Long-Term PF-06651600 for the Treatment of Alopecia Areata
NCT04006457
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
-
For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:
- Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
- De novo participants >=12 to <18 years of age: >=50% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
- De novo participants >=18 years of age and participants from Study B7931005 or B7981015 with >30 days between first visit in B7981032 and last dose in the prior study: >=25% terminal hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
- No evidence of terminal scalp hair regrowth within 6 months (de novo only)
- Current episode of terminal scalp hair loss <=10 years (de novo only)
-
For de novo participants and participants from Study B7931005 and B7981015 with >30 days
between first visit in B7981032 and last dose in the prior study:
- Hearing loss with progression over previous 5 years, or sudden hearing loss, or middle
or inner ear disease, or other auditory condition that is considered acute,
fluctuating or progressive
- History of or current malignancies with the exception of adequately treated or excised
non metastatic basal cell or squamous cell cancer of the skin or cervical carcinoma in
situ
- History of a single episode of disseminated herpes zoster or disseminated herpes
simplex, or a history of more than one episode of localized, dermatomal herpes zoster
- Infection requiring hospitalization, or parenteral antimicrobial therapy within 6
months prior to Day 1
Exclusion criteria for all participants:
- Participants who have previously taken Janus kinase (JAK) inhibitors other than
PF-06651600 must have received the last dose >12 weeks prior to the screening visit
NEED INFO?
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Descriptive Information | |||||||
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Brief Title ICMJE | Long-Term PF-06651600 for the Treatment of Alopecia Areata | ||||||
Official Title ICMJE | A PHASE 3 OPEN-LABEL, MULTI-CENTER, LONG-TERM STUDY INVESTIGATING THE SAFETY AND EFFICACY OF PF-06651600 IN ADULT AND ADOLESCENT PARTICIPANTS WITH ALOPECIA AREATA | ||||||
Brief Summary | This is a global Phase 3 study to evaluate the safety and effectiveness of an investigational study drug (called PF-06651600) in adults and adolescents (12 years and older) who have alopecia areata. Eligible patients from the prior studies B7931005 (NCT02974868) and B7981015 (NCT03732807) will have an opportunity to enroll as well as patients who have not previously participated in either of these studies. The study is open-label and all patients entering the study will receive active study drug. A sub-study of approximately 60 adult patients who are participating in the B7981032 study will be conducted at select sites in the US and Canada. The sub-study will evaluate the immune response to tetanus and meningococcal vaccines in patients who have received a minimum of 6 months of 50 mg PF-06651600. | ||||||
Detailed Description | Not Provided | ||||||
Study Type ICMJE | Interventional | ||||||
Study Phase ICMJE | Phase 3 | ||||||
Study Design ICMJE | Allocation: Non-Randomized Intervention Model: Parallel Assignment Masking: None (Open Label) Primary Purpose: Treatment | ||||||
Condition ICMJE | Alopecia Areata | ||||||
Intervention ICMJE |
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Study Arms ICMJE |
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Publications * | Not Provided | ||||||
* 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 | Recruiting | ||||||
Estimated Enrollment ICMJE | 960 | ||||||
Original Estimated Enrollment ICMJE | 860 | ||||||
Estimated Study Completion Date ICMJE | August 14, 2023 | ||||||
Estimated Primary Completion Date | August 14, 2023 (Final data collection date for primary outcome measure) | ||||||
Eligibility Criteria ICMJE | Inclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:
Exclusion Criteria- For de novo participants and participants from Study B7931005 and B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:
Exclusion criteria for all participants: - Participants who have previously taken Janus kinase (JAK) inhibitors other than PF-06651600 must have received the last dose >12 weeks prior to the screening visit | ||||||
Sex/Gender ICMJE |
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Ages ICMJE | 12 Years and older (Child, Adult, Older Adult) | ||||||
Accepts Healthy Volunteers ICMJE | No | ||||||
Contacts ICMJE |
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Listed Location Countries ICMJE | Argentina, Australia, Canada, Chile, China, Colombia, Czechia, Germany, Hungary, Japan, Korea, Republic of, Mexico, Poland, Russian Federation, Spain, Taiwan, United Kingdom, United States | ||||||
Removed Location Countries | |||||||
Administrative Information | |||||||
NCT Number ICMJE | NCT04006457 | ||||||
Other Study ID Numbers ICMJE | B7981032 2019-001084-71 ( EudraCT Number ) ALLEGRO LT ( Other Identifier: Alias Study Number ) | ||||||
Has Data Monitoring Committee | Yes | ||||||
U.S. FDA-regulated Product |
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IPD Sharing Statement ICMJE |
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Responsible Party | Pfizer | ||||||
Study Sponsor ICMJE | Pfizer | ||||||
Collaborators ICMJE | Not Provided | ||||||
Investigators ICMJE |
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PRS Account | Pfizer | ||||||
Verification Date | January 2021 | ||||||
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |