Incyte reports positive Phase III results of ruxolitinib

Top-line results from the Phase III TRuE-AD2 clinical trial have demonstrated that Incyte’s ruxolitinib cream met the primary goal in atopic dermatitis (AD) patients aged above 12 years.

Ruxolitinib cream is a topical formulation of Incyte’s ruxolitinib drug, a selective JAK1/JAK2 inhibitor.

The randomised, double-blind, vehicle-controlled TRuE-AD2 compared the safety and efficacy of ruxolitinib cream to the vehicle in more than 600 patients eligible for topical treatment.

The primary endpoint was the proportion of patients with an Investigator’s Global Assessment (IGA) score of zero (clear) or one (almost clear) and a minimum of two-point improvement from baseline at week eight.

Key secondary endpoints include a 75% improvement in the Eczema Area and Severity Index (EASI75) and at least a four-point improvement in the itch numerical rating scale (NRS).

The trial met its primary goal, where more patients treated with 0.75% and 1.5% ruxolitinib cream had an IGA score of zero or one with at least a two-point improvement at week eight, compared to vehicle control.

The overall safety and efficacy profile of the cream was found to be consistent with prior data, without any new safety signals.

Incyte Inflammation & AutoImmunity group vice-president Jim Lee said: “This positive top-line result reinforces the potential of ruxolitinib cream, if approved, to offer AD patients a much-needed effective, non-steroidal therapy.

“We look forward to the results of the TRuE-AD1 trial, the second study in the pivotal clinical trial programme, later this quarter, and to sharing these data with the medical community as part of our commitment to develop a new first-line treatment option for these patients.”

The TRuE-AD2 results come soon after Eli Lilly and Incyte reported positive data from the Phase III BREEZE-AD4 trial of baricitinib plus topical corticosteroids (TCS) for moderate to severe AD.