Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
- Registration Number
- NCT04286607
- Lead Sponsor
- Arcutis Biotherapeutics, Inc.
- 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
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 333
-
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.
- 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.
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description ARQ-151 Cream 0.3% Topical roflumilast -
- Primary Outcome Measures
Name Time Method Occurrence of treatment emergent AEs (TEAEs) 24 weeks The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs
- Secondary Outcome Measures
Name Time Method Achievement of a 100% reduction in PASI over time 24 weeks In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). 24 weeks Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time 24 weeks Achievement of a 90% reduction in PASI over time 24 weeks Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. 24 weeks Achievement of a 75% reduction in PASI over time 24 weeks Change in Worst Itch Numeric Rating Scale) WI-NRS score over time 24 weeks
Trial Locations
- 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
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