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Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis

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ClinicalTrials.gov Identifier: NCT03850483
Recruitment Status : Recruiting
First Posted : February 21, 2019
Last Update Posted : September 9, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE February 20, 2019
First Posted Date  ICMJE February 21, 2019
Last Update Posted Date September 9, 2019
Actual Study Start Date  ICMJE April 8, 2019
Estimated Primary Completion Date May 13, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
Change from baseline in Psoriasis Area and Severity Index (PASI) score. [ Time Frame: Day 1 to Week 12 ]
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03850483 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 20, 2019)
  • Percentage of participants with Physician's Global Assessment (PGA) score clear (0) or almost clear (1) and 2 points improvement. [ Time Frame: Day 1 to Week 12 ]
  • Percentage of participants achieving PASI 75 [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  • Percentage change from baseline in PASI score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  • Percentage of participants with PGA score clear (0) or almost clear (1) and 2 points improvement [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 14, 16 ]
  • Absolute Peak Pruritus Numerical Rating Scale score [ Time Frame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  • Change from baseline in Psoriasis Symptom Inventory score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  • The percentage of participants who achieved a Psoriasis Symptom Inventory score of 0 (not at all) or 1 (mild) on every item [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  • Number of participants with adverse events (AEs) by seriousness and relationship to treatment [ Time Frame: Day 1 to Week 16 ]
  • Number of participants with change from baseline in laboratory test results [ Time Frame: Day 1 to Week 16 ]
  • Number of participants with clinically relevant changes from baseline in electrocardiogram parameters [ Time Frame: Day 1 to Week 12 ]
  • Number of participants with clinically relevant changes from baseline in vital signs [ Time Frame: Day 1 to Week 16 ]
  • Number of participants with each severity grade in skin tolerability assessment at the sites of IP application [ Time Frame: Day 1 to Week 16 ]
  • Change from baseline in PASI score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 14, 16 ]
  • Change from baseline in Absolute Peak Pruritus Numerical Rating Scale score [ Time Frame: Day 1 to Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
  • Psoriasis Symptom Inventory score [ Time Frame: Day 1, Week 1, 2, 4, 6, 8, 10, 12, 14, 16 ]
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 Dose Ranging Study To Assess Efficacy, Safety and Tolerability Of PF-06700841 Topical Cream In Psoriasis
Official Title  ICMJE A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL-GROUP, DOSE RANGING STUDY TO ASSESS EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 TOPICAL CREAM APPLIED ONCE OR TWICE DAILY FOR 12 WEEKS IN PARTICIPANTS WITH MILD TO MODERATE CHRONIC PLAQUE PSORIASIS
Brief Summary This is a Phase 2b, randomized, double blind, vehicle controlled, parallel group, multicenter study in participants with mild to moderate plaque psoriasis. The duration of study participation will be approximately 22 weeks, including up to a 6 week screening period, 12 week treatment period, and approximately 4 week follow up period. Approximately 240 participants are planned to be randomized into the study.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Psoriasis
Intervention  ICMJE
  • Drug: PF-06700841
    PF-06700841 topical cream
  • Drug: Vehicle (Placebo)
    Vehicle topical cream
Study Arms  ICMJE
  • Placebo Comparator: Vehicle cream QD
    Vehicle cream applied once daily (QD)
    Intervention: Drug: Vehicle (Placebo)
  • Experimental: PF-06700841 0.1% cream QD
    PF-06700841 0.1% cream applied once daily (QD)
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 0.3% cream QD
    PF-06700841 0.3% cream applied once daily (QD)
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 1% cream QD
    PF-06700841 1% cream applied once daily (QD)
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 3% cream QD
    PF-06700841 3% cream applied once daily (QD)
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 0.3% cream BID
    PF-06700841 0.3% cream applied twice daily (BID)
    Intervention: Drug: PF-06700841
  • Experimental: PF-06700841 1% cream BID
    PF-06700841 1% cream applied twice daily (BID)
    Intervention: Drug: PF-06700841
  • Placebo Comparator: Vehicle cream BID
    Vehicle cream applied twice daily (BID)
    Intervention: Drug: Vehicle (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: February 20, 2019)
240
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 13, 2020
Estimated Primary Completion Date May 13, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • plaque psoriasis for 6 months
  • PGA score mild or moderate
  • body surface area (BSA) 2-15%

Exclusion Criteria:

  • other skin conditions that would interfere with the evaluation of psoriasis
  • history of herpes zoster or simplex
  • Infected with Mycobacterium tuberculosis
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 Center 1-800-718-1021 ClinicalTrials.gov_Inquiries@pfizer.com
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Latvia,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03850483
Other Study ID Numbers  ICMJE B7931023
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: Yes
Plan Description: Information relating to our policy on data sharing and the process for requesting data can be found at the following link: http://www.pfizer.com/research/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 September 2019

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