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

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ClinicalTrials.gov Identifier: NCT03895372
Recruitment Status : Completed
First Posted : March 29, 2019
Last Update Posted : February 8, 2021
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 13, 2019
First Posted Date  ICMJE March 29, 2019
Last Update Posted Date February 8, 2021
Actual Study Start Date  ICMJE June 27, 2019
Actual Primary Completion Date May 21, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • Change from Baseline of Participants With a Psoriasis Area and Severity Index 90 (PASI 90) Response [ Time Frame: Baseline, Week 16 ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of BSA" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 90 response was defined as at least a 90% reduction in PASI relative to Baseline.
  • Number of Participants With Adverse Events [ Time Frame: Week 16 through to follow-up at week 44 ]
    The incidence, severity and seriousness of adverse events, withdrawals due to adverse events will be analyzed.
  • Number of Participants With Clinically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline up to 40 weeks ]
    Following parameters will be analyzed for examination of vital signs: blood pressure, pulse rate and body temperature.
  • Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings [ Time Frame: Baseline up to 40 weeks ]
    Clinically significant ECG findings include: corrected QT (QTc) > 450 ms, QTc >500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.
  • Number of Participants With Change From Baseline in Laboratory Tests Results [ Time Frame: Baseline up to 40 weeks ]
    Laboratory values include hematology, blood chemistry including lipid panel and urinalysis. Any laboratory value that is identified as clinically significant will be reported as an AE.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: March 27, 2019)
  • Percentage of Participants With a Psoriasis Area and Severity Index 75 (PASI 75) Response [ Time Frame: Baseline, Week 16 ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 75 response was defined as at least a 75 percent (%) reduction in PASI relative to Baseline.
  • Percentage of Participants With Physician Global Assessment (PGA) of Psoriasis Score of 'Clear' or 'Almost Clear' [ Time Frame: Baseline, Week 16 ]
    The PGA of psoriasis is scored on a 5-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 5-point severity scale (0 [no symptom] to 4 [severe symptom]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the PGA score and category (0=clear; 1=almost clear; 2=mild; 3=moderate; and 4=severe). PGA response was defined as 0 (clear) or 1 (almost clear).
  • Percentage of Participants With a Psoriasis Area and Severity Index 50 (PASI 50) Response [ Time Frame: Baseline, Week 16 ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 50 response was defined as at least a 50 percent (%) reduction in PASI relative to Baseline.
  • Percentage of Participants With a Psoriasis Area and Severity Index 100 (PASI 100) Response [ Time Frame: Baseline, Week 16 ]
    The PASI quantifies the severity of a participant's psoriasis based on both, "lesion severity" and the "percent of body surface area (BSA)" affected. PASI is a composite scoring by the investigator of degree of erythema, induration, and scaling (each scored separately) for each of 4 body regions (head and neck, upper limbs, trunk [including axillae and groin], and lower limbs [including buttocks]), with adjustment for the percent of BSA involved for each body region and for the proportion of the body region to the whole body. The PASI score can vary in increments of 0.1 and range from 0.0 to 72.0, with higher scores representing greater severity of psoriasis. PASI 100 response was defined as at least a 100 percent (%) reduction in PASI relative to Baseline.
  • Percent change and absolute score of Peak Pruritis Numerical Rating Scale (PPNRS) score [ Time Frame: Baseline, Week 16 ]
    The intensity of pruritis is assessed on a patient reported scale 0 to 10. The absolute score and change relative to baseline score of PPNRS will be measured.
  • Number of Participants With Adverse Events [ Time Frame: Baseline, Week 16 ]
    The incidence, severity and seriousness of adverse events, withdrawals due to adverse events will be analyzed.
  • Number of Participants With Clnically Significant Change From Baseline in Vital Signs [ Time Frame: Baseline, Week 16 ]
    Following parameters will be analyzed for examination of vital signs: blood pressure, pulse rate and body temperature.
  • Number of Participants With Clinically Significant Treatment-emergent Electrocardiogram (ECG) Findings [ Time Frame: Baseline, Week 16 ]
    Clinically significant ECG findings include: corrected QT (QTc)> 450ms, QTc > 500 ms, change in QTc between 30 and 60 ms, change in QTc greater than or equal to 60 ms.
  • Number of Participants With Change From Baseline in Laboratory Tests Results [ Time Frame: Baseline, Week 16 ]
    Laboratory values include hematology, blood chemistry including lipid panel and urinalysis. Any laboratory value that was identified as clinically significant will be reported as an AE.
  • Percent change and absolute score of Psoriasis Symptom Inventory (PSI) [ Time Frame: Baseline, Week 16 ]
    The Psoriasis Symptom Inventory (PSI) is a patient reported 8 item questionnaire that measures severity of symptoms over 24 hours or the past week. The percent change relative to baseline and absolute score of PSI will be measured.
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
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 Completed
Actual Enrollment  ICMJE
 (submitted: August 27, 2020)
179
Original Estimated Enrollment  ICMJE
 (submitted: March 27, 2019)
160
Actual Study Completion Date  ICMJE November 26, 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/data_requests.
Responsible Party Pfizer
Study Sponsor  ICMJE Pfizer
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Pfizer CT.gov Call Center Pfizer
PRS Account Pfizer
Verification Date February 2021

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