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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/show/NCT04128007




Registration number
NCT04128007
Ethics application status
Date submitted
14/10/2019
Date registered
16/10/2019
Date last updated
19/10/2020

Titles & IDs
Public title
Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis
Scientific 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
Secondary ID [1] 0 0
ARQ-154-204
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis 0 0
Condition category
Condition code
Skin 0 0 0 0
Dermatological conditions
Skin 0 0 0 0
Other skin conditions

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - ARQ-154

Experimental: ARQ-154 foam 0.3% -

Placebo Comparator: ARQ foam VehicleRQ-154 foam Vehicle -


Treatment: Drugs: ARQ-154
active vs vehicle

Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Scalp Investigator Global Assessment Scale - Achievement of a Scalp IGA score of 'Clear' or 'Almost Clear' plus a 2-grade improvement from Baseline. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).
Timepoint [1] 0 0
8 weeks
Secondary outcome [1] 0 0
Psoriasis Scalp Severity Index-50 score change - Achieve a 50% reduction in Psoriasis Scalp Severity Index (PSSI) from Baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
Timepoint [1] 0 0
Week 8
Secondary outcome [2] 0 0
Psoriasis Scalp Severity Index-score change - Time to Psoriasis Scalp Severity Index (PSSI)-50. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
Timepoint [2] 0 0
Baseline, Week 2, Week 4, Week 8
Secondary outcome [3] 0 0
Psoriasis Area Severity Index-50 score change - Achieve a 50% reduction in Psoriasis Area Severity Index (PASI) from Baseline. PASI combines the assessment of the severity of lesions and the area affected into single score in the range of 0 (no disease) to 72 (maximal disease). The body is divided into 4 sections (head, arms, trunk, legs); each area is scored by itself and scores are combined into the final PASI. For each section, the percent of area of skin involved is estimated: 0 (0%) to 6 (90% - 100%). For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Timepoint [3] 0 0
Week 8
Secondary outcome [4] 0 0
Psoriasis Area Severity Index-50 score change - Time to Psoriasis Area Severity Index (PASI)-50. PASI combines the assessment of the severity of lesions and the area affected into single score in the range of 0 (no disease) to 72 (maximal disease). The body is divided into 4 sections (head, arms, trunk, legs); each area is scored by itself and scores are combined into the final PASI. For each section, the percent of area of skin involved is estimated: 0 (0%) to 6 (90% - 100%). For each section percent area of skin involved was estimated: 0 (0%) to 6 (90 - 100%), and severity was estimated by clinical signs: erythema, induration, and desquamation; scale: 0 (none) to 4 (maximum). Final PASI = sum of severity parameters for each section * area score * weight of section (head: 0.1, arms: 0.2, body: 0.3, legs: 0.4).
Timepoint [4] 0 0
Baseline, Week 2, Week 4, Week 8
Secondary outcome [5] 0 0
Psoriasis Scalp Severity Index-75 score change - Achieve a 75% reduction in Psoriasis Scalp Severity Index (PSSI) from Baseline. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
Timepoint [5] 0 0
Week 8
Secondary outcome [6] 0 0
Psoriasis Scalp Severity Index-75 score change - Time to Psoriasis Scalp Severity Index (PSSI)-75. The PSSI measures the extent of psoriasis involvement and the severity of erythema, induration, and desquamation of the scalp. Involvement and severity of psoriasis for the PSSI is scored using a scale of 0 to 72, where 0 = no psoriasis and higher scores indicating more severe disease.
Timepoint [6] 0 0
Baseline, Week 2, Week 4, Week 8
Secondary outcome [7] 0 0
Scalp Itch Numerical Rating Score score change - For subjects with a Baseline Scalp Itch Numerical Rating Score (SI-NRS) of > 4, achievement of a > 4-point improvement from Baseline at Weeks 2, 4, and 8. SI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
Timepoint [7] 0 0
Weeks 2, 4, 8
Secondary outcome [8] 0 0
Psoriasis Symptoms Diary score change - Change from Baseline in total Psoriasis Symptoms Diary (PSD) score at Weeks 4 and 8. The PSD is a 16-item patient reported outcome (PRO) measure developed and validated in accordance with the FDA PRO Guidance
Timepoint [8] 0 0
Weeks 4 and 8

Eligibility
Key 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.
Minimum age
12 Years
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key 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.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 2
Type of endpoint(s)
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
Recruitment hospital [1] 0 0
Arcutis Biotherapeutics Clinical Site 51 - Kogarah
Recruitment hospital [2] 0 0
Arcutis Biotherapeutics Clinical Site 52 - Westmead
Recruitment hospital [3] 0 0
Arcutis Biotherapeutics Clinical Site 54 - Hectorville
Recruitment hospital [4] 0 0
Arcutis Biotherapeutics Clinical Site 50 - East Melbourne
Recruitment postcode(s) [1] 0 0
2217 - Kogarah
Recruitment postcode(s) [2] 0 0
2145 - Westmead
Recruitment postcode(s) [3] 0 0
5073 - Hectorville
Recruitment postcode(s) [4] 0 0
3002 - East Melbourne
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arkansas
Country [2] 0 0
United States of America
State/province [2] 0 0
California
Country [3] 0 0
United States of America
State/province [3] 0 0
Connecticut
Country [4] 0 0
United States of America
State/province [4] 0 0
Florida
Country [5] 0 0
United States of America
State/province [5] 0 0
Illinois
Country [6] 0 0
United States of America
State/province [6] 0 0
Indiana
Country [7] 0 0
United States of America
State/province [7] 0 0
Kentucky
Country [8] 0 0
United States of America
State/province [8] 0 0
Louisiana
Country [9] 0 0
United States of America
State/province [9] 0 0
Minnesota
Country [10] 0 0
United States of America
State/province [10] 0 0
Missouri
Country [11] 0 0
United States of America
State/province [11] 0 0
New Hampshire
Country [12] 0 0
United States of America
State/province [12] 0 0
North Carolina
Country [13] 0 0
United States of America
State/province [13] 0 0
Ohio
Country [14] 0 0
United States of America
State/province [14] 0 0
Oregon
Country [15] 0 0
United States of America
State/province [15] 0 0
Pennsylvania
Country [16] 0 0
United States of America
State/province [16] 0 0
Tennessee
Country [17] 0 0
United States of America
State/province [17] 0 0
Texas
Country [18] 0 0
United States of America
State/province [18] 0 0
Virginia
Country [19] 0 0
Bulgaria
State/province [19] 0 0
Pleven
Country [20] 0 0
Bulgaria
State/province [20] 0 0
Sevlievo
Country [21] 0 0
Bulgaria
State/province [21] 0 0
Sofia
Country [22] 0 0
Bulgaria
State/province [22] 0 0
Stara Zagora
Country [23] 0 0
Canada
State/province [23] 0 0
Alberta
Country [24] 0 0
Canada
State/province [24] 0 0
Ontario
Country [25] 0 0
Canada
State/province [25] 0 0
Quebec

Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
Name
Arcutis Biotherapeutics, Inc.
Address
Country

Ethics approval
Ethics application status

Summary
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
Trial website
https://clinicaltrials.gov/show/NCT04128007
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for scientific queries

Summary results
Other publications