Transcript BWH Dermatology 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:
– Brodalumab (IL-17 inhibitor) Compared With Placebo and
Ustekinumab in Subjects With Moderate to Severe Plaque
Psoriasis (Amgen)
– Closed to enrollment
BWH Dermatology Clinical Trials
Psoriatic Arthritis
• A PHASE 3, RANDOMIZED, DOUBLE-BLIND, PLACEBOCONTROLLED 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)
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
BWH Dermatology Clinical Trials
• Inadequate response to a TNF or intolerance
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
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
BWH Dermatology Clinical Trials
IIS
• Trial of Abatacept for Vitiligo (BMS)
– Vaneeta Sheth (PI)
– Approved
– Close to enrollment
– Stand-by…
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
BWH Dermatology Clinical Trials
Contact
Mary O’Donnell:
[email protected]
(617) 732-6378