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Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis | Clinical Trials | Clareo Health

COMPLETEDPHASE3

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

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis

NCT04286607•Arcutis Biotherapeutics, Inc.

View on ClinicalTrials.gov

Summary

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

Detailed Description

This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Eligibility

Age

2 - 11 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•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:
•1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
•2. 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.

Exclusion Criteria

•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.

Locations (85)

Arcutis Biotherapeutics Clinical Site 203

Scottsdale, Arizona, United States

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

Key Dates

Start Date

February 12, 2020

Primary Completion Date

January 22, 2024

Completion Date

January 22, 2024

Last Updated

January 7, 2025

Enrollment

333

ACTUAL participants

Conditions

Chronic Plaque Psoriasis

Interventions

Topical roflumilast

DRUG

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03370133

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis+1 more

View study

COMPLETEDPHASE3

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

NCT03598790

Chronic Plaque PsoriasisModerate to Severe Chronic Plaque Psoriasis

View study

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: January 7, 2025Data 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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Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Inclusion Criteria

Exclusion Criteria

A Study to Evaluate the Efficacy and Safety of Bimekizumab Compared to Placebo and an Active Comparator in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

A Study to Evaluate the Efficacy and Safety of Bimekizumab in Adult Subjects With Moderate to Severe Chronic Plaque Psoriasis

Open Label Study to Investigate the Safety and Efficacy of Ponesimod in Moderate-to-Severe Chronic Plaque Psoriasis

Safety and Tolerability of Repeat Courses of IM Alefacept

A Study to Evaluate the Long-term Safety, Tolerability and Efficacy of Bimekizumab in Adult Patients With Chronic Plaque Psoriasis

Study to Evaluate the Safety and Antipsoriatic Efficacy of BOS-475 in a Psoriasis Plaque Test