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

NCT04804605 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-151-313
• Study Type: interventional
• Target: 1,220
• Locations: 2 countries
• Sites: 92

Brief Summary

This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.

Conditions

Atopic Dermatitis Eczema

Outcome Measures

Primary Outcomes (1)

• Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)

  The number of participants with ≥1 TEAE(s) is reported.

  Up to 52 weeks

Secondary Outcomes (4)

• Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) Score of 0 or 1 at Each Assessment

  Weeks 4, 12, 24, 36, and 52

• Percentage of Participants With vIGA-AD Success

  Weeks 4, 12, 24, 36, and 52

• Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study

  Weeks 4, 12, 24, 36, and 52

• Percent Change From Baseline in EASI Score

  Weeks 4, 12, 24, 36, and 52

Study Arms (1)

ARQ-151 Cream 0.05%

EXPERIMENTAL

Participants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks.

Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Interventions

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% DRUG

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Also known as: Roflumilast

ARQ-151 Cream 0.05%

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.)
• 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.
• 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.
• 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).
• 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.

You may not qualify if:

• Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
• Subjects that use any Excluded Medications and Treatments.
• 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.
• Subjects with known genetic dermatological conditions that overlap with AD.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• 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.
• 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.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (92)

Arcutis Clinical Site 112

Birmingham, Alabama, 35209, United States

Location

Arcutis Clinical Site 73

Birmingham, Alabama, 35244, United States

Location

Arcutis Clinical Site 63

Scottsdale, Arizona, 85255, United States

Location

Arcutis Clinical Site 106

Bryant, Arkansas, 72022, United States

Location

Arcutis Clinical Site 116

Fort Smith, Arkansas, 72916, United States

Location

Arcutis Clinical Site 69

Beverly Hills, California, 90212, United States

Location

Arcutis Clinical Site 81

Inglewood, California, 90301, United States

Location

Clinical Site 08

San Francisco, California, 94132, United States

Location

Arcutis Clinical Site 31

Santa Monica, California, 90404, United States

Location

Arcutis Clinical Site 130

Thousand Oaks, California, 91320, United States

Location

Arcutis Clinical Site 123

Centennial, Colorado, 80112, United States

Location

Arcutis Clinical Site 59

Coral Gables, Florida, 33134, United States

Location

Arcutis Clinical Site 72

Coral Gables, Florida, 33146, United States

Location

Arcutis Clinical Site 79

Delray Beach, Florida, 33484, United States

Location

Arcutis Clinical Site 103

Hollywood, Florida, 33021, United States

Location

Clinical Site 04

Jacksonville, Florida, 32256, United States

Location

Arcutis Clinical Site 15

Largo, Florida, 33770, United States

Location

Arcutis Clinical Site 67

Miami, Florida, 33162, United States

Location

Arcutis Clinical Site 95

Miami, Florida, 33173, United States

Location

Arcutis Clinical Site 68

Miami, Florida, 33174, United States

Location

Arcutis Clinical Site 29

Sanford, Florida, 32771, United States

Location

Clinical Site 01

Tampa, Florida, 33613, United States

Location

Arcutis Clinical Site 138

Wellington, Florida, 33449, United States

Location

Arcutis Clinical Site 47

Sandy Springs, Georgia, 30328, United States

Location

Arcutis Clinical Site 145

Boise, Idaho, 83706, United States

Location

Arcutis Clinical Site 13

Rolling Meadows, Illinois, 33770, United States

Location

Arcutis Clinical Site 93

Clarksville, Indiana, 47129, United States

Location

Clinical Site 22

Plainfield, Indiana, 46168, United States

Location

Arcutis Clinical Site 114

West Lafayette, Indiana, 47906, United States

Location

Clinical Site 03

Louisville, Kentucky, 40217, United States

Location

Arcutis Clinical Site 80

Covington, Louisiana, 70433, United States

Location

Arcutis Clinical Site 85

Lake Charles, Louisiana, 70605, United States

Location

Arcutis Clinical Site 24

Metairie, Louisiana, 70006, United States

Location

Arcutis Clinical Site 76

Rockville, Maryland, 20850, United States

Location

Arcutis Clinical Site 94

Bay City, Michigan, 48706, United States

Location

Arcutis Clinical Site 88

Clarkston, Michigan, 48346, United States

Location

Arcutis Clinical Site 58

Clinton Township, Michigan, 48038, United States

Location

Arcutis Clinical Site 66

Detroit, Michigan, 48202, United States

Location

Arcutis Clinical Site 132

Troy, Michigan, 48084, United States

Location

Clinical Site 10

New Brighton, Minnesota, 55112, United States

Location

Arcutis Clinical Site 102

Saint Joseph, Missouri, 64506, United States

Location

Arcutis Clinical Site 62

Reno, Nevada, 89509, United States

Location

Arcutis Clinical Site 71

East Windsor, New Jersey, 08520, United States

Location

Arcutis Clinical Site 96

Kew Gardens, New York, 11415, United States

Location

Arcutis Clinical Site 82

Rochester, New York, 14623, United States

Location

Arcutis Clinical Site 19

High Point, North Carolina, 27262, United States

Location

Arcutis Clinical Site 17

Gresham, Oregon, 97030, United States

Location

Arcutis Clinical Site 108

Portland, Oregon, 97210, United States

Location

Arcutis Clinical Site 16

Portland, Oregon, 97223, United States

Location

Arcutis Clinical Site 14

Portland, Oregon, 97239, United States

Location

Arcutis Clinical Site 53

Hershey, Pennsylvania, 17033, United States

Location

Arcutis Clinical Site 64

Newtown Square, Pennsylvania, 19073, United States

Location

Arcutis Clinical Site 25

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Clinical Site 101

Johnston, Rhode Island, 02919, United States

Location

Arcutis Clinical Site 77

Charleston, South Carolina, 29407, United States

Location

Arcutis Clinical Site 41

Charleston, South Carolina, 29425, United States

Location

Clinical Site 33

North Charleston, South Carolina, 29420, United States

Location

Arcutis Clinical Site 91

Summerville, South Carolina, 29486, United States

Location

Arcutis Clinical Site 60

Murfreesboro, Tennessee, 37130, United States

Location

Arcutis Clinical Site 34

Arlington, Texas, 76011, United States

Location

Clinical Site 23

Austin, Texas, 78759, United States

Location

Arcutis Clinical Site 84

Bellaire, Texas, 77401, United States

Location

Arcutis Clinical Site 21

College Station, Texas, 77845, United States

Location

Arcutis Clinical Site 126

Frisco, Texas, 75034, United States

Location

Arcutis Clinical Site 118

Grapevine, Texas, 76051, United States

Location

Arcutis Clinical Site 48

Houston, Texas, 77030, United States

Location

Arcutis Clinical Site 35

Houston, Texas, 77056, United States

Location

Arcutis Clinical Site 109

Katy, Texas, 77494, United States

Location

Clinical Site 20

San Antonio, Texas, 78213, United States

Location

Arcutis Clinical Site 49

San Antonio, Texas, 78218, United States

Location

Arcutis Clinical Site 74

Orem, Utah, 84058, United States

Location

Arcutis Clinical Site 36

West Jordan, Utah, 84088, United States

Location

Arcutis Clinical Site 51

Burke, Virginia, 22015, United States

Location

Arcutis Clinical Site 40

Norfolk, Virginia, 23502, United States

Location

Arcutis Clinical Site 12

Spokane, Washington, 99202, United States

Location

Arcutis Clinical Site 133

Kenosha, Wisconsin, 53142, United States

Location

Arcutis Clinical Site 70

Calgary, Alberta, T2J 7E1, Canada

Location

Arcutis Clinical Site 27

Surrey, British Columbia, V3R 6A7, Canada

Location

Arcutis Clinical Site 55

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Clinical Site 50

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Arcutis Clinical Site 43

Ajax, Ontario, L1S 7K8, Canada

Location

Arcutis Clinical Site 52

London, Ontario, N6H 5L5, Canada

Location

Clinical Site 11

Markham, Ontario, L3P 1X3, Canada

Location

Clinical Site 46

Mississauga, Ontario, L5H 1G9, Canada

Location

Arcutis Clinical Site 46

Montréal, Ontario, H2X 2V1, Canada

Location

Arcutis Clinical Site 61

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Clinical Site 54

Toronto, Ontario, M4W 2N4, Canada

Location

Arcutis Clinical Site 39

Waterloo, Ontario, N2J 1C4, Canada

Location

Clinical Site 09

Windsor, Ontario, N8W 1E6, Canada

Location

Arcutis Clinical Site 26

Drummondville, Quebec, J2B 5L4, Canada

Location

Arcutis Clinical Site 45

Montreal, Quebec, H2X 2V1, Canada

Location

Arcutis Clinical Site 56

Montreal, Quebec, H3Z 2S6, Canada

Location

MeSH Terms

Interventions

Roflumilast

Results Point of Contact

• Title: Arcutis Medical Information
• Organization: Arcutis Biotherapeutics

medinfo@arcutis.com

+1 (844) 692-6729

Study Officials

• David Berk, MD

  Arcutis Biotherapeutics, Inc.

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 16, 2021
• First Posted: March 18, 2021
• Study Start: February 25, 2021
• Primary Completion: May 28, 2024
• Study Completion: May 28, 2024
• Last Updated: December 23, 2025
• Results First Posted: December 23, 2025

Record last verified: 2025-12

Locations

US (76); CA (16)