A multi-center, single-arm phase IV clinical trial to evaluate the safety of Dupilumab in adult Indian patients with moderate-to-severe atopic dermatitis
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 56
- 试验地点
- 8
- 主要终点
- To describe safety of dupilumab in Indian adult patients with moderate-to-severe Atopic Dermatitis
研究概览
简要总结
This study will describe safety of the study drug in adult participants with atopic dermatitis. It will also look at the improvement of atopic dermatitis signs and symptoms in these participants.
This is an interventional phase IV clinical study
Atopic dermatitis is a condition that causes itching, inflammation, redness, and irritation of the skin.
Study duration: The maximum study duration would be 32 weeks which includes the below:
Up to 28 days of screening period in which the doctor will assess if the participant can be recruited in this study
Treatment duration is 16 weeks
Follow up period: during which the participant will be followed for 12 weeks to check for any safety events.
Visit frequency: The visit frequency will be every 4 weeks during the 16 weeks treatment duration and then 12 weeks after the last dose of the study treatment. Total number of visits will be 7.
Number of participants:
Approximately 56 participants will be enrolled to the investigational intervention.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 99.00 Year(s)（—）
- 性别
- All
入选标准
- •Participant must be ≥ 18 years of age, at the time of signing the informed consent.
- •Atopic dermatitis (AD) as defined by American Academy of Dermatology Consensus Criteria, that has been present for at least ≥1 year prior to screening
- •Participants with moderate-to-severe atopic dermatitis whose disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable
- •Candidate for systemic therapy (disease is not adequately controlled with topical prescription therapies or when those therapies are not advisable)
- •Male or Female
- •Participant with pruritus NRS ≥ 4 at baseline
- •Capable of giving signed informed consent (including compliance with the requirements and restrictions listed in the informed consent form (ICF) and in the protocol).
排除标准
- •Any contraindications according to the PI
- •Positive hepatitis B surface antigen, or hepatitis C antibody or HIV antibody at screening
- •Patients with known helminth infection (current andor past infection).
- •Current enrolment or past participation within the last 30 days before signing of informed consent in any other clinical study involving an investigational study treatment or any other type of medical research
- •Participation in a prior dupilumab clinical trial or any prior use of dupilumab
- •Immunosuppressive or immunomodulating drugs or live vaccines or phototherapy for AD within 4 weeks before baseline, or any condition that in the opinion of the investigator, is likely to require such treatments during the first 2 weeks of study treatment
- •Has a history of or ongoing drug or alcohol abuse.
结局指标
主要结局
To describe safety of dupilumab in Indian adult patients with moderate-to-severe Atopic Dermatitis
时间窗: 16 weeks
次要结局
- To describe efficacy of dupilumab in Indian adult patients with moderate-to-severe Atopic Dermatitis(Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI-75) at week 16)