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

Part of paid clinical trials in Beverly Hills, California.

Sponsor
Arcutis Biotherapeutics, Inc.
Study ID
NCT03764475
Phase
PHASE2
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Roflumilast — DRUG
    Roflumilast cream 0.3% for topical application

Study Details

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.

Key Dates

Start date
Dec 18, 2018
Status verified
Aug 2022
Primary completion
Oct 8, 2020
Completion
Oct 8, 2020

Study Design

Enrollment
332 participants (actual)
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: Long-term Safety of Roflumilast
    Participants applied roflumilast (ARQ-151) cream 0.3% once daily for 52 weeks

Primary Outcome Measure

Number of Participants Experiencing ≥1 Treatment-emergent Adverse Event (TEAE) [ Time Frame: Up to 52 weeks ]

Locations (20)

FacilityCityStateZIPSite coordinators
Arcutis Clinical Site 35Beverly HillsCalifornia90212-
Arcutis Clinical Site 29NorthridgeCalifornia91324-
Arcutis Clinical Site 28San DiegoCalifornia92123-
Arcutis Clinical Site 27Santa MonicaCalifornia90403-
Arcutis Clinical Site 12MiamiFlorida33144-
Arcutis Clinical Site 16SanfordFlorida32771-
Arcutis Clinical Site 21LouisvilleKentucky40217-
Arcutis Clinical Site 34Clinton TownshipMichigan48038-
Arcutis Clinical Site 33DetroitMichigan48202-
Arcutis Clinical Site 20FridleyMinnesota55432-
Arcutis Clinical Site 22New YorkNew York10029-
Arcutis Clinical Site 14High PointNorth Carolina27262-
Arcutis Clinical Site 39BexleyOhio43209-
Arcutis Clinical Site 15PittsburghPennsylvania15213-
Arcutis Clinical Site 19College StationTexas77845-
Arcutis Clinical Site 13HoustonTexas77056-
Arcutis Clinical Site 37HoustonTexas77004-
Arcutis Clinical Site 23San AntonioTexas78213-
Arcutis Clinical Site 24WebsterTexas77598-
Arcutis Clinical Site 31NorfolkVirginia23502-

Find similar trials in Beverly Hills, CA

By condition
Psoriasis
By specialty
DermatologyRheumatologyAutoimmune disease
By research site
Arcutis Clinical· Beverly Hills, CAArcutis Clinical· Northridge, CAArcutis Clinical· San Diego, CAArcutis Clinical· Santa Monica, CAArcutis Clinical· Miami, FLArcutis Clinical· Sanford, FL

Related Studies