Clinical trial NCT04286607: Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis
Official title: A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% 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: 2020-02-27
Enrollment: 333
Sex: ALL
Minimum age (years): 2
Maximum age (years): 11
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Detailed description: This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Eligibility criteria: Inclusion Criteria:

* Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws
* Males and females ages 2 years and older (inclusive)
* Subjects with chronic plaque psoriasis who meet eligibility criteria and:

  1. Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or
  2. Are naïve to treatment with ARQ-151 cream (Cohort 2)
* Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial.

Exclusion Criteria:

* Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study.
* 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.
* 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: Occurrence of treatment emergent AEs (TEAEs)
timeFrame: 24 weeks
Secondary outcomes:
measure: Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time.
timeFrame: 24 weeks
measure: In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response).
timeFrame: 24 weeks
measure: Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time
timeFrame: 24 weeks
measure: Achievement of a 75% reduction in PASI over time
timeFrame: 24 weeks
measure: Achievement of a 90% reduction in PASI over time
timeFrame: 24 weeks
measure: Achievement of a 100% reduction in PASI over time
timeFrame: 24 weeks
measure: Change in Worst Itch Numeric Rating Scale) WI-NRS score over time
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arcutis Biotherapeutics Clinical Site 203
state: Arizona
city: Beverly Hills
country: United States
facility: Arcutis Biotherapeutics Clinical Site 239
state: California
city: Encinitas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 127
state: California
city: Encino
country: United States
facility: Arcutis Biotherapeutics Clinical Site 225
state: California
city: Fountain Valley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 509
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: Los Angeles
country: United States
facility: Arcutis Biotherapeutics Clinical Site 508
state: California
city: Rancho Santa Margarita
country: United States
facility: Arcutis Biotherapeutics Clinical Site 511
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 123
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 220
state: California
city: San Francisco
country: United States
facility: Arcutis Biotherapeutics Clinical Site 136
state: California
city: Santa Monica
country: United States
facility: Arcutis Biotherapeutics Clinical Site 208
state: California
city: Santa Monica
country: United States
facility: Arcutis Biotherapeutics Clinical Site 215
state: California
city: Boynton Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 223
state: Florida
city: DeLand
country: United States
facility: Arcutis Biotherapeutics Clinical Site 237
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 118
state: Florida
city: Hialeah
country: United States
facility: Arcutis Biotherapeutics Clinical Site 202
state: Florida
city: Largo
country: United States
facility: Arcutis Biotherapeutics Clinical Site 228
state: Florida
city: Miami
country: United States
facility: Arcutis Biotherapeutics Clinical Site 131
state: Florida
city: North Miami Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 201
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: Sweetwater
country: United States
facility: Arcutis Biotherapeutics Clinical Site 209
state: Florida
city: Boise
country: United States
facility: Arcutis Clinical Site 602
state: Idaho
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: Indianapolis
country: United States
facility: Arcutis Biotherapeutics Clinical Site 214
state: Indiana
city: Louisville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 217
state: Kentucky
city: Baton Rouge
country: United States
facility: Arcutis Biotherapeutics Clinical Site 111
state: Louisiana
city: Lake Charles
country: United States
facility: Arcutis Biotherapeutics Clinical Site 211
state: Louisiana
city: Metairie
country: United States
facility: Arcutis Biotherapeutics Clinical Site 213
state: Louisiana
city: New Orleans
country: United States
facility: Arcutis Biotherapeutics Clinical Site 224
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: Detroit
country: United States
facility: Arcutis Biotherapeutics Clinical Site 212
state: Michigan
city: Fridley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 216
state: Minnesota
city: Saint Joseph
country: United States
facility: Arcutis Biotherapeutics Clinical Site 227
state: Missouri
city: Las Vegas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 219
state: Nevada
city: Las Vegas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 231
state: Nevada
city: Reno
country: United States
facility: Arcutis Biotherapeutics Clinical Site 139
state: Nevada
city: Reno
country: United States
facility: Arcutis Biotherapeutics Clinical Site 240
state: Nevada
city: Portsmouth
country: United States
facility: Arcutis Biotherapeutics Clinical Site 236
state: New Hampshire
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 222
state: Oklahoma
city: Oklahoma City
country: United States
facility: Arcutis Biotherapeutics Clinical Site 134
state: Oklahoma
city: Broomall
country: United States
facility: Arcutis Biotherapeutics Clinical Site 229
state: Pennsylvania
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: Knoxville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 233
state: Tennessee
city: Murfreesboro
country: United States
facility: Arcutis Biotherapeutics Clinical Site 221
state: Tennessee
city: Arlington
country: United States
facility: Arcutis Biotherapeutics Clinical Site 206
state: Texas
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: Frisco
country: United States
facility: Arcutis Biotherapeutics Clinical Site 519
state: Texas
city: Houston
country: United States
facility: Arcutis Biotherapeutics Clinical Site 238
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: West Jordan
country: United States
facility: Arcutis Biotherapeutics Clinical Site 210
state: Utah
city: Richmond
country: United States
facility: Arcutis Biotherapeutics Clinical Site 230
state: Virginia
city: Calgary
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 132
state: Alberta
city: Surrey
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 207
state: British Columbia
city: Surrey
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 226
state: British Columbia
city: Winnepeg
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 232
state: Manitoba
city: Fredericton
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 234
state: New Brunswick
city: Ajax
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 205
state: Ontario
city: Barrie
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 218
state: Ontario
city: London
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 103
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: Toronto
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 235
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 106
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 204
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
city: Santo Domingo
country: Dominican Republic
facility: Arcutis Clinical Site 601
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: