US-based biotechnology company Arcutis Biotherapeutics has enrolled the first child in an open-label Phase II trial of Zoryve (roflumilast) for atopic dermatitis (AD).
The INTEGUMENT-INFANT trial will assess the efficacy of roflumilast cream 0.05% when given to infant subjects aged between three and 24 months with mild to moderate AD.
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Zoryve is a selective phosphodiesterase-4 (PDE4) inhibitor designed for topical application.
The multi-centre study will enrol around 35 infants whose AD covers at least 3% of their body surface area.
It will test the tolerability and safety of the investigational cream in this subject group when applied once a day over four weeks.
Also referred to as eczema, AD is a prevalent chronic inflammatory skin condition among children and infants.
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By GlobalDataAccording to Arcutis, Zoryve is the first branded topical treatment to target seborrheic dermatitis, plaque psoriasis and AD.
The US Food and Drug Administration (FDA) has approved Zoryve 0.3% for plaque psoriasis, including in sensitive areas, for individuals aged six years and older.
Zoryve 0.15% has also received FDA approval for the treatment of mild to moderate AD for the same age group.
The INTEGUMENT-INFANT trial follows the outcomes from the ARQ-151-105 (MUSE) study, which also focused on assessing Zoryve 0.05% for AD in infants.
Arcutis Biotherapeutics chief medical officer Patrick Burnett said: “Despite the high prevalence, early onset, and serious impact of AD, there are very few topical or systemic therapies approved for infants, making new clinical research for tolerable and effective treatments that can be used over a lifetime and can reduce or replace steroids, critically important for this age group.
“Enrolling the first child in this study is a meaningful step forward and builds on our mission to address unmet needs in paediatric dermatology.”
Arcutis previously shared data from a Phase II safety study of roflumilast cream in adults with chronic plaque psoriasis.
