(103) Efficacy and safety of roflumilast foam 0.3% in patients with psoriasis of the scalp and body in the phase 3 ARRECTOR trial

Wednesday, October 29, 2025

Primary Author(s)

Melinda Gooderham, MD

Dermatologist
SkiN Centre for Dermatology, Probity Medical Research and Queen’s University
Peterborough, Ontario, Canada

Co-Author(s)

Jerry Bagel, MD, MS

Dermatologist
Psoriasis Treatment Center of Central New Jersey
Windsor, New Jersey, United States
Janet C. DuBois, MD

Principal Investigator
DermResearch, Inc.
Austin, Texas, United States
Leon H. Kircik, MD

Dermatologist
Icahn School of Medicine at Mount Sinai, Indiana Medical Center, Physicians Skin Care, PLLC, and Skin Sciences, PLLC
New York, New York, United States
Benjamin Lockshin, MD

Director of Clinical Trial Center
US Dermatology Partners
Rockville, Maryland, United States
Kim A. Papp, MD, PhD

Dermatologist
Probity Medical Research and K Papp Clinical Research
Waterloo, Ontario, Canada
Jennifer Soung, MD

Dermatologist
Southern California Dermatology
Santa Ana, California, United States
David Krupa, MS

Director, Biostatistics
Arcutis Biotherapeutics, Inc.
Westlake Village, California, United States
Patrick Burnett, MD, PhD

Chief Medical Officer
Arcutis Biotherapeutics, Inc.
Westlake Village, California, United States

Presenter(s)

Brett Stephenson, PharmD

Director, Health Economics Outcomes Research
Arcutis Biotherapeutics, Inc.
Westlake Village, California, United States

Co-Author(s)

David R. Berk, MD

Vice President, Clinical Development
Arcutis Biotherapeutics, Inc.
Westlake Village, California, United States

Background: : Roflumilast is a novel, selective, highly potent phosphodiesterase 4 inhibitor under investigation for treatment of psoriasis of the scalp and body. Roflumilast foam 0.3% is approved for the treatment of plaque psoriasis of the scalp and body in adults and adolescents aged ≥12 years.

Objective: : Evaluate the efficacy and safety of roflumilast foam 0.3% for the treatment of psoriasis of the scalp and body.

Methods: : This phase 3 randomized controlled trial (ARRECTOR; NCT05028582) was conducted in patients aged ≥12 years with psoriasis of the scalp and body, minimum Scalp-Investigator Global Assessment (S-IGA) of moderate (3 on a 5-point scale), and minimum Body-IGA (B-IGA) of mild (2 on a 5-point scale). Overall body surface area affected by psoriasis was to be ≤25% (including ≤20% for non-scalp areas, not including palm/soles). Patients were randomized 2:1 to apply once-daily roflumilast foam 0.3% or vehicle for 8 weeks. The co-primary efficacy endpoints were S-IGA and B-IGA success (S-IGA/B-IGA of clear [0] or almost clear [1] plus ≥2 grade improvement from baseline) at week 8.

Results: : Significantly greater proportions of patients treated with roflumilast (n=281) versus vehicle (n=151) achieved S IGA success (66.4% vs 27.8%; P< 0.0001) and B IGA success (45.5% vs 20.1%; P< 0.0001), with 40.0% and 27.8% of patients treated with roflumilast achieving S-IGA and B IGA 0, respectively (P < 0.0001; nominal for B-IGA) at week 8. Notably, improvement in itch was observed as early as 24 hours following first application (P=0.0164) as measured by change from baseline in Scalp Itch-Numeric Rating Score. Roflumilast was well tolerated with ≥95% of patients reporting no or mild sensation. Rates of discontinuation because of adverse events were low and similar among roflumilast (1.8%) and vehicle (1.3%) groups.

Conclusions: : Roflumilast foam 0.3% improved psoriasis of the scalp and body across multiple efficacy endpoints while demonstrating favorable safety and tolerability profiles.

Sponsorship:: Arcutis Biotherapeutics, Inc.