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Pfizer Reports Positive Top-line Results From Phase 3 JADE TEEN Trial Of Abrocitinib - Quick Facts

Pfizer Inc. (PFE) announced Wednesday positive top-line results from the Phase 3 JADE TEEN trial of Abrocitinib in adolescents with moderate-to-severe atopic dermatitis (AD). Both doses of abrocitinib met the co-primary endpoints and were generally well tolerated.

Abrocitinib is an investigational oral once-daily Janus kinase 1 (JAK1) inhibitor, in patients 12 to <18 years of age with moderate to severe AD who were also on background topical therapy.

Results showed that the percentage of patients achieving each co-primary efficacy endpoint at Week 12 was statistically significantly higher with both doses of abrocitinib than with placebo.

As a key secondary endpoint, the percentage of patients who had a clinically significant reduction in itch by Weeks 2, 4, and 12 of treatment was statistically significantly higher at each time point, compared to placebo. The safety profile seen with abrocitinib was consistent with previous studies.

AD is a chronic skin disease characterized by inflammation of the skin and skin barrier defects. Lesions of AD are characterized by erythema (redness), itching, induration (hardening)/papulation (formulation of papules), and oozing/crusting.

JADE TEEN was a randomized, double-blind, placebo-controlled, parallel group study. A total of 285 subjects 12 to <18 years of age with moderate to severe atopic dermatitis were randomized to receive once-daily abrocitinib 200mg, abrocitinib 100mg, or placebo for 12 weeks while also on background topical therapy.

JADE TEEN is the fourth trial in the JAK1 Atopic Dermatitis Efficacy and Safety (JADE) global development program. Pfizer recently announced complete results from the second trial in the program, JADE MONO-2.

Abrocitinib received Breakthrough Therapy designation from the FDA for the treatment of patients with moderate to severe AD in February 2018.

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