Trial of PDE4 Inhibition With Roflumilast (ARQ-154) Foam 0.3% for the Management of Seborrheic Dermatitis (STRATUM)

NCT04973228 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-154-304
• Study Type: interventional
• Target: 457
• Locations: 2 countries
• Sites: 53

Brief Summary

This phase 3, double-blind, vehicle-controlled study assessed the safety and efficacy of roflumilast (ARQ-154) foam 0.3% applied once daily (qd) for 8 weeks by participants with seborrheic dermatitis.

Conditions

Seborrheic Dermatitis

Outcome Measures

Primary Outcomes (1)

• Achievement of Success on the Investigator Global Assessment (IGA) at Week 8

  The percentage of participants achieving IGA "success" is presented. Success is defined as a score of 0 ('clear') or 1 ('almost clear') plus a 2-point improvement at Week 8. The IGA is 5-point scale assessing the severity of seborrheic dermatitis with total scores ranging from 0 ('clear') to 4 ('severe') \[higher scores indicating greater severity\].

  Week 8

Secondary Outcomes (7)

• Achievement of Success in the Worst Itch Numeric Rating Scale (WI-NRS) at Week 8

  Week 8

• Achievement of Success in the WI-NRS at Week 4

  Week 4

• Achievement of Success in the WI-NRS at Week 2

  Week 2

• Achievement of Success on the IGA at Week 2

  Week 2

• Achievement of Success on the IGA at Week 4

  Week 4

Study Arms (2)

Roflumilast Foam 0.3%

EXPERIMENTAL

Participants with seborrheic dermatitis apply roflumilast foam 0.3% once daily (QD) for 8 weeks.

Drug: Roflumilast Foam

Vehicle Foam

PLACEBO COMPARATOR

Participants with seborrheic dermatitis apply vehicle foam QD for 8 weeks.

Drug: Vehicle Foam

Interventions

Roflumilast Foam DRUG

Roflumilast 0.3% foam for topical application

Also known as: ARQ-154

Roflumilast Foam 0.3%

Vehicle Foam DRUG

Vehicle foam for topical application

Vehicle Foam

Eligibility Criteria

• Age: 9 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
• Males and females ages 9 years and older at the time of consent.
• Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
• Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas.
• An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline.
• Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline.
• Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2).
• Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
• Subjects in good health as judged by the Investigator.
• Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment.

You may not qualify if:

• Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study.
• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• Previous treatment with ARQ-154 or ARQ-151.
• 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.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
• Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s).
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (53)

Arcutis Biotherapeutics Clinical Site 01

Scottsdale, Arizona, 85255, United States

Location

Arcutis Biotherapeutics Clinical Site 45

Encinitas, California, 92024, United States

Location

Arcutis Biotherapeutics Clinical Site 46

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, 90404, United States

Location

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, 33134, United States

Location

Arcutis Biotherapeutics Clinical Site 57

Delray Beach, Florida, 33484, United States

Location

Arcutis Biotherapeutics Clinical Site 33

Largo, Florida, 33770, United States

Location

Arcutis Biotherapeutics Clinical Site 31

North Miami Beach, Florida, 33162, United States

Location

Arcutis Biotherapeutics Clinical Site 65

Sanford, Florida, 32771, United States

Location

Arcutis Biotherapeutics Clinical Site 12

Tampa, Florida, 33613, United States

Location

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, 60008, United States

Location

Arcutis Biotherapeutics Clinical Site 03

Indianapolis, Indiana, 46250, United States

Location

Arcutis Biotherapeutics Clinical Site 22

Plainfield, Indiana, 46168, United States

Location

Arcutis Biotherapeutics Clinical Site 15

Louisville, Kentucky, 40217, United States

Location

Arcutis Biotherapeutics Clinical Site 04

Lake Charles, Louisiana, 70605, United States

Location

Arcutis Biotherapeutics Clinical Site 02

Rockville, Maryland, 20850, United States

Location

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, 20850, United States

Location

Arcutis Biotherapeutics Clinical Site 40

Clinton Township, Michigan, 48038, United States

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Arcutis Biotherapeutics Clinical Site 20

Detroit, Michigan, 48202, United States

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Arcutis Biotherapeutics Clinical Site 14

Fridley, Minnesota, 55432, United States

Location

Arcutis Biotherapeutics Clinical Site 44

Saint Joseph, Missouri, 64506, United States

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Arcutis Biotherapeutics Clinical Site 19

Reno, Nevada, 89509, United States

Location

Arcutis Biotherapeutics Clinical Site 34

East Windsor, New Jersey, 08520, United States

Location

Arcutis Biotherapeutics Clinical Site 66

New York, New York, 10065, United States

Location

Arcutis Biotherapeutics Clinical Site 63

The Bronx, New York, 10462, United States

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Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, 27262, United States

Location

Arcutis Biotherapeutics Clinical Site 70

Winston-Salem, North Carolina, 27104, United States

Location

Arcutis Biotherapeutics Clinical Site 18

Bexley, Ohio, 43209, United States

Location

Arcutis Biotherapeutics Clinical Site 71

Portland, Oregon, 97223, United States

Location

Arcutis Biotherapeutics Clinical Site 08

Broomall, Pennsylvania, 19008, United States

Location

Arcutis Biotherapeutics Clinical Site 27

Pittsburgh, Pennsylvania, 15213, United States

Location

Arcutis Biotherapeutics Clinical Site 06

Knoxville, Tennessee, 37922, United States

Location

Arcutis Biotherapeutics Clinical Site 13

Arlington, Texas, 76011, United States

Location

Arcutis Biotherapeutics Clinical Site 11

Austin, Texas, 78759, United States

Location

Arcutis Biotherapeutics Clinical Site 41

College Station, Texas, 77845, United States

Location

Arcutis Biotherapeutics Clinical Site 60

Houston, Texas, 77030, United States

Location

Arcutis Biotherapeutics Clinical Site 26

Pflugerville, Texas, 78660, United States

Location

Arcutis Biotherapeutics Clinical Site 72

Plano, Texas, 75024, United States

Location

Arcutis Biotherapeutics Clinical Site 54

San Antonio, Texas, 78213, United States

Location

Arcutis Biotherapeutics Clinical Site 24

San Antonio, Texas, 78218, United States

Location

Arcutis Biotherapeutics Clinical Site 07

West Jordan, Utah, 84088, United States

Location

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, 23502, United States

Location

Arcutis Biotherapeutics Clinical Site 35

Calgary, Alberta, T2J 7E1, Canada

Location

Arcutis Biotherapeutics Clinical Site 37

Surrey, British Columbia, V3V 0C6, Canada

Location

Arcutis Biotherapeutics Clinical Site 47

Winnipeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Biotherapeutics Clinical Site 43

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Arcutis Biotherapeutics Clinical Site 16

London, Ontario, N6H 5L5, Canada

Location

Arcutis Biotherapeutics Clinical Site 29

Mississauga, Ontario, L5H 1G9, Canada

Location

Arcutis Biotherapeutics Clinical Site 30

North Bay, Ontario, P1B 3Z7, Canada

Location

Arcutis Biotherapeutics Clinical Site 32

Peterborough, Ontario, K9J 5K2, Canada

Location

Arcutis Biotherapeutics Clinical Site 36

Waterloo, Ontario, N2J 1C4, Canada

Location

Arcutis Biotherapeutics Clinical Site 09

Westmount, Quebec, H3Z 2S6, Canada

Location

MeSH Terms

Conditions

Dermatitis, Seborrheic

Condition Hierarchy (Ancestors)

Dermatitis; Skin Diseases; Skin and Connective Tissue Diseases; Sebaceous Gland Diseases; Skin Diseases, Eczematous; Skin Diseases, Papulosquamous

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: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 13, 2021
• First Posted: July 22, 2021
• Study Start: July 8, 2021
• Primary Completion: April 6, 2022
• Study Completion: April 6, 2022
• Last Updated: March 12, 2024
• Results First Posted: March 12, 2024

Record last verified: 2024-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (43); CA (10)