Incyte’s Opzelura Cream Demonstrates Strong Efficacy in Phase IIIb Atopic Dermatitis Trial

Incyte’s Phase IIIb TRuE-AD4 trial confirmed the strong safety and efficacy of Opzelura (ruxolitinib cream) in adults with moderate atopic dermatitis unresponsive or intolerant to standard treatments. Among 241 participants, 70% of those receiving Opzelura achieved at least 75% improvement in EASI scores by week eight, compared to 18.5% on placebo. Additionally, 61.3% reached Investigator’s Global Assessment success versus 13.6% for vehicles. Remarkably, 62.5% of patients reported a four-point itch improvement, with relief beginning within 15 minutes of application. Nearly 40% achieved near-clear skin, alongside significant gains in quality-of-life measures. Opzelura was well tolerated, with no reports of major cardiovascular events, infections, or malignancies—the most common side effect being mild application site acne. These findings will support Incyte’s European Type-II variation filing for ruxolitinib cream 1.5%.

28-10-2025