NCT07711418招募中3 期
A Phase 3, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Rezpegaldesleukin (NKTR-358) Monotherapy in the Treatment of Patients ≥ 12 Years of Age With Moderate-to- Severe Atopic Dermatitis
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 510
- 试验地点
- 13
- 主要终点
- US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24
研究概览
简要总结
This is an interventional, randomized, parallel group, treatment, Phase 3, double blind study to assess the effect of Rezpegaldesleukin in participants 12 years of age or older with moderate to severe atopic dermatitis, as compared to placebo.
The estimated participant overall duration is approximately 15 months.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female patients, ≥ 12 years of age on the day of signing the informed consent form and weighing ≥ 40 kg prior to randomization at Baseline
- •Chronic atopic dermatitis (AD) defined as onset of AD signs and symptoms
- •≥ 12 months prior to Screening as determined by the Investigator through patient interview and/or review of medical history at the Screening Visit
- •Patients must meet the following AD severity criteria:
- •IGA score ≥ 3 (scale of 0 to 4) at Screening and Baseline
- •≥ 10.0% of BSA involvement at Screening and Baseline
- •EASI ≥ 16.0 at Screening and Baseline
- •Are candidates for systemic therapy and have history, documented by a physician and/or the Investigator, of inadequate response to existing topical medications within 6 months preceding Screening, or history of intolerance to a topical therapy
- •Provide written, informed consent to participate in the study and follow the study procedures, including compliance with the use of highly effective contraceptives
排除标准
- •Are currently experiencing or have a history of concomitant skin conditions other than AD, including skin infection in the area affected by the patient's AD that requires treatment with systemic antimicrobial therapy
- •Are currently experiencing or have a history of unstable course of AD
- •History of chronic idiopathic urticaria at any time or urticaria from other causes within 4 weeks prior to randomization at the Baseline Visit.
- •Have a history of TCS use suggestive of a high risk for topical corticosteroid (TCS) withdrawal
- •Have received any of the following treatments at any time before Screening: aldesleukin; investigational IL-2 analog; systemic biologic; oral JAKi; or any prior investigational agent for AD
- •Have a current or recent acute, active infection
研究组 & 干预措施
Blinded Induction Period: Rezpegaldesleukin every 2 weeks
Experimental
Rezpegaldesleukin every 2 weeks during the induction period
干预措施: Rezpegaldesleukin (Drug)
Blinded Induction Period: Placebo
Placebo Comparator
Placebo every 2 weeks during the induction period
干预措施: Placebo (Drug)
Blinded Maintenance Period: Rezpegaldesleukin every 4 weeks
Experimental
Rezpegaldesleukin every 4 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Blinded Maintenance Period: Placebo
Placebo Comparator
Placebo every 4 weeks during the maintenance period
干预措施: Placebo (Drug)
Blinded Maintenance Period: Rezpegaldesleukin every 12 weeks
Experimental
Rezpegaldesleukin every 12 weeks during the maintenance period
干预措施: Rezpegaldesleukin (Drug)
Open-Label Escape
Experimental
Rezpegaldesleukin at a frequency determined by the investigator during the open-label escape
干预措施: Rezpegaldesleukin (Drug)
结局指标
主要结局
US only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 and reduction ≥ 2 points from baseline at Week 24
时间窗: Week 0 and Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with an Investigator's Global Assessment (IGA) score of 0 or 1 at Week 24
时间窗: Week 0 and Week 24
The IGA scale ranges from 0 to 4, with higher score indicating more severe disease.
Non-US regions only: Number of participants with a ≥ 75% reduction in Eczema Area and Severity Index (EASI) score from baseline at Week 24 (EASI-75)
时间窗: Week 0 and Week 24
The EASI scores range from 0 to 72, with higher scores indicating more severe atopic dermatitis.
次要结局
- Number of participants with TEAEs leading to treatment discontinuation(Through participant study completion, approximately Week 56)
- Number of participants with TEAEs leading to dose hold(Through participant study completion, approximately Week 56)
- Number of participants with TEAEs leading to dose modifications(Through participant study completion, approximately Week 56)
- Number of participants with treatment emergent adverse events (TEAEs)(Through participant study completion, approximately Week 56)
- Number of participants with treatment emergent serious adverse events(Through participant study completion, approximately Week 56)
- Number of participants with treatment related serious adverse events(Through participant study completion, approximately Week 56)
- Number of participants with treatment emergent adverse events of special interest(Through participant study completion, approximately Week 56)
- Number of participants with treatment related adverse events of special interest(Through participant study completion, approximately Week 56)
- US only: Number of participants with a ≥ 75% reduction in EASI score from baseline at Week 24 (EASI-75)(Week 0 and Week 24)
- Number of participants with a ≥ 90% reduction in EASI score from baseline at Week 24 (EASI-90)(Week 0 and Week 24)
- Number of participants at week 6 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants with a 4-point or greater Itch NRS at baseline(Week 0 and Week 6)
- Number of participants at week 24 achieving a 4-point or greater improvement in Itch numerical rating scale (NRS) in the subset of participants with a 4-point or greater Itch NRS at baseline(Week 0 and Week 24)
- Number of participants at week 6 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline(Week 0 and Week 6)
- Number of participants at week 24 achieving a 4-point or greater improvement in Skin Pain numerical rating scale (NRS) in the subset of participants with a 4-point or greater Skin Pain NRS at baseline(Week 0 and Week 24)
- Number of participants at week 6 achieving a 1.25-point or greater improvement in Atopic Dermatitis Sleep Scale Question 1 (ADSS Q1) in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline(Week 0 and Week 6)
- Number of participants at week 24 achieving a 1.25-point or greater improvement in ADSS Q1 in the subset of participants with a 1.25-point or greater ADSS Q1 at baseline(Week 0 and Week 24)
- Change in Asthma Control Questionnaire-5 (ACQ-5) score from baseline at Week 24 in the subpopulation of patients with a 0.5-point or greater ACQ-5 at baseline(Week 0 and Week 24)
- Number of participants at week 24 achieving a 0.5-point or greater improvement in ACQ-5 in the subset of participants with a 0.5-point or greater ACQ-5 at baseline(Week 0 and Week 24)
- Change in Sino-Nasal Outcome Test (SNOT-22) score from baseline at Week 24 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline(Week 0 and Week 24)
- Number of participants at Week 24 achieving a 8.9-point or greater reduction from baseline in SNOT-22 in the subpopulation of patients with an 8.9-point or greater SNOT-22 at baseline(Week 0 and Week 24)
- Number of participants at week 24 achieving an Adapted Investigator's Global Assessment (aIGA) response of 0 or 1(Week 0 and Week 24)
研究者
研究点 (13)
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