A Multicenter Open-Label Interventional Biomarker Study of Lutikizumab in Adult Subjects With Moderate-to-Severe Hidradenitis Suppurativa or Adult Subjects With Moderate-to-Severe Atopic Dermatitis
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 2
- 主要终点
- Number of Participants With Adverse Events (AEs)
研究概览
简要总结
Hidradenitis suppurativa (HS) and atopic dermatitis (AD) are chronic inflammatory skin diseases that lead to the development of skin lesions and symptoms such as pain and discomfort. The purpose of this study is to assess molecular changes in adult participants with moderate to severe HS or with moderate to severe AD.
Lutikizumab (ABT-981) is an investigational drug being developed for the treatment of HS and AD. This study will consist of 2 sub-studies: Sub-Study 1 moderate to severe hidradenitis suppurativa and Sub-Study 2 moderate to severe atopic dermatitis. Approximate 60 participants will be enrolled in the study at approximately 2 sites in the US.
In Sub-Study 1 HS participants will receive subcutaneous (SC) injections of lutikizumab for up to week 15 with a 70-day follow-up period. In Sub-Study 2 AD, participants will receive subcutaneous (SC) injections of lutikizumab for up to week 14 with a 70-day follow-up period. The study duration for Sub-Studies 1 and 2 is expected to last up to 30 weeks.
Participants in Sub-Study 1 (HS) who complete Week 16 and showed a therapeutic benefit to lutikizumab, as confirmed by the investigator, will have the option to enter an open-label long-term extension (LTE) to continue to receive lutikizumab for up to an additional 140 weeks, followed by a 70-day follow-up period.
There may be higher treatment burden for participants in this trial compared to their standard of care. Participants will attend regular visits during the study at a hospital or clinic and may require frequent medical assessments, blood tests, and biomarker collections.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Sub-Study 1 hidradenitis suppurativa (HS):
- •Participants with a diagnosis of moderate-to-severe HS for at least 6 months prior to Baseline as determined by the investigator
- •Participants naïve to biologic treatment for HS or must have a prior inadequate response or loss of response to anti-TNF therapy for HS (>= 12 weeks of therapy).
- •Sub-Study 2 atopic dermatitis (AD):
- •Participants with a diagnosis of moderate-to-severe AD with onset of symptoms at least 1 year prior to Baseline.
- •Participants naïve to biologic treatment for AD or must have a prior inadequate response or loss of response to dupilumab for AD (defined as >= 8 weeks of therapy with dupilumab).
排除标准
- •History of any malignancy within the last 5 years except for successfully treated nonmelanoma skin cancer (NMSC) or localized carcinoma in situ of the cervix.
- •History of active skin disease (other than HS for Sub-Study 1 or AD for Sub-Study 2) that could interfere with the assessment of HS (for Sub-Study 1) or AD (for Sub-Study 2), including skin infections (e.g., bacterial, fungal, or viral) requiring systemic treatment within 4 weeks of the Baseline.
研究组 & 干预措施
SS 1: Lutikizumab Hidradenitis Suppurativa (HS) Bio-Naïve
HS Bio-naïve participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration, with the option to enter an open-label LTE to continue to receive Lutikizumab Dose B at Week 16 and every week thereafter.
干预措施: Lutikizumab (Drug)
SS 1: Lutikizumab HS Tumor Necrosis Factor-Inadequate Response
Tumor Necrosis Factor-Inadequate Response (TNF-IR) participants will receive Lutikizumab Dose A followed by Dose B as part of the 16 week treatment duration.
干预措施: Lutikizumab (Drug)
SS 2: Lutikizumab Atopic Dermatitis (AD) Bio-naïve
AD Bio-naïve participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
干预措施: Lutikizumab (Drug)
SS 2: Lutikizumab AD Dupilumab-Inadequate Response (IR)
AD Dupilumab-IR participants will receive Lutikizumab Dose C followed by Dose D as part of the 16 week treatment duration.
干预措施: Lutikizumab (Drug)
结局指标
主要结局
Number of Participants With Adverse Events (AEs)
时间窗: Up to Approximately 30 weeks
An AE is defined as any untoward medical occurrence in a patient or clinical investigation participant administered a pharmaceutical product which does not necessarily have a causal relationship with this treatment.
次要结局
未报告次要终点