A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects

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NCT03715829

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Study Location
Clinical Science Institute
Santa Monica, California, 90404, United States
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Contact
1-800-718-1021
[email protected]
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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Active Non-segmental Vitiligo
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-65 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.

- Must have moderate to severe active non-segmental vitiligo.

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)

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Active Non-segmental VitiligoA Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
NCT03715829
  1. Santa Monica, California
  2. Chicago, Illinois
  3. Kogarah, New South Wales
  4. Erlangen,
  5. Mainz,
  6. Incheon,
  7. Huntington Beach, California
  8. Irvine, California
  9. Los Angeles, California
  10. Murrieta, California
  11. Oceanside, California
  12. Sacramento, California
  13. Bridgeport, Connecticut
  14. Westport, Connecticut
  15. Miami, Florida
  16. Orange Park, Florida
  17. Tampa, Florida
  18. Chevy Chase, Maryland
  19. Chevy Chase, Maryland
  20. Rockville, Maryland
  21. Boston, Massachusetts
  22. Worcester, Massachusetts
  23. Worcester, Massachusetts
  24. Worcester, Massachusetts
  25. Worcester, Massachusetts
  26. Detroit, Michigan
  27. Minneapolis, Minnesota
  28. Verona, New Jersey
  29. New York, New York
  30. New York, New York
  31. New York, New York
  32. Oceanside, New York
  33. Wilmington, North Carolina
  34. Columbus, Ohio
  35. Columbus, Ohio
  36. Tulsa, Oklahoma
  37. Austin, Texas
  38. Dallas, Texas
  39. Houston, Texas
  40. Houston, Texas
  41. Norfolk, Virginia
  42. Vienna, Virginia
  43. Darlinghurst, New South Wales
  44. Kogarah, New South Wales
  45. Woolloongabba, Queensland
  46. Carlton, Victoria
  47. East Melbourne, Victoria
  48. Parkville, Victoria
  49. Brussels,
  50. Brussel,
  51. Gent,
  52. Liege,
  53. Surrey, British Columbia
  54. Surrey, British Columbia
  55. Vancouver, British Columbia
  56. Winnipeg, Manitoba
  57. Ajax, Ontario
  58. London, Ontario
  59. Markham, Ontario
  60. Mississauga, Ontario
  61. North York, Ontario
  62. Oakville, Ontario
  63. Richmond Hill, Ontario
  64. Waterloo, Ontario
  65. Montreal, Quebec
  66. Sherbrooke, Quebec
  67. Quebec,
  68. Quebec,
  69. Bad Bentheim,
  70. Frankfurt am Main,
  71. Luebeck,
  72. Muenster,
  73. Nagoya, Aichi
  74. Sendai, Miyagi
  75. Bunkyo-ku, Tokyo
  76. Shinjuku-ku, Tokyo
  77. Kofu, Yamanashi
  78. Goyang-si, Gyeonggi-do
  79. Suwon-si, Gyeonggi-do
  80. Suwon, Gyeonggi-do
  81. Seoul,
  82. Barcelona,
  83. Cordoba,
  84. Madrid,
  85. Madrid,
  86. Valencia,
  87. Kaohsiung,
  88. Kaohsiung,
  89. Tainan,
  90. Taipei,
  91. Taipei,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Phase 2b Study To Evaluate The Efficacy And Safety Profile Of PF-06651600 And PF-06700841 In Active Non-segmental Vitiligo Subjects
Official Title  ICMJE A PHASE 2B RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTICENTER, DOSE-RANGING STUDY TO EVALUATE THE EFFICACY AND SAFETY PROFILE OF PF-06651600 WITH A PARTIALLY BLINDED EXTENSION PERIOD TO EVALUATE THE EFFICACY AND SAFETY OF PF-06651600 AND PF-06700841 IN SUBJECTS WITH ACTIVE NON-SEGMENTAL VITILIGO
Brief Summary This is a Phase 2b, randomized, double blind, parallel group, multicenter study with an extension period. The study will have a maximum duration of approximately 60 weeks. This includes an up to 4 weeks Screening Period, a 24 week dose ranging period, an up to 24 week extension period and a 8 week Follow up Period.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Dose ranging period is a parallel design. Extension period is a sequential design.
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Masking Description:
Dose ranging period is blinded. The partially blinded extension period includes open arms and blinded arms.
Primary Purpose: Treatment
Condition  ICMJE Active Non-segmental Vitiligo
Intervention  ICMJE
  • Drug: PF-06651600
    Induction dose 1. Oral tablet taken QD
  • Drug: PF-06651600
    Induction dose 2. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance dose A. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance Dose B. Oral tablet taken QD
  • Drug: PF-06651600
    Maintenance Dose C. Oral tablet taken QD
  • Drug: placebo
    placebo
  • Drug: PF06700841
    Oral tablet taken QD
  • Device: narrow-band UVB phototherapy
    Phototherapy will be combined with PF-06651600
Study Arms  ICMJE
  • Experimental: Cohort 1
    Induction dose 1 given once a day(QD) for 4 weeks followed by maintenance dose A given QD for 20 weeks
    Interventions:
    • Drug: PF-06651600
    • Drug: PF-06651600
  • Experimental: Cohort 2
    Induction dose 2 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
    Interventions:
    • Drug: PF-06651600
    • Drug: PF-06651600
  • Experimental: Cohort 3
    Maintenance dose A given QD for 24 weeks
    Intervention: Drug: PF-06651600
  • Experimental: Cohort 4
    Maintenance dose B given QD for 24 weeks
    Intervention: Drug: PF-06651600
  • Experimental: Cohort 5
    Maintenance dose C given QD for 24 weeks
    Intervention: Drug: PF-06651600
  • Placebo Comparator: Cohort 6
    Placebo given QD for 24 weeks
    Intervention: Drug: placebo
  • Experimental: Extension Cohort 1
    4 week drug holiday (no drug given) followed by PF-06700841 oral tablet QD for 20 weeks
    Intervention: Drug: PF06700841
  • Experimental: Extension Cohort 2
    Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks in conjunction with narrow band UVB phototherapy
    Interventions:
    • Drug: PF-06651600
    • Drug: PF-06651600
    • Device: narrow-band UVB phototherapy
  • Experimental: Extension Cohort 3
    Induction dose 1 given QD for 4 weeks followed by maintenance dose A given QD for 20 weeks
    Interventions:
    • Drug: PF-06651600
    • Drug: PF-06651600
  • Experimental: Extension Cohort 4
    Maintenance dose A given QD for 24 weeks
    Intervention: Drug: PF-06651600
  • Experimental: Extension Cohort 5
    Maintenance dose B given QD for 24 weeks
    Intervention: Drug: PF-06651600
  • No Intervention: Extension Cohort 6
    Observation period for 24 weeks
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: February 4, 2020)		366
Original Estimated Enrollment  ICMJE
 (submitted: October 19, 2018)		330
Estimated Study Completion Date  ICMJE February 5, 2021
Estimated Primary Completion Date February 5, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female subjects between 18-65 years of age, inclusive, at time of informed consent.
  • Must have moderate to severe active non-segmental vitiligo.

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)
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 18 Years to 65 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,   Belgium,   Canada,   Germany,   Italy,   Japan,   Korea, Republic of,   Spain,   Taiwan,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03715829
Other Study ID Numbers  ICMJE B7981019
2018-001271-20 ( EudraCT Number )
Has Data Monitoring Committee Not Provided
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 December 2020

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