Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis

NCT03903822

Last updated date
Study Location
Innovaderm Research Inc.
Montreal, Quebec, H2X 2V1, Canada
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Atopic Dermatitis
Sex
Females and Males
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
12-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Clinical diagnosis of Atopic Dermatitis for at least 3 months

- Investigator's Global Assessment (IGA) Score of 2 or 3

- Eczema Area Severity Index (EASI) score of 3-21

- Body Surface Area (BSA) of 2-20%

- Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

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


- Other forms of dermatological diseases (other than atopic dermatitis)


- Fitzpatrick skin type score greater than 5


- Clinically significant abnormal ECG, vital signs, and laboratory values


- Infection with HBV, HCV, herpes zoster or tuberculosis

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Advanced Information
Descriptive Information
Brief Title  ICMJE Dose Ranging Study to Assess Efficacy, Safety, Tolerability and Pharmacokinetics of PF-06700841 Topical Cream in Participants With Mild or Moderate Atopic Dermatitis
Official Title  ICMJE A PHASE 2B, RANDOMIZED, DOUBLE BLIND, VEHICLE CONTROLLED, PARALLEL GROUP, DOSE RANGING STUDY TO ASSESS THE EFFICACY, SAFETY, TOLERABILITY AND PHARMACOKINETICS OF PF-06700841 CREAM APPLIED ONCE OR TWICE DAILY FOR 6 WEEKS IN PARTICIPANTS WITH MILD OR MODERATE ATOPIC DERMATITIS
Brief Summary This study is being conducted to provide data on efficacy, safety, tolerability and PK of multiple topical formulation concentrations of PF-06700841 topical cream in the treatment of mild to moderate atopic dermatitis (AD). The study is intended to enable selection of the dose and dosing regimen (once daily [QD] vs twice daily [BID] application) for the future clinical development of topical PF-06700841.
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 Atopic Dermatitis
Intervention  ICMJE
  • Drug: PF-06700841
    PF-06700841 topical cream
  • Drug: Vehicle (Placebo)
    Vehicle topical cream
Study Arms  ICMJE
  • 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 QD
    Vehicle cream applied once daily (QD)
    Intervention: Drug: Vehicle (Placebo)
  • 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 Completed
Actual Enrollment  ICMJE
 (submitted: June 5, 2020)
295
Original Estimated Enrollment  ICMJE
 (submitted: April 2, 2019)
280
Actual Study Completion Date  ICMJE May 7, 2020
Actual Primary Completion Date May 7, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Clinical diagnosis of Atopic Dermatitis for at least 3 months
  • Investigator's Global Assessment (IGA) Score of 2 or 3
  • Eczema Area Severity Index (EASI) score of 3-21
  • Body Surface Area (BSA) of 2-20%
  • Peak pruritus-Numerical Rating Scale (PPNRS) of Grade 2 or more

Exclusion Criteria:

  • Other forms of dermatological diseases (other than atopic dermatitis)
  • Fitzpatrick skin type score greater than 5
  • Clinically significant abnormal ECG, vital signs, and laboratory values
  • Infection with HBV, HCV, herpes zoster or tuberculosis
Sex/Gender  ICMJE
Sexes Eligible for Study:All
Ages  ICMJE 12 Years to 75 Years   (Child, 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 NCT03903822
Other Study ID Numbers  ICMJE B7931022
2018-003050-24 ( 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 2020

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