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Lebrikizumab AD


Title A Phase 3, 16-week, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Study to Assess the Impact of Lebrikizumab on Vaccine Responses in Adult Patients with Moderate-to-Severe Atopic Dermatitis
Therapeutic Area Atopic Dermatitis
Principal Investigator David Rosmarin, MD
Min Age 18 Years
Max Age 55 Years
Gender All
Contact Nicole Dumont
617 636 7462
ndonovan1@tuftsmedicalcenter.org
More Information https://clinicaltrials.gov/ct2/show/NCT04626297

Overview

Phase 3, randomized, double-blind, placebo-controlled study to assess the impact of lebrikizumab on vaccine immune responses in adult patients with moderate-to-severe atopic dermatitis (AD). This study will evaluate the effect of lebrikizumab treatment on 2 vaccines commonly used in adults with moderate to severe AD

Study Details

Inclusion Criteria

  • Have chronic AD that has been present for ≥1 year before the screening visit;
  • Have ≥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

  • Have a history of anaphylaxis;
  • Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids;
  • Have an active chronic or acute infection requiring treatment with systemic antibiotics,antivirals, antiparasitics, antiprotoxoals, or antifungals within 2 weeks before the baseline visit

Study Requirements

10 visit over 16 weeks, with the option to enroll into an open-label long term extension study.