Psoriasis
Conditions
Keywords
Scalp and Body Psoriasis
Brief summary
This study will evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile and assess the safety and tolerability of ARQ-154 foam 0.3%.
Detailed description
ARQ-154-127 is a Phase 1, open-label, single arm, maximum usage pharmacokinetic and safety study of roflumilast foam 0.3% in participants with scalp and body psoriasis. The goal of the study is to: * Evaluate the systemic exposure and characterize the plasma pharmacokinetic (PK) profile of ARQ-154 foam 0.3%. * Assess the safety and tolerability of ARQ-154 foam 0.3%
Interventions
DRUGARQ-154 Foam 0.3%
ARQ-154 Foam 0.3%
Sponsors
Arcutis Biotherapeutics, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
2 Years to 12 Years
Healthy volunteers
No
Inclusion criteria
* Males and females, ages 2 years to \< 12 years old at Day 1. * Clinical diagnosis of psoriasis vulgaris of at least 2 months duration at Screening as determined by the Investigator. * Scalp psoriasis with an Investigator Global Assessment (S-IGA) of scalp disease severity of at least Moderate ('3') at Day 1. * An IGA of body (non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Day 1. * Extent of scalp psoriasis involving ≥ 10% of the total scalp at Day 1. * Body psoriasis (non-scalp) involving at least 3% BSA on Day 1.
Exclusion criteria
* Participants who cannot discontinue medications and treatments prior to Day 1 (first application of IP). * Current diagnosis of non-plaque forms of psoriasis. Current diagnosis of drug-induced psoriasis. * Participants who have significant active systemic or localized infection or have had any infection that required oral or intravenous administration of antibiotics, antifungal or antiviral agents within 7 days prior to Day 1. * Participants with skin conditions other than psoriasis vulgaris that would interfere with evaluations of the effect of the study medication, as determined by the Investigator. * Participants who cannot discontinue the use of strong cytochrome P-450 CYP3A4 inhibitors for 2 weeks prior to Day 1 and during the study period. * A medical history of severe renal insufficiency, moderate to severe hepatic disorders (e.g., Child-Pugh B or C), or chronic infectious disease (e.g., hepatitis B, hepatitis C, or human immunodeficiency virus \[HIV\]). * Participants who are family members of the clinical study staff or sponsor.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Concentration of Roflumilast and Roflumilast N-Oxide from plasma | 2 Weeks | Assessment of steady-state trough plasma concentrations after 2 weeks of study drug administration. |
| Participant incidence of adverse events | 6 Weeks | Number of participants with adverse events during treatment will be assessed |
| Incidence of application site reactions | 6 Weeks | Number of participants that experience an application site skin reaction by investigator assessment and participant assessment will be assessed |
| The incidence of changes from Baseline in the total Children's Depression Inventory 2 (CDI-2)score. | 6 Weeks | The CDI-2 is an assessment instrument used to evaluate the severity of depressive symptoms in children. |
Countries
United States
Outcome results
None listed