1 / 10

Dermatology Clinical Trials Update: Psoriasis & Psoriatic Arthritis

Updates on latest trials for Psoriasis & Psoriatic Arthritis, including Phase 3 studies on Brodalumab and Tofacitinib. Inclusion criteria and ongoing trials mentioned. Contact for more info.

yatesjohn
Download Presentation

Dermatology Clinical Trials Update: Psoriasis & Psoriatic Arthritis

An Image/Link below is provided (as is) to download presentation Download Policy: Content on the Website is provided to you AS IS for your information and personal use and may not be sold / licensed / shared on other websites without getting consent from its author. Content is provided to you AS IS for your information and personal use only. Download presentation by click this link. While downloading, if for some reason you are not able to download a presentation, the publisher may have deleted the file from their server. During download, if you can't get a presentation, the file might be deleted by the publisher.

E N D

Presentation Transcript

  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

More Related