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

Korábbi kezelés

• 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.
• Subjects with a history of chronic alcohol or drug abuse within 6 months of initiation of investigational product.

Más betegség

• 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.

Laborértékek

• 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.

Egyéb

• 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.

• 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.