Roflumilast Cream 0.3% for Moderate to Severe Atopic Dermatitis (INTEGUMENT 3)

A Phase 3, 52-Week Study of Once-Daily Roflumilast Cream 0.3% in Participants With Moderate to Severe Atopic Dermatitis, Including a 4-Week Double-Blind, Vehicle-Controlled Phase Followed by a 48-Week Open-Label Extension

This Phase 3 study is designed to evaluate the efficacy and safety of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis. Approximately 415 participants will be randomized in a 2:1 ratio to receive roflumilast cream 0.3% or matching vehicle cream during a 4-week double-blind, vehicle-controlled treatment period.

Following completion of the double-blind treatment period, all participants will enter a 48-week open-label extension and receive roflumilast cream 0.3%. The study will assess the efficacy of roflumilast cream 0.3% in improving signs and symptoms of atopic dermatitis and evaluate its long-term safety and tolerability through Week 52.

Study Overview

• Status: Not yet recruiting
• Conditions: Atopic Dermatitis; Atopic Dermatitis (Eczema); Atopic Dermatitis (AD)
• Intervention / Treatment: Drug: Vehicle Cream; Drug: Roflumilast Cream 0.3%

Detailed Description

This Phase 3, multicenter, randomized, double-blind, vehicle-controlled study is designed to evaluate the efficacy, safety, and tolerability of once-daily roflumilast cream 0.3% in children, adolescents, and adults with moderate to severe atopic dermatitis.

Approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis will be randomized in a 2:1 ratio to receive either roflumilast cream 0.3% or matching vehicle cream once daily for 4 weeks during the double-blind treatment period.

The primary objective of the study is to evaluate the efficacy of roflumilast cream 0.3% compared with vehicle cream at Week 4. Secondary objectives include evaluation of additional efficacy measures related to the signs and symptoms of atopic dermatitis.

Participants who complete the double-blind treatment period will be eligible to enter a 48-week open-label extension period, during which all participants will receive once-daily roflumilast cream 0.3%. The open-label extension is designed to evaluate the long-term safety, tolerability, and efficacy of roflumilast cream 0.3% through Week 52.

Safety assessments will include adverse events, local tolerability, clinical laboratory evaluations, vital signs, physical examinations, and other protocol-specified safety assessments.

• Study Type: Interventional
• Enrollment (Estimated): 415
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Arcutis Medical Information; Phone Number: 1-844-692-6729; Email: medinfo@arcutis.com

Study Locations

• United States
  • Illinois
    • Chicago, Illinois, United States, 60523
      • Arcutis Site 1

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Male or female participants aged 6 years and older.
2. Clinical diagnosis of moderate to severe atopic dermatitis.
3. vIGA-AD score of 3 (Moderate) or 4 (Severe) at baseline.
4. EASI score ≥5 at baseline.
5. Atopic dermatitis involvement of ≥3% and ≤30% body surface area.
6. Able and willing to comply with study procedures.
7. Participant or parent/legal guardian able to provide informed consent/assent.

Exclusion Criteria:

1. Uncontrolled medical conditions that could interfere with study participation.
2. Skin disorders that may confound study assessments.
3. Active infection requiring systemic treatment.
4. Known hypersensitivity to roflumilast or formulation components.
5. Use of prohibited medications within protocol-defined washout periods.
6. Pregnant or breastfeeding participants.
7. Participation in another interventional clinical trial within the protocol-defined timeframe.
8. Any condition that, in the investigator's opinion, would make participation unsafe or interfere with study results.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Placebo Comparator: Vehicle Cream; Participants will apply matching vehicle cream once daily during the 4-week double-blind treatment period.	Drug: Vehicle Cream; Matching vehicle cream administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants will receive roflumilast cream 0.3% during the open-label extension phase.
Experimental: Roflumilast Cream 0.3%; Participants will apply roflumilast cream 0.3% once daily during the 4-week double-blind treatment period.	Drug: Roflumilast Cream 0.3%; Roflumilast cream 0.3% administered topically once daily to affected areas during the 4-week double-blind treatment period. Participants may continue treatment with roflumilast cream 0.3% during the 48-week open-label extension.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of vIGA-AD Success at Week 4	vIGA-AD Success is defined as achieving a Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) score of Clear (0) or Almost Clear (1) with at least a 2-grade improvement from Baseline.	Week 4

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Achievement of at least a 75% reduction in the Eczema Area and Severity Index (EASI-75)	EASI-75 is defined as achieving at least a 75% reduction from Baseline in Eczema Area and Severity Index (EASI) score.	Week 4
In participants ≥12 years old with Baseline Itch-NRS ≥ 4, achievement of at least a 4-point reduction on the Itch-NRS	In participants aged ≥12 years and older with a Baseline Itch Numeric Rating Scale (Itch-NRS) score of 4 or greater who achieve at least a 4-point reduction from Baseline in the Itch-NRS score at Week 4. The Itch-NRS is an 11-point scale ranging from 0 (no itch) to 10 (worst itch imaginable), with higher scores indicating greater itch severity.	Week 4

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Estimated): October 20, 2026
• Primary Completion (Estimated): April 27, 2028
• Study Completion (Estimated): March 28, 2029

Study Registration Dates

• First Submitted: October 30, 2026
• First Submitted That Met QC Criteria: October 30, 2026
• First Posted (Actual): November 4, 2026

Study Record Updates

• Last Update Posted (Actual): November 4, 2026
• Last Update Submitted That Met QC Criteria: October 30, 2026
• Last Verified: October 1, 2026

More Information

Terms related to this study

• Keywords: Atopic Dermatitis; Pruritus; Dermatology; Eczema; Roflumilast; Topical Therapy; Moderate Atopic Dermatitis; Severe Atopic Dermatitis; Inflammatory Skin Disease; Phosphodiesterase 4 Inhibitor; PDE4 Inhibitor; Roflumilast Cream
• Additional Relevant MeSH Terms: Genetic Diseases, Inborn; Immune System Diseases; Skin Manifestations; Hypersensitivity, Immediate; Hypersensitivity; Skin Diseases; Skin Diseases, Genetic; Skin Diseases, Eczematous; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Pathological Conditions, Signs and Symptoms; Skin and Connective Tissue Diseases; Signs and Symptoms; Dermatitis, Atopic; Dermatitis; Eczema; Pruritus
• Other Study ID Numbers: ARQ-151-323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No