ARQT - Arcutis initiates late-stage ARQ-151 atopic dermatitis study

Arcutis Biotherapeutics (ARQT) initiates a pivotal Phase 3 clinical trial evaluating topical roflumilast cream (ARQ-151) as a potential treatment for mild-to-moderate atopic dermatitis ((AD)) in patients between the ages of 2 and 5 years.Roflumilast cream is a once daily topical formulation of roflumilast, a highly potent and selective phosphodiesterase type 4 inhibitor ((PDE4)), which the company is developing for plaque psoriasis and AD.In the trial, about 650 subjects will be randomized 2:1 to either roflumilast cream 0.05% or matching vehicle cream.The primary endpoint of the trial is Investigator Global Assessment ((IGA)) Success, defined as a Validated Investigator Global Assessment - Atopic Dermatitis (vIGA-AD) score of ‘clear’ or ‘almost clear’ plus a 2-grade improvement from baseline at Week 4. The company expects topline data from INTEGUMENT-PED in the second half of 2022.

For further details see:

Arcutis initiates late-stage ARQ-151 atopic dermatitis study