Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata



Status:Active, not recruiting
Conditions:Dermatology, Dermatology, Hair Loss
Therapuetic Areas:Dermatology / Plastic Surgery
Healthy:No
Age Range:18 - 75
Updated:12/13/2018
Start Date:December 2016
End Date:May 2019

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A Phase 2a Randomized, Double-blind, Placebo-controlled, Multicenter Study To Evaluate The Efficacy And Safety Profile Of Pf-06651600 And Pf-06700841 In Subjects With Moderate To Severe Alopecia Areata With A Single-blind Extension Period And A Cross-over Open Label Extension Period

This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an
extension period. The study will have a maximum duration of approximately 113 weeks. This
includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday
(#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind)
Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension
Period and a 4 week Follow up Period.


Inclusion Criteria:

- Male or female subjects between 18 75 years of age, inclusive, at time of informed
consent.

- Must have moderate to severe alopecia areata:

Exclusion Criteria:

- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,

- Infected with hepatitis B or hepatitis C viruses.

- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)

- Have received any of the following treatment regiments specified in the timeframes
outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
of first dose of study drug: Participation in other studies involving investigational
drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
(NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal
medications with unknown properties or known beneficial effects for AA.
We found this trial at
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New York, New York 10021
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800 Washington St
Boston, Massachusetts 02111
(617) 636-5000
Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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601 Elmwood Avenue
Rochester, New York 14642
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Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
918-392-4550
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500 22nd Street South
Birmingham, Alabama 35233
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Indianapolis, Indiana 46256
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Indianapolis, Indiana 46256
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Kogarah, New South Wales 2217
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243 6100 South
Murray, Utah 84107
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New Haven, Connecticut 06510
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New Haven, Connecticut 06520
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New Haven, Connecticut 06519
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800 Howard Avenue
New Haven, Connecticut 06519
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1428 Madison Ave
New York, New York 10029
(212) 241-6500
Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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5 East 98th Street
New York, New York 10029
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New York, New York 10065
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Newnan, Georgia 30263
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Norfolk, Virginia 23507
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Orange Park, Florida 32073
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Rapid City, South Dakota 57702
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Rochester, New York 14642
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Salt Lake City, Utah 84132
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Santa Ana, California 92701
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Santa Monica, California 90404
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Santa Monica, California 90403
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2001 Santa Monica Boulevard
Santa Monica, California 90404
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Tampa, Florida 33609
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2605 West Kennedy Boulevard
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Tampa, Florida 33624
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2835 West De Leon Street
Tampa, Florida 33609
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