Status:
COMPLETED
Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Conditions:
Chronic Plaque Psoriasis
Eligibility:
All Genders
2-11 years
Phase:
PHASE3
Brief 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 Criteria
Inclusion
- 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:
- Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
- 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
- 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.
Key Trial Info
Start Date :
February 12 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 22 2024
Estimated Enrollment :
333 Patients enrolled
Trial Details
Trial ID
NCT04286607
Start Date
February 12 2020
End Date
January 22 2024
Last Update
January 7 2025
Active Locations (85)
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1
Arcutis Biotherapeutics Clinical Site 203
Scottsdale, Arizona, United States, 85255
2
Arcutis Biotherapeutics Clinical Site 239
Beverly Hills, California, United States, 90212
3
Arcutis Biotherapeutics Clinical Site 127
Encinitas, California, United States, 92024
4
Arcutis Biotherapeutics Clinical Site 225
Encino, California, United States, 91436