Arcutis Biotherapeutics has reported data from its Phase II safety study of roflumilast cream in adult chronic plaque psoriasis patients.
The single-arm, multicentre, open-label, long-term Phase II safety trial enrolled two cohorts of participants.
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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.
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Arcutis stated that the percentage of participants achieving IGA success and an IGA of clear or almost clear were maintained over 52 weeks.
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By GlobalDataLong-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.”
