A Phase 2b Study of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis

Description

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

Interventions

  • Biological: Lebrikizumab
  • Drug: Placebos

Study ID

Dermira, Inc. -- DRM06-AD01

Status

Unknown

Trial ID

NCT03443024

Study Type

Interventional

Trial Phase

Phase 2

Enrollment Quota

275

Sponsor

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.

Gender

All

Ages

18 Years and older

Accepts Healthy Volunteers

No

Study Locations and Contact Information (4)

Study Location Distance Name Phone Email
Sadick Research Group LLC - New York, New York 50.7 miles Monica Serra 212-772-7242 mserra@sadickdermatology.com
Dermatology Trial Associates - Bryant, Arkansas 1,143.8 miles Makenzie Mixon 501-655-6138 mmixon@burkepharmaceutical.com
Northwest Arkansas Clinical Trials Center - Rogers, Arkansas 1,173.9 miles Julie Filmer 479-876-8205 None
Dermatology Research Associates - Los Angeles, California 2,500.0 miles Dasmany Deniz 310-337-7171 ddeniz@drsofen.com

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