Maximal Usage Pharmacokinetics and Safety Study of ARQ-154 Foam 0.3% in Pediatric Participants With Scalp and Body Psoriasis

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

16 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-12-15

Study Completion Date

2027-02-28

Brief Summary

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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%.

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Detailed Description

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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%

Conditions

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Psoriasis

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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ARQ-154 Foam 0.3%

ARQ-154 foam 0.3% will be applied QD. Treatment duration will be up to 6 weeks, including 2 weeks under maximal usage conditions, followed by an optional 4 weeks under non-maximal usage conditions.

Group Type EXPERIMENTAL

ARQ-154 Foam 0.3%

Intervention Type DRUG

ARQ-154 Foam 0.3%

Interventions

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ARQ-154 Foam 0.3%

Intervention Type DRUG

Eligibility Criteria

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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.

Minimum Eligible Age

2 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No