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Long-Term Safety of ARQ-151 Cream in Adult Subjects With Chronic Plaque Psoriasis

NCT03764475 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 332

Last updated 2022-09-02

Study results available
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Summary

This is an open-label, long-term safety study of roflumilast (ARQ-151) 0.3% cream in subjects with chronic plaque psoriasis involving up to 25% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks at home. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Conditions

Interventions

DRUG

Roflumilast

Roflumilast cream 0.3% for topical application

Sponsors & Collaborators

  • Arcutis Biotherapeutics, Inc.

    lead INDUSTRY

Principal Investigators

  • David Berk, MD · Arcutis Biotherapeutics

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2018-12-18
Primary Completion
2020-10-08
Completion
2020-10-08
FDA Drug
Yes

Countries

  • United States
  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03764475 on ClinicalTrials.gov