PF-06651600 for the Treatment of Alopecia Areata

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NCT03732807

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Study Location
Mosaic Dermatology
Beverly Hills, California, 90211, United States
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Contact
1-800-718-1021
[email protected]
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FOR MORE INFORMATION

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

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Pfizer Clinical Trials Contact Center

1-800-718-1021

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[email protected]

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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

- Clinical diagnosis of alopecia areata with no other cause of hair loss

- ≥50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months

- Current episode of hair loss ≤10 years

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


- Other types of alopecia or other diseases that can cause hair loss


- Other scalp diseases that could interfere with assessment of hair loss/regrowth


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


- Any previous use of any Janus kinase (JAK) inhibitor

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Advanced Information
Descriptive Information
Brief Title  ICMJE PF-06651600 for the Treatment of Alopecia Areata
Official Title  ICMJE A PHASE 2B/3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, DOSE-RANGING STUDY TO INVESTIGATE THE EFFICACY AND SAFETY OF PF-06651600 IN ADULT AND ADOLESCENT ALOPECIA AREATA (AA) SUBJECTS WITH 50% OR GREATER SCALP HAIR LOSS
Brief Summary This is a global Phase 2b/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 50% or greater scalp hair loss. The study is placebo-controlled, meaning that some patients entering the study will not receive active study drug but will receive tablets with no active ingredients (a placebo). This is a dose-ranging study, investigating 5 different dosing regimens. It will be double-blinded, meaning that the sponsor, the study doctors, the staff, and the patients will not know whether a patient is on active study drug (or the dose) or placebo.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: PF-06651600 Induction Dose
    Oral tablets taken once daily (QD)
  • Drug: PF-06651600 Maintenance Dose #1
    Oral tablets taken QD
  • Drug: PF-06651600 Maintenance Dose #2
    Oral tablets taken QD
  • Drug: PF-06651600 Maintenance Dose #3
    Oral tablets taken QD
  • Drug: Placebo
    Oral tablets taken QD
Study Arms  ICMJE
  • Experimental: Sequence A
    Induction dose given once daily (QD) for 4 weeks followed by maintenance dose #1 given QD for 44 weeks
    Interventions:
    • Drug: PF-06651600 Induction Dose
    • Drug: PF-06651600 Maintenance Dose #1
  • Experimental: Sequence B
    Induction dose given QD for 4 weeks followed by maintenance dose #2 given QD for 44 weeks
    Interventions:
    • Drug: PF-06651600 Induction Dose
    • Drug: PF-06651600 Maintenance Dose #2
  • Experimental: Sequence C
    Maintenance dose #1 given QD for 48 weeks
    Intervention: Drug: PF-06651600 Maintenance Dose #1
  • Experimental: Sequence D
    Maintenance dose #2 given QD for 48 weeks
    Intervention: Drug: PF-06651600 Maintenance Dose #2
  • Experimental: Sequence E
    Maintenance dose #3 given QD for 48 weeks
    Intervention: Drug: PF-06651600 Maintenance Dose #3
  • Experimental: Sequence F
    Placebo given QD for 24 weeks followed by induction dose given QD for 4 weeks then maintenance dose #1 given QD for 20 weeks
    Interventions:
    • Drug: PF-06651600 Induction Dose
    • Drug: PF-06651600 Maintenance Dose #1
    • Drug: Placebo
  • Experimental: Sequence G
    Placebo given QD for 24 weeks followed by maintenance dose #1 given QD for 24 weeks
    Interventions:
    • Drug: PF-06651600 Maintenance Dose #1
    • Drug: Placebo
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 Active, not recruiting
Actual Enrollment  ICMJE
 (submitted: September 8, 2020)		718
Original Estimated Enrollment  ICMJE
 (submitted: November 5, 2018)		660
Estimated Study Completion Date  ICMJE July 11, 2021
Estimated Primary Completion Date January 3, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of alopecia areata with no other cause of hair loss
  • ?50% hair loss of the scalp, including alopecia totalis and alopecia universalis, without evidence of terminal hair regrowth within 6 months
  • Current episode of hair loss ?10 years

Exclusion Criteria:

  • Other types of alopecia or other diseases that can cause hair loss
  • Other scalp diseases that could interfere with assessment of hair loss/regrowth
  • Subjects with shaved heads must not enter the study until hair has grown back & is considered stable by the investigator
  • Any previous use of any Janus kinase (JAK) inhibitor
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 information is only displayed when the study is recruiting subjects
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 Singapore
 
Administrative Information
NCT Number  ICMJE NCT03732807
Other Study ID Numbers  ICMJE B7981015
2018-001714-14 ( EudraCT Number )
ALLEGRO 2B/3 ( Other Identifier: Alias Study Number )
Has Data Monitoring Committee Yes
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/d….
URL:https://www.pfizer.com/science/clinical_trials/trial_data_and_results/d…
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director:Pfizer CT.gov Call CenterPfizer
PRS Account Pfizer
Verification Date October 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP