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The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE2

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

A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis

NCT03638258•Arcutis Biotherapeutics, Inc.

View on ClinicalTrials.gov

Summary

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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.

Exclusion Criteria

•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.

Locations (30)

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

Key Dates

Start Date

September 21, 2018

Primary Completion Date

May 29, 2019

Completion Date

May 29, 2019

Last Updated

September 2, 2022

Enrollment

331

ACTUAL participants

Conditions

Plaque Psoriasis

Interventions

Roflumilast Cream 0.3%

DRUG

Roflumilast Cream 0.15%

DRUG

Vehicle Cream

DRUG

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

NCT07116967

Plaque Psoriasis

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RECRUITINGPHASE3

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

NCT07250802

Plaque Psoriasis

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RECRUITINGPHASE2

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

NCT07449702

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: September 2, 2022Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Long-Term Safety Study of Deucravacitinib Versus Ustekinumab in Participants With Psoriasis (PRAGMATYK)

A Long-Term Study of Zasocitinib in Children and Teenagers With Plaque Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis

Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis

A Study to Assess the Concentration of Bimekizumab in Mature Breast Milk From Mothers Receiving Treatment With Bimzelx® (Bimekizumab)

A Study to Evaluate Effectiveness and Safety of a TYK2 Inhibitor in Subjects With Moderate to Severe Plaque Psoriasis