Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Phase 3

Completed

• Conditions: Atopic Dermatitis Eczema
• Interventions: Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

• Registration Number: NCT04804605
• Lead Sponsor: Arcutis Biotherapeutics, Inc.

Brief Summary

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

Detailed Description

This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Study Timeline

• Study Start: 2021-02-25
• Study First Submitted: 2021-03-16
• Study First Submitted QC: 2021-03-17
• Study First Posted: 2021-03-18
• Primary Completion: 2024-05-28
• Study Completion: 2024-05-28
• Disposition First Posted: 2024-06-04
• Status Verified: 2025-05
• Disposition First Submitted: 2025-05-07
• Last Update Submitted: 2025-05-08
• Last Update Posted: 2025-05-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1220

Inclusion Criteria

1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. 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. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
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 who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
2. Subjects that use any Excluded Medications and Treatments.
3. Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
4. Subjects with known genetic dermatological conditions that overlap with AD.
5. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%	ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%	ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Primary Outcome Measures

Name	Time	Method
To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs	24 or 52 weeks	AEs and SAEs

Secondary Outcome Measures

Name	Time	Method
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment	24 or 52 weeks	The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).
vIGA-AD success	24 or 52 weeks	Defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline
WI-NRS score over time	24 or 52 weeks	WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").
EASI score over time	24 or 52 weeks	EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.

Trial Locations

Locations (92)

Arcutis Clinical Site 112; 🇺🇸 Birmingham, Alabama, United States

Arcutis Clinical Site 73; 🇺🇸 Birmingham, Alabama, United States

Arcutis Clinical Site 63; 🇺🇸 Scottsdale, Arizona, United States

Arcutis Clinical Site 106; 🇺🇸 Bryant, Arkansas, United States

Arcutis Clinical Site 116; 🇺🇸 Fort Smith, Arkansas, United States

Arcutis Clinical Site 69; 🇺🇸 Beverly Hills, California, United States

Arcutis Clinical Site 81; 🇺🇸 Inglewood, California, United States

Clinical Site 08; 🇺🇸 San Francisco, California, United States

Arcutis Clinical Site 31; 🇺🇸 Santa Monica, California, United States

Arcutis Clinical Site 130; 🇺🇸 Thousand Oaks, California, United States

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