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Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis

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ClinicalTrials.gov Identifier: NCT03469336
Recruitment Status : Completed
First Posted : March 19, 2018
Last Update Posted : April 8, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE March 13, 2018
First Posted Date  ICMJE March 19, 2018
Last Update Posted Date April 8, 2019
Actual Study Start Date  ICMJE April 24, 2018
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Change from baseline in psoriatic skin infiltrate thickness [ Time Frame: Day 1 to Day 19 ]
    Change in skin infiltrate thickness in response to PF-06763809 2.3%, 0.8% and 0.23% applied topically as compared to the vehicle control
  • Number of Participants With Adverse Events (AEs) by Seriousness and Relationship to Treatment [ Time Frame: Day 1 to Day 49 ]
  • Number of Participants With Clinically Significant Change From Baseline in Laboratory Abnormalities [ Time Frame: Day 1 to Day 49 ]
  • Number of participants with clinically relevant changes from baseline in ECG parameters [ Time Frame: Day 1 to Day 49 ]
  • Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 to Day 49 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03469336 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: March 13, 2018)
  • Area Under the Curve of the psoriatic skin infiltrate thickness [ Time Frame: Day 1 to Day 19 ]
  • Change from baseline in psoriatic skin infiltrate thickness [ Time Frame: Day 1 to Day 19 ]
    Change in skin infiltrate thickness in response to PF-06763809 compared to calcipotriene/calcipotriol solution.
  • Change from baseline in psoriatic skin infiltrate thickness [ Time Frame: Day 1 to Day 19 ]
    Change in skin infiltrate thickness in response to PF-06763809 compared to betamethasone solution.
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 Safety, Tolerability And Efficacy Study Of Topical PF-06763809 In Subjects With Mild To Moderate Chronic Plaque Psoriasis
Official Title  ICMJE A PHASE 1, RANDOMIZED, DOUBLE-BLIND, VEHICLE AND ACTIVE COMPARATOR-CONTROLLED, PSORIASIS PLAQUE TEST STUDY TO ASSESS SAFETY, TOLERABILITY, AND PSORIATIC SKIN INFILTRATE THICKNESS FOLLOWING REPEATED, TOPICAL DOSES OF PF-06763809 SOLUTION IN SUBJECTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary The study is a randomized, double blinded, vehicle and active comparator controlled, multiple dose study in subjects with chronic plaque psoriasis. The study will have approximately 15 completers. Each subjects will receive three different topical doses of PF 06763809, PF 06763809 vehicle, and two active comparators. These will be applied to six different treatment fields for 18 days. The total duration of participation in the study will be approximately 7 weeks (minimum) to approximately 11 weeks (maximum), including the interval from Screening to the Follow up phone call visit.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Masking Description:
This study is a single arm multi-intervention study. The interventions are masked to participant, investigator, providers and assessors.
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: PF-06763809
    Three different concentrations will be administered to three different treatment fields: 2.3%, 0.8% and 0.23%
  • Other: Vehicle
    Vehicle matching PF-06763809.
  • Drug: Calcipotriene/calcipotriol
    Calcipotriene/calcipotriol 50 ug/mL solution
  • Drug: Betamethasone
    Betamethasone 1 mg/g solution
Study Arms  ICMJE All subjects
All subjects will receive all six interventions/treatments applied to six different treatment fields.
Interventions:
  • Drug: PF-06763809
  • Other: Vehicle
  • Drug: Calcipotriene/calcipotriol
  • Drug: Betamethasone
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: March 15, 2019)
18
Original Estimated Enrollment  ICMJE
 (submitted: March 13, 2018)
15
Actual Study Completion Date  ICMJE March 20, 2019
Actual Primary Completion Date March 20, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Psoriasis vulgaris in a chronic stable phase and with a plaque area of mild to moderate severity sufficient for six treatment fields located in up to three plaque areas
  • Target lesion(s) should be on the trunk or extremities (excluding palms/soles).

Exclusion Criteria:

  • History of skin sensitivity to topical prescription or non prescription products such as creams, lotions and cosmetics
  • Psoriasis guttata, psoriasis punctata, psoriasis erythrodermatica, and pustular psoriasis
  • Treatment with any biologics within 3 months prior to Day 1 of the study and during the study
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (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 Germany
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03469336
Other Study ID Numbers  ICMJE C3561001
2017-002684-18 ( EudraCT Number )
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
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 April 2019

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