The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis

Completed · Phase 2

Conditions studied: Plaque Psoriasis

In brief

This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

Key facts

Study ID

NCT03638258

Run by

Arcutis Biotherapeutics, Inc.

People needed

331

Starts

2018-09-21

Expected to finish

2019-05-29

Last updated by the study team

2022-09-02

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants legally competent to sign and give informed consent
• Males and females ages 18 years and older (inclusive)
• Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
• Females of childbearing potential (FOCBP) must have a negative urine 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 are 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 or tanning bed.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Previous treatment with roflumilast cream 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 study medication.
• 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 Clinical Site 35 — Beverly Hills, California, United States
• Arcutis Clinical Site 29 — Northridge, California, United States
• Arcutis Clinical Site 28 — San Diego, California, United States
• Arcutis Clinical Site 27 — Santa Monica, California, United States
• Arcutis Clinical Site 12 — Miami, Florida, United States
• Arcutis Clinical Site 16 — Sanford, Florida, United States
• Arcutis Clinical Site 21 — Louisville, Kentucky, United States
• Arcutis Clinical Site 34 — Clinton Township, Michigan, United States
• Arcutis Clinical Site 33 — Detroit, Michigan, United States
• Arcutis Clinical Site 20 — Fridley, Minnesota, United States
• Arcutis Clinical Site 22 — New York, New York, United States
• Arcutis Clinical Site 14 — High Point, North Carolina, United States
• Arcutis Clinical Site 39 — Bexley, Ohio, United States
• Arcutis Clinical Site 15 — Pittsburgh, Pennsylvania, United States
• Arcutis Clinical Site 19 — College Station, Texas, United States
• Arcutis Clinical Site 37 — Houston, Texas, United States
• Arcutis Clinical Site 13 — Houston, Texas, United States
• Arcutis Clinical Site 23 — San Antonio, Texas, United States
• Arcutis Clinical Site 24 — Webster, Texas, United States
• Arcutis Clinical Site 31 — Norfolk, Virginia, United States
• Arcutis Clinical Site 18 — Surrey, British Columbia, Canada
• Arcutis Clinical Site 11 — Surrey, British Columbia, Canada
• Arcutis Clinical Site 38 — Winnipeg, Manitoba, Canada
• Arcutis Clinical Site 10 — Ajax, Ontario, Canada
• Arcutis Clinical Site 25 — London, Ontario, Canada

Full record on ClinicalTrials.gov

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