Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata

Back to Search
Print
Bookmark Trial

NCT02974868

Last updated date
Back to Search
Print
Bookmark Trial
FOR MORE INFORMATION
Study Location
University of Alabama at Birmingham, Dermatology at the Whitaker Clinic
Birmingham, Alabama, 35233, United States
See other locations
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
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.

- Must have moderate to severe alopecia areata:

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


- History of human immunodeficiency virus (HIV) or positive HIV serology at screening,


- Infected with hepatitis B or hepatitis C viruses.


- Have evidence of active or latent or inadequately treated infection with Mycobacterium
tuberculosis (TB)


- Have received any of the following treatment regiments specified in the timeframes
outlined below:


Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of
first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks
of first dose of study drug: Participation in other studies involving investigational
drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or
attenuated live vaccine.


Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy
(NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning
booth/parlor.


Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal
medications with unknown properties or known beneficial effects for AA.

NEED INFO?

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

Pfizer Clinical Trials Contact Center

1-800-718-1021

[email protected]

Call Now

TRY A NEW SEARCH

Search for Clinical Trials by condition, keyword or trial number. Share your location or enter your city or zip code to find studies near you.

Advanced Search

Based on your search, you may also be interested in

Alopecia AreataTopical Crisaborole in Patients With Alopecia Areata
NCT04299503
  1. Boston, Massachusetts
ALL GENDERS
2 Years+
years
MULTIPLE SITES
Alopecia AreataPLACEBO-CONTROLLED SAFETY STUDY OF RITLECITINIB (PF-06651600) IN ADULTS WITH ALOPECIA AREATA
NCT04517864
  1. Stony Brook, New York
  2. Krakow,
  3. Wrocław,
  4. Huntington Beach, California
  5. Irvine, California
  6. Boca Raton, Florida
  7. Boynton Beach, Florida
  8. Hollywood, Florida
  9. Jacksonville, Florida
  10. Jacksonville, Florida
  11. Miami, Florida
  12. Miramar, Florida
  13. Orlando, Florida
  14. Oviedo, Florida
  15. Tampa, Florida
  16. Skokie, Illinois
  17. Skokie, Illinois
  18. Albuquerque, New Mexico
  19. Albuquerque, New Mexico
  20. Raleigh, North Carolina
  21. Memphis, Tennessee
  22. Memphis, Tennessee
  23. Austin, Texas
  24. Houston, Texas
  25. Franklin, Virginia
  26. Lynchburg, Virginia
  27. Norfolk, Virginia
  28. Kogarah, New South Wales
  29. Box Hill, Victoria
  30. East Melbourne, Victoria
  31. Markham, Ontario
  32. Peterborough, Ontario
  33. Verdun, Quebec
  34. Quebec,
  35. Bialystok,
  36. Katowice,
  37. Ostrowiec Swietokrzyski,
  38. Warszawa,
  39. Warszawa,
  40. Wroclaw,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Alopecia AreataLong-Term PF-06651600 for the Treatment of Alopecia Areata
NCT04006457
  1. Halifax, Nova Scotia
  2. Nanjing, Jiangsu
  3. Nanjing, Jiangsu
  4. Shanghai, Shanghai/china
  5. Birmingham, Alabama
  6. Birmingham, Alabama
  7. Birmingham, Alabama
  8. Birmingham, Alabama
  9. Beverly Hills, California
  10. Irvine, California
  11. Murrieta, California
  12. San Francisco, California
  13. San Francisco, California
  14. Santa Ana, California
  15. Aurora, Colorado
  16. Aurora, Colorado
  17. Aurora, Colorado
  18. New Haven, Connecticut
  19. New Haven, Connecticut
  20. New Haven, Connecticut
  21. Washington, District of Columbia
  22. Washington, District of Columbia
  23. Washington, District of Columbia
  24. Washington, District of Columbia
  25. Washington, District of Columbia
  26. Boynton Beach, Florida
  27. Orange Park, Florida
  28. Tampa, Florida
  29. Meridian, Idaho
  30. Chicago, Illinois
  31. Chicago, Illinois
  32. Chicago, Illinois
  33. Chicago, Illinois
  34. Chicago, Illinois
  35. Oakbrook Terrace, Illinois
  36. Skokie, Illinois
  37. Skokie, Illinois
  38. Springfield, Illinois
  39. Indianapolis, Indiana
  40. Iowa City, Iowa
  41. Chevy Chase, Maryland
  42. Boston, Massachusetts
  43. Minneapolis, Minnesota
  44. Minneapolis, Minnesota
  45. Omaha, Nebraska
  46. Verona, New Jersey
  47. New York, New York
  48. New York, New York
  49. New York, New York
  50. Chapel Hill, North Carolina
  51. Chapel Hill, North Carolina
  52. Chapel Hill, North Carolina
  53. Cleveland, Ohio
  54. Tulsa, Oklahoma
  55. Portland, Oregon
  56. Houston, Texas
  57. Vienna, Virginia
  58. Caba,
  59. Caba,
  60. Kogarah, New South Wales
  61. Kogarah, New South Wales
  62. Benowa, Queensland
  63. Woolloongabba, Queensland
  64. Carlton, Victoria
  65. East Melbourne, Victoria
  66. Parkville, Victoria
  67. Parkville, Victoria
  68. Winnipeg, Manitoba
  69. London, Ontario
  70. Markham, Ontario
  71. Oakville, Ontario
  72. Peterborough, Ontario
  73. Richmond Hill, Ontario
  74. Sudbury, Ontario
  75. Sudbury, Ontario
  76. Toronto, Ontario
  77. Montreal, Quebec
  78. Quebec,
  79. Santiago, LAS Condes
  80. Santiago, Recoleta
  81. Vina del Mar, Valparaiso
  82. Santiago, Vitacura
  83. Beijing, Beijing
  84. Guangzhou, Guangdong
  85. Hangzhou, Zhejiang/ China
  86. Medellin, Antioquia
  87. Medellin, Antioquia
  88. Bogota D.C.,
  89. Nachod,
  90. Olomouc,
  91. Praha 10,
  92. Praha 1,
  93. Praha 8,
  94. Bad Bentheim,
  95. Berlin,
  96. Erlangen,
  97. Frankfurt am Main,
  98. Luebeck,
  99. Budapest,
  100. Gyongyos,
  101. Nagoya, Aichi
  102. Sendai, Miyagi
  103. Osaka-City, Osaka
  104. Hamamatsu, Shizuoka
  105. Koto-ku, Tokyo
  106. Mitaka-shi, Tokyo
  107. Tokyo,
  108. Busan,
  109. Seoul,
  110. Seoul,
  111. Monterrey, Nuevo LEON
  112. Veracruz,
  113. Veracruz,
  114. Grodzisk Mazowiecki,
  115. Krakow,
  116. Lodz,
  117. Osielsko,
  118. Ostrowiec Swietokrzyski,
  119. Szczecin,
  120. Warszawa,
  121. Warszawa,
  122. Warszawa,
  123. Warszawa,
  124. Wroclaw,
  125. Wroclaw,
  126. Wroclaw,
  127. Chelyabinsk,
  128. Kirov,
  129. Moscow,
  130. Moscow,
  131. Rostov-on-Don,
  132. Saint Petersburg,,
  133. Saint Petersburg,
  134. Saint Petersburg,
  135. Yaroslavl,
  136. Badalona, Barcelona
  137. Barcelona,
  138. Cordoba,
  139. Madrid,
  140. Madrid,
  141. Valencia,
  142. Taichung, R.o.c.
  143. Kaohsiung City,
  144. Kaohsiung,
  145. New Taipei City,
  146. Taipei,
  147. Taoyuan City,
  148. Brighton, EAST Sussex
  149. Southampton, Hampshire
  150. Southampton, Hampshire
  151. Glasgow,
  152. London,
  153. London,
  154. London,
  155. London,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Alopecia AreataPF-06651600 for the Treatment of Alopecia Areata
NCT03732807
  1. Beverly Hills, California
  2. Richmond Hill, Ontario
  3. Birmingham, Alabama
  4. Irvine, California
  5. Murrieta, California
  6. San Francisco, California
  7. San Francisco, California
  8. Santa Ana, California
  9. Aurora, Colorado
  10. New Haven, Connecticut
  11. New Haven, Connecticut
  12. New Haven, Connecticut
  13. New Haven, Connecticut
  14. Washington, District of Columbia
  15. Washington, District of Columbia
  16. Washington, District of Columbia
  17. Boynton Beach, Florida
  18. Orange Park, Florida
  19. Tampa, Florida
  20. Meridian, Idaho
  21. Chicago, Illinois
  22. Chicago, Illinois
  23. Chicago, Illinois
  24. Chicago, Illinois
  25. Skokie, Illinois
  26. Springfield, Illinois
  27. Indianapolis, Indiana
  28. Iowa City, Iowa
  29. Iowa City, Iowa
  30. Chevy Chase, Maryland
  31. Boston, Massachusetts
  32. Minneapolis, Minnesota
  33. Minneapolis, Minnesota
  34. Omaha, Nebraska
  35. Verona, New Jersey
  36. New York, New York
  37. New York, New York
  38. New York, New York
  39. New York, New York
  40. Chapel Hill, North Carolina
  41. Chapel Hill, North Carolina
  42. Chapel Hill, North Carolina
  43. Cleveland, Ohio
  44. Tulsa, Oklahoma
  45. Houston, Texas
  46. Caba,
  47. Caba,
  48. Kogarah, New South Wales
  49. Kogarah, New South Wales
  50. Benowa, Queensland
  51. Woolloongabba, Queensland
  52. Carlton, Victoria
  53. East Melbourne, Victoria
  54. Parkville, Victoria
  55. Parkville, Victoria
  56. Winnipeg, Manitoba
  57. Halifax, Nova Scotia
  58. London, Ontario
  59. Markham, Ontario
  60. Oakville, Ontario
  61. Peterborough, Ontario
  62. Sudbury, Ontario
  63. Sudbury, Ontario
  64. Toronto, Ontario
  65. Montreal, Quebec
  66. Quebec,
  67. Santiago, LAS Condes
  68. Santiago, Recoleta
  69. Santiago, Region Metropolitana
  70. Vina del Mar, Valparaiso
  71. Beijing, Beijing
  72. Beijing, Beijing
  73. Beijing, Beijing
  74. Guangzhou, Guangdong
  75. Shenzhen, Guangdong
  76. Wuhan, Hubei
  77. Nanjing, Jiangsu
  78. Shanghai, Shanghai
  79. Hangzhou, Zhejiang
  80. Hangzhou, Zhejiang
  81. Shanghai,
  82. Medellin, Antioquia
  83. Medellin, Antioquia
  84. Bogota, D.c.
  85. Brno,
  86. Brno,
  87. Nachod,
  88. Náchod,
  89. Olomouc,
  90. Praha 10,
  91. Praha 1,
  92. Praha 8 - Liben,
  93. Praha 8- Liben,
  94. Praha2,
  95. Bad Bentheim,
  96. Berlin,
  97. Erlangen,
  98. Frankfurt am Main,
  99. Luebeck,
  100. Luebeck,
  101. Muenster,
  102. Budapest,
  103. Debrecen,
  104. Gyongyos,
  105. Szeged,
  106. Nagoya, Aichi
  107. Sendai, Miyagi
  108. Hamamatsu, Shizuoka
  109. Koto-ku, Tokyo
  110. Shinjuku-ku, Tokyo
  111. Osaka,
  112. Busan,
  113. Seoul,
  114. Seoul,
  115. Veracruz,
  116. Krakow,
  117. Lodz,
  118. Szczecin,
  119. Warszawa,
  120. Warszawa,
  121. Wroclaw,
  122. Chelyabinsk,
  123. Kirov,
  124. Moscow,
  125. Moscow,
  126. Rostov-on-Don,
  127. Saint Petersburg,,
  128. Saint Petersburg,
  129. Saint Petersburg,
  130. Yaroslavl,
  131. Badalona, Barcelona
  132. Barcelona,
  133. Barcelona,
  134. Barcelona,
  135. Córdoba,
  136. Madrid,
  137. Madrid,
  138. Valencia,
  139. Kaohsiung City,
  140. Kaohsiung,
  141. New Taipei City,
  142. New Taipei City,
  143. Taichung,
  144. Taichung,
  145. Taipei,
  146. Taoyuan City,
  147. Brighton, EAST Sussex
  148. Southampton, Hampshire
  149. Dundee,
  150. Glasgow,
  151. Hampshire,
  152. London,
  153. London,
ALL GENDERS
12 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Subjects With Alopecia Areata
Official Title  ICMJE A PHASE 2A RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH MODERATE TO SEVERE ALOPECIA AREATA WITH A SINGLE-BLIND EXTENSION PERIOD AND A CROSS-OVER OPEN LABEL EXTENSION PERIOD
Brief Summary This is a Phase 2a, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 113 weeks. This includes an up to 5 weeks Screening Period, a 24 week Treatment Period, a 4 week Drug Holiday (#1), an up to 12 month Single Blind (investigator open, sponsor open and subject blind) Extension Period, a 4 week drug holiday (#2), a 6 month Cross Over Open Label Extension Period and a 4 week Follow up Period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model Description:
The first 24 weeks are parallel. The single-blind extension period will have a segment for non-responder and a withdrawal/retreatment segment for responder. The cross-over extension period is parallel for non-responders.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Alopecia Areata
Intervention  ICMJE
  • Drug: PF-06651600
    200 mg QD during induction and 50 mg QD during Maintenance
  • Drug: PF-06700841
    60 mg QD during induction and 30 mg QD during maintenance
  • Drug: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    PF-06651600
    Intervention: Drug: PF-06651600
  • Experimental: Cohort 2
    PF-06700841
    Intervention: Drug: PF-06700841
  • Placebo Comparator: Cohort placebo
    placebo
    Intervention: Drug: Placebo
Publications * Fensome A, Ambler CM, Arnold E, Banker ME, Brown MF, Chrencik J, Clark JD, Dowty ME, Efremov IV, Flick A, Gerstenberger BS, Gopalsamy A, Hayward MM, Hegen M, Hollingshead BD, Jussif J, Knafels JD, Limburg DC, Lin D, Lin TH, Pierce BS, Saiah E, Sharma R, Symanowicz PT, Telliez JB, Trujillo JI, Vajdos FF, Vincent F, Wan ZK, Xing L, Yang X, Yang X, Zhang L. Dual Inhibition of TYK2 and JAK1 for the Treatment of Autoimmune Diseases: Discovery of (( S)-2,2-Difluorocyclopropyl)((1 R,5 S)-3-(2-((1-methyl-1 H-pyrazol-4-yl)amino)pyrimidin-4-yl)-3,8-diazabicyclo[3.2.1]octan-8-yl)methanone (PF-06700841). J Med Chem. 2018 Oct 11;61(19):8597-8612. doi: 10.1021/acs.jmedchem.8b00917. Epub 2018 Aug 16.

*   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 Completed
Actual Enrollment  ICMJE
 (submitted: July 23, 2018)		142
Original Estimated Enrollment  ICMJE
 (submitted: November 23, 2016)		132
Actual Study Completion Date  ICMJE May 15, 2019
Actual Primary Completion Date May 15, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between 18 75 years of age, inclusive, at time of informed consent.
  • Must have moderate to severe alopecia areata:

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) or positive HIV serology at screening,
  • Infected with hepatitis B or hepatitis C viruses.
  • Have evidence of active or latent or inadequately treated infection with Mycobacterium tuberculosis (TB)
  • Have received any of the following treatment regiments specified in the timeframes outlined below:

Within 6 months of first dose of study drug: Any cell depleting agents Within 12 weeks of first dose of study drug: Any studies with JAK inhibitors; Other biologics Within 8 weeks of first dose of study drug: Participation in other studies involving investigational drug(s) Within 6 weeks of first dose of study drug: Have been vaccinated with live or attenuated live vaccine.

Within 4 weeks of first dose of study drug: Use of oral immune suppressants; Phototherapy (NB UVB) or broad band phototherapy; Regular use (more than 2 visits per week) of a tanning booth/parlor.

Within 2 week of first dose of study drug: Topical treatments that could affect AA; Herbal medications with unknown properties or known beneficial effects for AA.

Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 75 Years   (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 Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02974868
Other Study ID Numbers  ICMJE B7931005
2016-004048-13 ( EudraCT Number )
ALLEGRO ( 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 May 2020

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