Phase 3
N=654
Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis
Atopic Dermatitis Eczema
Bottom Line
View on ClinicalTrials.gov: NCT04773587 ↗Enrolled (actual)
654
Serious AEs
0.6%
Results posted
Oct 2024
Primary outcome: Primary: Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 — 32.0; 15.2 percentage of participants — p=<0.0001
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Roflumilast Cream 0.15% (Drug); Vehicle Cream (Drug)
- Age
- Pediatric, Adult, Older Adult · 6+ yrs
- Sex
- All
- Sponsor
- Arcutis Biotherapeutics, Inc.
- Primary completion
- Aug 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 |
32.0; 15.2 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores |
35.0; 17.5 | <0.0001 sig |
| SECONDARY Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 |
33.6; 20.7 | 0.0089 sig |
| SECONDARY Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 |
23.8; 9.8 | 0.0016 sig |
| SECONDARY Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4 |
9.5; 2.3 | 0.0159 sig |
| SECONDARY Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 |
43.2; 22.0 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4 |
41.5; 25.2 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Success at Week 2 |
21.2; 6.4 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Success at Week 1 |
8.1; 0.5 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2 |
31.8; 13.6 | <0.0001 sig |
| SECONDARY Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1 |
14.3; 5.9 | 0.0002 sig |
Summary
This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).
Eligibility Criteria
Inclusion Criteria
- Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
- Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
- 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.
- 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.
- In good health as judged by the Investigator.
- Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.
Exclusion Criteria
- 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
- Has unstable AD or any consistent requirement for high potency topical steroids.
- 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.
- Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
- Previous treatment with ARQ-151.
- Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
- 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.
- 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.
Data sourced from ClinicalTrials.gov (NCT04773587). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.