Phase 3
N=86
A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Atopic Dermatitis
Bottom Line
View on ClinicalTrials.gov: NCT05369403 ↗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
| Outcome | Result | p-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
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.