Plaque Psoriasis, Psoriasis
Conditions
Brief summary
This is a Phase 2, open label, maximal usage PK and safety study of ARQ-151 cream 0.3% in pediatric subjects (ages 6 to 11 years old) with plaque psoriasis:
Interventions
ARQ-151 cream 0.3% applied to chronic plaque psoriasis lesions once a day for 4 weeks
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
6 Years to 11 Years
Healthy volunteers
No
Inclusion criteria
* Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subject, as required by local laws. * Males or females, 6 to 11 years old (inclusive). * Clinical diagnosis of psoriasis vulgaris of at least 2 months duration as determined by the Investigator or through subject interview. Stable disease for the past 3 weeks. * Psoriasis vulgaris on the face, extremities, trunk, and/or intertriginous areas involving at least 2% of BSA (excluding the scalp, palms, and soles). * An Investigator Global Assessment of disease severity (IGA) of at least Mild ('2') at Baseline. * Subject has adequate venous access for PK sampling in areas not involved by plaque psoriasis and not being treated with ARQ-151 (e.g., back of the hands). * 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). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the duration of the trial and for one week after application of the last dose. * Females of non-childbearing potential must be pre-menarchal. * In good health as judged by the Investigator, based on medical history, physical examination, 12-lead electrocardiogram (ECG), serum chemistry labs, hematology values, and urinalysis. * Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and Visit Schedule, according to the judgment of the Investigator.
Exclusion criteria
* Subjects with any serious medical or psychiatric condition or clinically significant laboratory, ECG, vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. * Planned initiation or changes to concomitant medication that could, in the opinion of the Investigator, affect psoriasis vulgaris * Current diagnosis of non-plaque form 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. * Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inducers for 2 weeks prior to Baseline/Day 1and during the study period. * Subjects who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Baseline/Day 1 and during the study period. * Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study. * Subjects who cannot discontinue specific systemic therapies and/or topical therapies prior to the Baseline/Day 1 and during the study period according to the protocol. * Subjects with any infection requiring oral or intravenous administration of antibiotics, antifungal or antiviral agents within 2 weeks prior to Baseline/Day 1. * Subjects with a CDI-2 (parent report) raw score \>20 at Screening/Baseline
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Plasma Concentration of ARQ-151 Cream 0.3% | Predose on Days 14 and 28 | Plasma levels of circulating roflumilast were determined at 2 points in the study. |
| Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Predose on Days 14 and 28 | Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study. |
| Number of Participants With ≥1 Adverse Event (AE) | Up to 28 days | The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research. |
| Number of Participants With Application Site Reactions | Baseline (Day 1), Day 7, and Day 14 | The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product. |
Countries
Canada, Dominican Republic, United States
Participant flow
Pre-assignment details
Pediatric participants 6-11 years of age were enrolled at 17 study sites in the United States, Canada, and the Dominican Republic.
Participants by arm
| Arm | Count |
|---|---|
| ARQ-151 Cream 0.3% Participants apply ARQ-151 cream 0.3% to chronic plaque psoriasis lesions once daily for 4 weeks | 20 |
| Total | 20 |
Baseline characteristics
| Characteristic | ARQ-151 Cream 0.3% |
|---|---|
| Age, Continuous | 8.8 years STANDARD_DEVIATION 1.61 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 12 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 1 Participants |
| Race (NIH/OMB) Black or African American | 10 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 9 Participants |
| Sex: Female, Male Female | 7 Participants |
| Sex: Female, Male Male | 13 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 20 |
| other Total, other adverse events | 4 / 20 |
| serious Total, serious adverse events | 0 / 20 |
Outcome results
Primary
Number of Participants With ≥1 Adverse Event (AE)
The number of participants with adverse events during the treatment period is reported. An AE is any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.
Time frame: Up to 28 days
Population: All treated participants are included.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| ARQ-151 Cream 0.3% | Number of Participants With ≥1 Adverse Event (AE) | 4 Participants |
Primary
Number of Participants With Application Site Reactions
The number of subjects experiencing an application site skin reactions by investigator assessment is reported. The investigator assessed for erythema prior to that day's application of investigational product.
Time frame: Baseline (Day 1), Day 7, and Day 14
Population: All treated participants are included.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 1: No erythema | 18 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 1: Minimal erythema | 0 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 1: Definite erythema | 1 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 7: No erythema | 17 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 7: Minimal erythema | 3 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 7: Definite erythema | 0 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 14: No erythema | 19 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 14: Minimal erythema | 1 Participants |
| ARQ-151 Cream 0.3% | Number of Participants With Application Site Reactions | Day 14: Definite erythema | 0 Participants |
Primary
Plasma Concentration of ARQ-151 Cream 0.3%
Plasma levels of circulating roflumilast were determined at 2 points in the study.
Time frame: Predose on Days 14 and 28
Population: Participants with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARQ-151 Cream 0.3% | Plasma Concentration of ARQ-151 Cream 0.3% | Day 14 | 3.15 ng/mL | Standard Deviation 3.64 |
| ARQ-151 Cream 0.3% | Plasma Concentration of ARQ-151 Cream 0.3% | Day 28 | 1.68 ng/mL | Standard Deviation 1.57 |
Primary
Plasma Concentration of the Roflumilast Major N-oxide Metabolite
Plasma levels of circulating the roflumilast major N-oxide metabolite were determined at 2 points in the study.
Time frame: Predose on Days 14 and 28
Population: Participants with data available are included.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| ARQ-151 Cream 0.3% | Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Day 14 | 28.9 ng/mL | Standard Deviation 41.1 |
| ARQ-151 Cream 0.3% | Plasma Concentration of the Roflumilast Major N-oxide Metabolite | Day 28 | 15.7 ng/mL | Standard Deviation 15.8 |