Twin Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis (DERMIS-2)

Arcutis Biotherapeutics

Status and phase: Completed; Phase 3

Conditions: Chronic Plaque Psoriasis

Treatments: Drug: ARQ-151 vehicle cream; Drug: ARQ-151 0.3% cream

Study type: Interventional

Funder types: Industry

Identifiers

NCT04211389

ARQ-151-302

Details and patient eligibility

About

This study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

Full description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

Enrollment: 442 patients

Sex: All

Ages: 2+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Participants legally competent to sign and give informed consented and if appropriate assent as required by local laws
• Males and females ages 2 years and older (inclusive)
• Clinical diagnosis of psoriasis vulgaris of at least 6 months duration (3 months for children) as determined by the Investigator
• Females of childbearing potential (FOCBP) must have a negative 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 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, tanning bed or other LED.

  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • Previous treatment with ARQ-151 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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442 participants in 2 patient groups, including a placebo group

ARQ-151 cream 0.3%

Active Comparator group

Description:

Active comparator

Treatment:

Drug: ARQ-151 0.3% cream

ARQ-151 cream vehicle

Placebo Comparator group

Description:

Placebo comparator

Treatment:

Drug: ARQ-151 vehicle cream