Arcutis Announces Inclusion of Children in On-going Pivotal Phase 3 Clinical Trials

Arcutis Biotherapeutics, Inc. recently announced that, at the request of the  US FDA, it has submitted a protocol amendment to the FDA to include children ages 2 to 11 years old in the company’s on-going DERMIS-1 and DERMIS-2 pivotal Phase 3 clinical trials evaluating topical roflumilast cream as a potential topical treatment for plaque psoriasis. The trials’ previous inclusion criteria included patients ages 12 and older.

“After consultations with the FDA, we are delighted that the agency requested expanding the inclusion criteria to include children as young as 2 years of age in our pivotal Phase 3 clinical trials in patients with plaque psoriasis,” said Howard Welgus, MD, Chief Medical Officer at Arcutis. “Many treatment options approved for adults for this chronic skin condition have not been studied in children, a population in which additional caution regarding safety and tolerability is paramount. As no cure for psoriasis exists, patients, and dermatologists need new and better topical treatment options to manage this chronic inflammatory condition. Based on its safety, tolerability, and efficacy profile in our completed clinical trials, we believe topical roflumilast has the potential to be both the best-in-class topical PDE4 inhibitor and the only topical PDE4 inhibitor approved for plaque psoriasis, including in children.”

Topical roflumilast cream (ARQ-151) contains the highly potent and selective phosphodiesterase type 4 (PDE4) inhibitor roflumilast, which was approved globally for the systemic treatment of chronic obstructive pulmonary disease (COPD) in 2011, and has shown greater potency based on IC50 values (a non-clinical measure of a drug’s potency) than other PDE4 inhibitors. PDE4 is an intracellular enzyme that increases the production of pro-inflammatory mediators and decreases production of anti-inflammatory mediators,  and has been implicated in a wide range of inflammatory diseases including psoriasis, eczema, and COPD.  PDE4 is an established target in dermatology, and other PDE4 inhibitors have been approved by the FDA for the topical treatment of atopic dermatitis and the systemic treatment of plaque psoriasis.

Arcutis is currently conducting a Phase 3 clinical program with topical roflumilast cream, including two ongoing Phase 3 clinical trials (Studies ARQ-151-301 and ARQ-151-302) to support registration with the FDA. The studies, referred to as the “Trials of PDE4 inhibition with Roflumilast for the Management of Plaque Psoriasis” (DERMIS-1, DERMIS-2), are identical Phase 3 randomized, parallel, double-blind, vehicle-controlled, multi-national, multi-center studies in which 0.3% topical roflumilast cream or vehicle cream are applied once daily for 8 weeks to subjects aged 2 and older with mild, moderate, or severe chronic plaque psoriasis involving between 2% and 20% body surface area. The studies will each enroll approximately 400 patients. The primary endpoint of the studies is Investigator Global Assessment (IGA) Success, defined as an IGA score of clear or almost clear and at least a 2-grade improvement from baseline at week 8 on the IGA score. Multiple secondary endpoints will also be evaluated, including Intertriginous IGA (I-IGA) Success, and improvements in Psoriasis Area Severity Index (PASI), itch as measured by the Worst Itch-Numerical Rating Scale (WI-NRS) and patient perceptions of symptoms as measured by the Psoriasis Symptoms Diary (PSD). The company anticipates topline data from the Phase 3 studies in the first half of 2021.

Psoriasis is a common, non-contagious, immune-mediated skin disease that affects approximately 8.6 million patients in the US.  About 90% of patients with psoriasis have chronic plaque psoriasis, which is characterized by raised, red areas of skin covered with a silver or white layer of scale.  Psoriatic plaques can appear on any area of the body, but most often appear on the scalp, knees, elbows, trunk, and limbs, and are often itchy and sometimes painful.  Plaques in certain anatomical areas present particular treatment challenges, including the face, elbows and knees, scalp, and intertriginous regions such as the groin, axillae, and inframammary areas. Although uncommonly diagnosed in children and adolescents, particularly in children under the age of 5, plaque psoriasis occurs in approximately 0.5% of children and adolescents.

Arcutis is a late-stage biopharmaceutical company focused on developing and commercializing treatments for unmet needs in immune-mediated dermatological diseases and conditions, or immuno-dermatology. Arcutis exploits recent innovations in inflammation and immunology to develop potential best-in-class therapies against validated biological targets, leveraging our deep development, formulation, and commercialization expertise to bring to market novel dermatology treatments, while maximizing our probability of technical success and financial resources.  Arcutis is currently developing three novel compounds (topical roflumilast cream, topical roflumilast foam and ARQ-252) for multiple indications, including psoriasis, atopic dermatitis, seborrheic dermatitis, and eczema. For more information, visit