Arcutis Begins Enrolling Phase 3 Study Evaluating ZORYVE® (roflumilast) Cream 0.3% in Moderate to Severe Atopic Dermatitis

Arcutis aims to extend ZORYVE treatment beyond mild to moderate atopic dermatitis to patients with more severe disease.

Rhea-AI Summary

Arcutis Biotherapeutics (ARQT) enrolled the first participant in its Phase 3 INTEGUMENT-3 trial evaluating ZORYVE cream for moderate to severe atopic dermatitis. The study evaluates once-daily roflumilast cream 0.3% in individuals ages 6 and older. Arcutis aims to expand ZORYVE treatment to this population beyond its existing mild to moderate atopic dermatitis indications.

Approximately 415 participants will be randomly assigned in a 2:1 ratio to receive ZORYVE or matching vehicle cream, the comparison cream without the active treatment, for 4 weeks. Participants and investigators will not know treatment assignments during this period. Those completing it may enter a 48-week open-label extension, in which everyone receives ZORYVE. The study will assess safety and efficacy against vehicle over 4 weeks and evaluate longer-term safety, tolerability, and efficacy for up to 52 weeks.

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Positive

• Moderate pointFirst participant enrolled in Phase 3 INTEGUMENT-3, advancing development for moderate to severe atopic dermatitis.
• Minor point. Forward-looking: it has not happened yet and may not happen.Indication expansion is Arcutis' goal for ZORYVE cream 0.3% in patients ages 6 and older.
• Minor point. Forward-looking: it has not happened yet and may not happen.Up to 52 weeks of evaluation is planned to assess longer-term safety, tolerability, and efficacy.

Negative

• None.

Key Figures

Study population: Approximately 415 participants Randomization: 2:1 Double-blind treatment period: 4 weeks +2 more

Study population

Approximately 415 participants

Ages 6 and older with moderate to severe atopic dermatitis

Randomization

2:1

ZORYVE cream 0.3% versus matching vehicle

Double-blind treatment period

4 weeks

Once-daily study treatment

Long-term assessment

Up to 52 weeks

Secondary safety and efficacy objective

Open-label extension

48 weeks

Eligible participants receive once-daily ZORYVE cream 0.3%

Previous Clinical trial Reports

1 past event · Latest: Feb 02

Same Type 1 event

1. Feb 02

   Phase 2 results

   24h Move

   +0.8%

   INTEGUMENT-INFANT reported 58% achieving EASI-75 at Week 4 in infants with mild-to-moderate disease.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Key Terms

vehicle-controlled, double-blind, easi, pde4

4 terms

vehicle-controlled technical

"Phase 3, multicenter, randomized, double-blind, vehicle-controlled study"

A vehicle-controlled study compares a drug or therapy against the same formulation without the active ingredient — the “vehicle” is the inactive carrier or delivery medium. Think of testing a recipe by serving two dishes that look and taste the same except one lacks the key ingredient; any difference shows the ingredient’s real effect. Investors watch vehicle-controlled results because they provide a cleaner measure of a treatment’s benefit and safety, shaping regulatory decisions, clinical value, and company valuation.

double-blind technical

"randomized, double-blind, vehicle-controlled study"

A double-blind process means that neither the people conducting an activity nor the people involved know certain key details, such as who is receiving a treatment or a placebo. This approach helps prevent bias from influencing the results, making the outcome more trustworthy. For investors, it ensures that decisions or judgments are based on unbiased information rather than preconceived opinions or expectations.

easi medical

"vIGA-AD score of 3 or 4, EASI ≥5, and BSA 3%-30%"

Eczema Area and Severity Index (EASI) is a standardized clinical score used to measure the extent and intensity of atopic dermatitis (eczema) on a patient’s body, combining how much skin is affected and how severe symptoms like redness and thickness are. For investors, EASI matters because it is often a primary endpoint in dermatology drug trials: larger or faster improvements in EASI can increase the chance of regulatory approval and commercial success, much like a clear test score can boost confidence in a new product.

pde4 medical

"an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor"

PDE4 is an enzyme in the body that helps turn down certain cellular signals involved in inflammation and brain activity; think of it as a volume knob that lowers a chemical signal. Drugs that block PDE4 can boost those signals to reduce inflammation or alter mood, so progress or setbacks in developing PDE4-targeting drugs can materially affect a biotech or pharmaceutical company's clinical trial outcomes, regulatory prospects, and potential future revenue.

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• New INTEGUMENT-3 study to evaluate efficacy, safety, and tolerability of investigational ZORYVE® cream 0.3% in individuals with moderate to severe atopic dermatitis
• Study aims to expand once-daily ZORYVE cream treatment to individuals with moderate to severe atopic dermatitis
• Builds on existing evidence of ZORYVE cream 0.15% for individuals ages 6 and older and ZORYVE cream 0.05% for children ages 2 to 5 with mild to moderate atopic dermatitis
  
  

WESTLAKE VILLAGE, Calif., Nov. 05, 2026 (GLOBE NEWSWIRE) -- Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT), a commercial-stage biopharmaceutical company focused on developing meaningful innovations in immuno-dermatology, today announced that the first participant has been enrolled in a Phase 3, double-blind, randomized, vehicle-controlled study, INTEGUMENT-3. The study is designed to evaluate the efficacy, safety, and tolerability of once-daily ZORYVE® (roflumilast) cream 0.3% for the treatment of individuals ages 6 and older with moderate to severe atopic dermatitis.

“ZORYVE cream has an established efficacy and safety profile in mild to moderate atopic dermatitis, and we see an opportunity to bring the benefits of this innovative treatment to more people living with the disease by evaluating the higher concentration of ZORYVE cream 0.3% in individuals with more severe atopic dermatitis,” said Patrick Burnett, MD, PhD, FAAD, chief medical officer at Arcutis. “Despite advances in treatment, many people with moderate to severe atopic dermatitis continue to experience significant disease burden and are in need of additional treatment options. The initiation of INTEGUMENT-3 marks an important step towards expanding the indication of ZORYVE to fill this gap.”

About INTEGUMENT-3
INTEGUMENT-3 (ARQ-151-323) is a Phase 3, multicenter, randomized, double-blind, vehicle-controlled study evaluating the efficacy, safety, and tolerability of once-daily ZORYVE cream 0.3% in children, adolescents, and adults 6 years of age and older with moderate to severe atopic dermatitis.

Approximately 415 participants aged 6 years and older with moderate to severe atopic dermatitis (validated Investigator Global Assessment for Atopic Dermatitis [vIGA-AD] score of 3 or 4, EASI ≥5, and BSA 3%-30%) will be randomized in a 2:1 ratio to receive either ZORYVE 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 assess the safety and efficacy of ZORYVE cream 0.3% compared with vehicle cream administered once daily for 4 weeks in participants aged 6 years and older with moderate to severe atopic dermatitis. A secondary objective is to assess the long-term safety and efficacy of ZORYVE cream 0.3% administered once daily for up to 52 weeks in this patient population.

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 ZORYVE cream 0.3%. The open-label extension is designed to evaluate the long-term safety, tolerability, and efficacy of ZORYVE cream 0.3% up to 52 weeks.

About Atopic Dermatitis
Atopic dermatitis is the most common type of eczema, affecting approximately 9.6 million children and 16.5 million adults in the United States. Atopic dermatitis is a chronic, relapsing, and genetically predisposed inflammatory skin disease. The disease typically appears as a red, intensely itchy rash that can occur anywhere on the body. Younger children may have especially widespread atopic dermatitis, including on the face and neck.

Atopic dermatitis is often initially diagnosed during childhood with approximately 90% of people with atopic dermatitis developing symptoms by age 5 and up to 60% of children developing symptoms within their first year. Pediatric atopic dermatitis can negatively impact the entire family by significantly disrupting sleep, increasing the risk of skin infections, and leading to developmental and emotional strain for both the child and caregivers.

Atopic dermatitis is often characterized as mild to moderate and moderate to severe. Severe eczema can come with additional complications beyond itchy skin and rashes, such as infections that can lead to hospitalization if left untreated.

About ZORYVE® (roflumilast) 
ZORYVE is the number one prescribed branded topical therapy across three major inflammatory dermatoses combined — atopic dermatitis (eczema), seborrheic dermatitis, and plaque psoriasis. ZORYVE is a topical formulation of roflumilast, an advanced targeted topical phosphodiesterase type 4 (PDE4) inhibitor. Inhibiting PDE4, an intracellular enzyme that is an established target in dermatology, decreases the production of pro-inflammatory mediators. This decreases inflammation in the skin and balances the skin’s immune system.

Demonstrating both clinical impact and broad industry recognition, ZORYVE has been honored with multiple prestigious awards, including three from major beauty magazines: Allure’s "2025 Best of Beauty Breakthrough Award," Glamour’s 2024 Beauty and Wellness Award for “Best Eczema Product,” and most recently, Marie Claire’s “2026 Best Prescription Skin Solution” Award.

In addition, the National Psoriasis Foundation honored ZORYVE with its Seal of Recognition and the American Academy of Dermatology (AAD) issued a strong recommendation for the use of ZORYVE cream 0.15% in adults with mild to moderate atopic dermatitis and ZORYVE cream 0.05% for children aged 2-5 years, as well as a strong recommendation for ZORYVE cream 0.15% for children aged 6 years and older with mild to moderate atopic dermatitis in its first-ever pediatric atopic dermatitis guidelines.

INDICATIONS
ZORYVE cream, 0.05%, is indicated for topical treatment of mild to moderate atopic dermatitis in pediatric patients 2 to 5 years of age.

ZORYVE cream, 0.15%, is indicated for topical treatment of mild to moderate atopic dermatitis in adult and pediatric patients 6 years of age and older.

ZORYVE cream, 0.3%, is indicated for topical treatment of plaque psoriasis, including intertriginous areas, in adult and pediatric patients 6 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of plaque psoriasis of the scalp and body in adult and pediatric patients 12 years of age and older.

ZORYVE topical foam, 0.3%, is indicated for the treatment of seborrheic dermatitis in adult and pediatric patients 9 years of age and older.

IMPORTANT SAFETY INFORMATION
ZORYVE is contraindicated in patients with moderate to severe liver impairment (Child-Pugh B or C).

Flammability: The propellants in ZORYVE foam are flammable. Avoid fire, flame, and smoking during and immediately following application.

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.05% for pediatric patients with atopic dermatitis 2 to 5 years of age were upper respiratory tract infection (4.1%), diarrhea (2.5%), vomiting (2.1%), rhinitis (1.6%), conjunctivitis (1.4%), and headache (1.1%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.15% for patients with atopic dermatitis 6 years of age or older were headache (2.9%), nausea (1.9%), application site pain (1.5%), diarrhea (1.5%), and vomiting (1.5%).

The most common adverse reactions reported (≥1%) for ZORYVE cream 0.3% for plaque psoriasis were diarrhea (3.1%), headache (2.4%), insomnia (1.4%), nausea (1.2%), application site pain (1.0%), upper respiratory tract infection (1.0%), and urinary tract infection (1.0%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for plaque psoriasis were headache (3.1%), diarrhea (2.5%), nausea (1.7%), and nasopharyngitis (1.3%).

The most common adverse reactions reported (≥1%) for ZORYVE foam 0.3% for seborrheic dermatitis were nasopharyngitis (1.5%), nausea (1.3%), and headache (1.1%).

Please see full Prescribing Information for ZORYVE foam and full Prescribing Information for ZORYVE cream.

About Arcutis
Arcutis Biotherapeutics, Inc. (Nasdaq: ARQT) is a commercial-stage medical dermatology company delivering meaningful innovation to address the needs of individuals living with chronic inflammatory skin diseases. Over the past decade, Arcutis has successfully developed a robust portfolio of advanced targeted topicals approved to treat three major inflammatory skin diseases, driven by a commitment to solving the most persistent patient challenges in dermatology. Arcutis’ unique dermatology development platform, built on established scientific pathways and coupled with deep clinical dermatology and commercial expertise, enables us to efficiently develop, scale, and deliver our differentiated therapies while advancing a growing pipeline across a range of inflammatory dermatological conditions. For more information, visit www.arcutis.com or follow Arcutis on LinkedIn, Facebook, Instagram, and X. 

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. For example, statements contained in this press release regarding matters that are not historical facts are forward-looking statements. These statements are based on the Company’s current beliefs and expectations. Such forward-looking statements include, but are not limited to, statements regarding the potential of ZORYVE cream 0.3% to advance the standard of care in atopic dermatitis. These statements are subject to substantial known and unknown risks, uncertainties, and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from the information expressed or implied by these forward-looking statements. Risks and uncertainties that may cause our actual results to differ include risks inherent in our business, reimbursement and access to our products, the impact of competition and other important factors discussed in the “Risk Factors” section of our Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on February 25, 2026, as well as any subsequent filings with the SEC. Any forward-looking statements that the Company makes in this press release are made pursuant to the Private Securities Litigation Reform Act of 1995, as amended, and speak only as of the date of this press release. Except as required by law, we undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available.

Contacts:
Media
Amanda Sheldon, Head of Corporate Communications
media@arcutis.com

Investors
Brian Schoelkopf, Head of Investor Relations
ir@arcutis.com

FAQ

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What is Arcutis testing in the Phase 3 INTEGUMENT-3 ZORYVE trial?

INTEGUMENT-3 evaluates once-daily ZORYVE cream 0.3% for moderate to severe atopic dermatitis in individuals ages 6 and older. Approximately 415 participants will be randomized in a 2:1 ratio to ZORYVE or matching vehicle cream for a 4-week double-blind treatment period.

What disease severity criteria apply to Arcutis' INTEGUMENT-3 ZORYVE trial?

Participants must have a validated Investigator Global Assessment for Atopic Dermatitis score of 3 or 4, an Eczema Area and Severity Index score of at least 5, and affected body surface area of 3%-30%. These are the study's stated disease severity criteria for patients ages 6 and older.