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