NCT05214326已完成不适用
A Real-World Study to Assess the Disease Control of Moderate to Severe Atopic Dermatitis in Patients Receiving Dupilumab Therapy, With Atopic Dermatitis Control Tool in Gulf Countries
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Sanofi
- 入组人数
- 187
- 试验地点
- 3
- 主要终点
- Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)
研究概览
简要总结
Primary objective:
To assess the disease control of moderate to severe atopic dermatitis in patients aged 12 years and above treated with dupilumab therapy using Atopic Dermatitis Control Tool (ADCT) after 24 weeks of treatment.
Secondary objectives:
- To figure the proportion of patients with reduction of ADCT score by 5 points after 4, 12, and 24 weeks of treatment.
- To figure the proportion of patients with ADCT score less than 7 at weeks 4, 12, and 24.
- Assess the effectiveness of dupilumab in moderate to severe atopic dermatitis (AD) patients, using the severity score as routine practice SCORing Atopic Dermatitis (SCORAD).
- To describe comorbidities related to type 2 inflammation.
- To characterize the safety profile of dupilumab in the local Gulf population.
- To evaluate treatment satisfaction in the local Gulf population.
详细描述
24 weeks
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
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
- •Having moderate to severe atopic dermatitis:
- •Moderate atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis body surface area (BSA) involvement ≥10%; and ii) Pruritus numerical rating scale (NRS) ≥3, Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline, Investigator's Global Assessment (IGA)=3, or SCORing Atopic Dermatitis (SCORAD) is between 25 and
- •Severe atopic dermatitis is defined at screening and baseline as i) Atopic dermatitis BSA involvement ≥10%; ii) Eczema Area and Severity Index (EASI) score ≥20; iii) Investigator's Global Assessment (IGA) score = 4, or SCORAD ≥
- •Initiating dupilumab therapy within 30 days of enrollment, according to the treating physician's decision independently of study participation.
- •Participants and/or his legally approved representatives (LAR, in case of minor subject) agrees to sign an informed consent or an assent.
- •Age of 12 years or above.
排除标准
- •Participation in another trial.
- •Pregnancy or lactating or planning/intending to be pregnant in the next 6 months.
- •Presence of active chronic or acute infection requiring systemic treatment
- •Diagnosed active endoparasites infection, or suspected high risk of infection.
- •Human immunodeficiency virus (HIV), hepatitis B or C, malignancy, or other concomitant illnesses.
- •The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial.
结局指标
主要结局
Percentage of patients achieving an Atopic Dermatitis Control Tool (ADCT) score less than 7 (defined as in control according to ADCT)
时间窗: At week 24
ADCT is a questionnaire to assess patient-self-perceived control of their atopic dermatitis (AD) with a total score from 0 to 24; higher scores indicate lower AD control.
次要结局
- Percentages (%) of patients with ADCT score less than 7(At weeks 4 and 12)
- Number of patients with at least one type-2 inflammation comorbidity(Baseline (week 0) to week 24)
- Adverse events of special interest (AESI) related to dupilumab use(Baseline (week 0) to week 24)
- Treatment satisfaction: Number of patients achieving patient global assessment of treatment effect (PGATE) level very good(At week 24)
- Percentages (%) of patients achieving a reduction of 5 points from baseline in ADCT(At weeks 4, 12, and 24)
- Percentages (%) for patients achieving 50% and 75% reduction from baseline in SCORAD score (SCORAD-50 and SCORAD-75)(At week 24)
- Treatment interruption due to any adverse drug reaction (ADR), AE, SAE, or AESI(Baseline (week 0) to week 24)
- Mean change in SCORAD(From baseline (week 0) to week 24)
- Adverse events (AEs) related to dupilumab use(Baseline (week 0) to week 24)
- Serious adverse events (SAEs) related to dupilumab use(Baseline (week 0) to week 24)
研究者
研究点 (3)
Loading locations...
相似试验
尚未招募
4 期
Efficacy and Safety of Dupilumab in Combination With Tofacitinib in Moderate to Severe Adult AD PatientsAtopic DermatitisNCT06465732Second Affiliated Hospital, School of Medicine, Zhejiang University220
已完成
2 期
Efficacy and Safety of a a Biofunctional Textile in the Management of Atopic DermatitisAtopic DermatitisNCT01597817Universidade do Porto78
已完成
2 期
Secukinumab for Treatment of Atopic DermatitisAtopic DermatitisNCT02594098Icahn School of Medicine at Mount Sinai41
已完成
1 期
A Study to Evaluate the Efficacy and Safety of HAT01H in Atopic DermatitisEczemaAtopic DermatitisNCT03089229Haus Bioceuticals30
已完成
2 期
Evaluation of FB-401 in Children, Adolescents and Adults (2 Years and Older) With Mild to Moderate Atopic DermatitisAtopic DermatitisNCT04504279Forte Biosciences, Inc.154