2025-521833-97-00尚未招募4 期
A Phase IV, non-randomized, open-label multinational trial to assess the mechanism of action for Lebrikizumab in moderate-to-severe atopic dermatitis
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 入组人数
- 12
- 试验地点
- 1
- 主要终点
- Degree of normalization of transcriptomic and epigenetic profile in skin biopsies from baseline over time, measuring molecular changes after treatment with lebrikizumab
研究概览
简要总结
Determine the kinetics and maintenance of the molecular response and epigenetic changes of treatment with lebrikizumab in moderate-to-severe AD to increase understanding of clinical responses, including durable long-term improvements in the skin.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- Period 1
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Male or Female subjects aged ≥ 18 years at the screening visit.
- •Established diagnosis of AD for at least 1 year before the screening visit and topical treatment was inadequate or inadvisable.
- •Moderate-to-severe AD with involvement > 10% of body-surface-area (BSA) and investigator global assessment (IGA) score ≥ 3 (based on the IGA scale ranging from 0 to 4, in which 3 is moderate and 4 is severe) at both the screening and baseline visits.
- •Subject has an Eczema Area and Severity Index (EASI) score ≥ 16 at screening and baseline.
- •Subject has a pruritus NRS ≥
- •Subject is biologic naïve.
- •Female subjects of childbearing potential (i.e., fertile, following menarche and until becoming post-menopausal unless permanently sterile) must agree either to commit to true abstinence throughout the study and for at least 17 weeks after the last study drug (SD) injection, when this is in line with the preferred and usual lifestyle of the subject, or to use a highly-effective and approved method of contraception throughout the study and for at least 17 weeks after the last study drug injection.
- •Subject willing and able to comply with all of the clinical study protocol's time commitments and procedural requirements.
- •Understand and sign an informed consent form (ICF) (and assent form, when applicable) before any investigational procedure(s) are performed.
排除标准
- •Previous treatment with lebrikizumab or participation in a lebrikizumab study.
- •Uncontrolled chronic disease that might require bursts of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma requiring systemic [oral and/or parenteral] corticosteroid treatment or hospitalization for > 24 hours).
- •Active chronic or acute infection (including Helminth infections) requiring treatment with systemic antibiotics, antivirals, anti-parasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit, or superficial skin infections within 1 week before the baseline visit. NOTE: patients may be rescreened after infection resolves.
- •Evidence of active acute or chronic hepatitis (as defined by the Department of Health & Human Services Centers for Disease Control and Prevention) or known liver cirrhosis.
- •Diagnosed active endoparasitic infections or at high risk of these infections.
- •Known or suspected history of immunosuppression, including history of invasive opportunistic infections (e.g., tuberculosis [TB], histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis, and aspergillosis) despite infection resolution: or unusually frequent, recurrent, or prolonged infections, per the Investigator’s judgment.
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •In the Investigator’s opinion, any clinically significant laboratory results from the chemistry, hematology or urinalysis tests available in the medical history.
- •Presence of skin comorbidities that may interfere with study assessments.
- •History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- •Severe concomitant illness(es) that in the Investigator’s judgment would adversely affect the patient’s participation in the study. Any other medical or psychological condition that in the opinion of the Investigator may suggest a new and/or insufficiently understood disease, may present an unreasonable risk to the study patient because of his/her participation in this clinical trial, may make patient’s participation unreliable, or may interfere with study assessments.
- •History of anaphylaxis as defined by the Sampson criteria.
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •Treatment with topical corticosteroids, calcineurin inhibitors, Jak inhibitors, or crisaborole within 1 week prior to the baseline visit.
- •Prior treatment with dupilumab or tralokinumab.
- •Treatment with any of the following agents within 4 weeks prior to the baseline visit: a. Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors (JAKi), azathioprine, methotrexate). b. Phototherapy and photochemotherapy (PUVA) for AD.
- •Treatment with the following prior to the baseline visit: a. An investigational drug within 8 weeks or 5 half-lives (if known), whichever is longer. b. Cell-depleting biologics, including to rituximab, within 6 months. c. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- •Use of prescription moisturizers within 7 days of the baseline visit.
- •Regular use (more than 2 visits per week) of a tanning booth/parlor within 4 weeks of the screening visit.
- •Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
结局指标
主要结局
Degree of normalization of transcriptomic and epigenetic profile in skin biopsies from baseline over time, measuring molecular changes after treatment with lebrikizumab
Degree of normalization of transcriptomic and epigenetic profile in skin biopsies from baseline over time, measuring molecular changes after treatment with lebrikizumab
次要结局
- 1. Molecular (transcriptomic/epigenetic) response to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60.
- 2. Molecular (transcriptomic/epigenetic) change to lebrikizumab among patients with atopic dermatitis at baseline to weeks 2, 24, 36, and 60.
- 3. Molecular (transcriptomic/epigenetic) response after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm.
- 4. Molecular (transcriptomic/epigenetic) changes after lebrikizumab discontinuation among patients with atopic dermatitis from week 36 to week 60 in the withdrawal arm and active treatment arm.
- 5. Improvement in skin barrier function as assessed by serial TEWL measurements in lesional skin from baseline to week 60 in all subjects.
- 6. Correlation between clinical response (EASI/IGA and Pruitis NRS) with molecular (transcriptomic/epigenetic) at weeks 2, 24, 36, and 60.
研究者
Johann Gudjonsson, MD, PhD
Scientific
University Of Michigan
研究点 (1)
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