Clinical trial NCT04211363: Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Official title: A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.3% Administered QD in Subjects With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Chronic Plaque Psoriasis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-12-26
Enrollment: 439
Sex: ALL
Minimum age (years): 2
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility criteria: Inclusion Criteria:

* Participants legally competent to sign and give informed consent 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

Primary outcomes:
measure: Number of Participants Achieving Success in Investigator Global Assessment (IGA) Scale Assessment of Disease Severity at Week 8
timeFrame: Baseline (Day 1) and Week 8
Secondary outcomes:
measure: Time to Achieve Psoriasis Area Severity Index-50 (PASI-50)
timeFrame: From start of treatment to achievement of PASI-50 or study completion/early termination (maximum duration = 121 days)
measure: Number of Participants Achieving Psoriasis Area Severity Index 75 (PASI-75)
timeFrame: Baseline (Day 1) and Week 8
measure: Number of Participants Achieving Psoriasis Area Severity Index-90 (PASI-90)
timeFrame: Baseline (Day 1) and Week 8
measure: Number of Participants Achieving Intertriginous IGA (I-IGA) Success at Week 8
timeFrame: Baseline (Day 1) and Week 8
measure: Number of Participants Achieving Score of 'Clear' in I-IGA at Week 8
timeFrame: Week 8
measure: Number of Participants Achieving Worst Itch Numerical Rating Score (WI-NRS) Success
timeFrame: Baseline (Day 1) and Weeks 2, 4, and 8
measure: Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
timeFrame: Weeks 4 and 8
Other outcomes:
Locations:
city: Encinitas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 127
state: California
city: Fremont
country: United States
facility: Arcutis Biotherapeutics Clinical Site 112
state: California
city: Irvine
country: United States
facility: Arcutis Biotherapeutics Clinical Site 120
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 123
state: California
city: San Francisco
country: United States
facility: Arcutis Biotherapeutics Clinical Site 136
state: California
city: Delray Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 118
state: Florida
city: Miami
country: United States
facility: Arcutis Biotherapeutics Clinical Site 131
state: Florida
city: Ocala
country: United States
facility: Arcutis Biotherapeutics Clinical Site 137
state: Florida
city: Sanford
country: United States
facility: Arcutis Biotherapeutics Clinical Site 105
state: Florida
city: Plainfield
country: United States
facility: Arcutis Biotherapeutics Clinical Site 114
state: Illinois
city: Rolling Meadows
country: United States
facility: Arcutis Biotherapeutics Clinical Site 102
state: Illinois
city: Baton Rouge
country: United States
facility: Arcutis Biotherapeutics Clinical Site 111
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 125
state: Maryland
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 138
state: Maryland
city: Brighton
country: United States
facility: Arcutis Biotherapeutics Clinical Site 101
state: Massachusetts
city: Clinton Township
country: United States
facility: Arcutis Biotherapeutics Clinical Site 116
state: Michigan
city: Reno
country: United States
facility: Arcutis Biotherapeutics Clinical Site 139
state: Nevada
city: East Windsor
country: United States
facility: Arcutis Biotherapeutics Clinical Site 129
state: New Jersey
city: New York
country: United States
facility: Arcutis Biotherapeutics Clinical Site 121
state: New York
city: Rochester
country: United States
facility: Arcutis Biotherapeutics Clinical Site 130
state: New York
city: Stony Brook
country: United States
facility: Arcutis Biotherapeutics Clinical Site 108
state: New York
city: High Point
country: United States
facility: Arcutis Biotherapeutics Clinical Site 115
state: North Carolina
city: Fairborn
country: United States
facility: Arcutis Biotherapeutics Clinical Site 124
state: Ohio
city: Oklahoma City
country: United States
facility: Arcutis Biotherapeutics Clinical Site 134
state: Oklahoma
city: Duncansville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 128
state: Pennsylvania
city: Exton
country: United States
facility: Arcutis Biotherapeutics Clinical Site 113
state: Pennsylvania
city: Pittsburgh
country: United States
facility: Arcutis Biotherapeutics Clinical Site 135
state: Pennsylvania
city: College Station
country: United States
facility: Arcutis Biotherapeutics Clinical Site 104
state: Texas
city: Dallas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 119
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 110
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 117
state: Texas
city: Calgary
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 132
state: Alberta
city: London
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 103
state: Ontario
city: Markham
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 122
state: Ontario
city: Mississauga
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 133
state: Ontario
city: Ottawa
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 140
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 109
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 106
state: Ontario
city: Montreal
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 107
state: Quebec
city: Québec
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 126
state: Quebec
Study officials:
References:
citation: Lebwohl MG, Kircik LH, Moore AY, Stein Gold L, Draelos ZD, Gooderham MJ, Papp KA, Bagel J, Bhatia N, Del Rosso JQ, Ferris LK, Green LJ, Hebert AA, Jones T, Kempers SE, Pariser DM, Yamauchi PS, Zirwas M, Albrecht L, Devani AR, Lomaga M, Feng A, Snyder S, Burnett P, Higham RC, Berk DR. Effect of Roflumilast Cream vs Vehicle Cream on Chronic Plaque Psoriasis: The DERMIS-1 and DERMIS-2 Randomized Clinical Trials. JAMA. 2022 Sep 20;328(11):1073-1084. doi: 10.1001/jama.2022.15632.