Arcutis Biotherapeutics announced positive Phase 3 trial results for ZORYVE foam 0.3% in treating scalp and body psoriasis. The ARRECTOR study demonstrated significant improvements in clearing psoriasis plaques and reducing itch, just 24 hours after the first application. The FDA is currently reviewing a supplemental New Drug Application for ZORYVE foam for this indication, with a decision expected by May 22, 2025.
The successful trial results are particularly important given that scalp psoriasis affects over half of the nine million Americans with plaque psoriasis. Current treatment options for scalp psoriasis can be challenging, making a safe, effective, and easy-to-apply topical therapy a significant advancement. The rapid onset of itch relief also addresses a major patient concern, which can improve quality of life and treatment adherence.
In the ARRECTOR trial, 66.4% of participants using ZORYVE foam achieved clear or almost clear scalp psoriasis after eight weeks, compared to 27.8% in the control group. Similarly, 45.5% achieved the same result for body psoriasis, compared to 20.1% in the control group. The foam was well-tolerated, with low and comparable adverse event rates between the treatment and control groups. The most common side effects were headache, diarrhea, and nausea.
A potential approval of ZORYVE foam 0.3% for scalp and body psoriasis would offer patients a convenient, once-daily treatment option that effectively addresses both skin clearance and itch. This could reshape the treatment landscape for this prevalent condition by providing a versatile solution for different areas of the body, potentially improving patient compliance and long-term outcomes. This approval could also solidify Arcutis’ position as a leader in topical therapies for inflammatory skin diseases.
Jon Napitupulu is Director of Media Relations at The Clinical Trial Vanguard. Jon, a computer data scientist, focuses on the latest clinical trial industry news and trends.
