4 vIGA-AD scale, a vIGA-AD score of 3 and 4 represents moderate and severe, respectively).
- •AD involvement of 10% or more of Body Surface Are (BSA) at baseline (Day 1)
- •Weekly average of daily Peak Pruritis-Numerical Rating (PP-NRS) score of ≥4 at baseline (Day 1)
- •Must have applied a stable dose of topical bland emollient (simple moisturizer, no additives [eg, urea]) at least once daily for a minimum of 5 out of 7 consecutive days before baseline (Day 1).
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •Skin comorbidity that would adversely affect the ability to undertake AD assessments (eg, psoriasis, tinea corporis, and lupus erythematosus) according to the Investigator's judgment.
- •Known history of, or suspected, significant current immunosuppression
- •NOTE: The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial
研究组 & 干预措施
Lunsekimig arm A
Participants will receive subcutaneous injection of lunsekimig dosing regimen A.
干预措施: Lunsekimig (Drug)
Placebo arm B
Participants will receive subcutaneous injection of matching placebo.
干预措施: Placebo (Drug)
Lunsekimig arm E
Participants will receive subcutaneous injection of lunsekimig dosing regimen E.
干预措施: Lunsekimig (Drug)
Placebo arm F
Participants will receive subcutaneous injection of matching placebo.
干预措施: Placebo (Drug)
Lunsekimig arm C
Participants will receive subcutaneous injection of lunsekimig dosing regimen C.
干预措施: Lunsekimig (Drug)
Placebo arm D
Participants will receive subcutaneous injection of matching placebo.
干预措施: Placebo (Drug)
结局指标
主要结局
Percent change in Eczema Area and Severity Index (EASI) score from baseline to Week 24
时间窗: From Baseline throughout the study, up to Week 24
Eczema Area and Severity index is an Investigator-assessed validated tool used to measure the extent (area) and severity of atopic dermatitis (AD). Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
次要结局
- Proportion of participants achieving EASI-75 at Week 24(From Baseline throughout the study, up to Week 24)
- Proportion of participants with a Validated Investigator Global Assessment Scale for Atopic Dermatitis (vIGA-AD) score of 0 (clear) or 1 (almost clear) and a reduction from Baseline of ≥2 points at Week 24(From Baseline throughout the study, up to Week 24)
- Proportion of participants with reduction (improvement) of ≥4 in the weekly average of daily Peak Pruritis-Numerical Rating Scale (PP-NRS) score from Baseline to Week 24(From Baseline throughout the study, up to Week 24)
- Absolute change from Baseline in EASI score at Week 24(From Baseline throughout the study, up to Week 24)
- Percent change from Baseline in EASI score throughout the study(From Baseline throughout the study, up to Week 24)
- Proportion of participants with a vIGA-AD score of 0 (clear) or 1 (almost clear) at Week 24(From Baseline throughout the study, up to Week 24)
- Proportion of participants with a response of vIGA-AD 0 or 1 and a reduction from Baseline of ≥2 points throughout the study(From Baseline throughout the study, up to Week 24)
- Percent change in the weekly average of daily PPNRS scores from Baseline to Week 24(From Baseline throughout tje study, up to Week 24)
- Percent change in the weekly average of daily sleep disturbance NRS score from Baseline to Week 24(From Baseline throughout the study, up to Week 24)
- Percent change in the weekly average of daily skin pain NRS score from Baseline to Week 24(From Baseline throughout the study, up to Week 24)
- Change in percent Body Surface Area (BSA) affected by Atopic Dermatitis from Baseline to Week 24.(From Baseline throughout the study, up to Week 24)
- Proportion of participants achieving EASI-50 at Week 24(From Baseline throughout the study, up to Week 24)
- Proportion of participants achieving EASI-90 at Week 24(From Baseline throughout the study, up to Week 24)
- Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily PP NRS scores from Baseline throughout the study(From Baseline throughout the study, up to Week 24)
- Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily SD-NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily SD-NRS scores of ≥4 points(From Baseline throughout the study, up to Week 24)
- Proportion of participants with improvement (reduction) of ≥4 points in the weekly average of daily Skin Pain NRS scores from Baseline to Week 24, in participants with a baseline weekly average of daily Skin Pain NRS scores of ≥4 points(From Baseline throughout the study, up to Week 24)
- Percent change in Scoring of Atopic Dermatitis (SCORAD) Index from Baseline to Week 24(From Baseline throughout the study, up to Week 24)
- Proportion of participants with an improvement of ≥4 points in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study(From Baseline throughout the study, up to Week 24)
- Percent change in Dermatology Life Quality Index (DLQI) score from Baseline to Week 24 and throughout the study(From Baseline throughout the study, up to Week 24)
- Percent change in Patient Oriented Eczema Measure (POEM) score from Baseline to Week 24(From Baseline throughout the study, up to Week 24,)
- Percent change in Hospital Anxiety and Depression Scale (HADS) from Baseline to Week 24(From Baseline throughout the study, up to to Week 24)
- Incidence of Antidrug antibody (ADA) against lunsekimig up to end of study(From Baseline throughout the study, up to Week 32)
- Serum concentrations of lunsekimig throughout the study(From Baseline throughout the study, up to Week 32)
- Serum concentrations of lunsekimig in the pharmacokinetic/pharmacodynamics (PK/PD) subgroup throughout the study(From Baseline throughout the study, up to Week 32)
- Number of participants with treatment-emergent adverse events (TEAEs), including local reactions, adverse events of special interest (AESIs), and serious adverse events (SAEs)(From Baseline throughout the study, up to Week 32)