NCT07006792进行中（未招募）4 期
A Phase 4, Multicenter, Open-label, Single-arm Study to Investigate the Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate Atopic Dermatitis and High Itch Burden
适应症
干预措施
相关药物
试验速览
- 阶段
- 4 期
- 状态
- 进行中（未招募）
- 入组人数
- 233
- 试验地点
- 135
- 主要终点
- Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline
研究概览
简要总结
The purpose of this study is to measure how well taking lebrikizumab alone works for participants with fewer places on the body with eczema (atopic dermatitis), but these places may be very itchy.
Participation in this study will last up to approximately 38 weeks (9 and a half months) including 24 weeks (6 months) of treatment.
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
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Have chronic atopic dermatitis (AD) (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before screening visit.
- •Have 10% to 25% body surface area (BSA) of AD involvement at screening and baseline.
- •Have pruritus numeric rating scale (NRS) ≥6 at baseline.
- •Have an Eczema Area and Severity Index (EASI) score ≥16 at screening and baseline.
- •Have an Investigator's Global Assessment (IGA) score ≥3 (on a scale of 0 to 4) at screening and baseline.
- •Based on investigator judgement, have a history of inadequate response to treatment with topical medications, or determination that topical treatments are otherwise medically inadvisable.
- •For participants aged 12 to less than 18, have a body weight ≥40 kilograms (kg) at baseline.
排除标准
- •Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator).
- •Have known liver cirrhosis and/or chronic hepatitis of any etiology.
- •History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved nonmetastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
- •Are diagnosed with active endoparasitic infections or at high risk of these infections.
- •Have a known or suspected history of immunosuppression, including history of invasive opportunistic infections despite infection resolution; or unusually frequent, recurrent, or prolonged infections, per the investigator's judgment.
- •Have presence of skin comorbidities that may interfere with study assessments.
- •Have a severe concomitant illness(es) that in the investigator's judgment would adversely affect the participant's participation in the study.
- •Have had any of the following types of infection within 3 months of screening or develop any of these infections during screening:
- •Serious (requiring hospitalization, and/or intravenous or equivalent oral antibiotic treatment).
- •Opportunistic - Note: Herpes zoster is considered active and ongoing until all vesicles are dry and crusted over.
- •Chronic (duration of symptoms, signs, and/or treatment of 6 weeks or longer).
- •Recurring (including, but not limited to, recurring cellulitis and chronic osteomyelitis).
- •Have an active or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before the baseline visit or superficial skin infections within 1 week before the baseline visit.
- •Have had any prior treatment with a biologic therapy for AD.
- •Have had treatment with any of the following agents within 4 weeks prior to the baseline visit:
- •systemic immunosuppressive or immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, interferon-gamma,
- •azathioprine, methotrexate, and other immunosuppressants)
- •small molecules (for example, Janus kinase inhibitors [topical or systemic]), or
- •phototherapy and photochemotherapy for AD.
- •Treatment with B-cell-depleting biologics, including rituximab, within 6 months prior to baseline.
研究组 & 干预措施
Lebrikizumab
Experimental
Lebrikizumab administered subcutaneously (SC).
干预措施: Lebrikizumab (Drug)
结局指标
主要结局
Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) (≥75% Reduction from Baseline in EASI), or a ≥4-point Reduction in Pruritus Numerical Rating Scale (NRS) from Baseline
时间窗: Week 16
The primary endpoint will be a composite endpoint as defined by achieving either EASI-75 or Pruritus NRS≥4-point Reduction from Baseline.
次要结局
- Percentage of Participants Achieving EASI-75(Baseline to Week 24)
- Percentage of Participants Achieving a ≥4-point Reduction from Baseline in Pruritus NRS(Baseline to Week 24)
- Percentage of Participants with a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a ≥4-point Reduction(Baseline to Week 24)
- Percentage of Participants with an Investigator's Global Assessment (IGA) of 0 or 1 and a Reduction ≥2 points from Baseline(Baseline to Week 24)
- Change from Baseline in Dermatology Quality of Life (DLQI)(Baseline, Week 24)
- Percentage of Participants Achieving EASI-90(Baseline to Week 24)
- Change from Baseline in Body Surface Area (BSA) Involvement(Baseline, Week 24)
- Percentage of Change from Baseline in Pruritus NRS Score(Baseline, Week 24)
- Percentage of Participants with a Sleep-loss Scale Score of ≥2 points at Baseline Who Achieve a ≥ 2-point Reduction(Baseline to Week 24)
- Percentage Change from Baseline in Sleep-loss Scale(Baseline, Week 24)
- Change from Baseline in Children's Dermatology Quality of Life (CDLQI)(Baseline, Week 24)
研究者
研究点 (135)
Loading locations...
相似试验
进行中（未招募）
3 期
A Study of Lebrikizumab (LY3650150) With/Without Topical Corticosteroid Treatment in Participants With Moderate-to-Severe Atopic DermatitisAtopic DermatitisNCT06280716Eli Lilly and Company301
招募中
3 期
A Study of Lebrikizumab (LY3650150) in Participants With Chronic Rhinosinusitis and Nasal Polyps Treated With Intranasal Corticosteroids (CONTRAST-NP)Chronic Rhinosinusitis With Nasal Polyps (CRSwNP)NCT06338995Eli Lilly and Company510
已完成
3 期
A Study of Lebrikizumab in Combination With Topical Corticosteroids in Patients With Atopic Dermatitis (AD) That Are Not Adequately Controlled With or Are Non-eligible for CyclosporineDermatitis, AtopicEczemaNCT05149313Almirall, S.A.331
已完成
2 期
A Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic DermatitisAtopic DermatitisNCT03443024Eli Lilly and Company280
已完成
3 期
Effectiveness and Safety of Lebrikizumab Treatment in Adults and Adolescents With Moderate-to-Severe Atopic DermatitisEczemaAtopic DermatitisNCT05990725Almirall, S.A.260