Safety Study of Roflumilast Cream 0.05% in Infants Aged 3 Months to Less Than 2 Years With Atopic Dermatitis

Arcutis Biotherapeutics

Status and phase: Enrolling; Phase 2

Conditions: Atopic Dermatitis (Eczema)

Treatments: Drug: ARQ-151 cream 0.05%

Study type: Interventional

Funder types: Industry

Identifiers

NCT06998056

ARQ-151-218

Details and patient eligibility

About

This study will assess the safety and tolerability of ARQ-151 cream 0.05% applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Full description

This study is an open label safety study in which ARQ-151 cream 0.05% is applied once a day for 4 weeks in infants with atopic dermatitis (eczema).

Enrollment: 100 estimated patients

Sex: All

Ages: 3 months to 2 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Informed consent of a parent(s) or legal guardian(s), as required by local laws.
2. Males and females, ages 3 months to <2 years old at Day 1.
3. Diagnosed with mild to moderate Atopic Dermatitis (AD) for at least 1 month duration prior to or at the screening visit.
4. Has AD involvement of ≥3% BSA at Day1.
5. In good health as judged by the Investigator
6. 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

1. Subjects with any serious medical condition, clinically significant vital signs, or physical examination abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator.
2. Subjects who have unstable AD or any consistent requirement for high potency topical steroids to manage AD signs or symptoms.
3. Subjects previously treated with ARQ-151
4. Subjects currently undergoing allergy testing or food challenges, or plan to do so during the study.
5. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language. Subjects who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
6. Subjects who are family members of the clinical study staff or sponsor.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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100 participants in 1 patient group

ARQ-151 roflumilast cream 0.05% (open label)

Experimental group

Description:

This single study arm is open label in which ARQ-151 cream 0.05% is applied daily for 4 weeks.

Treatment:

Drug: ARQ-151 cream 0.05%