A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa

NCT04092452

Last updated date
Study Location
UCSF Dermatology Clinic
San Francisco, California, 94115, United States
Contact
1-800-718-1021

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

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Pfizer Clinical Trials Contact Center

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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.
Acne Inversa
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 participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa

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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Acne InversaA Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
NCT04092452
  1. San Francisco, California
  2. San Francisco, California
  3. San Francisco, California
  4. Scottsdale, Arizona
  5. Fremont, California
  6. Long Beach, California
  7. Los Angeles, California
  8. Santa Monica, California
  9. Bridgeport, Connecticut
  10. Shelton, Connecticut
  11. Jacksonville, Florida
  12. Largo, Florida
  13. Miami, Florida
  14. North Miami Beach, Florida
  15. Ocala, Florida
  16. Ocala, Florida
  17. Orange Park, Florida
  18. Ormond Beach, Florida
  19. Pembroke Pines, Florida
  20. Tampa, Florida
  21. Tampa, Florida
  22. Newnan, Georgia
  23. Sandy Springs, Georgia
  24. Watkinsville, Georgia
  25. Skokie, Illinois
  26. Skokie, Illinois
  27. Clarksville, Indiana
  28. Indianapolis, Indiana
  29. Louisville, Kentucky
  30. Boston, Massachusetts
  31. Boston, Massachusetts
  32. Boston, Massachusetts
  33. Detroit, Michigan
  34. Troy, Michigan
  35. Minneapolis, Minnesota
  36. Minneapolis, Minnesota
  37. Minneapolis, Minnesota
  38. Saint Joseph, Missouri
  39. Saint Louis, Missouri
  40. Saint Louis, Missouri
  41. Omaha, Nebraska
  42. Bronx, New York
  43. Bronx, New York
  44. New York, New York
  45. New York, New York
  46. New York, New York
  47. Tulsa, Oklahoma
  48. Hershey, Pennsylvania
  49. Hershey, Pennsylvania
  50. Philadelphia, Pennsylvania
  51. Philadelphia, Pennsylvania
  52. Philadelphia, Pennsylvania
  53. Humboldt, Tennessee
  54. Jackson, Tennessee
  55. Arlington, Texas
  56. Pflugerville, Texas
  57. Murray, Utah
  58. Richmond, Virginia
  59. Bellevue, Washington
  60. Seattle, Washington
  61. Phillip, Australian Capital Territory
  62. Darlinghurst, New South Wales
  63. Kogarah, New South Wales
  64. Sydney, New South Wales
  65. Westmead, New South Wales
  66. Woolloongabba, Queensland
  67. Carlton, Victoria
  68. East Melbourne, Victoria
  69. Barrie, Ontario
  70. London, Ontario
  71. London, Ontario
  72. Peterborough, Ontario
  73. Richmond Hill, Ontario
  74. Sherbrooke, Quebec
  75. Quebec,
  76. Quebec,
ALL GENDERS
18 Years+
years
MULTIPLE SITES
Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Safety and Efficacy of PF-06650833, PF-06700841, and PF 06826647 in Adults With Hidradenitis Suppurativa
Official Title  ICMJE A PHASE 2A, MULTICENTER, RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, 16-WEEK STUDY EVALUATING THE SAFETY AND EFFICACY OF PF-06650833, PF-06700841, AND PF-06826647 IN ADULTS WITH MODERATE TO SEVERE HIDRADENITIS SUPPURATIVA
Brief Summary This is a study with 3 kinase inhibitors (PF 06650833, PF 06700841 and PF 06826647) in participants with moderate to severe HS. The study will have a maximum duration of approximately 26 weeks. This includes an up to 6-week Screening Period, a 16 week Dosing 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: Parallel Assignment
Intervention Model Description:
The treatment period is a parallel design
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Acne Inversa
Intervention  ICMJE
  • Drug: PF-06650833
    400 mg QD
  • Drug: PF-06700841
    45 mg QD
  • Drug: PF-06826647
    400 mg QD
  • Drug: Placebo
    placebo
Study Arms  ICMJE
  • Experimental: Cohort 1
    PF-06650833
    Intervention: Drug: PF-06650833
  • Experimental: Cohort 2
    PF-6700841
    Intervention: Drug: PF-06700841
  • Experimental: Cohort 3
    PF-06826647
    Intervention: Drug: PF-06826647
  • Placebo Comparator: Cohort placebo
    placebo
    Intervention: 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: September 15, 2019)
192
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 27, 2021
Estimated Primary Completion Date November 27, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • male or female participants, between 18-75, with a diagnosis of moderate to severe Hidradenitis Suppurativa

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 75 Years   (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 Australia,   Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04092452
Other Study ID Numbers  ICMJE C2501007
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 Not Provided
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 April 2021

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