Ruxolitinib cream achieves primary endpoint in atopic dermatitis study

Ruxolitinib cream met its primary endpoint in the TRuE-AD2 study in adolescent and adult patients with atopic dermatitis, according to a press release from Incyte.

“This positive topline result reinforces the potential of ruxolitinib cream, if approved, to offer AD patients a much-needed effective, nonsteroidal therapy,” Jim Lee, MD, group vice president of inflammation and autoimmunity at Incyte, said in the release.

TRuE-AD2 is a randomized, double-blind, placebo-controlled phase 3 study that evaluated the safety and efficacy of ruxolitinib cream 0.75% and 1.5% twice daily compared with placebo in more than 600 patients who had been diagnosed with AD for at least 2 years.

The primary endpoint was the proportion of patients who achieved an Investigator’s Global Assessment Treatment Success score of 0 (clear) or 1 (almost clear) with at least a two-point improvement from baseline to week 8.

TRuE-AD2 is one of two phase 3 studies in the TRuE-AD clinical trial program evaluating ruxolitinib cream in patients with AD. TRuE-AD1 is ongoing, with the initial results expected later this quarter.

“We look forward to the results of the TRuE-AD1 trial, the second study in the pivotal clinical trial program, 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,” Lee said.