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 |
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.
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
38
sites
Univ of Rochester Medical Center One of the nation's top academic medical centers, the University...
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Tufts Medical Center Tufts Medical Center is an internationally-respected academic medical center – a teaching...
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6565 S. Yale Ave.
Tulsa, Oklahoma 74136
Tulsa, Oklahoma 74136
918-392-4550
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
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12605 East 16th Avenue
Aurora, Colorado 80045
Aurora, Colorado 80045
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500 22nd Street South
Birmingham, Alabama 35233
Birmingham, Alabama 35233
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Boston, Massachusetts 02114
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Icahn School of Medicine at Mount Sinai Icahn School of Medicine at Mount Sinai is...
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9933 Woods Drive
Skokie, Illinois 60077
Skokie, Illinois 60077
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