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Trial record 1 of 1 for:    NCT03349060
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Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis (JADE Mono-1)

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ClinicalTrials.gov Identifier: NCT03349060
Recruitment Status : Completed
First Posted : November 21, 2017
Last Update Posted : August 22, 2019
Sponsor:
Information provided by (Responsible Party):
Pfizer

Tracking Information
First Submitted Date  ICMJE November 17, 2017
First Posted Date  ICMJE November 21, 2017
Last Update Posted Date August 22, 2019
Actual Study Start Date  ICMJE December 7, 2017
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 12 ]
    Response based on IGA score of clear (0) or almost clear (1) (on a 5 point scale) and a reduction from baseline of >=2 points at Week 12
  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 12 ]
    Response based on 75% improvement from baseline on EASI (EASI-75) at Week 12
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03349060 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: May 30, 2018)
  • Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]
    Response based on at least 4 points improvement in severity of pruritus NRS from baseline at Weeks 2, 4 and 12
  • Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) [ Time Frame: Baseline, Week 12 ]
    Change from baseline in PSAAD total score at Week 12
  • Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 8, Week 16 (follow-up) ]
    Response based on at least 4 points improvement in severity of pruritus NRS from baseline at Weeks 8 and 16 (follow-up)
  • Prutitus Numerical Rating Scale (NRS) [ Time Frame: Time from Baseline ]
    Time from baseline to achieve at least a 4 points improvement in the severity of pruritus NRS
  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on 75% improvement from baseline in EASI (EASI-75) at Week 2, Week 4, Week 8, Week 16 (follow-up)
  • Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on the IGA of clear (0) or almost clear (1) and >=2 point reduction from baseline at Week 2, Week 4, Week 8, Week 16 (follow-up)
Original Secondary Outcome Measures  ICMJE
 (submitted: November 17, 2017)
  • Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 2, Week 4, Week 12 ]
    Response based on at least 4 points improvement in pruritus NRS from baseline at Weeks 2, 4 and 12
  • Pruritus and Symptoms Assessment for Atopic Dermatitis (PSAAD) [ Time Frame: Baseline, Week 12 ]
    Change from baseline in PSAAD at Week 12
  • Pruritus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Week 8, Week 16 (follow-up) ]
    Response based on at least 4 points improvement in pruritus NRS from baseline at Weeks 8 and 16 (follow-up)
  • Prutitus Numerical Rating Scale (NRS) [ Time Frame: Baseline, Day 15 ]
    Time to achieve a 4-point improvement in pruritus NRS from baseline to Day 15
  • Eczema Area and Severity Index (EASI) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on 75% improvement from baseline in EASI (EASI-75) at Week 2, Week 4, Week 8, Week 16 (follow-up)
  • Investigator's Global Assessment (IGA) [ Time Frame: Baseline, Week 2, Week 4, Week 8, Week 16 (follow-up) ]
    Response based on the IGA for clear (0) or almost clear (1) and >=2 point reduction from baseline at Week 2, Week 4, Week 8, Week 16 (follow-up)
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis
Official Title  ICMJE A PHASE 3 RANDOMIZED, DOUBLE-BLIND, PLACEBO-CONTROLLED, PARALLEL GROUP, MULTI-CENTER STUDY TO EVALUATE THE EFFICACY AND SAFETY OF PF-04965842 MONOTHERAPY IN SUBJECTS AGED 12 YEARS AND OLDER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS
Brief Summary B7451012 is a Phase 3 study to evaluate PF-04965842 in patients aged 12 years and older with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. The efficacy and safety of two dosage strengths of PF-04965842, 100 mg and 200 mg taken orally once daily, will be evaluated relative to placebo over 12 weeks of study participation. Eligible patients will have an option to enter a long-term extension study after completing 12 weeks of treatment.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Dermatitis, Atopic
Intervention  ICMJE
  • Drug: PF-04965842 100 mg
    PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 12 weeks
  • Drug: PF-04965842 200 mg
    PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 12 weeks
  • Drug: Placebo
    Placebo, administered as two tablets to be taken orally once daily for 12 weeks
Study Arms  ICMJE
  • Experimental: PF-04965842 100 mg
    Intervention: Drug: PF-04965842 100 mg
  • Experimental: PF-04965842 200 mg
    Intervention: Drug: PF-04965842 200 mg
  • Placebo Comparator: Placebo
    Intervention: Drug: 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: April 17, 2019)
387
Original Estimated Enrollment  ICMJE
 (submitted: November 17, 2017)
375
Actual Study Completion Date  ICMJE March 26, 2019
Actual Primary Completion Date March 26, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • 12 years of age or older with a minimum body weight of 40 kg
  • Diagnosis of atopic dermatitis (AD) for at least 1 year and current status of moderate to severe disease (>= the following scores: BSA 10%, IGA 3, EASI 16, Pruritus NRS 4)
  • Recent history of inadequate response or inability to tolerate topical AD treatments or require systemic treatments for AD control

Exclusion Criteria:

  • Unwilling to discontinue current AD medications prior to the study or require treatment with prohibited medications during the study
  • Prior treatment with JAK inhibitors
  • Other active nonAD inflammatory skin diseases or conditions affecting skin
  • Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, Q wave interval abnormalities, current or history of certain infections, cancer, lymphoproliferative disorders and other medical conditions at the discretion of the investigator
  • Pregnant or breastfeeding women, or women of childbearing potential who are unwilling to use contraception
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years and older   (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,   Canada,   Czechia,   Germany,   Hungary,   Poland,   United Kingdom,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03349060
Other Study ID Numbers  ICMJE B7451012
2017-003651-29 ( EudraCT Number )
MONO-1 ( Other Identifier: Alias Study Number )
JADE MONO-1 ( Other Identifier: Alias Study 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: 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.
URL: 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 August 2019

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