Arcutis has reported positive topline data from the INTEGUMENT-INFANT Phase II trialassessing Zoryve (roflumilast) cream 0.05% in infants aged three months to below 24 months with mild to moderate atopic dermatitis (AD).
Zoryve cream is a potent topical phosphodiesterase 4 (PDE4) inhibitor.
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The multi-centre, open-label INTEGUMENT-INFANT Phase II study evaluated once-daily application of Zoryve cream 0.05% over four weeks in 101 infants.
This study builds upon the previous Maximal Usage (MUSE) pharmacokinetics ARQ-151-105 trial, which also assessed Zoryve in this age group.
The data showed a favourable safety and tolerability profile consistent with earlier Zoryve clinical trials.
The incidence of adverse events in the study was low, with all reported events rated as mild to moderate severity.
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By GlobalDataZoryve improved both disease severity and reduced the area of skin affected by AD, with 58% of participants achieving an eczema area and severity index 75 (EASI-75) by week four of the study.
Arcutis R&D strategy and clinical development vice-president David Berk said: “Reaching this clinical development milestone for Zoryve through the INTEGUMENT‑INFANT study underscores our commitment toward providing safe, effective non-steroidal treatment options for even the youngest patients with atopic dermatitis who have substantial disease burden and very limited treatment options today.”
The Phase II study findings support the previously observed tolerability and safety of Zoryve cream 0.05% seen during the pivotal four-week INTEGUMENT-PED trial in children aged two to five years.
The most common adverse events, each reported in 3% or more of 101 participants, included nasopharyngitis, diarrhoea, vomiting, and upper respiratory tract infection. Only one participant discontinued due to an adverse event, with no serious adverse events observed.
In June 2025, Arcutis enrolled the first child in an open-label Phase II trial of Zoryve for AD.
