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

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NCT04006457

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Study Location
Yale School of Medicine
New Haven, Connecticut, 06510, 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

Contact

[email protected]

Call Now

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

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

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

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Questions about a trial? Call or email to reach a Pfizer Clinical Trial Contact Center Representative

Pfizer Clinical Trials Contact Center

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[email protected]

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Alopecia AreataLong-Term PF-06651600 for the Treatment of Alopecia Areata
NCT04006457
  1. New Haven, Connecticut
  2. New Haven, Connecticut
  3. Meridian, Idaho
  4. Caba,
  5. Carlton, Victoria
  6. Bogota D.C.,
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  8. Veracruz,
  9. Moscow,
  10. Saint Petersburg,
  11. Saint Petersburg,
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  13. Birmingham, Alabama
  14. Irvine, California
  15. Murrieta, California
  16. San Francisco, California
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  18. Santa Ana, California
  19. Santa Monica, California
  20. Washington, District of Columbia
  21. Washington, District of Columbia
  22. Washington, District of Columbia
  23. Washington, District of Columbia
  24. Washington, District of Columbia
  25. Boynton Beach, Florida
  26. Orange Park, Florida
  27. Tampa, Florida
  28. Oakbrook Terrace, Illinois
  29. Skokie, Illinois
  30. Springfield, Illinois
  31. Indianapolis, Indiana
  32. Chevy Chase, Maryland
  33. Boston, Massachusetts
  34. Minneapolis, Minnesota
  35. Minneapolis, Minnesota
  36. Omaha, Nebraska
  37. Verona, New Jersey
  38. New York, New York
  39. New York, New York
  40. New York, New York
  41. New York, New York
  42. Chapel Hill, North Carolina
  43. Chapel Hill, North Carolina
  44. Chapel Hill, North Carolina
  45. Tulsa, Oklahoma
  46. Vienna, Virginia
  47. Caba,
  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
  61. Sudbury, Ontario
  62. Sudbury, Ontario
  63. Toronto, Ontario
  64. Montreal, Quebec
  65. Quebec,
  66. Nagoya, Aichi
  67. Sendai, Miyagi
  68. Osaka-City, Osaka
  69. Hamamatsu, Shizuoka
  70. Koto-ku, Tokyo
  71. Mitaka-shi, Tokyo
  72. Busan,
  73. Seoul,
  74. Seoul,
  75. Chelyabinsk,
  76. Kirov,
  77. Moscow,
  78. Rostov-on-Don,
  79. Saint Petersburg,,
  80. Yaroslavl,
  81. Taichung, R.o.c.
  82. Kaohsiung City,
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  84. New Taipei City,
  85. Taichung,
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ALL GENDERS
12 Years+
years
MULTIPLE SITES
Alopecia AreataPF-06651600 for the Treatment of Alopecia Areata
NCT03732807
  1. Chevy Chase, Maryland
  2. Parkville, Victoria
  3. Birmingham, Alabama
  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
  47. Caba,
  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
  74. Beijing, Beijing
  75. Guangzhou, Guangdong
  76. Shenzhen, Guangdong
  77. Wuhan, Hubei
  78. Nanjing, Jiangsu
  79. Shanghai, Shanghai
  80. Hangzhou, Zhejiang
  81. Hangzhou, Zhejiang
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  85. Bogota, D.c.
  86. Brno,
  87. Brno,
  88. Nachod,
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  92. Praha 1,
  93. Praha 8 - Liben,
  94. Praha 8- Liben,
  95. Praha2,
  96. Bad Bentheim,
  97. Berlin,
  98. Erlangen,
  99. Frankfurt am Main,
  100. Luebeck,
  101. Luebeck,
  102. Muenster,
  103. Budapest,
  104. Debrecen,
  105. Gyongyos,
  106. Szeged,
  107. Nagoya, Aichi
  108. Sendai, Miyagi
  109. Hamamatsu, Shizuoka
  110. Koto-ku, Tokyo
  111. Shinjuku-ku, Tokyo
  112. Osaka,
  113. Busan,
  114. Seoul,
  115. Seoul,
  116. Veracruz,
  117. Krakow,
  118. Lodz,
  119. Szczecin,
  120. Warszawa,
  121. Warszawa,
  122. Wroclaw,
  123. Chelyabinsk,
  124. Kirov,
  125. Moscow,
  126. Moscow,
  127. Rostov-on-Don,
  128. Saint Petersburg,,
  129. Saint Petersburg,
  130. Saint Petersburg,
  131. Yaroslavl,
  132. Badalona, Barcelona
  133. Barcelona,
  134. Barcelona,
  135. Barcelona,
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MULTIPLE SITES
Alopecia AreataStudy To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
NCT02974868
  1. Birmingham, Alabama
  2. Birmingham, Alabama
  3. Santa Ana, California
  4. Santa Monica, California
  5. Santa Monica, California
  6. Santa Monica, California
  7. Aurora, Colorado
  8. Aurora, Colorado
  9. Aurora, Colorado
  10. New Haven, Connecticut
  11. New Haven, Connecticut
  12. New Haven, Connecticut
  13. New Haven, Connecticut
  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
  52. Oakville, Ontario
  53. Peterborough, Ontario
  54. Richmond Hill, Ontario
  55. Richmond Hill, Ontario
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
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 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.
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 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 Date May 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 Argentina,   Australia,   Canada,   Colombia,   Japan,   Korea, Republic of,   Mexico,   Russian Federation,   Taiwan,   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
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 March 2020

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