PF-06651600 for the Treatment of Alopecia Areata

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NCT03732807

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Study Location
Medstar Georgetown University Hospital - Department of Dermatology
Chevy Chase, Maryland, 20815, United States
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Contact
1-800-718-1021
[email protected]
Related Links

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

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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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Pfizer Clinical Trials Contact Center

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Alopecia AreataLong-Term PF-06651600 for the Treatment of Alopecia Areata
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  25. Boynton Beach, Florida
  26. Orange Park, Florida
  27. Tampa, Florida
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  29. Skokie, Illinois
  30. Springfield, Illinois
  31. Indianapolis, Indiana
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  33. Boston, Massachusetts
  34. Minneapolis, Minnesota
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  36. Omaha, Nebraska
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  38. New York, New York
  39. New York, New York
  40. New York, New York
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  42. Chapel Hill, North Carolina
  43. Chapel Hill, North Carolina
  44. Chapel Hill, North Carolina
  45. Tulsa, Oklahoma
  46. Vienna, Virginia
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  48. Kogarah, New South Wales
  49. Kogarah, New South Wales
  50. Benowa, Queensland
  51. Woolloongabba, Queensland
  52. East Melbourne, Victoria
  53. Parkville, Victoria
  54. Parkville, Victoria
  55. Winnipeg, Manitoba
  56. London, Ontario
  57. Markham, Ontario
  58. Oakville, Ontario
  59. Peterborough, Ontario
  60. Richmond Hill, Ontario
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  62. Sudbury, Ontario
  63. Toronto, Ontario
  64. Montreal, Quebec
  65. Quebec,
  66. Nagoya, Aichi
  67. Sendai, Miyagi
  68. Osaka-City, Osaka
  69. Hamamatsu, Shizuoka
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  72. Busan,
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  75. Chelyabinsk,
  76. Kirov,
  77. Moscow,
  78. Rostov-on-Don,
  79. Saint Petersburg,,
  80. Yaroslavl,
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ALL GENDERS
12 Years+
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MULTIPLE SITES
Alopecia AreataPF-06651600 for the Treatment of Alopecia Areata
NCT03732807
  1. Chevy Chase, Maryland
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  4. Irvine, California
  5. Murrieta, California
  6. San Francisco, California
  7. San Francisco, California
  8. Santa Ana, California
  9. Santa Monica, California
  10. Aurora, Colorado
  11. New Haven, Connecticut
  12. New Haven, Connecticut
  13. New Haven, Connecticut
  14. New Haven, Connecticut
  15. New Haven, Connecticut
  16. Washington, District of Columbia
  17. Washington, District of Columbia
  18. Washington, District of Columbia
  19. Boynton Beach, Florida
  20. Orange Park, Florida
  21. Tampa, Florida
  22. Meridian, Idaho
  23. Chicago, Illinois
  24. Chicago, Illinois
  25. Chicago, Illinois
  26. Chicago, Illinois
  27. Skokie, Illinois
  28. Springfield, Illinois
  29. Indianapolis, Indiana
  30. Iowa City, Iowa
  31. Iowa City, Iowa
  32. Boston, Massachusetts
  33. Minneapolis, Minnesota
  34. Minneapolis, Minnesota
  35. Omaha, Nebraska
  36. Verona, New Jersey
  37. New York, New York
  38. New York, New York
  39. New York, New York
  40. New York, New York
  41. Chapel Hill, North Carolina
  42. Chapel Hill, North Carolina
  43. Chapel Hill, North Carolina
  44. Cleveland, Ohio
  45. Tulsa, Oklahoma
  46. Houston, Texas
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  48. Caba,
  49. Kogarah, New South Wales
  50. Kogarah, New South Wales
  51. Benowa, Queensland
  52. Woolloongabba, Queensland
  53. Carlton, Victoria
  54. East Melbourne, Victoria
  55. Parkville, Victoria
  56. Winnipeg, Manitoba
  57. Halifax, Nova Scotia
  58. London, Ontario
  59. Markham, Ontario
  60. Oakville, Ontario
  61. Peterborough, Ontario
  62. Richmond Hill, Ontario
  63. Sudbury, Ontario
  64. Sudbury, Ontario
  65. Toronto, Ontario
  66. Montreal, Quebec
  67. Quebec,
  68. Santiago, LAS Condes
  69. Santiago, Recoleta
  70. Santiago, Region Metropolitana
  71. Vina del Mar, Valparaiso
  72. Beijing, Beijing
  73. Beijing, Beijing
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  75. Guangzhou, Guangdong
  76. Shenzhen, Guangdong
  77. Wuhan, Hubei
  78. Nanjing, Jiangsu
  79. Shanghai, Shanghai
  80. Hangzhou, Zhejiang
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  85. Bogota, D.c.
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  87. Brno,
  88. Nachod,
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  96. Bad Bentheim,
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  100. Luebeck,
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  102. Muenster,
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  105. Gyongyos,
  106. Szeged,
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  108. Sendai, Miyagi
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Alopecia AreataStudy To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
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  10. New Haven, Connecticut
  11. New Haven, Connecticut
  12. New Haven, Connecticut
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  14. New Haven, Connecticut
  15. Orange Park, Florida
  16. Orange Park, Florida
  17. Tampa, Florida
  18. Tampa, Florida
  19. Tampa, Florida
  20. Tampa, Florida
  21. Newnan, Georgia
  22. Skokie, Illinois
  23. Indianapolis, Indiana
  24. Indianapolis, Indiana
  25. Boston, Massachusetts
  26. Boston, Massachusetts
  27. New York, New York
  28. New York, New York
  29. New York, New York
  30. New York, New York
  31. Rochester, New York
  32. Rochester, New York
  33. Rochester, New York
  34. Rochester, New York
  35. Tulsa, Oklahoma
  36. Rapid City, South Dakota
  37. Murray, Utah
  38. Salt Lake City, Utah
  39. Norfolk, Virginia
  40. Hurstville, New South Wales
  41. Kogarah, New South Wales
  42. Kogarah, New South Wales
  43. Kogarah, New South Wales
  44. Benowa, Queensland
  45. Woolloongabba, Queensland
  46. Carlton, Victoria
  47. East Melbourne, Victoria
  48. Richmond, Victoria
  49. Richmond, Victoria
  50. Winnipeg, Manitoba
  51. Markham, Ontario
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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 Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 5, 2018)		660
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE March 28, 2021
Estimated Primary Completion Date September 18, 2020   (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: Pfizer CT.gov Call Center1-800-718-1021[email protected]
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 July 2020

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