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Completed NCT04286607

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

Conditions: Chronic Plaque Psoriasis

Sex: All
Ages: 2 Years – 11 Years
Healthy volunteers: No
Phase: PHASE3
Enrollment: 337
Sponsor: Arcutis Biotherapeutics, Inc.

Location: Arcutis Biotherapeutics Clinical Site 203 Scottsdale Arizona

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

Eligibility Criteria

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.

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT04286607). StuddyBuddy aggregates publicly available trial information.