A Phase 2b 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.

Study Start Date

January, 30 2018

Estimated Completion Date

May 2019


  • Biological: Lebrikizumab
  • Drug: Placebos

Study ID

Dermira, Inc. -- DRM06-AD01



Trial ID


Study Type


Trial Phase

Phase 2

Enrollment Quota



Dermira, Inc.

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-?, 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.




18 Years and older

Accepts Healthy Volunteers


Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Sadick Research Group LLC - New York, New York 187.1 miles Monica Serra 212-772-7242 mserra@sadickdermatology.com
Dermatology Trial Associates - Bryant, Arkansas 1,273.6 miles Makenzie Mixon 501-655-6138 mmixon@burkepharmaceutical.com
Northwest Arkansas Clinical Trials Center - Rogers, Arkansas 1,297.4 miles Julie Filmer 479-876-8205 None
Dermatology Research Associates - Los Angeles, California 2,606.2 miles Dasmany Deniz 310-337-7171 ddeniz@drsofen.com

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