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

• Status: Enrolling by invitation
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

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

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Arcutis Biotherapeutics, Inc.

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.