| Study to Investigate Efficacy and Safety of PF-04965842 in Subjects Aged 12 Years and Over With Moderate to Severe Atopic Dermatitis With the Option of Rescue Treatment in Flaring Subjects
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| A PHASE 3 RANDOMIZED WITHDRAWAL, DOUBLE-BLIND, PLACEBO-CONTROLLED, MULTI-CENTER STUDY INVESTIGATING THE EFFICACY AND SAFETY OF PF-04965842 IN SUBJECTS AGED 12 YEARS AND OVER, WITH MODERATE TO SEVERE ATOPIC DERMATITIS WITH THE OPTION OF RESCUE TREATMENT IN FLARING SUBJECTS
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| B7451014 is a Phase 3 study to investigate PF-04965842 in patients aged 12 years and over with a minimum body weight of 40 kg who have moderate to severe atopic dermatitis. Subjects responding well to an initial open-label 12 week treatment of PF-04965842 (200 mg) taken orally once daily (QD) will be identified and randomized in a double-blind manner to receive 200 mg QD PF-04965842, 100 mg QD PF-04965842, or QD placebo. Efficacy and safety of 2 doses of PF-04965842 will be evaluated relative to placebo over 40 weeks. Subjects experiencing significant worsening of their symptoms, i.e., protocol-defined flare, enter 12 weeks rescue treatment and receive 200 mg PF-04965842 together with a marketed topical medicine. Eligible patients will have the option to enter a long-term extension study after completing the initial 12 week treatment, the 12 week rescue treatment, and the 40 week blinded treatment.
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| Responder criteria for randomization at week 12 are defined as a) achieving an IGA of clear (0) or almost clear (1) (on a 5 point scale), b) a reduction from IGA baseline of 2 or more points, and c) reaching an EASI-75 response compared to baseline. Flare requiring rescue treatment is defined as a loss of at least 50% of the EASI response at Week 12 and an IGA score of 2 or higher.
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| Interventional
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| Phase 3
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Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
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- Dermatitis
- Dermatitis, Atopic
- Eczema
- Skin Diseases
- Skin Diseases, Genetic
- Genetic Diseases, Inborn
- Skin Diseases, Eczematous
- Hypersensitivity
- Hypersensitivity, Immediate
- Immune System Diseases
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- Drug: PF-04965842 100 mg
PF-04965842 100 mg, administered as two tablets to be taken orally once daily for 40 weeks
- Drug: PF-04965842 200 mg
PF-04965842 200 mg, administered as two tablets to be taken orally once daily for 40 weeks
- Drug: Placebo
Placebo, administered as two tablets to be taken orally once daily for 40 weeks
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- Experimental: PF-04965842 100 mg QD
Double-blind randomized treatment following open label run-in period.
Intervention: Drug: PF-04965842 100 mg
- Experimental: PF-04965842 200 mg QD
Double-blind randomized treatment following open label run-in period.
Intervention: Drug: PF-04965842 200 mg
- Placebo Comparator: Placebo QD
Double-blind randomized treatment following open label run-in period.
Intervention: Drug: Placebo
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| Not Provided
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| Active, not recruiting
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| 1231
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| 1370
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| August 27, 2020
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| August 27, 2020 (Final data collection date for primary outcome measure)
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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: BSA10%, 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
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| Sexes Eligible for Study: |
All |
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| 12 Years and older (Child, Adult, Older Adult)
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| No
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Contact information is only displayed when the study is recruiting subjects
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| Argentina, Belgium, Brazil, Bulgaria, Canada, Chile, China, Germany, Israel, Italy, Latvia, Mexico, Netherlands, Poland, Romania, Russian Federation, Serbia, Slovakia, Spain, Taiwan, United States
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| NCT03627767
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B7451014
JADE REGIMEN ( Other Identifier: Alias Study Number )
2018-000501-23 ( EudraCT Number )
REGIMEN ( Other Identifier: Alias Study Number )
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| Yes
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| Studies a U.S. FDA-regulated Drug Product: |
Yes |
| Studies a U.S. FDA-regulated Device Product: |
No |
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| Pfizer
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| Pfizer
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| Not Provided
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| Study Director: |
Pfizer CT.gov Call Center |
Pfizer |
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| Pfizer
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| February 2020
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