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
- Biological: Lebrikizumab
- Drug: Placebos
Dermira, Inc. -- DRM06-AD01
- 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.
- 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)
|Sadick Research Group LLC - New York, New York||187.1 miles||Monica Serrafirstname.lastname@example.org|
|Dermatology Trial Associates - Bryant, Arkansas||1,273.6 miles||Makenzie Mixonemail@example.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 Denizfirstname.lastname@example.org|