Pfizer’s crisaborole ointment (Eucrisa) was well-tolerated in children aged 3 months to less than 24 months with mild to moderate atopic dermatitis (AD), according to top-line results from a Phase 4 study (CrisADe CARE 1).
The data from the trial are supportive of the primary study objective to examine the safety of crisaborole in this patient population and are consistent with previous clinical trial experience.
Crisaborole ointment, 2%, is a novel, steroid-free, topical phosphodiesterase (PDE4) inhibitor. It is approved in the U.S. and Canada as Eucrisa and in Israel and Australia as Staquis for mild to moderate AD in patients two years of age and older.
“This study reinforces our commitment to young AD patients worldwide who need more options,” says Michael Corbo, Chief Development Officer, Inflammation & Immunology, Pfizer Global Product Development, in a news release. “These results add to the growing body of evidence that underscores the strength of data for crisaborole as a steroid-free, topical treatment option for people with mild to moderate atopic dermatitis. We look forward to discussing the data with regulatory authorities in the future.”
The primary endpoints of CrisADe CARE 1 were the number of patients with treatment-emergent adverse events (AEs) and severe adverse events (SAEs) and number of patients with clinically significant changes from baseline in height, weight, vital signs, electrocardiogram (ECG), and clinical laboratory parameters.
Detailed analyses of the study will be submitted for presentation at a future scientific meeting.