A Randomized, Double-blind, Placebo-controlled Phase 2 Study to Evaluate the Effect of Amlitelimab on Vaccine Antibody Responses 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
- 224
- 试验地点
- 113
- 主要终点
- Percentage of participants with a positive tetanus response at Week 16
研究概览
简要总结
This is a Phase 2, multicenter, randomized, double-blind placebo controlled, 2-arm study to evaluate the effect of amlitelimab on vaccine antibody responses, and the safety of amlitelimab concurrently administered with non-live vaccines in adult participants with moderate-to-severe atopic dermatitis (AD).
The purpose of this study is to compare the immune responses to concomitantly administered Boostrix (tetanus, diphtheria, and acellular pertussis [Tdap]) and Pneumovax 23 (PPSV) vaccines in adult participants with moderate-to-severe AD treated with amlitelimab versus placebo. The study will evaluate the percentage of participants achieving a positive anti-tetanus response at Week 16 (primary endpoint) and a positive anti-pneumococcal response at Week 16 (key secondary endpoint).
Study details include:
The study duration will be up to 36 weeks (for participants not entering the LTS17367 [RIVER-AD]).
The screening period will be 9 days to 4 weeks. The treatment duration will be up to 16 weeks. The post-treatment safety follow-up period will be16 weeks. The number of visits will be up to 7 (or 6 for those entering LTS17367 [RIVER-AD]).
详细描述
The study duration will be up to 36 weeks
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 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be 18 years of age (when signing informed consent form)
- •Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
- •Documented history (within 6 months before screening) of either inadequate response or inadvisability to topical treatments
- •Validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 3 or 4 at baseline visit
- •Eczema area and severity index (EASI) score of 12 or higher at baseline
- •AD involvement of 10% or more of body surface area (BSA) at baseline
- •Able and willing to comply with requested study visits and procedures
- •Body weight ≥40 kg and ≤150 kg
排除标准
- •Skin co-morbidity that would adversely affect the ability to undertake AD assessments
- •Receipt of any vaccine (expect influenza and COVID-19 vaccines) within 3 months prior to screening
- •Receipt of any pneumococcal vaccine within approximate timeframe of 5 years prior to screening
- •Prior receipt of two or more doses of Pneumovax 23 at any time
- •Receipt of any tetanus-, diphtheria-, or pertussis-containing vaccine within approximate timeframe of 5 years prior to screening
- •Participants for whom administration of the pneumococcal vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
- •Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable, according to local label of the vaccine
- •Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
- •Known history of or suspected significant current immunosuppression
- •Any malignancies or history of malignancies prior to baseline (excluding non-melanoma skin cancer excised and cured >5 years prior to baseline)
- •History of solid organ or stem cell transplant
- •Any active or chronic infection including helminthic infection requiring systemic treatment within 2 weeks prior baseline
- •Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
- •Participants with active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
研究组 & 干预措施
Amlitelimab
Participants will receive amlitelimab and vaccines as per protocol.
干预措施: Amlitelimab (Drug)
Amlitelimab
Participants will receive amlitelimab and vaccines as per protocol.
干预措施: PPS vaccine (Biological)
Placebo
Participants will receive placebo matching amlitelimab and vaccines as per protocol.
干预措施: Placebo (Drug)
Placebo
Participants will receive placebo matching amlitelimab and vaccines as per protocol.
干预措施: PPS vaccine (Biological)
Placebo
Participants will receive placebo matching amlitelimab and vaccines as per protocol.
干预措施: Tdap vaccine (Biological)
Amlitelimab
Participants will receive amlitelimab and vaccines as per protocol.
干预措施: Tdap vaccine (Biological)
结局指标
主要结局
Percentage of participants with a positive tetanus response at Week 16
时间窗: Week 16
Positive tetanus response is defined as ≥2.5 IU/mL in anti-tetanus immunoglobulin G \[IgG\] titer for participants with a pre-vaccination baseline \[Week 12\] tetanus antibody titer of \>1 IU/mL or a titer ≥ 3-fold increase for participants with a pre-vaccination titer of ≤1IU/mL).
次要结局
- Percentage of participants with a positive pneumococcal vaccine response at Week 16(Week 16)
- Percentage of participants who experienced treatment-emergent adverse events (TEAE), including serious adverse events (SAE) and adverse events of special interest (AESI)(Week 0 up to Week 32)
- Percentage of participants with potentially clinically significant abnormalities (PCSA) for vital signs and clinical laboratory assessments(Week 0 up to Week 32)
- Percentage of participants discontinued from study treatment due to TEAEs(Week 0 up to Week 32)
- Proportion of participants with validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction of ≥2 points from baseline at Week 16(Week 16)
- Proportion of participants with a ≥75% reduction in EASI score (EASI-75) from baseline at Week 16(Week 16)
- Serum amlitelimab concentrations(Week 0 up to Week 16)
- Incidence of antidrug antibodies (ADAs) of amlitelimab(Week 0 up to Week 16)