Clinical trial NCT04128007: Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis
Official title: A Phase 2b, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Adolescents and Adults With Scalp and Body Psoriasis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Plaque Psoriasis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2019-10-16
Enrollment: 304
Sex: ALL
Minimum age (years): 12
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-154 foam vs placebo applied once a day for 56 days by subjects with scalp and body psoriasis

Detailed description: This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily x 8 weeks to adolescent and adult subjects with scalp and body psoriasis

Eligibility criteria: Inclusion Criteria:

* Participants legally competent to read, write, sign and give informed consent, or, in the case of adolscents, assent with consent of a parent(s) or legal guardian, as required by local laws.
* Males and females ages 12 years and older (inclusive) at the time of consent for assent (for adolescents).
* Scalp psoriasis with an Investigator Global Assessment of Scalp disease severity (S-IGA) of at least Mild ('2') at Baseline.
* A Psoriasis Scalp Severity Index (PSSI) score of at least 6 at Baseline.
* A PASI score of at least 2 (excluding the palms and soles) at Baseline.
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
* Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
* Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
* Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.
* Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

Exclusion Criteria:

* Subjects who cannot discontinue medications and treatments prior to the Baseline visit and during the study according to Excluded Medications and Treatments.
* Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
* Subjects currently taking lithium or antimalarial drugs.
* Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris (e.g. beta blockers, ACE inhibitors).
* Current diagnosis of non-plaque forms of psoriasis (e.g., guttate, erythrodermic/exfoliative, palmoplantar only involvement, or pustular psoriasis). Current diagnosis of drug-induced psoriasis.
* Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
* Known allergies to excipients in ARQ-154.
* Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin for two weeks prior to the Baseline visit (Visit 2) and during the study.
* Subjects who cannot discontinue the use of strong P-450 cytochrome inducers e.g., efavirenz, nevirapine, glucocorticoids, barbiturates (including phenobarbital), phenytoin, rifampin, and carbamazepine for two weeks prior to the Baseline visit (Visit 2) and during the study.
* Subjects with PHQ-8 \>/= 10 or modified PHQ-A \>/= 10 at Screening or Baseline.
* 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 the investigational product.
* Subjects with a history of a major surgery within 4 weeks prior to Baseline (Visit 2) or has a major surgery planned during the study.
* 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.
* Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.
* Subjects with active infection that required oral or intravenous administration of antibiotics, antifungal, or antiviral agents within 7 days of Baseline/Day 0.
* Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.

Primary outcomes:
measure: Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
timeFrame: Week 8
Secondary outcomes:
measure: Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
timeFrame: Week 8
measure: Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
timeFrame: Baseline and Weeks 2, 4, 8
measure: Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
timeFrame: Baseline and Weeks 4 and 8
measure: Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
timeFrame: Up to 8 weeks
measure: Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
timeFrame: Week 8
measure: Number of Participants Achieving PSSI-90
timeFrame: Baseline and Week 8
Other outcomes:
Locations:
city: Rogers
country: United States
facility: Arcutis Biotherapeutics Clinical Site 71
state: Arkansas
city: Fremont
country: United States
facility: Arcutis Biotherapeutics Clinical Site 72
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 85
state: California
city: Cromwell
country: United States
facility: Arcutis Biotherapeutics Clinical Site 21
state: Connecticut
city: Boynton Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 91
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Biotherapeutics Clinical Site 20
state: Florida
city: Miami
country: United States
facility: Arcutis Biotherapeutics Clinical Site 88
state: Florida
city: Miami
country: United States
facility: Arcutis Biotherapeutics Clinical Site 90
state: Florida
city: Sweetwater
country: United States
facility: Arcutis Biotherapeutics Clinical Site 83
state: Florida
city: Rolling Meadows
country: United States
facility: Arcutis Biotherapeutics Clinical Site 99
state: Illinois
city: Indianapolis
country: United States
facility: Arcutis Biotherapeutics Clinical Site 78
state: Indiana
city: Plainfield
country: United States
facility: Arcutis Biotherapeutics Clinical Site 95
state: Indiana
city: Louisville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 77
state: Kentucky
city: Covington
country: United States
facility: Arcutis Biotherapeutics Clinical Site 79
state: Louisiana
city: Metairie
country: United States
facility: Arcutis Biotherapeutics Clinical Site 94
state: Louisiana
city: Fridley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 73
state: Minnesota
city: Saint Joseph
country: United States
facility: Arcutis Biotherapeutics Clinical Site 84
state: Missouri
city: Portsmouth
country: United States
facility: Arcutis Biotherapeutics Clinical Site 98
state: New Hampshire
city: High Point
country: United States
facility: Arcutis Biotherapeutics Clinical Site 87
state: North Carolina
city: Bexley
country: United States
facility: Arcutis Biotherapeutics Clinical Site 96
state: Ohio
city: Portland
country: United States
facility: Arcutis Biotherapeutics Clinical Site 82
state: Oregon
city: Broomall
country: United States
facility: Arcutis Biotherapeutics Clinical Site 80
state: Pennsylvania
city: Murfreesboro
country: United States
facility: Arcutis Biotherapeutics Clinical Site 97
state: Tennessee
city: Arlington
country: United States
facility: Arcutis Biotherapeutics Site 70
state: Texas
city: Austin
country: United States
facility: Arcutis Biotherapeutics Clinical Site 76
state: Texas
city: College Station
country: United States
facility: Arcutis Biotherapeutics Clinical Site 86
state: Texas
city: Houston
country: United States
facility: Arcutis Biotherapeutics Clinical Site 74
state: Texas
city: Pflugerville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 89
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 93
state: Texas
city: Norfolk
country: United States
facility: Arcutis Biotherapeutics Clinical Site 81
state: Virginia
city: Richmond
country: United States
facility: Arcutis Biotherapeutics Clinical Site 75
state: Virginia
city: Kogarah
country: Australia
facility: Arcutis Biotherapeutics Clinical Site 51
state: New South Wales
city: Westmead
country: Australia
facility: Arcutis Biotherapeutics Clinical Site 52
state: New South Wales
city: Hectorville
country: Australia
facility: Arcutis Biotherapeutics Clinical Site 54
state: South Australia
city: East Melbourne
country: Australia
facility: Arcutis Biotherapeutics Clinical Site 50
state: Victoria
city: Pleven
country: Bulgaria
facility: Arcutis Biotherapeutics Clinical Site 11
city: Sevlievo
country: Bulgaria
facility: Arcutis Biotherapeutics Clinical Site 13
city: Sofia
country: Bulgaria
facility: Arcutis Biotherapeutics Clinical Site 14
city: Sofia
country: Bulgaria
facility: Arcutis Biotherapeutics Clinical Site 10
city: Stara Zagora
country: Bulgaria
facility: Arcutis Biotherapeutics Clinical Site 12
city: Calgary
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 64
state: Alberta
city: Barrie
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 61
state: Ontario
city: London
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 60
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 62
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 63
state: Ontario
city: Montréal
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 66
state: Quebec
city: Westmount
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 65
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics
name: David Berk, MD
role: STUDY_DIRECTOR
References: