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

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NCT03850483

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Study Location
ForCare Clinical Research
Tampa, Florida, 33613, United States
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Contact
1-800-718-1021
[email protected]
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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

- plaque psoriasis for 6 months

- PGA score mild or moderate

- body surface area (BSA) 2-15%

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


- other skin conditions that would interfere with the evaluation of psoriasis


- history of herpes zoster or simplex


- Infected with Mycobacterium tuberculosis

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Advanced Information
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 280 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)
  • Experimental: PF-06700841 3% cream BID
    PF-06700841 3% cream applied twice daily (BID)
    Intervention: Drug: PF-06700841
Publications * Forman SB, Pariser DM, Poulin Y, Vincent MS, Gilbert SA, Kieras EM, Qiu R, Yu D, Papacharalambous J, Tehlirian C, Peeva E. TYK2/JAK1 Inhibitor PF-06700841 in Patients with Plaque Psoriasis: Phase IIa, Randomized, Double-Blind, Placebo-Controlled Trial. J Invest Dermatol. 2020 Dec;140(12):2359-2370.e5. doi: 10.1016/j.jid.2020.03.962. Epub 2020 Apr 18.

*   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: May 20, 2021)		344
Original Estimated Enrollment  ICMJE
 (submitted: February 20, 2019)		240
Actual Study Completion Date  ICMJE April 20, 2021
Actual Primary Completion Date April 20, 2021   (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 information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Bulgaria,   Canada,   Denmark,   Germany,   Hungary,   Japan,   Latvia,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03850483
Other Study ID Numbers  ICMJE B7931023
2018-003051-38 ( 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: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/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 June 2021

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