跳至主要内容
MedPath Trial logoMedPath TrialMedPath Trial Home
临床试验/NCT05590585
NCT05590585已完成4 期

An Open-Label Single-Arm Study of Dupilumab in Adolescent and Adult Skin of Color Patients With Moderate-to-Severe Atopic Dermatitis

Regeneron Pharmaceuticals60 个研究点 分布在 1 个国家目标入组 124 人开始时间: 2023年1月11日最近更新:
Share to TwitterShare to FacebookShare to LinkedInShare to Reddit
适应症
干预措施
相关药物

试验速览

阶段
4 期
状态
已完成
入组人数
124
试验地点
60
主要终点
Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75)
研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验

研究概览

简要总结

The study is focused on skin of color participants who have moderate-to-severe atopic dermatitis. Atopic dermatitis, also referred to as eczema, is a condition that causes the skin to become itchy, dry, and cracked.

From the previous studies on the study drug, it is seen that the study drug has an acceptable safety and effectiveness in participants with atopic dermatitis.

The aim of this study is to get additional information on the safety and effectiveness of the study drug, particularly the information on aspects of atopic dermatitis in skin of color participants.

The study is looking at several other research questions, including:

  • What side effects may happen from taking the study drug
  • How much study drug is in your blood at different times
  • How much the study drug improves quality of life and mental health

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Treatment
盲法
None

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

  • •Skin of color, defined as Fitzpatrick skin type ≥4 at screening visit
  • •Diagnosis of moderate-to-severe atopic dermatitis (AD) that cannot be adequately controlled with topical AD medications, as defined in protocol
  • •Has applied a stable dose of topical emollient (moisturizer) twice daily as per physician recommendation starting at screening visit

排除标准

  • •Self-reported Caucasian or White race
  • •Adolescent body weight less than 30 kg at screening
  • •Prior use of dupilumab within 6 months of screening
  • •Concomitant skin diseases or other pigmentary disorder that could confound AD assessments
  • •Current or prior use, within 12 weeks before the screening visit, of phototherapy or tanning beds
  • •Active helminthic infections; suspected or high risk of helminthic infection, unless clinical and (if necessary) laboratory assessments have ruled out active infection before baseline
  • •Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 7 days prior to baseline
  • •Planned or anticipated use of any prohibited medications and procedures, as defined in protocol
  • •Has received a COVID-19 vaccination within 1 week of planned start of study medication or for which the planned COVID-19 vaccinations would not be completed 1 week prior to start of study drug
  • •NOTE: Other Protocol Defined Inclusion / Exclusion Criteria Apply

研究组 & 干预措施

dupilumab

Experimental

Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight

干预措施: Topical emollient (moisturizer) (Other)

dupilumab

Experimental

Adolescents and adults will receive 1 of 2 dose regimens based on age and body weight

干预措施: dupilumab (Drug)

结局指标

主要结局

Percentage of Participants With ≥75% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-75)

时间窗: Week 24

The EASI score was used to measure the severity and extent of atopic dermatitis (AD) and measures erythema, infiltration, excoriation and lichenification on 4 anatomic regions of the body: head, trunk, upper and lower extremities. The total EASI score ranges from 0 (minimum) to 72 (maximum) points, with the higher scores reflecting the worse severity of AD. EASI-75 responders were the participants who achieved ≥75% overall improvement in EASI score from baseline to Week 24.

次要结局

  • Change From Baseline in EASI Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Total IgE(Weeks 4, 12 and 24)
  • Trough Concentration of Functional Dupilumab in Serum(Week 12 and Week 24)
  • Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in EASI Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Weekly Average of Daily PP NRS Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Weekly Average of Daily PP NRS Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Percent Body Surface Area (BSA)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Skin Pain NRS (SP NRS) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Weekly Average Sleep Quality NRS Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs)(Day 1 through Week 24)
  • Change From Baseline in Total Immunoglobulin (E) IgE(Weeks 4, 12 and 24)
  • Percentage of Participants With an Investigator's Global Assessment (IGA) Score 0 to 1(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in EASI Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in EASI Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥50% Reduction From Baseline in EASI Score (EASI-50)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥75% Reduction From Baseline in EASI Score (EASI-75)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥90% Reduction From Baseline in EASI Score (EASI-90)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Total Scoring Atopic Dermatitis (SCORAD) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With ≥50% Reduction From Baseline in SCORAD Score (SCORAD-50)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily Peak Pruritus (PP) Numerical Rating Scale (NRS) Score ≥3(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With Improvement (Reduction) From Baseline of Weekly Average of Daily PP NRS Score ≥4(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Weekly Average of Daily PP NRS Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Weekly Average of Daily PP NRS Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percent Change From Baseline in Percent Body Surface Area (BSA)(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Health-related Quality of Life (QOL) as Measured by Dermatology Life Quality Index (DLQI; Age ≥16) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Health-related QOL as Measured by Children's Dermatology Life Quality Index (CDLQI; Age <16) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Patient Oriented Eczema Measure (POEM) Total Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Hospital Anxiety and Depression Scale (HADS) Total Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Skin Pain NRS (SP NRS) Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Change From Baseline in Weekly Average Sleep Quality NRS Score(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With Patient Global Impression of Disease (PGID) Response as No Symptoms(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants With PGID Response as No Symptoms or Mild Symptoms(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants Who Rated Their Eczema Symptoms in the Patient Global Impression of Change (PGIC) as "Much Better"(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Percentage of Participants Who Rated Their Eczema Symptoms in the PGIC as "Moderately Better"(Weeks 2, 4, 8, 12, 16, 20, and 24)
  • Number of Participants With Non-herpetic Skin Infection Treatment-emergent Adverse Events (TEAEs)(Day 1 through Week 24)
  • Change From Baseline in Total Immunoglobulin (E) IgE(Weeks 4, 12 and 24)
  • Percent Change From Baseline in Total IgE(Weeks 4, 12 and 24)
  • Trough Concentration of Functional Dupilumab in Serum(Week 12 and Week 24)

研究者

申办方类型
Industry
责任方
Sponsor

研究点 (60)

Loading locations...

相似试验

终止
4 期
Tralokinumab for Dupilumab FailuresAtopic Dermatitis
NCT06773455Psoriasis Treatment Center of Central New Jersey7
已完成
2 期
Atopic Dermatitis Biomarker Identification Trial in Omalizumab UsageAtopic EczemaAtopic Dermatitis
NCT01179529Technical University of Munich
已完成
2 期
A Study of Adalimumab to Treat Sarcoidosis of the SkinSarcoidosis
NCT00274352Pariser, Robert J., M.D.16
招募中
4 期
Dupilumab De-escalation in Pediatric Atopic DermatitisAtopic Dermatitis
NCT06116526Johns Hopkins University30
终止
2 期
Topical Application of AS101 for the Treatment of Atopic DermatitisAtopic Dermatitis
NCT00927212BioMAS Ltd5