Clinical trial NCT04211389: Twin 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: 442
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 study will assess the safety and efficacy of ARQ-151 cream vs placebo applied once a day for 56 days by subjects with chronic plaque psoriasis

Detailed description: This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily x 8 weeks to subjects with psoriasis

Eligibility criteria: Inclusion Criteria:

* Participants legally competent to sign and give informed consented 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 on the Investigator Global Assessment (IGA) Scale
timeFrame: 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 = 124 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 Success in Intertriginous Investigator Global Assessment (I-IGA) Scale Assessment of Disease Severity at Week 8
timeFrame: Week 8
measure: Number of Participants Achieving I-IGA Score of 'Clear' at Week 8
timeFrame: Week 8
measure: Number of Participants Achieving Success in Worst Itch Numerical Rating Scale (WI-NRS) Pruritus Score
timeFrame: Baseline (Day 1) and Week 2, Week 4, Week 8
measure: Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
timeFrame: Baseline (Day 1) and Weeks 4 and 8
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: Encino
country: United States
facility: Arcutis Biotherapeutics Clinical Site 225
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 220
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: Largo
country: United States
facility: Arcutis Biotherapeutics Clinical Site 228
state: Florida
city: North Miami Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 201
state: Florida
city: Sweetwater
country: United States
facility: Arcutis Biotherapeutics Clinical Site 209
state: Florida
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: 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: 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 240
state: Nevada
city: Portsmouth
country: United States
facility: Arcutis Biotherapeutics Clinical Site 236
state: New Hampshire
city: Oklahoma City
country: United States
facility: Arcutis Biotherapeutics Clinical Site 222
state: Oklahoma
city: Broomall
country: United States
facility: Arcutis Biotherapeutics Clinical Site 229
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: Houston
country: United States
facility: Arcutis Biotherapeutics Clinical Site 238
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: 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: Toronto
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 235
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 204
state: Ontario
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
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.