An Open-Label Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
试验速览
- 阶段
- 3 期
- 状态
- 已完成
- 入组人数
- 86
- 试验地点
- 37
- 主要终点
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16
研究概览
简要总结
The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.
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
- •All participants must have prior treatment with dupilumab 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 (at labeled dose level) for at least 4 months.
- •Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
- •Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
- •Participants who have chronic AD that has been present for ≥1 year before screening.
- •Have EASI ≥16 at baseline
- •Have IGA score ≥3 (Scale of 0 to 4) at baseline
- •Have ≥10% body surface area (BSA) of AD involvement at baseline
- •Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
- •Adolescents body weight must be ≥40 kg at baseline.
排除标准
- •History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- •Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
- •Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
- •Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.
- •Have uncontrolled asthma that
- •might require bursts of oral or systemic corticosteroids, or
- •required the following due to ≥1 exacerbations within 12 months before baseline
- •systemic (oral and/or parenteral) corticosteroid treatment, or
- •hospitalization for >24 hours.
- •Have known liver cirrhosis and/or chronic hepatitis of any etiology.
- •Had Dupilumab treatment within 4 weeks prior to baseline
- •Had prior treatment with tralokinumab.
- •Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline
- •Treatment with any of the following agents within 4 weeks prior to the baseline
- •systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
- •small molecules (e.g. JAK inhibitors)
- •phototherapy and photochemotherapy for AD
研究组 & 干预措施
Lebrikizumab 250 mg Q2W
Participants received a 500 milligram (mg) loading dose of Lebrikizumab subcutaneously (SC) once every 2 weeks (Q2W) at baseline and Week 2, followed by 250 mg SC once Q2W until Week 16.
干预措施: Lebrikizumab (Drug)
Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q2W
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who did not achieve Investigator Global Assessment (IGA) 0 or 1 (clear or almost clear) or a 75% reduction in the Eczema Area and Severity Index (EASI) score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.
干预措施: Lebrikizumab (Drug)
Lebrikizumab 250 mg Q2W to Lebrikizumab 250 mg Q4W
Participants who received Lebrikizumab 250 mg SC once Q2W until Week 16 and who achieved IGA 0 or 1 (clear or almost clear) or a 75% reduction in the EASI score from baseline (EASI-75) at Week 16 continued to receive 250 mg SC once Q2W until Week 24. Eligible participants entered the Continued Access Period, receiving the assigned same dose until the product was commercially available in the United States or discontinuation criteria were met.
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) at Week 16
时间窗: Week 16
The EASI assesses objective physician estimates of 2 dimensions of atopic dermatitis - disease extent and clinical signs affected: 0 = 0%; 1 = 1-9%; 2 = 10-29%; 3 = 30-49%; 4 = 50-69%; 5 = 70-89%; 6 = 90-100% and the severity of 4 clinical signs: (1) erythema, (2) edema/papulation, (3) excoriation, and (4) lichenification each on a scale of 0 to 3 (0 = none, absent; 1 = mild; 2 = moderate; 3 = severe) at 4 body sites (head/neck, trunk, upper limbs, and lower limbs). Half scores are allowed between severities 1, 2, and 3. The final EASI score was obtained by weight-averaging these 4 scores and will range from 0 to 72 (severe). The EASI-75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
次要结局
- Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24(Baseline to Week 24)
- Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16(Baseline, Week 16)
- Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Sleep-Loss Scale of ≥2 Points at Baseline Who Achieve at Least 2-point Reduction From Baseline to Week 24(Baseline to Week 24)
- Change From Baseline in Sleep-Loss Scale From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in Sleep-Loss Scale From Baseline to Week 24(Baseline, Week 24)
- Change From Baseline in Skin Pain NRS From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in Skin Pain NRS From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants With an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24(Baseline to Week 24)
- Percentage Change From Baseline in EASI Total Score From Baseline to Week 16(Baseline, Week 16)
- Percentage Change From Baseline in EASI Score From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Achieving EASI-90 From Baseline to Week 24(Baseline to Week 24)
- Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24(Baseline to Week 24)
- Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16(Baseline to Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in DLQI From Baseline to Week 24(Baseline, Week 24)
- Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in CDLQI From Baseline to Week 24(Baseline, Week 24)
- Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16(Baseline, Week 16)
- Percentage Change From Baseline in SCORAD From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Achieving EASI-75 at Week 24(Week 24)
- Change in EASI Score From Baseline to Week 16(Baseline, Week 16)
- Change in EASI Score From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16(Week 16)