Incyte has announced positive topline results from its randomized phase 3 trial, TRuE-AD3, which evaluated the safety and efficacy of ruxolitinib cream (Opzelura®) in pediatric patients aged 2 to 12 years with atopic dermatitis (AD).
The TRuE-AD study was a randomized, double-blind, vehicle-controlled, phase 3 study that enrolled over 300 pediatric patients from 2 to 12 years of age diagnosed with AD for at least three months and were candidates for topical therapy.
Patients with an Investigator’s Global Assessment (IGA) score of two to three and with AD on 3% to 20% of their Body Surface Area were randomized 2:2:1 to receive either ruxolitinib cream 0.75% (administered twice a day), ruxolitinib 1.5%, or vehicle (non-medicated cream). Those participants who successfully completed an efficacy assessment at week eight were offered participation in the 44-week, long-term safety treatment extension period with their same treatment group (ruxolitinib cream 0.75% or 1.5%). Participants initially randomized to vehicle were re-randomized (1:1) in a blinded manner to one of the active treatment groups.
The study met its primary endpoint of the proportion of patients achieving an Investigator’s Global Assessment Treatment Success (IGA-TS) defined as an IGA score of 0 (clear) or 1 (almost clear), with at least a two-point improvement from baseline at week eight. Significantly more patients treated with ruxolitinib cream 0.75% and 1.5% achieved IGA-TS than patients treated with the vehicle.
Secondary endpoints included the proportion of patients achieving at least 75% improvement from baseline in the Eczema Area and Severity Index score and the proportion of participants with at least a four-point improvement in the itch numerical rating scale.
The overall safety profile of ruxolitinib cream remains consistent with previous data and no new safety signals were observed during the study.
"We have already seen the benefit that ruxolitinib cream can have among adult and adolescent patients with atopic dermatitis in the TRuE-AD1 and TRuE-AD2 studies, and this new positive data reinforces the potential of ruxolitinib cream to offer children a much-needed effective, non-steroidal topical therapy. We look forward to discussing these data with regulatory agencies to determine next steps."
