The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis (ARQ-151-201)

Arcutis Biotherapeutics

Status and phase: Completed; Phase 2

Conditions: Plaque Psoriasis

Treatments: Drug: Roflumilast Cream 0.3%; Drug: Roflumilast Cream 0.15%; Drug: Vehicle Cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT03638258

ARQ-151-201

Details and patient eligibility

About

This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.

Enrollment: 331 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants legally competent to sign and give informed consent
• Males and females ages 18 years and older (inclusive)
• Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
• Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at Screening (Visit 1) and Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.
• In good health as judged by the Investigator, based on medical history, physical examination, serum chemistry labs, hematology values, and urinalysis.
• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion criteria

• Planned excessive exposure of treated area(s) to either natural or artificial sunlight or tanning bed.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Previous treatment with roflumilast cream or its active ingredient
• 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 study medication.
• 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

---

331 participants in 3 patient groups, including a placebo group

Roflumilast Cream 0.3%

Experimental group

Description:

Roflumilast cream 0.3% topically applied QD for 12 weeks.

Treatment:

Drug: Roflumilast Cream 0.3%

Roflumilast Cream 0.15%

Experimental group

Description:

Roflumilast cream 0.15% topically applied QD for 12 weeks.

Treatment:

Drug: Roflumilast Cream 0.15%

Vehicle Cream

Placebo Comparator group

Description:

Vehicle cream matched to roflumilast cream (containing only excipients of active cream) applied QD for 12 weeks.

Treatment:

Drug: Vehicle Cream