Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Arcutis Biotherapeutics, Inc.
This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis
Age
2–11
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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.
Clareo Health | Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
