Status:
COMPLETED
JAK1 Inhibitor With Medicated Topical Therapy in Adolescents With Atopic Dermatitis
Lead Sponsor:
Pfizer
Conditions:
Atopic Dermatitis
Eligibility:
All Genders
12-17 years
Phase:
PHASE3
Brief Summary
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderat...
Detailed Description
This is a randomized, double blind, placebo controlled, parallel group, Phase 3 study to evaluate the efficacy and safety of PF 04965842 in adolescent participants 12 to \<18 years of age with moderat...
Eligibility Criteria
Inclusion
- Aged between 12 and to 17 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 severity 4)
Exclusion
- Acute or chronic medical or laboratory abnormality that may increase the risk associated with study participation
- 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 non-AD inflammatory skin diseases or conditions affecting skin
- Medical history including thrombocytopenia, coagulopathy or platelet dysfunction, malignancies, current or history of certain infections, 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
Key Trial Info
Start Date :
February 18 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 8 2020
Estimated Enrollment :
287 Patients enrolled
Trial Details
Trial ID
NCT03796676
Start Date
February 18 2019
End Date
April 8 2020
Last Update
April 13 2022
Active Locations (136)
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1
Clinical Research Center of Alabama, LLC
Birmingham, Alabama, United States, 35244
2
Madera Family Medical Group
Madera, California, United States, 93637
3
Allergy & Asthma Associates of Southern California dba Southern California Research
Mission Viejo, California, United States, 92691
4
UC Davis
Sacramento, California, United States, 95816