Twin 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 vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

Key facts

Study ID

NCT04211389

Run by

Arcutis Biotherapeutics, Inc.

People needed

442

Starts

2019-12-17

Expected to finish

2020-11-23

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 consented 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 203 — Scottsdale, Arizona, United States
• Arcutis Biotherapeutics Clinical Site 239 — Beverly Hills, California, United States
• Arcutis Biotherapeutics Clinical Site 225 — Encino, California, United States
• Arcutis Biotherapeutics Clinical Site 220 — San Diego, 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 228 — Largo, Florida, United States
• Arcutis Biotherapeutics Clinical Site 201 — North Miami Beach, Florida, United States
• Arcutis Biotherapeutics Clinical Site 209 — Sweetwater, Florida, United States
• Arcutis Biotherapeutics Clinical Site 214 — Indianapolis, Indiana, United States
• Arcutis Biotherapeutics Clinical Site 217 — Louisville, Kentucky, United States
• Arcutis Biotherapeutics Clinical Site 211 — Lake Charles, Louisiana, United States
• Arcutis Biotherapeutics Clinical Site 213 — Metairie, Louisiana, United States
• Arcutis Biotherapeutics Clinical Site 224 — New Orleans, Louisiana, United States
• Arcutis Biotherapeutics Clinical Site 212 — Detroit, Michigan, United States
• Arcutis Biotherapeutics Clinical Site 216 — Fridley, Minnesota, United States
• Arcutis Biotherapeutics Clinical Site 227 — Saint Joseph, Missouri, United States
• Arcutis Biotherapeutics Clinical Site 219 — Las Vegas, Nevada, United States
• Arcutis Biotherapeutics Clinical Site 231 — Las Vegas, Nevada, United States
• Arcutis Biotherapeutics Clinical Site 240 — Reno, Nevada, United States
• Arcutis Biotherapeutics Clinical Site 236 — Portsmouth, New Hampshire, United States
• Arcutis Biotherapeutics Clinical Site 222 — Oklahoma City, Oklahoma, United States
• Arcutis Biotherapeutics Clinical Site 229 — Broomall, Pennsylvania, United States

Full record on ClinicalTrials.gov

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