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Trial details imported from ClinicalTrials.gov
For full trial details, please see the original record at
https://clinicaltrials.gov/ct2/show/NCT04128007
Registration number
NCT04128007
Ethics application status
Date submitted
14/10/2019
Date registered
16/10/2019
Date last updated
26/10/2022
Titles & IDs
Public title
Safety and Efficacy of ARQ-154 Foam in Adolescent and Adult Subjects With Scalp and Body Psoriasis
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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
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Secondary ID [1]
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ARQ-154-204
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Universal Trial Number (UTN)
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Trial acronym
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Linked study record
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Health condition
Health condition(s) or problem(s) studied:
Plaque Psoriasis
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Condition category
Condition code
Skin
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Dermatological conditions
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Skin
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Other skin conditions
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Intervention/exposure
Study type
Interventional
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Description of intervention(s) / exposure
Treatment: Drugs - Roflumilast foam 0.3%
Treatment: Drugs - Vehicle foam
Experimental: ARQ-154 foam 0.3% - active
Placebo Comparator: ARQ foam VehicleRQ-154 foam Vehicle - placebo
Treatment: Drugs: Roflumilast foam 0.3%
experimental
Treatment: Drugs: Vehicle foam
experimental
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Intervention code [1]
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Treatment: Drugs
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Comparator / control treatment
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Control group
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Outcomes
Primary outcome [1]
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Number of Participants Achieving Success in the Scalp Investigator Global Assessment (S-IGA) Scale
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Assessment method [1]
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The number of participants achieving success in the S-IGA scale is presented for each arm. Success is defined as an S-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline.The S-IGA is 5-point scale assessing the severity of plaque psoriasis on the scalp, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
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Timepoint [1]
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Week 8
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Secondary outcome [1]
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Number of Participants Achieving Body Investigator Global Assessment (B-IGA) Success at Week 8
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Assessment method [1]
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The number of participants achieving success in the B-IGA scale is presented for each arm. Success is defined as a B-IGA score of 0 ('clear') or 1 ('almost clear'), plus a 2-grade improvement from baseline. The B-IGA is 5-point scale assessing the severity of plaque psoriasis on the body, with scores ranging from 0 ('clear') to 4 ('severe'). Higher scores indicate greater symptom severity.
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Timepoint [1]
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Week 8
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Secondary outcome [2]
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Number of Participants Achieving Success in Scalp Itch Numerical Rating Scale (SI-NRS) Score
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Assessment method [2]
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The number of participants with a baseline SI-NRS score =4 who achieve success (a =4-point improvement from Baseline) at Weeks 2, 4, and 8 is presented for each arm. The SI-NRS is a participant-reported rating of severity of itch at its highest intensity during the previous 24-hour period. The scale ranges from 0 ('no itch') to 10 ('worst imaginable itch'), with higher scores indicating greater symptom severity. Results are based on observed data only.
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Timepoint [2]
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Baseline and Weeks 2, 4, 8
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Secondary outcome [3]
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Change From Baseline in Psoriasis Symptoms Diary (PSD) Score
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Assessment method [3]
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The change from baseline in total PSD scores at Weeks 4 and 8 is presented for each arm. The PSD is a 16-item questionnaire asking subjects to rate the severity of psoriasis-related symptoms in the past 24 hours. Each question is scored from 0 ("no symptoms") to 10 ("worst imaginable symptoms"). Scores range from 0 to 160, with higher scores indicating greater symptom severity.
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Timepoint [3]
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Baseline and Weeks 4 and 8
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Secondary outcome [4]
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Time to Achieve a 50% Reduction From Baseline in Psoriasis Scalp Severity Index (PSSI-50) Score
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Assessment method [4]
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The time to achieve PSSI-50 (i.e., a 50% reduction from baseline in PSSI score) is presented for each arm. 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 greater symptom severity. Results are based on observed data only.
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Timepoint [4]
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Up to 8 weeks
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Secondary outcome [5]
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Number of Participants Achieving Psoriasis Scalp Severity Index-75 (PSSI-75)
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Assessment method [5]
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The number of participants achieving a 75% reduction in PSSI score (i.e., PSSI-75) 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 indicate greater symptom severity. Results are based on observed data only.
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Timepoint [5]
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Week 8
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Secondary outcome [6]
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Number of Participants Achieving PSSI-90
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Assessment method [6]
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The number of participants achieving a 90% reduction from baseline PSSI score (i.e., PSSI-90) is presented for each arm. 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 indicate greater symptom severity. Results are based on observed data only.
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Timepoint [6]
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Baseline and Week 8
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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.
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Minimum age
12
Years
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Maximum age
No limit
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Sex
Both males and females
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Can healthy volunteers participate?
No
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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.
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Study design
Purpose of the study
Treatment
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Allocation to intervention
Randomised controlled trial
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Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
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Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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Masking / blinding
Blinded (masking used)
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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
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Intervention assignment
Parallel
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Other design features
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Phase
Phase 2
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Type of endpoint/s
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Statistical methods / analysis
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Recruitment
Recruitment status
Completed
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Data analysis
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Reason for early stopping/withdrawal
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Other reasons
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Date of first participant enrolment
Anticipated
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Actual
13/01/2020
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Date of last participant enrolment
Anticipated
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Actual
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Date of last data collection
Anticipated
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Actual
25/09/2020
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Sample size
Target
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Accrual to date
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Final
304
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Recruitment in Australia
Recruitment state(s)
NSW,SA,VIC
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Recruitment hospital [1]
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Arcutis Biotherapeutics Clinical Site 51 - Kogarah
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Recruitment hospital [2]
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Arcutis Biotherapeutics Clinical Site 52 - Westmead
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Recruitment hospital [3]
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Arcutis Biotherapeutics Clinical Site 54 - Hectorville
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Recruitment hospital [4]
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Arcutis Biotherapeutics Clinical Site 50 - East Melbourne
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Recruitment postcode(s) [1]
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2217 - Kogarah
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Recruitment postcode(s) [2]
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2145 - Westmead
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Recruitment postcode(s) [3]
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5073 - Hectorville
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Recruitment postcode(s) [4]
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3002 - East Melbourne
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Recruitment outside Australia
Country [1]
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United States of America
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State/province [1]
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Arkansas
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Country [2]
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United States of America
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State/province [2]
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California
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United States of America
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State/province [3]
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Connecticut
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United States of America
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State/province [4]
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Florida
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Country [5]
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United States of America
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State/province [5]
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Illinois
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Country [6]
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United States of America
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State/province [6]
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Indiana
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Country [7]
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United States of America
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State/province [7]
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Kentucky
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Country [8]
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United States of America
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State/province [8]
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Louisiana
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Country [9]
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United States of America
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State/province [9]
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Minnesota
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Country [10]
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Missouri
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New Hampshire
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Country [12]
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North Carolina
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Ohio
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Oregon
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Country [15]
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State/province [15]
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Pennsylvania
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Country [16]
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Tennessee
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Texas
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Virginia
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Country [19]
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Bulgaria
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Pleven
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Country [20]
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Bulgaria
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Sevlievo
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Country [21]
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Bulgaria
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State/province [21]
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Sofia
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Bulgaria
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Stara Zagora
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Canada
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Alberta
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Canada
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Ontario
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Canada
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Quebec
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Funding & Sponsors
Primary sponsor type
Commercial sector/Industry
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Name
Arcutis Biotherapeutics, Inc.
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Address
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Country
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Ethics approval
Ethics application status
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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
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Trial website
https://clinicaltrials.gov/ct2/show/NCT04128007
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Trial related presentations / publications
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Public notes
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Contacts
Principal investigator
Name
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David Berk, MD
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Address
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Arcutis Biotherapeutics
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Country
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Phone
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Fax
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Email
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Contact person for public queries
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Address
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Fax
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Contact person for scientific queries
Summary Results
For IPD and results data, please see
https://clinicaltrials.gov/ct2/show/NCT04128007
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