Pipeline
Topical Roflumilast Cream
(ARQ-151)
Clinical development
Topical roflumilast cream (ARQ-151) is a small molecule inhibitor of phosphodiesterase-4 (PDE4), an intracellular enzyme that increases the production of proinflammatory mediators and decreases the production of anti-inflammatory mediators, and has been implicated in a wide range of inflammatory diseases, including psoriasis, atopic dermatitis, and chronic obstructive pulmonary disease (COPD).
PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the systemic treatment of plaque psoriasis. Topical roflumilast cream is a highly potent, selective PDE4 inhibitor in a convenient, once-daily formulation that Arcutis is studying in atopic dermatitis.
Explore our first
FDA approval.
Atopic Dermatitis
In our atopic dermatitis development program, we initiated pivotal Phase 3 trials in patients with atopic dermatitis (INTEGUMENT-1 and INTEGUMENT-2) in January 2021, with topline data anticipated in the second half of 2022.
We previously completed a 136-patient Phase 2 proof-of-concept study of topical roflumilast cream. In this study, topical roflumilast cream demonstrated symptomatic improvement across endpoints and favorable tolerability in this patient population. The higher dose tested of roflumilast cream 0.15% demonstrated a trend towards significance on the primary endpoint. Both doses tested (0.15% and 0.05%) were statistically significant compared to vehicle on key secondary endpoints.
Arcutis’ pipeline will change as molecules move through the drug development process. Safety and efficacy of these investigational agents have not been established. These uses have not been approved by the US Food and Drug Administration or other regulatory authorities.
Clinical Trials and Publications
Active
Plaque Psoriasis
u003ca href=u0022https://clinicaltrials.gov/ct2/show/NCT04286607u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eTopical Roflumilast Cream (ARQ-151) Phase 3 Plaque Psoriasis Open Label Extension (DERMIS-OLE)u003c/au003ern
Atopic Dermatitis
u003ca href=u0022https://clinicaltrials.gov/ct2/show/NCT04773587?term=roflumilastu0026amp;cond=atopic+dermatitisu0026amp;draw=2u0026amp;rank=3u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eTopical Roflumilast Cream (ARQ-151) Phase 3 in Atopic Dermatitis (INTEGUMENT-1)rnu003c/au003ernrnu003ca href=u0022https://clinicaltrials.gov/ct2/show/NCT04773600?term=roflumilastu0026amp;cond=atopic+dermatitisu0026amp;draw=1u0026amp;rank=4u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eTopical Roflumilast Cream (ARQ-151) Phase 3 in Atopic Dermatitis (INTEGUMENT-2)rnu003c/au003ernrnu003ca href=u0022https://clinicaltrials.gov/ct2/show/NCT04845620?term=roflumilastu0026amp;cond=atopic+dermatitisu0026amp;draw=1u0026amp;rank=5u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eTopical Roflumilast Cream (ARQ-151) Phase 3 in Atopic Dermatitis patients aged 2-5 years (INTEGUMENT-PED)rnu003c/au003ernrnu003ca href=u0022https://clinicaltrials.gov/ct2/show/NCT04804605?term=roflumilastu0026amp;cond=atopic+dermatitisu0026amp;draw=1u0026amp;rank=6u0022 target=u0022_blanku0022 rel=u0022noopeneru0022u003eTopical Roflumilast Cream (ARQ-151) Phase 3 open label extension in Atopic Dermatitis (INTEGUMENT-OLE)u003c/au003e
Completed
Plaque Psoriasis
u003ca href=u0022/wp-content/uploads/2021/05/Roflumilast-cream-Study-301-302-EADV-presentation_FINAL.pdfu0022 target=u0022_blanku0022u003eTopical Roflumilast Cream (ARQ-151) Phase 3 in Plaque Psoriasis (DERMIS-1) and (DERMIS-2)u003c/au003ernrnu003ca href=u0022/wp-content/uploads/2021/03/AU001-20-InnovationsDerm21-Study-202-LTS-ePoster_MT05.sw-cm_Final.pdfu0022 target=u0022_blanku0022u003eTopical Roflumilast Cream (ARQ-151) Phase 2b long term safety in Plaque Psoriasisrnu003c/au003ernrnu003ca href=u0022https://www.nejm.org/doi/full/10.1056/NEJMoa2000073u0022 target=u0022_blanku0022u003eTrial of Roflumilast Cream for Chronic Plaque Psoriasis Phase 2b – New England Journal of Medicine – July 2020u003c/au003ernrnu003ca href=u0022https://jddonline.com/articles/dermatology/S1545961620P0734Xu0022 target=u0022_blanku0022u003eRoflumilast Cream, Results of Phase 1/2a Studyrnu003c/au003e
Atopic Dermatitis
u003ca href=u0022/wp-content/uploads/2021/10/Gooderham_212-AD-EADV-oral-presentation_v4_21Sep2020_Final-Uploaded.pdfu0022 target=u0022_blanku0022u003eTopical Roflumilast Cream (ARQ-151) Phase 2 in Atopic Dermatitisu003c/au003e
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