Clinical trial NCT03638258: The Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream in Subjects With Chronic Plaque Psoriasis
Official title: A Phase 2b 12-Week Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety, Efficacy and Pharmacokinetics of ARQ-151 Cream 0.3% and ARQ-151 Cream 0.15% Administered Once Daily in Subjects With Chronic Plaque Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-20
Enrollment: 331
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Parallel group, double blind, vehicle-controlled study
Primary purpose: TREATMENT

Brief summary: This is a parallel group, double blind, vehicle-controlled study in which roflumilast (ARQ-151) cream 0.3%, roflumilast cream 0.15%, or vehicle cream is applied once daily (QD) for 84 days to subjects with chronic plaque psoriasis involving between 2 and 20% body surface area.


Eligibility criteria: Inclusion Criteria:

* Participants legally competent to sign and give informed consent
* Males and females ages 18 years and older (inclusive)
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator
* Females of childbearing potential (FOCBP) must have a negative urine 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 are 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 or tanning bed.
* Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
* Previous treatment with roflumilast cream 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 study medication.
* 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: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' at Week 6
timeFrame: Week 6
Secondary outcomes:
measure: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear'
timeFrame: Weeks 4, 8, and 12
measure: Change From Baseline in Modified Psoriasis Area Severity Index (mPASI) Score
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Percent Change From Baseline in Body Surface Area (BSA) Affected
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Percentage of Participants With an Investigator Global Assessment (IGA) Score of 'Clear' or 'Almost Clear' Plus a 2-Grade Improvement From Baseline
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Percentage of Participants With an Intertriginous Area Investigator Global Assessment (I-IGA) Score of 'Clear' or 'Almost Clear' Who Had at Least Mild Lesions at Baseline
timeFrame: Weeks 4, 6, 8, and 12
measure: Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Percentage of Participants With Baseline Worst Itch-Numeric Rating Scale (WI-NRS) Pruritus Score ≥6 Who Experienced a 4-point Reduction
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-75 (mPASI-75) Compared to Baseline
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Percentage of Participants Achieving a Modified Psoriasis Area Severity Index-90 (mPASI-90) Compared to Baseline
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Change From Baseline in Psoriasis Symptom Diary (PSD) Total Score
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Change From Baseline in Itch-Related Sleep Loss Numeric Rating Scale (NRS) Score
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Change From Baseline in Dermatology Life Quality Index (DLQI) Score
timeFrame: Baseline (Day 1) and Weeks 4, 6, 8, and 12
measure: Responses to Individual Questions of the Psoriasis Symptom Diary (PSD)
timeFrame: Weeks 4, 6, 8, and 12
Other outcomes:
Locations:
city: Beverly Hills
country: United States
facility: Arcutis Clinical Site 35
state: California
city: Northridge
country: United States
facility: Arcutis Clinical Site 29
state: California
city: San Diego
country: United States
facility: Arcutis Clinical Site 28
state: California
city: Santa Monica
country: United States
facility: Arcutis Clinical Site 27
state: California
city: Miami
country: United States
facility: Arcutis Clinical Site 12
state: Florida
city: Sanford
country: United States
facility: Arcutis Clinical Site 16
state: Florida
city: Louisville
country: United States
facility: Arcutis Clinical Site 21
state: Kentucky
city: Clinton Township
country: United States
facility: Arcutis Clinical Site 34
state: Michigan
city: Detroit
country: United States
facility: Arcutis Clinical Site 33
state: Michigan
city: Fridley
country: United States
facility: Arcutis Clinical Site 20
state: Minnesota
city: New York
country: United States
facility: Arcutis Clinical Site 22
state: New York
city: High Point
country: United States
facility: Arcutis Clinical Site 14
state: North Carolina
city: Bexley
country: United States
facility: Arcutis Clinical Site 39
state: Ohio
city: Pittsburgh
country: United States
facility: Arcutis Clinical Site 15
state: Pennsylvania
city: College Station
country: United States
facility: Arcutis Clinical Site 19
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 37
state: Texas
city: Houston
country: United States
facility: Arcutis Clinical Site 13
state: Texas
city: San Antonio
country: United States
facility: Arcutis Clinical Site 23
state: Texas
city: Webster
country: United States
facility: Arcutis Clinical Site 24
state: Texas
city: Norfolk
country: United States
facility: Arcutis Clinical Site 31
state: Virginia
city: Surrey
country: Canada
facility: Arcutis Clinical Site 18
state: British Columbia
city: Surrey
country: Canada
facility: Arcutis Clinical Site 11
state: British Columbia
city: Winnipeg
country: Canada
facility: Arcutis Clinical Site 38
state: Manitoba
city: Ajax
country: Canada
facility: Arcutis Clinical Site 10
state: Ontario
city: London
country: Canada
facility: Arcutis Clinical Site 25
state: Ontario
city: Markham
country: Canada
facility: Arcutis Clinical Site 26
state: Ontario
city: Oakville
country: Canada
facility: Arcutis Clinical Site 32
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Clinical Site 17
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Clinical Site 30
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Clinical Site 36
state: Ontario
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References:
citation: Stein Gold L, Alonso-Llamazares J, Draelos ZD, Gooderham MJ, Kempers SE, Kircik LH, Lebwohl MG, Papp KA, Pariser DM, Toth DP, Yosipovitch G, Higham RC, Feng A, Berk DR. Effect of Roflumilast Cream (ARQ-151) on Itch and Itch-Related Sleep Loss in Adults with Chronic Plaque Psoriasis: Patient-Reported Itch Outcomes of a Phase 2b Trial. Am J Clin Dermatol. 2023 Mar;24(2):305-313. doi: 10.1007/s40257-022-00739-3. Epub 2022 Nov 12.
citation: Lebwohl MG, Papp KA, Stein Gold L, Gooderham MJ, Kircik LH, Draelos ZD, Kempers SE, Zirwas M, Smith K, Osborne DW, Trotman ML, Navale L, Merritt C, Berk DR, Welgus H; ARQ-151 201 Study Investigators. Trial of Roflumilast Cream for Chronic Plaque Psoriasis. N Engl J Med. 2020 Jul 16;383(3):229-239. doi: 10.1056/NEJMoa2000073.