Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
NCT02974868
ABOUT THIS STUDY
FOR MORE INFORMATION
Contact a representative by phone, email, or visiting the study website. Please see the references below:
Pfizer Clinical Trials Contact Center
1-800-718-1021
- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
- Must have moderate to severe alopecia areata:
- 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.
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Descriptive Information | |||||||
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Brief Title ICMJE | Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata | ||||||
Official Title ICMJE | 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 | ||||||
Brief Summary | 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. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 2 | ||||||
Study Design ICMJE | Allocation: Randomized Intervention Model Description: The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders. Masking: Triple (Participant, Investigator, Outcomes Assessor)Primary Purpose: Treatment | ||||||
Condition ICMJE | Alopecia Areata | ||||||
Intervention ICMJE |
| ||||||
Study Arms ICMJE |
| ||||||
Publications * | Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16. | ||||||
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. | |||||||
Recruitment Information | |||||||
Recruitment Status ICMJE | Completed | ||||||
Actual Enrollment ICMJE | 142 | ||||||
Original Estimated Enrollment ICMJE | 132 | ||||||
Actual Study Completion Date ICMJE | May 15, 2019 | ||||||
Actual Primary Completion Date | May 15, 2019 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
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. | ||||||
Sex/Gender ICMJE |
| ||||||
Ages ICMJE | 18 Years to 75 Years (Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||||
Listed Location Countries ICMJE | Australia, Canada, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT02974868 | ||||||
Other Study ID Numbers ICMJE | B7931005 2016-004048-13 ( EudraCT Number ) ALLEGRO ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
| ||||||
IPD Sharing Statement ICMJE |
| ||||||
Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
| ||||||
PRS Account | Pfizer | ||||||
Verification Date | May 2020 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |