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
Keck School of Medicine of University of Southern California
Los Angeles, California, 90033, United States
Contact
1-800-718-1021

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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. Los Angeles, California
  2. Los Angeles, California
  3. Bridgeport, Connecticut
  4. Shelton, Connecticut
  5. Pembroke Pines, Florida
  6. Sandy Springs, Georgia
  7. Fremont, California
  8. Long Beach, California
  9. Santa Monica, California
  10. Largo, Florida
  11. Miami, Florida
  12. North Miami Beach, Florida
  13. Orange Park, Florida
  14. Ormond Beach, Florida
  15. Tampa, Florida
  16. Tampa, Florida
  17. Newnan, Georgia
  18. Skokie, Illinois
  19. Skokie, Illinois
  20. Indianapolis, Indiana
  21. Boston, Massachusetts
  22. Boston, Massachusetts
  23. Troy, Michigan
  24. Saint Joseph, Missouri
  25. Saint Louis, Missouri
  26. Omaha, Nebraska
  27. Tulsa, Oklahoma
  28. Philadelphia, Pennsylvania
  29. Arlington, Texas
  30. Pflugerville, Texas
  31. Richmond, Virginia
  32. Richmond, Virginia
  33. Bellevue, Washington
  34. Seattle, Washington
  35. Phillip, Australian Capital Territory
  36. Woolloongabba, Queensland
  37. Carlton, Victoria
  38. East Melbourne, Victoria
  39. Barrie, Ontario
  40. London, Ontario
  41. Peterborough, Ontario
  42. Richmond Hill, Ontario
  43. 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 October 16, 2021
Estimated Primary Completion Date September 18, 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 June 2020

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