Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Completed · Phase 3

Conditions studied: Chronic Plaque Psoriasis

In brief

This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.

Key facts

Study ID

NCT04211363

Run by

Arcutis Biotherapeutics, Inc.

People needed

439

Starts

2019-12-20

Expected to finish

2020-11-16

Last updated by the study team

2022-12-07

Who can join

Age: 2 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants legally competent to sign and give informed consent and if appropriate assent as required by local laws
• Males and females ages 2 years and older (inclusive)
• Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
• Females of childbearing potential (FOCBP) must have a negative pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
• In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
• Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

You may not qualify if…

• 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.
• Previous treatment with ARQ-151 or its active ingredient
• 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 127 — Encinitas, 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 123 — San Diego, California, United States
• Arcutis Biotherapeutics Clinical Site 136 — San Francisco, California, United States
• Arcutis Biotherapeutics Clinical Site 118 — Delray Beach, Florida, United States
• Arcutis Biotherapeutics Clinical Site 131 — Miami, 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 114 — Plainfield, Illinois, United States
• Arcutis Biotherapeutics Clinical Site 102 — Rolling Meadows, Illinois, United States
• Arcutis Biotherapeutics Clinical Site 111 — Baton Rouge, Louisiana, United States
• Arcutis Biotherapeutics Clinical Site 125 — Rockville, Maryland, United States
• Arcutis Biotherapeutics Clinical Site 138 — Rockville, Maryland, United States
• Arcutis Biotherapeutics Clinical Site 101 — Brighton, Massachusetts, United States
• Arcutis Biotherapeutics Clinical Site 116 — Clinton Township, Michigan, United States
• Arcutis Biotherapeutics Clinical Site 139 — Reno, Nevada, United States
• Arcutis Biotherapeutics Clinical Site 129 — East Windsor, New Jersey, United States
• Arcutis Biotherapeutics Clinical Site 121 — New York, New York, United States
• Arcutis Biotherapeutics Clinical Site 130 — Rochester, New York, United States
• Arcutis Biotherapeutics Clinical Site 108 — Stony Brook, New York, United States
• Arcutis Biotherapeutics Clinical Site 115 — High Point, North Carolina, United States
• Arcutis Biotherapeutics Clinical Site 124 — Fairborn, Ohio, United States
• Arcutis Biotherapeutics Clinical Site 134 — Oklahoma City, Oklahoma, United States
• Arcutis Biotherapeutics Clinical Site 128 — Duncansville, Pennsylvania, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.