Arcutis Biotherapeutics, Inc. (ARQT) has announced the completion of enrollment in its INTEGUMENT-INFANT Phase 2 trial, which is evaluating ZORYVE (roflumilast) cream 0.05% in infants aged 3 months to less than 24 months with mild to moderate atopic dermatitis.
Atopic dermatitis, a common form of eczema, affects nearly 9.6 million children in the U.S., with up to 60% developing symptoms in their first year of life. The disease often presents as an intensely itchy rash that can disrupt sleep and daily activities, impacting both children and families.
ZORYVE is a topical PDE4 inhibitor and the leading branded therapy across atopic dermatitis, seborrheic dermatitis, and plaque psoriasis. By blocking PDE4, it reduces pro-inflammatory mediators, helping to calm skin inflammation and restore immune balance.
The INTEGUMENT-INFANT study is an open-label, multicenter Phase 2 trial designed to assess the safety and tolerability of ZORYVE cream 0.05% over a four-week period in 101 infants. Topline data from this study are expected to be available in Q1 2026.
ZORYVE cream 0.05% received FDA approval in October 2025 for children ages 2 to 5 years with mild to moderate atopic dermatitis, offering a steroid-free topical PDE4 inhibitor as an alternative to corticosteroids. However, it has not yet been approved for infants under 2 years, and the ongoing INTEGUMENT-INFANT study is specifically designed to evaluate its safety and tolerability in that younger population.
ARQT has traded in the range of $8.90- $27.08 over the past year. The stock closed yesterday's trading at $22.86, down 2.52%, but rose to $23.51 in overnight trading, up 2.84%.
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