A Randomized, Double-Blind, Placebo-Controlled Study to Assess Immunization Responses in Adult and Adolescent Subjects With Moderate-to-Severe Atopic Dermatitis Treated With Nemolizumab
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- Galderma R&D
- 入组人数
- 242
- 试验地点
- 127
- 主要终点
- Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)
研究概览
简要总结
The purpose of this study is to assess the effect of nemolizumab (CD14152) on humoral immune responses to tetanus and meningococcal vaccination in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD).
详细描述
This is a randomized, double-blind, placebo-controlled, multi-center, parallel-group study in adult and adolescent participants (≥ 12 to 54 years) with moderate-to-severe AD. Eligible participants must have a documented history of inadequate response to topical AD medication(s). Approximately 200 participants were randomized 1:1 to receive either 30 mg nemolizumab (with a 60 mg loading dose) or placebo, stratified by baseline disease severity Investigator Global Assessment (IGA) (IGA = 3, moderate; IGA = 4, severe). The study consisted of a 2- to 4-week screening period, a 16-week treatment period, and an 8-week follow-up period (12 weeks after the last study drug injection).
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
- 12 Years 至 54 Years（Child, Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Chronic AD for at least 2 years
- •EASI score >= 16
- •IGA score >= 3
- •AD involvement >= 10% of BSA
- •Peak (maximum) pruritus NRS score of at least 4.0
排除标准
- •Body weight < 30 kilogram (kg)
- •History of hypersensitivity (including anaphylaxis) to an immunoglobulin product (plasma-derived or recombinant, eg, monoclonal antibody) or to any of the study drug excipients
- •History of severe allergic reaction to either vaccine or to vaccine components including alum, thimerosal, phenol
- •Participants for whom administration of the meningococcal vaccine provided in this study is contraindicated or medically inadvisable
- •Participants for whom administration of the tetanus, diphtheria, and pertussis vaccine provided in this study is contraindicated or medically inadvisable
- •Receipt of any vaccine (except inactivated influenza vaccine) within 12 weeks prior to screening, any meningococcal vaccine within 1 year prior to screening, or any tetanus-, diphtheria-, or pertussis-containing vaccine within 5 years prior to screening
研究组 & 干预措施
Placebo
Participants received a placebo via 2 SC injections at baseline. Placebo was administered via a single subcutaneous injection Q4W at Weeks 4, 8, and 12.
干预措施: Placebo (Drug)
Nemolizumab
Participants received a loading dose of nemolizumab (60 milligram [mg]) via 2 subcutaneous (SC) injections at baseline. Nemolizumab (30 mg) was administered via a single subcutaneous injection every 4 weeks (Q4W) at Weeks 4, 8, and 12.
干预措施: Nemolizumab (Drug)
结局指标
主要结局
Percentage of Participants With a Positive Serum Immunoglobulin G (IgG) Response (>= 4-Fold Increase or >= 0.2 IU/mL in Anti-Tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)
时间窗: At Week 16 (4 weeks post-vaccination)
Percentage of participants with a positive serum IgG response to tetanus toxoid, defined as greater than or equal to (\>=) 4-fold increase in anti-tetanus IgG concentrations from baseline in participants with pre-vaccination anti-tetanus IgG concentrations \>= 0.1 international unit per milliliter (IU/mL); or \>= 0.2 IU/mL anti-tetanus IgG concentrations in participants with pre-vaccination antitetanus IgG concentrations less than (\<) 0.1 IU/mL, at Week 16 (4 weeks post-vaccination) were reported.
次要结局
- Percentage of Participants With a Positive Serum IgG Response (>=2-Fold Increase or >= 0.2 IU/mL in Anti-tetanus IgG Concentrations) to Tetanus Toxoid at Week 16 (4 Weeks Post-vaccination)(At Week 16 (4 weeks post-vaccination))
- Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 0.1 IU/mL at Week 16(At Week 16)
- Percentage of Participants With Serum Anti-tetanus IgG Concentrations of >= 1.0 IU/mL at Week 16(At Week 16)
- Percentage of Participants With a Positive Serum Bactericidal Antibody (SBA) Response to Meningococcal Serogroup C (MenC) Polysaccharide at Week 16(At Week 16)
- Percentage of Participants With a Positive SBA Response (Defined as SBA Reciprocal Titer ≥8) to MenC Polysaccharide at Week 16(At Week 16)