NCT06773455终止4 期
A Single-Center, Open-Label Study to Evaluate Tralokinumab in Atopic Dermatitis Subjects Who Experienced Inadequate Response on Dupilumab
Psoriasis Treatment Center of Central New Jersey2 个研究点 分布在 1 个国家目标入组 7 人开始时间: 2023年9月11日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 终止
- 发起方
- 入组人数
- 7
- 试验地点
- 2
- 主要终点
- Proportion of subjects achieving IGA 0 or 1 at week 16
研究概览
简要总结
24-week study of 20 atopic dermatitis patients who have been treated with dupilumab will receive Tralokinumab 600mg at week 0 followed by 300mg Q2W for 24 weeks.
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
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Male or female adult ≥ 18 years of age;
- •All participants must have prior treatment with dupilumab for atopic dermatitis meeting one of the following conditions:
- •Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab for at least 12 weeks.
- •Participants who stopped dupilumab treatment due to intolerance or AEs to the drug may enter the study with no required prior length of dupilumab treatment. AE's must be resolved prior to 1st tralokinumab dose.
- •Females of childbearing potential (FCBP) must have a negative urine pregnancy test at Baseline. FCBP who engage in activity in which conception is possible must use one of the approved contraceptive options: hormonal contraception; intrauterine device (IUD); tubal ligation; or partner's vasectomy; Male or female condom diaphragm with spermicide, cervical cap with spermicide, or contraceptive sponge with spermicide.
- •Subject is a candidate for systemic therapy.
- •Subject must be in general good health as judged by the Investigator, based on medical history, physical examination.
- •Able and willing to give written informed consent prior to performance of any study-related procedures.
排除标准
- •Subjects with previous exposure to tralokinumab.
- •Known or suspected hypersensitivity to tralokinumab or any of its excipients.
- •Women of childbearing potential who are pregnant, intend to become pregnant, or are lactating.
- •Use of tanning beds or phototherapy within 4 weeks of baseline
- •Use of systemic therapies (systemic steroids, cyclosporine, oral JAK inhibitors etc.) for atopic dermatitis within 4 weeks
- •Patient non-compliant with Dupixent dosing based on investigator discretion.
- •Any clinically significant (as determined by the investigator) cardiac, endocrinologic, pulmonary, neurologic, psychiatric, hepatic, renal, hematologic, immunologic disease, or other major disease that is uncontrolled.
研究组 & 干预措施
Tralokinumab
Experimental
干预措施: tralokinumab (Drug)
结局指标
主要结局
Proportion of subjects achieving IGA 0 or 1 at week 16
时间窗: 16 Weeks
次要结局
未报告次要终点
研究者
研究点 (2)
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