A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis

NCT03895372

Last updated date
Study Location
Center for Dermatology and Plastic Surgery
Scottsdale, Arizona, 85260, 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.
Psoriasis
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 between the ages of 18 and 75 years.

- Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.

- Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).

- Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

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


- Have non-plaque forms of psoriasis.


- Drug-induced psoriasis.


- Current active infection.


- Infected with Mycobacterium tuberculosis (TB).


- Have any history of malignancies.


- Require treatment with prohibited concomitant medications(s).


- Positive for hepatitis B or C, or human immunodeficiency virus (HIV).

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Advanced Information
Descriptive Information
Brief Title  ICMJE A Study to Evaluate Safety and Efficacy of PF-06826647 For Moderate To Severe Plaque Psoriasis
Official Title  ICMJE A PHASE 2, RANDOMIZED, DOUBLE BLIND, PLACEBO-CONTROLLED, STUDY TO EVALUATE THE SAFETY AND EFFICACY OF PF-06826647 IN PARTICIPANTS WITH MODERATE TO SEVERE PLAQUE PSORIASIS
Brief Summary This multicenter study is being conducted to provide additional PF-06826647 safety and tolerability data, and to further explore the clinical efficacy of PF-06826647 in the treatment of moderate to severe plaque psoriasis. Additionally, the study is intended to enable selection of oral dose and dosing regimen for the future clinical development of PF-06826647.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: PF-06826647 or Placebo
    Delivered orally (tablet) once daily (QD) for 16 weeks during the Investigational Treatment Period
  • Drug: PF-06826647
    Delivered orally (tablet) once daily (QD) for 24 weeks during the Extension Period
Study Arms  ICMJE
  • Experimental: PF-06826647 Drug Dose Level 1
    Delivered orally for 16 weeks during the Investigational Treatment Period
    Intervention: Drug: PF-06826647 or Placebo
  • Experimental: PF-06826647 Placebo
    Delivered orally for 16 weeks during the Investigational Treatment Period
    Intervention: Drug: PF-06826647 or Placebo
  • Experimental: PF-06826647 Drug Dose Level 2
    Delivered orally for 16 weeks during the Investigational Treatment Period
    Intervention: Drug: PF-06826647 or Placebo
  • Experimental: PF-06826647 Drug Dose Level 3
    Delivered orally for 16 weeks during the Investigational Treatment Period then 24 weeks in Extension Period.
    Interventions:
    • Drug: PF-06826647 or Placebo
    • Drug: PF-06826647
  • Experimental: PF-06826647 Drug Dose Level 4
    Delivered orally for 16 weeks then for 24 weeks in Extension Period.
    Interventions:
    • Drug: PF-06826647 or Placebo
    • Drug: PF-06826647
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: August 27, 2020)
179
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2019)
160
Estimated Study Completion Date  ICMJE December 3, 2020
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Male or female between the ages of 18 and 75 years.
  • Participants with a diagnosis of plaque psoriasis (psoriasis vulgaris) for at least 6 months.
  • Have a PASI score of 12 or greater AND a Physician Global Assessment score of 3 (moderate) or 4 (severe).
  • Have plaque-type psoriasis covering at least 10 % of total body surface area (BSA).

Exclusion Criteria:

  • Have non-plaque forms of psoriasis.
  • Drug-induced psoriasis.
  • Current active infection.
  • Infected with Mycobacterium tuberculosis (TB).
  • Have any history of malignancies.
  • Require treatment with prohibited concomitant medications(s).
  • Positive for hepatitis B or C, or human immunodeficiency virus (HIV).
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 Canada,   Japan,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03895372
Other Study ID Numbers  ICMJE C2501004
2018-004669-16 ( EudraCT 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:No
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….
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 August 2020

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