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Safety and Efficacy of Baricitinib in Patients with Atopic Dermatitis

Title A Phase 3 Multicenter, Double-Blind Study to Evaluate the Long Term Safety and Efficacy of Baricitinib in Adult Patients with Atopic Dermatitis
Therapeutic Area Atopic Dermatitis
Principal Investigator David Rosmarin, MD
Min Age 18 Years
Gender Any
Contact Nicole Dumont
617-636-7462
ndonovan1@tuftsmedicalcenter.org
More Information https://www.clinicaltrials.gov/ct2/show/study/NCT03435081

Overview

Study I4V-MC-JAHN (JAHN) is a Phase 3, multicenter, double-blind study to evaluate the long-term safety and efficacy of baricitnib (1-mg once daily, 2-mg once daily and 4-mg once daily) in adult patients with AD for approximately 2 years.

Study Details

Inclusion Criteria

  • Have completed the final active treatment visit for an originating study (i.e., Visit 8, Week 16 of JAHL or JAHM) eligible to enroll patients directly into Study JAHN.

Exclusion Criteria

  • Have significant uncontrolled cerebro-cardiovascular (e.g., myocardial infarction [MI], unstable angina, unstable arterial hypertension, severe heart failure, or cerebrovascular accident), respiratory, hepatic, renal, gastrointestinal, endocrine, hematologic, neuropsychiatric disorders, or abnormal laboratory values that develop during a previous baricritinib study that, in the opinion of the investigator, pose an unacceptable risk to the patient.

Study Requirements

The study duration will be approximately 2 years with 17 study visits.