Study to Evaluate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years And Older With Moderate to Severe Atopic Dermatitis

NCT03349060

Last updated date
Study Location
Kirk Barber Research
Calgary, Alberta, T2G 1B1, Canada
Contact
1-800-718-1021

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

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


- 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

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  63. Tacoma, Washington
  64. Tacoma, Washington
  65. Tacoma, Washington
  66. Maroubra, New South Wales
  67. Maroubra, New South Wales
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  69. Woolloongabba, Queensland
  70. Camberwell, Victoria
  71. Carlton, Victoria
  72. Carlton, Victoria
  73. East Melbourne, Victoria
  74. Parkville, Victoria
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Advanced Information
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/d….
URL:https://www.pfizer.com/science/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 November 2019

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