The single-arm, multicentre, open-label, long-term Phase II safety trial enrolled two cohorts of participants.
Cohort-1 participants are those who have completed the Phase IIb trial through to week 12, and the second cohort participants were recently enrolled.
The findings showed that nearly 57.1% of participants treated with roflumilast have achieved an Investigator Global Assessment (IGA) of clear or almost clear at any time in the study.
They had a median duration of an IGA of clear or almost clear of over ten months.
Arcutis stated that the percentage of participants achieving IGA success and an IGA of clear or almost clear were maintained over 52 weeks.
Long-term IGA success and Intertriginous-IGA (I-IGA) success results were also consistent with the results from the Phase III DERMIS-1 and DERMIS-2 clinical trials.
In the trial, the roflumilast cream was found to be safe and very well-tolerated, and the efficacy was consistent over time in participants who achieved an IGA of clear or almost clear.
Arcutis chief medical officer Patrick Burnett said: “These new findings are significant, as the data builds upon previous results from our clinical trial programs and our FDA approval, demonstrating durable safety and long-term efficacy of roflumilast cream for those with psoriasis, including people with the condition in intertriginous areas.
“This growing body of evidence continues to reinforce that ZORYVE should be a preferred treatment option for those with this condition, especially in areas of the body that are traditionally difficult to treat.”