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Phase 3 N=86 Treatment

A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab

Atopic Dermatitis

Enrolled (actual)
86
Serious AEs
1.4%
Results posted
Mar 2025
Primary outcome: Primary: Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16 — 57.4 percentage of participants

Study Design & Population

Study type
Interventional
Phase
Phase 3
Interventions
Lebrikizumab (Drug)
Age
Pediatric, Adult, Older Adult · 12+ yrs
Sex
All
Sponsor
Eli Lilly and Company
Primary completion
Jan 2024

Outcome Measures

OutcomeResultp-value
PRIMARY
Percentage of Participants Achieving Eczema Area and Severity Index 75 (EASI-75) at Week 16
57.4
SECONDARY
Percentage of Participants Achieving EASI-75 at Week 24
31.3; 71.8
SECONDARY
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
38.7
SECONDARY
Percentage of Participants With an IGA Score of 0 or 1 and a Reduction ≥2 Points From Baseline to Week 24
12.5; 48.7
SECONDARY
Percentage Change From Baseline in EASI Total Score From Baseline to Week 16
-73.3
SECONDARY
Percentage Change From Baseline in EASI Score From Baseline to Week 24
-64.6; -82.4
SECONDARY
Change in EASI Score From Baseline to Week 16
-17.4
SECONDARY
Change in EASI Score From Baseline to Week 24
-17.4; -19.0
SECONDARY
Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) at Week 16
29.5
SECONDARY
Percentage of Participants Achieving EASI-90 From Baseline to Week 24
12.5; 35.9
SECONDARY
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
53.2
SECONDARY
Percentage of Participants With a Pruritus NRS of ≥4 Points at Baseline Who Achieve at Least 4-point Reduction From Baseline to Week 24
53.8; 65.4
SECONDARY
Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 16
72.9
SECONDARY
Percentage of Participants With a Pruritus NRS of ≥3 Points at Baseline Who Achieve at Least 3-point Reduction From Baseline to Week 24
76.9; 77.8
SECONDARY
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 16
-55.6
SECONDARY
Percentage Change From Baseline in Pruritus NRS Score From Baseline to Week 24
-30.0; -62.0
SECONDARY
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
41.7
SECONDARY
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
40.0; 42.9
SECONDARY
Change From Baseline in Sleep-Loss Scale From Baseline to Week 16
-1.0
SECONDARY
Change From Baseline in Sleep-Loss Scale From Baseline to Week 24
-0.7; -1.1
SECONDARY
Change From Baseline in Skin Pain NRS From Baseline to Week 16
-3.2
SECONDARY
Change From Baseline in Skin Pain NRS From Baseline to Week 24
-2.8; -3.3
SECONDARY
Change From Baseline in Dermatology Life Quality Index (DLQI) From Baseline to Week 16
-8.7
SECONDARY
Change From Baseline in DLQI From Baseline to Week 24
-7.5; -9.5
SECONDARY
Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) From Baseline to Week 16
-3.0
SECONDARY
Change From Baseline in CDLQI From Baseline to Week 24
-1.0; -3.3
SECONDARY
Percentage Change From Baseline in SCORing Atopic Dermatitis (SCORAD) From Baseline to Week 16
-55.7
SECONDARY
Percentage Change From Baseline in SCORAD From Baseline to Week 24
-47.4; -60.1

Summary

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.

Eligibility Criteria

Inclusion Criteria

  • 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.

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 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
View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT05369403). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.

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