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Pariser Dermatology Specialists

Atopic Dermatitis Study

Study Purpose:
The primary purpose of this clinical research study is to evaluate the safety and efficacy of the
investigational medication lebrikizumab (DRM06) in adolescents (≥ 12 to < 18 years of age and weighing
≥ 40 kg or 88 lb.) with moderate to severe AD.

Eligibility Criteria:
Adolescents (≥ 12 to < 18 years of age and weighing ≥ 40 kg or 88 lb.) who have had atopic dermatitis for at least one year may be eligible to participate in the Adore Study.

Key inclusion criteria:
         • Male and female adolescents (≥ 12 to < 18 years of age and weighing ≥ 40 kg or 88 lb.)
         • Chronic AD that has been present for ≥ 1 year before the screening visit
         • Eczema Area and Severity Index (EASI) score ≥ 16 at the baseline visit
         • Investigator Global Assessment (IGA) score ≥ 3 (scale of 0 to 4) at the baseline visit
         • ≥ 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

Key exclusion criteria:
        • Participation in a prior lebrikizumab clinical study
        • History of anaphylaxis as defined by the Sampson criteria
        • Treatment with topical corticosteroids, calcineurin inhibitors or phosphodiesterase-4 inhibitor (e.g., crisaborole) within 1 week prior to the                               baseline visit
        • Treatment with any of the following agents within 4 weeks prior to the baseline visit:
                o Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase                                    inhibitors, azathioprine, methotrexate, etc.)
                o Phototherapy and photochemotherapy (PUVA) for AD
        • Treatment with the following prior to the baseline visit:
                o An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer
                o Dupilumab within 8 weeks
                o B cell-depleting biologics, including rituximab, within 6 months
                o Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer

Other Trial Details (Benefits, For More Information, etc.):
A special website has been created to provide more information about the ADore Study, which is a part of
the ADvocate Studies program. The website includes information on what to expect if you or your child is
enrolled. Visit www.ADvocatestudies.com for more information.



Thank you for your interest! Please reach out with questions or comments using the information below. We look forward to hearing from you!

Phone
(757) 625-0151

Hours of Operation
Monday – Friday: 7:30 a.m. – 4:00 p.m.

Address
6160 Kempsville Circle, #200A, 
Norfolk, VA 23502

Our practice is located between Newtown Road and Virginia Beach Boulevard on Kempsville Road, adjacent to Sentara Leigh Hospital in the Smithfield building.

Service Area
Norfolk, Virginia Beach, & the Hampton Roads Area

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