Trial Search Results

A Study of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

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.

Stanford is currently not accepting patients for this trial.

Lead Sponsor:

Dermira, Inc.

Stanford Investigator(s):

Intervention(s):

  • Biological: Lebrikizumab
  • Drug: Placebos

Phase:

Phase 2

Eligibility


Inclusion Criteria:

   - 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.

Exclusion Criteria:

   - 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.

Ages Eligible for Study

18 Years - N/A

Genders Eligible for Study

All

Not currently accepting new patients for this trial

Contact Information

Stanford University
School of Medicine
300 Pasteur Drive
Stanford, CA 94305
Not Recruiting