Phase 3
Completed N=206
Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Atopic Dermatitis
Source: ClinicalTrials.gov NCT04250350 ↗
Enrolled (actual)
206
Serious AEs
2.4%
Results posted
Feb 2023
Primary outcomePrimary: Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs) — 2.4 percentage of participants
◆ Published Evidence
Established
41citations · ~14 / year
Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study.
Summary
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.
Linked Publications
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Safety and Efficacy of Lebrikizumab in Adolescent Patients with Moderate-to-Severe Atopic Dermatitis: A 52-Week, Open-Label, Phase 3 Study.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants Discontinued From Study Treatment Due to Adverse Events (AEs) |
2.4 | — |
| SECONDARY Percentage of Participants With an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points From Baseline |
62.6 | — |
| SECONDARY Percentage of Participants Achieving ≥75% Reduction From Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI-75) |
81.9 | — |
| SECONDARY Percentage Change From Baseline in EASI Score |
-86.0 | — |
| SECONDARY Percentage of Participants Achieving EASI-50 (≥50 Reduction From Baseline in EASI Score) |
94.4 | — |
| SECONDARY Percentage of Participants Achieving EASI-90 (≥90% Reduction From Baseline in EASI Score) |
61.4 | — |
| SECONDARY Change From Baseline in Body Surface Area (BSA) |
-37.63 | — |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety |
-6.34 | — |
| SECONDARY Change From Baseline in Patient-Reported Outcomes Information System (PROMIS) Depression |
-3.43 | — |
| SECONDARY Change From Baseline in Dermatology Life Quality Index (DLQI) |
-8.92 | — |
| SECONDARY Change From Baseline in Children's Dermatology Life Quality Index (CDLQI) |
-6.45 | — |
| SECONDARY Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab |
82.3 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
- Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
- ≥10% body surface area (BSA) of AD involvement at the baseline visit.
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Exclusion Criteria
- Participation in a prior lebrikizumab clinical study.
- Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- Dupilumab within 8 weeks.
- B-cell-depleting biologics, including to rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
Data sourced from ClinicalTrials.gov (NCT04250350) and the linked publication. 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. Informational only — not medical advice.