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Lebrikizumab for Atopic Dermatitis


Title A Randomized, Double-Blind, Placebo-Controlled Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients with Moderate-to-Severe Atopic Dermatitis
Therapeutic Area Atopic Dermatitis
Principal Investigator David Rosmarin, MD
Min Age 12 Years
Gender All
Contact Nicole Dumont
617 636 7462
ndonovan1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04146363

Overview

This is a randomized, double-blind, placebo-controlled, parallel-group study which is 52 weeks in duration.  The study is designed to confirm the safety and efficacy of lebrikizumab.

Study Details

Inclusion Criteria

  • Male or female adults and adolescents (≥12 years and ≥40 kg). 
  • Participants who agree to discontinue all agents used to treat vitiligo
  • Chronic atopic dermatitis (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening 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 topical corticosteroids, calcineurin inhibitors or Eucrisa within  1 week prior to the baseline visit.
  • Prior treatment with dupilumab or tralokinumab

Study Requirements

he study duration will be approximately 56 weeks with approximately 20 study visits.