An Open-Label, 24-Week Study to Investigate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color
Overview
- Phase
- Phase 3
- Intervention
- Lebrikizumab
- Conditions
- Atopic Dermatitis
- Sponsor
- Eli Lilly and Company
- Enrollment
- 90
- Locations
- 36
- Primary Endpoint
- Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) at Week 16
- Status
- Completed
- Last Updated
- last month
Overview
Brief Summary
The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent.
- •Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.
- •Participants who are Fitzpatrick phototype IV-VI
- •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.
- •Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.
Exclusion Criteria
- •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 (HBsAg) 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.
Arms & Interventions
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.
Intervention: Lebrikizumab
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. After 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.
Intervention: Lebrikizumab
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 75% reduction in the EASI score from baseline (EASI-75) at Week 16, received 250 mg once every 4 weeks (Q4W) until Week 24. After 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.
Intervention: Lebrikizumab
Outcomes
Primary Outcomes
Percentage of Participants Achieving Eczema Area and Severity Index 75 (≥75% Reduction From Baseline in EASI) at Week 16
Time Frame: 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) at each time point. The EASI75 responder is defined as a ≥ 75% improvement from baseline in the EASI score.
Secondary Outcomes
- Percentage of Participants With a Sleep-Loss Scale Score of ≥2 Points at Baseline Who Achieve a 2-point Reduction From Baseline to Week 16(Baseline to Week 16)
- Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16(Baseline to Week 16)
- 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 Change From Baseline in Total EASI Score From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in Total EASI Score From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus Numeric Rating Scale (NRS) of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 16(Baseline to Week 16)
- Percentage of Participants With a Pruritus NRS ≥3 Points at Baseline Who Achieve at Least 3- Point Reduction From Baseline to Week 16(Baseline to Week 16)
- Percentage Change in Pruritus NRS Score From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16(Baseline, Week 16)
- Change From Baseline in Children's Dermatology Life Quality Index (cDLQI) From Baseline to Week 16(Baseline, Week 16)
- Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 16(Baseline to Week 16)
- Percentage Change From Baseline in Sleep-Loss Scale Score From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants With a Skin Pain NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24(Baseline to Week 24)
- Percentage of Participants With a Sleep-Loss Scale Score of ≥2 Points at Baseline Who Achieve a 2-point Reduction From Baseline to Week 24(Baseline to Week 24)
- Percentage of Participants Achieving EASI 75 at Week 24(Week 24)
- 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 Total EASI Score From Baseline to Week 24(Baseline, Week 24)
- Change From Baseline in Total 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 NRS of ≥4 Points at Baseline Who Achieve a 4-point Reduction From Baseline to Week 24(Baseline to Week 24)
- Percentage of Participants With a Pruritus NRS ≥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 24(Baseline, Week 24)
- Change From Baseline in POEM From Baseline to Week 24(Baseline, Week 24)
- Change From Baseline in DLQI From Baseline to Week 24(Baseline, Week 24)
- Change From Baseline in cDLQI From Baseline to Week 24(Baseline, Week 24)
- Percentage of Participants With a DLQI of ≥4 Points at Baseline Who Achieve a ≥4-point Improvement in DLQI From Baseline to Week 24(Baseline to Week 24)
- Change From Baseline in Patient-Oriented Eczema Measure (POEM) From Baseline to Week 16(Baseline, Week 16)