Arcutis Releases Positive Results of Roflumilast Foam as Seborrheic Dermatitis Treatment

The topical therapy demonstrated significant improvements in the study, based on IGA success and other endpoints, according to investigators.

Arcutis Biotherapeutics released positive topline results from the STRATUM phase 3 trial investigating roflumilast foam as a treatment for individuals with moderate to severe seborrheic dermatitis.

Roflumilast 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 inhibitor. It is being developed to treat inflammatory dermatoses, particularly areas with hair, such as the scalp.

The topical treatment demonstrated significant improvements in the study, based on IGA success and other endpoints, according to investigators.

“Despite the prevalence and impact on quality of life of seborrheic dermatitis, there remains significant unmet need for new options to treat this condition, with individuals today left to manage their symptoms with multiple treatments and complex application routines,” Zoe Draelos, MD, a dermatologist in High Point, North Carolina, and president of Dermatology Consulting Services, PLLC, said in a statement. “As both a trial investigator and a clinician, I am excited by these results, because they demonstrate the potential for roflumilast foam to be a well-tolerated, easy-to-use, steroid-free treatment option for adults and adolescents with moderate to severe seborrheic dermatitis.”

The study met its primary endpoint, with approximately 80.1% of individuals treated with roflumilast achieving IGA Success, which is defined as an IGA score of clear or almost clear and grade 2 or greater improvement from baseline compared with 59.2% of individuals treated with the vehicle at week 8.

The improvements were seen as early as 2 weeks with IGA Success. Additionally, more than half the individuals treated with roflumilast foam achieved an IGA score of clear at week 8.

Roflumilast foam also demonstrated significant improvements compared witht the vehicle on key secondary endpoints, which included itch, redness, and scaling.

It was generally well tolerated, with the incidence of treatment-emergent adverse events (TEAEs) being low and similar between the active treatment and vehicle. Most TEAEs that were assessed were mild to moderate in severity. There were no treatment-related serious adverse events (AEs).

Overall, the most common AEs were COVID-19, nasopharyngitis, nausea, and urinary tract infection.

Investigators said that more than 90% of individuals who were randomized to use roflumilast completed the full 8 weeks and 0.7% in the roflumilast arm and 2% in the vehicle arm discontinued the study because of AEs.

“We are excited that investigational roflumilast foam demonstrated strong topline results in our pivotal phase 3 trial, consistent with previously reported data. These results move us one step closer to providing a new treatment option for the millions of people suffering from seborrheic dermatitis,” Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis, said in the statement. “We will now prepare an NDA for roflumilast foam for the treatment of seborrheic dermatitis to submit to the [FDA].”

Arcutis announced in January 2021 that, based on feedback received from the FDA, the company thinks that a single study with positive results would be sufficient basis for an NDA for roflumilast foam in dermatitis. Arcutis plans to submit an NDA in the first half of 2023.

Reference

Arcutis announces positive topline results from STRATUM pivotal phase 3 trial of roflumilast foam 0.3% in seborrheic dermatitis. Arcutis Biotherapeutics. News release. June 6, 2022. Accessed June 6, 2022. Email.