Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Conditions

• Chronic Plaque Psoriasis

Eligibility Criteria

Sex

ALL

Age

2 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Roflumilast 0.3% cream — DRUG
  Roflumilast 0.3% cream for topical application.
• Vehicle Cream — DRUG
  Vehicle cream for topical application.

Study Details

This is a double-blind, parallel group, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) 0.3% cream vs vehicle (placebo) cream for treatment of chronic plaque psoriasis (CPP) in adult participants with 2 to 20% body surface area (BSA) of CPP.

Key Dates

Start date

Dec 20, 2019

Status verified

Dec 2022

Primary completion

Nov 16, 2020

Completion

Nov 16, 2020

Study Design

Enrollment

439 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Rofumilast Cream 0.3%
  Participants receive roflumilast cream 0.3% once daily for 8 weeks.
• Placebo Comparator: Vehicle cream
  Participants receive vehicle cream once daily for 8 weeks.

Primary Outcome Measure

Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8 [ Time Frame: Baseline (Day 1) and Week 8 ]

Locations (31)

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