Clinical trial NCT05028582: Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)
Official title: A Randomized tRial Employing topiCal roflumilasT Foam to Treat Scalp Psoriasis (ARRECTOR)
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Scalp Psoriasis
Lead sponsor: Arcutis Biotherapeutics, Inc.
Sponsor class: INDUSTRY
First posted: 2021-08-31
Enrollment: 432
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 vehicle applied once daily for 8 weeks 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 foam is applied once daily for 8 weeks to subjects with scalp and body psoriasis.

Eligibility criteria: Inclusion Criteria:

* For adult subjects: Participants legally competent to read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws.
* Males and females ages 12 years and older (inclusive) at the time of consent or assent.
* Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline.
* Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline.
* A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline.
* An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Baseline.
* A PASI score of at least 2 (excluding palms and soles) at Baseline.
* Clinical diagnosis of psoriasis vulgaris of at least 6 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
* Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (not including palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%.
* Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception or a barrier method of contraception throughout the study according to Contraception Requirements for the protocol.
* Females of non-childbearing potential must either be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization according to Contraception Requirements for the protocol. Prepubescent females must agree to be abstinent during the study.
* Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.

Exclusion Criteria:

* Subjects who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study.
* Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED.
* Previous treatment with ARQ-151 or ARQ-154.
* 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 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.
* Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

Primary outcomes:
measure: Scalp Investigator Global Assessment (S-IGA) Score Change
timeFrame: 8 weeks
measure: Body Investigator Global Assessment (B-IGA) Score Change
timeFrame: 8 weeks
Secondary outcomes:
measure: In subjects with a Baseline SI-NRS (Scalp Itch-Numeric Rating Score) pruritus score of ≥ 4, SI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline.
timeFrame: Week 8
measure: SI-NRS (Scalp Itch-Numeric Rating Score) Success, defined as achievement of a ≥ 4-point improvement from Baseline.
timeFrame: Week 4
measure: SI-NRS (Scalp Itch-Numeric Rating Score) Success, defined as achievement of a ≥ 4-point improvement from Baseline.
timeFrame: Week 2
measure: Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score)
timeFrame: Week 1
measure: Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score)
timeFrame: 72 Hours
measure: Change from Baseline (CFB) SI-NRS (Scalp Itch-Numeric Rating Score)
timeFrame: Day 1
measure: In subjects with a Baseline WI-NRS (Worst Itch-Numeric Rating Score) pruritus score of ≥ 4, achievement of a ≥ 4-point improvement from Baseline
timeFrame: Week 8
measure: PASI-75 (Psoriasis Area and Severity Index-75)
timeFrame: Week 8
measure: Change From Baseline (CFB) in PSD (Psoriasis Symptoms Diary) items related to Itching, Pain, and Scaling (Questions 1, 9, and 11) aggregate score at Week 8
timeFrame: Week 8
measure: Psoriasis Symptoms Diary (PSD) related to Scaling (Question 11) = 0 at Week 8
timeFrame: Week 8
measure: Psoriasis Symptoms Diary (PSD) Item related to Itching (Question 1) = 0 at Week 8
timeFrame: Week 8
measure: Psoriasis Symptoms Diary (PSD) Item related to Pain (Question 9) = 0 at Week 8
timeFrame: Week 8
measure: Psoriasis Scalp Severity Index (PSSI-75)
timeFrame: Week 8
measure: S-IGA (Scalp Investigator Global Assessment) score of 'Clear'
timeFrame: Week 8
measure: S-IGA (Scalp Investigator Global Assessment) Success
timeFrame: Week 4
measure: Change from Baseline (CFB) in PASI (Psoriasis Scalp Severity Index)
timeFrame: Week 2
measure: S-IGA (Scalp Investigator Global Assessment) Success
timeFrame: Week 2
measure: Psoriasis Symptoms Diary (PSD) total Score = 0
timeFrame: Week 8
Other outcomes:
Locations:
city: Scottsdale
country: United States
facility: Arcutis Biotherapeutics Clinical Site 01
state: Arizona
city: Beverly Hills
country: United States
facility: Arcutis Biotherapeutics Clinical Site 50
state: California
city: Encinitas
country: United States
facility: Arcutis Biotherapeutics Clinical Site 45
state: California
city: San Diego
country: United States
facility: Arcutis Biotherapeutics Clinical Site 64
state: California
city: Santa Ana
country: United States
facility: Arcutis Biotherapeutics Clinical Site 72
state: California
city: Santa Monica
country: United States
facility: Arcutis Biotherapeutics Clinical Site 21
state: California
city: Clearwater
country: United States
facility: Arcutis Biotherapeutics Clinical Site 33
state: Florida
city: Coral Gables
country: United States
facility: Arcutis Biotherapeutics Clinical Site 42
state: Florida
city: Delray Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 57
state: Florida
city: North Miami Beach
country: United States
facility: Arcutis Biotherapeutics Clinical Site 31
state: Florida
city: Orlando
country: United States
facility: Arcutis Biotherapeutics Clinical Site 05
state: Florida
city: Sanford
country: United States
facility: Arcutis Biotherapeutics Clinical Site 65
state: Florida
city: Tampa
country: United States
facility: Arcutis Biotherapeutics Clinical Site 12
state: Florida
city: Plainfield
country: United States
facility: Arcutis Biotherapeutics Clinical Site 22
state: Illinois
city: Rolling Meadows
country: United States
facility: Arcutis Biotherapeutics Clinical Site 10
state: Illinois
city: Louisville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 15
state: Kentucky
city: Lake Charles
country: United States
facility: Arcutis Biotherapeutics Clinical Site 04
state: Louisiana
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 02
state: Maryland
city: Rockville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 28
state: Maryland
city: Detroit
country: United States
facility: Arcutis Biotherapeutics Clinical Site 20
state: Michigan
city: New Brighton
country: United States
facility: Arcutis Biotherapeutics Clinical Site 14
state: Minnesota
city: Saint Joseph
country: United States
facility: Arcutis Biotherapeutics Clinical Site 44
state: Missouri
city: East Windsor
country: United States
facility: Arcutis Biotherapeutics Clinical Site 34
state: New Jersey
city: Bronx
country: United States
facility: Arcutis Biotherapeutics Clinical Site 63
state: New York
city: Rochester
country: United States
facility: Arcutis Biotherapeutics Clinical Site 51
state: New York
city: High Point
country: United States
facility: Arcutis Biotherapeutics Clinical Site 23
state: North Carolina
city: Portland
country: United States
facility: Arcutis Biotherapeutics Clinical Site 25
state: Oregon
city: Pittsburgh
country: United States
facility: Arcutis Biotherapeutics Clinical Site 27
state: Pennsylvania
city: Knoxville
country: United States
facility: Arcutis Biotherapeutics Clinical Site 06
state: Tennessee
city: Arlington
country: United States
facility: Arcutis Biotherapeutics Clinical Site 13
state: Texas
city: Austin
country: United States
facility: Arcutis Biotherapeutics Clinical Site 11
state: Texas
city: College Station
country: United States
facility: Arcutis Biotherapeutics Clinical Site 41
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 54
state: Texas
city: San Antonio
country: United States
facility: Arcutis Biotherapeutics Clinical Site 24
state: Texas
city: West Jordan
country: United States
facility: Arcutis Biotherapeutics Clinical Site 07
state: Utah
city: Norfolk
country: United States
facility: Arcutis Biotherapeutics Clinical Site 17
state: Virginia
city: Calgary
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 35
state: Alberta
city: Surrey
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 37
state: British Columbia
city: Winnepeg
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 47
state: Manitoba
city: Fredericton
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 43
state: New Brunswick
city: Ajax
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 38
state: Ontario
city: London
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 16
state: Ontario
city: Mississauga
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 29
state: Ontario
city: North Bay
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 30
state: Ontario
city: Peterborough
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 32
state: Ontario
city: Toronto
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 71
state: Ontario
city: Waterloo
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 36
state: Ontario
city: Windsor
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 49
state: Ontario
city: Montreal
country: Canada
facility: Arcutis Biotherapeutics Clinical Site 09
state: Quebec
Study officials:
affiliation: Arcutis Biotherapeutics, Inc.
name: David Berk, MD
role: STUDY_DIRECTOR
References: