Summary

Eligibility
for people ages 12-17 (full criteria)
Location
at San Diego, California and other locations
Dates
study started
estimated completion

Description

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.

Official Title

An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis

Keywords

Atopic Dermatitis Eczema Dermatitis Dermatitis, Atopic Skin Diseases Lebrikizumab

Eligibility

You can join if…

Open to people ages 12-17

  1. Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
  2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
  3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
  4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
  5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
  6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

You CAN'T join if...

  1. Participation in a prior lebrikizumab clinical study.
  2. Treatment with the following prior to the baseline visit:
  3. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
  4. Dupilumab within 8 weeks.
  5. B-cell-depleting biologics, including to rituximab, within 6 months.
  6. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
  7. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
  8. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
  9. Evidence of active acute or chronic hepatitis
  10. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  11. 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.
  12. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Locations

  • University of California, San Diego/Rady Children's Hospital, San Diego - Pediatric & Adolescent Dermatology
    San Diego California 92123 United States
  • First OC Dermatology
    Fountain Valley California 92708 United States
  • MD Studies
    Fountain Valley California 92708 United States
  • Southern California Dermatology, Inc.
    Santa Ana California 92701 United States

Details

Status
in progress, not accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
Related Info Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)
ID
NCT04250350
Phase
Phase 3
Study Type
Interventional
Last Updated