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PF-06651600 for the Treatment of Alopecia Areata

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NCT03732807

Last updated on December 15, 2018
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FOR MORE INFORMATION
Study Location
Southern California Dermatology, Inc.
Santa Ana, California, 92701 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

- 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

NCT03732807
Pfizer
Recruiting
PF-06651600 for the Treatment of Alopecia Areata

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Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

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PF-06651600 for the Treatment of Alopecia Areata
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
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.
Not Provided
Interventional
Phase 2
Phase 3
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Alopecia Areata
  • 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
  • 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
Not Provided


*   Includes publications given by the data provider as well as publications
identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Not yet recruiting
660
Same as current
June 15, 2021
October 16, 2020   (Final data collection date for primary outcome measure)

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
Sexes Eligible for Study: All
12 Years and older   (Child, Adult, Older Adult)
No

Contact: Pfizer CT.gov Call Center 1-800-718-1021 [email protected]
Not Provided
 
 
NCT03732807
B7981015
2018-001714-14 ( EudraCT Number )
Yes
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Plan to Share IPD: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/clinical_trials/trial_data_and_results/da...
Pfizer
Pfizer
Not Provided
Study Director: Pfizer CT.gov Call Center Pfizer
Pfizer
November 2018

ICMJE     Data element required by the

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

FOR MORE INFORMATION

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

BY PHONE

Pfizer Clinical Trials Contact Center

1-800-718-1021

BY EMAIL

Contact

[email protected]

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