Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Completed · Phase 3

Conditions studied: Chronic Plaque Psoriasis

In brief

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Key facts

Study ID

NCT04286607

Run by

Arcutis Biotherapeutics, Inc.

People needed

333

Starts

2020-02-12

Expected to finish

2024-01-22

Last updated by the study team

2025-01-07

Who can join

Age: 2 and older, up to 11. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
• Males and females ages 2 years and older (inclusive)
• Subjects with chronic plaque psoriasis who meet eligibility criteria and:
• Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
• Are naïve to treatment with ARQ-151 cream (Cohort 2)
• Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

You may not qualify if…

• Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
• Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product.
• Subjects who are unable to communicate, read or understand the local language, or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.

Where it is running

• Arcutis Biotherapeutics Clinical Site 239 — Beverly Hills, California, United States
• Arcutis Biotherapeutics Clinical Site 127 — Encinitas, California, United States
• Arcutis Biotherapeutics Clinical Site 225 — Encino, California, United States
• Arcutis Biotherapeutics Clinical Site 509 — Fountain Valley, California, United States
• Arcutis Biotherapeutics Clinical Site 112 — Fremont, California, United States
• Arcutis Biotherapeutics Clinical Site 120 — Irvine, California, United States
• Arcutis Biotherapeutics Clinical Site 508 — Los Angeles, California, United States
• Arcutis Biotherapeutics Clinical Site 511 — Rancho Santa Margarita, California, United States
• Arcutis Biotherapeutics Clinical Site 123 — San Diego, California, United States
• Arcutis Biotherapeutics Clinical Site 220 — San Diego, California, United States
• Arcutis Biotherapeutics Clinical Site 136 — San Francisco, California, United States
• Arcutis Biotherapeutics Clinical Site 208 — Santa Monica, California, United States
• Arcutis Biotherapeutics Clinical Site 215 — Santa Monica, California, United States
• Arcutis Biotherapeutics Clinical Site 223 — Boynton Beach, Florida, United States
• Arcutis Biotherapeutics Clinical Site 237 — DeLand, Florida, United States
• Arcutis Biotherapeutics Clinical Site 118 — Delray Beach, Florida, United States
• Arcutis Biotherapeutics Clinical Site 202 — Hialeah, Florida, United States
• Arcutis Biotherapeutics Clinical Site 228 — Largo, Florida, United States
• Arcutis Biotherapeutics Clinical Site 131 — Miami, Florida, United States
• Arcutis Biotherapeutics Clinical Site 201 — North Miami Beach, Florida, United States
• Arcutis Biotherapeutics Clinical Site 137 — Ocala, Florida, United States
• Arcutis Biotherapeutics Clinical Site 105 — Sanford, Florida, United States
• Arcutis Biotherapeutics Clinical Site 209 — Sweetwater, Florida, United States
• Arcutis Clinical Site 602 — Boise, Idaho, United States
• Arcutis Biotherapeutics Clinical Site 203 — Scottsdale, Arizona, United States

Full record on ClinicalTrials.gov

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