Overview

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Status:
Recruiting
Trial end date:
2022-11-01
Target enrollment:
0
Participant gender:
All
Summary
This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema).
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Arcutis Biotherapeutics, Inc.
Criteria
Inclusion Criteria:

1. Participants legally competent to sign and give informed consent and, if appropriate,
assent as required by local laws.

2. Males and females, ages 6 years and older at time of signing Informed Consent
(Screening).

3. Diagnosed with atopic dermatitis 6 months duration (3 months for children), as
determined by the Investigator. Stable disease for the past 4 weeks with no
significant flares in atopic dermatitis before screening.

4. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at
Screening and a negative urine pregnancy test at Baseline/Day 1. In addition, sexually
active FOCBP must agree to use at least one form of a highly effective or barrier
method of contraception throughout the trial.

5. In good health as judged by the Investigator.

6. Subjects 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 or clinically significant abnormality that
would prevent study participation or place the subject at significant risk, as judged
by the Investigator

2. Has unstable AD or any consistent requirement for high potency topical steroids.

3. 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.

4. Females who are pregnant, wishing to become pregnant during the study, or are
breast-feeding.

5. Previous treatment with ARQ-151.

6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to
Screening.

7. Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the
local language(s). 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.

8. Subjects who are family members of the clinical study site, clinical study staff, or
sponsor, or family members of enrolled subjects living in the same house.