Phase 3 Data for Roflumilast Foam 0.3% in Seborrheic Dermatitis

About 80% of patients treated with roflumilast foam 0.3% (ARQ-154, Arcutis Biotherapeutics Inc) met the primary endpoint of the trial.

Arcutis Biotherapeutics announced topline results from STRATUM phase 3 trial (NCT04973228) which is investigating roflumilast foam 0.3% (ARQ-154, Arcutis Biotherapeutics Inc) as a potential treatment for patients 9 years and older with moderate to severe seborrheic dermatitis.1,2

Roflumilast foam 0.3% is an investigational once-daily topical foam formulation of a highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor. It is being investigated to treat inflammatory dermatoses, particularly in hair-bearing areas of the body, according to the press release, such as the scalp.

The primary endpoint of the trial was the percentage of patients who achieved Investigator Global Assessment (IGA) success which was defined as an IGA score of clear (0) or almost clear (1) plus a 2 or greater grade improvement from baseline. In total, 80.1% of patients treated with roflumilast foam achieved the primary endpoint vs 59.2% of patients treated with vehicle (P<.0001) at week 8. In the roflumilast foam treatment group, more than 50% of patients achieved IGA 0 at week 8. According to the release, treatment improved patients skin condition rapidly with many achieving IGA success at week 2. In the secondary endpoints of itch, scaling, and erythema, roflumilast foam demonstrated statistically significant improvement.

“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,” said Zoe Draelos, MD, study investigator, adjunct assistant professor of dermatology at Duke University School of Medicine in Durham, North Carolina, and chief medical editor of Dermatology Times®, said in the press release. “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 safety profile found that roflumilast foam was well-tolerated. Treatment Emergent Adverse Events (TEAEs) between active treatment and vehicle was similar and low, the press release explained, with the majority of TEAEs considered to be mild to moderate in severity. There were no treatment-related Serious Adverse Events (SAEs). The most common AEs were COVID-19, urinary tract infection, nasopharyngitis, and nausea.

“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,” said Patrick Burnett MD, PhD, FAAD, chief medical officer at Arcutis, in the press release. “We will now prepare an NDA for roflumilast foam for the treatment of seborrheic dermatitis to submit to the [FDA].”

Arcutis plans to submit an NDA in the first half of 2023, according to the press release.

Reference:

  1. Arcutis announces positive topline results from stratum pivotal phase 3 trial of roflumilast foam 0. 3% in seborrheic dermatitis. GlobeNewswire News Room. Published June 6, 2022. Accessed June 6, 2022. https://www.globenewswire.com/news-release/2022/06/06/2456603/0/en/Arcutis-Announces-Positive-Topline-Results-from-STRATUM-Pivotal-Phase-3-Trial-of-Roflumilast-Foam-0-3-in-Seborrheic-Dermatitis.html
  2. Arcutis Biotherapeutics, Inc. A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of Arq-154 Foam 0. 3% Administered Qd in Subjects with Seborrheic Dermatitis. clinicaltrials.gov; 2022. Accessed June 5, 2022. https://clinicaltrials.gov/ct2/show/NCT04973228