A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 1,153
- 试验地点
- 313
- 主要终点
- Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
研究概览
简要总结
This is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis. It will last up to 33 months.
详细描述
Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04 (NCT04146363), DRM06-AD05 (NCT04178967), DRM06-AD06 (NCT04250337), DRM06-AD17 (NCT04250350) or DRM06- AD18 (NCT04626297), will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment.
This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded.
This study will also include an Addendum to extend the study treatment period by an additional 32 weeks and to add a treatment arm testing dosing every 8 weeks. This Addendum will apply to existing study participants in selected countries. Treatment will not be blinded.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
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
- •Participants must meet all the following criteria to be eligible for this study addendum:
- •Male or female adults and adolescents (≥12 to <18 years of age and weighing ≥40 kilogram (kg).
- •Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening.
- •Eczema Area and Severity Index (EASI) score ≥16 at baseline.
- •Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at baseline.
- •≥10% body surface area (BSA) of AD involvement at baseline.
- •History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- •Open-Label Addendum
排除标准
- •Participants meeting any of the criteria below will be excluded from this study addendum:
- •Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
- •History of anaphylaxis
- •Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.
- •Treatment with any of the following agents within 4 weeks prior to the baseline.
- •Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, Interferon gamma (IFN-γ), Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •Phototherapy and photochemotherapy (PUVA) for AD.
- •Treatment with the following prior to baseline:
- •Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- •Phototherapy and photochemotherapy (PUVA) for AD.
- •Treatment with the following prior to baseline:
- •An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- •B Cell-depleting biologics, including rituximab, within 6 months.
- •Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
- •Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
- •Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
- •Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
- •Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
- •Evidence of active acute or chronic hepatitis
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
- •Open-Label Extension Addendum Inclusion Criteria:
- •Have completed Week 100 of Study KGAA and have not yet completed the safety follow-up visit for the main study.
- •Open-Label Extension Addendum Exclusion Criteria:
- •Have initiated treatment with a medication prohibited by Study KGAA before addendum baseline. This includes use of biologics for AD (for example, dupilumab and tralokinumab) during the safety follow-up period of Study KGAA.
研究组 & 干预措施
Lebrikizumab Q4W (Primary Treatment Period)
250 mg Lebrikizumab, subcutaneous injection administered every 2 weeks (Q2W) up to 100 weeks.
干预措施: Lebrikizumab (Biological)
Lebrikizumab Q2W (Primary Treatment Period)
250 milligrams (mg) of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 100 weeks.
干预措施: Lebrikizumab (Biological)
Open-Label Extension Addendum: Lebrikizumab Q4W
250 mg of Lebrikizumab, subcutaneous injection administered every 4 weeks (Q4W) up to 32 weeks.
干预措施: Lebrikizumab (Biological)
Open-Label Extension Addendum: Lebrikizumab Q8W
250 mg of Lebrikizumab, subcutaneous injection administered every 8 weeks (Q8W) up to 32 weeks.
干预措施: Lebrikizumab (Biological)
结局指标
主要结局
Primary Treatment Period: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events
时间窗: Baseline to Week 100
Percentage of participants discontinued from study treatment due to adverse events is reported.
次要结局
- Primary Treatment Period: Percentage of Participants With a Response of Investigator Global Assessment (IGA) Score 0 or 1 at Week 100(Week 100)
- Primary Treatment Period: Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) at Week 100(Week 100)