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
Ds Research
Clarksville, Indiana, 47129, 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:

By phone

Pfizer Clinical Trials Contact Center

1-800-718-1021

By email

Contact

[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. Clarksville, Indiana
  2. Ann Arbor, Michigan
  3. Ann Arbor, Michigan
  4. New York, New York
  5. New York, New York
  6. Philadelphia, Pennsylvania
  7. Philadelphia, Pennsylvania
  8. Phoenix, Arizona
  9. Scottsdale, Arizona
  10. Fremont, California
  11. Long Beach, California
  12. Los Angeles, California
  13. Los Angeles, California
  14. Santa Monica, California
  15. Bridgeport, Connecticut
  16. Shelton, Connecticut
  17. Jacksonville, Florida
  18. Largo, Florida
  19. Miami, Florida
  20. North Miami Beach, Florida
  21. Ocala, Florida
  22. Ocala, Florida
  23. Orange Park, Florida
  24. Ormond Beach, Florida
  25. Pembroke Pines, Florida
  26. Tampa, Florida
  27. Tampa, Florida
  28. Newnan, Georgia
  29. Sandy Springs, Georgia
  30. Watkinsville, Georgia
  31. Skokie, Illinois
  32. Skokie, Illinois
  33. Indianapolis, Indiana
  34. Louisville, Kentucky
  35. Boston, Massachusetts
  36. Boston, Massachusetts
  37. Brighton, Michigan
  38. Troy, Michigan
  39. Saint Joseph, Missouri
  40. Saint Louis, Missouri
  41. Omaha, Nebraska
  42. Henderson, Nevada
  43. Bronx, New York
  44. Bronx, New York
  45. New York, New York
  46. Tulsa, Oklahoma
  47. Hershey, Pennsylvania
  48. Hershey, Pennsylvania
  49. Philadelphia, Pennsylvania
  50. Humboldt, Tennessee
  51. Jackson, Tennessee
  52. Milan, Tennessee
  53. Arlington, Texas
  54. Pflugerville, Texas
  55. Richmond, Virginia
  56. Richmond, Virginia
  57. Bellevue, Washington
  58. Seattle, Washington
  59. Phillip, Australian Capital Territory
  60. Kogarah, New South Wales
  61. Westmead, New South Wales
  62. Woolloongabba, Queensland
  63. Carlton, Victoria
  64. East Melbourne, Victoria
  65. Barrie, Ontario
  66. London, Ontario
  67. Peterborough, Ontario
  68. Richmond Hill, Ontario
  69. Sherbrooke, Quebec
  70. 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 February 2, 2022
Estimated Primary Completion Date January 4, 2022   (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 October 2020

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