Transcript BWH Dermatology Clinical Trials

Clinical Trials
[Brief] Update
Joseph F. Merola, MD MMSc
Director of Clinical Trials, BWH Dermatology
1/9/2014 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
– Thank you for referrals!
– Co-I: Stephanie Liu, Abrar Qureshi
BWH Dermatology Clinical Trials
Psoriasis
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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)
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Subjects who meet certain eligibility criteria will receive etanercept twice a week for 12 weeks and
then once a week for 12 weeks
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Study participation includes approximately 9 visits
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Study visits every 4 weeks for 24 weeks, plus a follow up phone call 30 days after subject study
completion
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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
– Co-I: Stephanie Liu, Abrar Qureshi
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)
• Not yet open to enrollment
– (Coming soon: Late winter / early spring 2014)
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)
• Not yet open to enrollment
– (Coming soon: Late winter / early spring 2014)
• Co-I: Janice Lin, Ruth Ann, Mital, Elena Massarotti
BWH Dermatology Clinical Trials
Investigator-Initiated Trials Support
• Service for investigators interested in
observational and interventional trials
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Trial / protocol design
Building a budget
Contract
IRB support
Regulatory monitoring
Navigating and utilizing the CCI
Clinical support (consents, phlebotomy, scheduling
etc)
BWH Dermatology Clinical Trials
IIS
• Trial of Abatacept for Vitiligo (BMS)
– Vaneeta Sheth (PI)
BWH Dermatology Clinical Trials
In the works…
• Atopic Dermatitis (anti IL-4)
• Hidradenitis (anti IL-1)
– Mital Patel
Clinical Trials Team / Thank You
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Mary O’Donnell
Karen Coughlan
Jade Cumberbatch
Helen Kuo
Donna Sullivan
• Stephanie Liu
• Rob Fuhlbrigge, Alex Gionfriddo
• Meghan Hunt, Heather Centauro