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Clinical Trials

Clinical Trials. [Brief] Update. Joseph F. Merola, MD MMSc Director of Clinical Trials, BWH Dermatology 10/9/2014 update on trials for faculty mtg. BWH Dermatology Clinical Trials. Psoriasis. A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of:

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Clinical Trials

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  1. Clinical Trials [Brief] Update Joseph F. Merola, MD MMSc Director of Clinical Trials, BWH Dermatology 10/9/2014 update on trials for faculty mtg

  2. BWH Dermatology Clinical Trials Psoriasis • A Phase 3 Study to Evaluate the Efficacy and Safety of Induction and Maintenance Regimens of: • Brodalumab (IL-17 inhibitor) Compared With Placebo and Ustekinumab in Subjects With Moderate to Severe Plaque Psoriasis (Amgen) • Closed to enrollment

  3. BWH Dermatology Clinical Trials Psoriatic Arthritis • A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED STUDY OF THE EFFICACY AND SAFETY OF 2 DOSES OF TOFACITINIB IN SUBJECTS WITH ACTIVE PSORIATIC ARTHRITIS AND AN INADEQUATE RESPONSE TO AT LEAST ONE TNF INHIBITOR (Pfizer)

  4. BWH Dermatology Clinical Trials Inclusion / Exclusion • Diagnosed with PsA based on CASPAR criteria • On-going treatment with stable DMARD dose for past 4 weeks • History of at least 4 months of DMARD use (at least 3 of which may be in their treatment history • (MTX, SSZ, LFN; Other traditional non-biologic DMARDs may be permitted with approval

  5. BWH Dermatology Clinical Trials • Inadequate response to a TNF or intolerance

  6. BWH Dermatology Clinical Trials Psoriasis • Phase IV: “Open Label Study to Evaluate the Efficacy of Etanercept Treatment in Subjects with Moderate to Severe Plaque Psoriasis Who Have Lost a Satisfactory Response to Adalimumab” (Amgen) • Subjects who meet certain eligibility criteria will receive etanercept twice a week for 12 weeks and then once a week for 12 weeks • Study participation includes approximately 9 visits • Study visits every 4 weeks for 24 weeks, plus a follow up phone call 30 days after subject study completion • Lost response to Humira in the past 6 months • Other biologics in the past OK, ustekinumab > 6 months ago • Exclude if adverse event to other biologics • OPEN for enrollment

  7. BWH Dermatology Clinical Trials IIS: Cutaneous Lupus • A phase 0 biomarker pilot study to evaluate the feasibility of using tape harvesting to collect RNA from the upper epidermis of healthy volunteers and subjects with discoid lupus (Biogen IDEC) • Patients with active DLE as well as negative controls (normal skin / healthy volunteers) • Enrolling • Around 5 DLE patients; age / gender matched volunteers 2

  8. BWH Dermatology Clinical Trials IIS • Trial of Abatacept for Vitiligo (BMS) • Vaneeta Sheth (PI) • Approved • Close to enrollment • Stand-by…

  9. BWH Dermatology Clinical Trials In the works… • Atopic Dermatitis (anti IL-4) • Phase 3 • Dupilumab (Regeneron) • Topical tofacitinib (Pfizer) for alopecia areata • (Kathy Huang) • Submitted

  10. BWH Dermatology Clinical Trials Contact Mary O’Donnell: MODONNELL6@partners.org (617) 732-6378

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