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Long-Term PF-06651600 for the Treatment of Alopecia Areata

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NCT04006457

Last updated on November 13, 2019
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FOR MORE INFORMATION
Study Location
Medstar Georgetown University Hospital - Department of Dermatology
Chevy Chase, District of Columbia, 20815 United States
See other locations
Contact
1-800-718-1021
[email protected]
Related Links
Eligibility criteria
Condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Alopecia Areata
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12 + years
Inclusion criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

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.

- >=25% hair loss of the scalp due to AA, including alopecia totalis and alopecia
universalis

- No evidence of terminal hair regrowth within 6 months

- Current episode of hair loss

Exclusion criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details

B7981015 with >30 days between first visit in B7981032 and last dose in the prior study:

- Other types of diseases that can cause hair loss or that could interfere with
assessment of hair loss/regrowth

- Participants with shaved heads must not enter the study until hair has grown back & is
considered stable by the investigator

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

NCT04006457
Pfizer
Recruiting
Long-Term PF-06651600 for the Treatment of Alopecia Areata

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Descriptive Information
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 SummaryThis 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.
Detailed DescriptionNot 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 Drug: PF-06651600
50 mg oral tablets
Study Arms  ICMJE
  • Experimental: Treatment sequence 1
    Participants who did not previously receive study intervention in either study B7931005 or B7981015 will receive 200 milligrams (mg) PF-06651600, given as four 50 mg tablets once daily (QD) for 1 month, followed by 50 mg PF-06651600 given QD for 23 months
    Intervention: Drug: PF-06651600
  • Experimental: Treatment sequence 2
    Participants who previously received study intervention in either study B7931005 or B7981015 will receive 50 mg PF-06651600 given QD for 24 months
    Intervention: Drug: PF-06651600
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
 (submitted: July 1, 2019)		860
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 1, 2023
Estimated Primary Completion DateMay 1, 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:

  • Clinical diagnosis of alopecia areata (AA) with no other cause of hair loss. Androgenetic alopecia coexistent with AA is allowed.
  • >=25% hair loss of the scalp due to AA, including alopecia totalis and alopecia universalis
  • No evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss <=10 years

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:

  • Other types of diseases that can cause hair loss or that could interfere with assessment of hair loss/regrowth
  • Participants with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator

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
Sexes Eligible for Study:All
Ages  ICMJE 12 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Pfizer CT.gov Call Center1-800-718-1021[email protected]
Listed Location Countries  ICMJE Canada,   Japan,   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 CommitteeYes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product:Yes
Studies a U.S. FDA-regulated Device Product:No
IPD Sharing Statement  ICMJE
Plan to Share IPD:Yes
Plan Description:Pfizer will provide access to individual de-identified participant data and related study documents (e.g. protocol, Statistical Analysis Plan (SAP), Clinical Study Report (CSR)) upon request from qualified researchers, and subject to certain criteria, conditions, and exceptions. Further details on Pfizer's data sharing criteria and process for requesting access can be found at: https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da....
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/da...
Responsible PartyPfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS AccountPfizer
Verification DateOctober 2019

ICMJE     Data element required by the

International Committee of Medical Journal Editors and the
World Health Organization ICTRP

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Contact a representative by phone, email, or visiting the study website. Please see the references below:

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