Study Evaluating the Mechanism of Action of PF-04965842 Monotherapy for Moderate-to-severe Atopic Dermatitis
NCT ID: NCT03915496
Last Updated: 2023-02-08
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
46 participants
INTERVENTIONAL
2020-06-18
2021-11-16
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
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PF-04965842 200 mg
PF-04965842 200 mg
PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 100 mg
PF-04965842 100 mg
PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
Placebo
Placebo
Placebo administered as two tablets to be taken orally once daily for 12 weeks
Interventions
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PF-04965842 200 mg
PF-04965842 200 mg administered as two tablets to be taken orally once daily for 12 weeks
PF-04965842 100 mg
PF-04965842 100 mg administered as two tablets to be taken orally once daily for 12 weeks
Placebo
Placebo administered as two tablets to be taken orally once daily for 12 weeks
Eligibility Criteria
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Inclusion Criteria
* Recent history of inadequate response to medicated topical therapy for AD or required systemic therapy to control disease
* Moderate-to-severe AD defined as affected BSA at least 10%, IGA at least 3, EASI at least 16, Peak Pruritus NRS at least 4
Exclusion Criteria
* Currently have active forms of other inflammatory skin diseases, i.e. not AD, or have evidence of skin conditions (e.g. psoriasis, seborrheic dermatitis, lupus) at the time of Day 1 that would interfere with evaluation of AD or response to treatment
* Participants who have received prior treatment with any systemic JAK inhibitors
* Require treatment with prohibited concomitant medication(s) or have received a prohibited concomitant medication within specified time frames prior to the first dose of study medication, including topical treatments that could affect AD
* Pregnant or breastfeeding women or sexually-active women of childbearing potential who are unwilling to use contraception
18 Years
ALL
No
Sponsors
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Pfizer
INDUSTRY
Responsible Party
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Principal Investigators
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Pfizer CT.gov Call Center
Role: STUDY_DIRECTOR
Pfizer
Locations
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California Dermatology & Clinical Research Institute
Encinitas, California, United States
Keck School of Medicine of USC - IDS Pharmacy
Los Angeles, California, United States
USC/Norris Comprehensive Cancer Center
Los Angeles, California, United States
Olympian Clinical Research
Largo, Florida, United States
ForCare Clinical Research
Tampa, Florida, United States
The Indiana Clinical Trials Center, PC - Dermatology Research
Plainfield, Indiana, United States
Wayne Health - Wayne State Dermatology
Dearborn, Michigan, United States
Icahn School of Medicine at Mount Sinai
New York, New York, United States
Menter Dermatology Research Institute
Dallas, Texas, United States
Beacon Dermatology
Calgary, Alberta, Canada
Innovaderm Research, Inc.
Montreal, Quebec, Canada
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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To obtain contact information for a study center near you, click here.
Other Identifiers
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JADE MOA
Identifier Type: OTHER
Identifier Source: secondary_id
B7451037
Identifier Type: -
Identifier Source: org_study_id
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