Summary

for people ages 18 years and up (full criteria)
at San Diego, California and other locations
study started
estimated completion:
Tissa Hata

Description

Summary

The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in patients with moderate-to-severe atopic dermatitis.

Official Title

A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

Keywords

Atopic Dermatitis Eczema Dermatitis Dermatitis, Atopic Antibodies, Monoclonal Lebrikizumab

Eligibility

You can join if…

Open to people ages 18 years and up

  • Male or female, 18 years or older.
  • Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
  • Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
  • Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
  • ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.

You CAN'T join if...

  • Treatment with any of the following agents within 4 weeks prior to the baseline visit:
  • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids,cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine,methotrexate, etc.)
  • Phototherapy and photochemotherapy (PUVA) for AD.
  • Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI)within 1 week prior to the baseline visit.
  • Treatment with:
  • An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
  • Dupilumab within 3 months prior to baseline visit.
  • Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
  • Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit(whichever is longer).
  • Use of prescription moisturizers within 7 days of the baseline visit.

Locations

  • UCSD Dermatology accepting new patients
    San Diego California 92122 United States
  • TCR Medical Corporation accepting new patients
    San Diego California 92123 United States

Details

Status
accepting new patients
Start Date
Completion Date
(estimated)
Sponsor
Dermira, Inc.
ID
NCT03443024
Phase
Phase 2
Lead Scientist
Tissa Hata
Study Type
Interventional
Last Updated
August 23, 2018