Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

NCT05028582 | Completed Phase 3 Results FDA Drug

• 1 other identifier: ARQ-154-309
• Study Type: interventional
• Target: 432
• Locations: 2 countries
• Sites: 49

Brief Summary

This was a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-154) 0.3% foam vs vehicle foam applied once daily (qd) for 8 weeks by participants with plaque psoriasis of the scalp and body.

Conditions

Scalp Psoriasis

Outcome Measures

Primary Outcomes (2)

• Achievement of Scalp Investigator Global Assessment (S-IGA) "Success" at Week 8

  The percentage of participants with S-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.

  Week 8

• Achievement of Body Investigator Global Assessment (B-IGA) Success at Week 8

  The percentage of participants with B-IGA success at Week 8 is presented. Success is defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement from baseline at Week 8. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2),Moderate (3), Severe (4), with higher scores indicative of greater symptom severity.

  Week 8

Secondary Outcomes (18)

• Achievement of Scalp Itch-Numeric Rating Score (SI-NRS ) Success at Week 2

  Week 2

• Achievement of SI-NRS Success at Week 4

  Week 4

• Achievement of SI-NRS Success at Week 8

  Week 8

• Change From Baseline in SI-NRS Score at Day 1

  Day 1

• Change From Baseline in SI-NRS Score at Day 3

  Day 3

Study Arms (2)

Roflumilast Foam 0.3%

ACTIVE COMPARATOR

Participants with plaque psoriasis of the scalp and body applied roflumilast foam 0.3% once daily (qd) for 8 weeks.

Drug: Roflumilast Foam 0.3%

Vehicle Foam

PLACEBO COMPARATOR

Participants with plaque psoriasis of the scalp and body applied vehicle foam qd for 8 weeks.

Drug: Vehicle Foam

Interventions

Roflumilast Foam 0.3% DRUG

Roflumilast foam 0.3%

Also known as: ARQ-154 0.3%

Roflumilast Foam 0.3%

Vehicle Foam DRUG

Vehicle foam matched to roflumilast 0.3% foam.

Vehicle Foam

Eligibility Criteria

• Age: 12 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 read, write, and sign and give informed consent. For adolescent subjects: Informed consent of a parent(s) or legal guardian, and assent by the subjects, as required by local laws.
• Males and females ages 12 years and older (inclusive) at the time of consent or assent.
• Scalp psoriasis with a Scalp-Investigator Global Assessment of Disease (S IGA) severity of at least Moderate ('3') at Baseline.
• Extent of scalp psoriasis involving ≥ 10% of the total scalp at Baseline.
• A Psoriasis Scalp Severity Index (PSSI) of at least 6 at Baseline.
• An IGA of body (i.e., non-scalp) psoriasis (B-IGA) of at least Mild ('2') at Baseline.
• A PASI score of at least 2 (excluding palms and soles) at Baseline.
• Clinical diagnosis of psoriasis vulgaris of at least 6 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks.
• Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (not including palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%.
• Female subject of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and negative urine pregnancy test at Baseline (Visit 2). In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception or a barrier method of contraception throughout the study according to Contraception Requirements for the protocol.
• Females of non-childbearing potential must either be premenarchal, post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status will be confirmed with FSH testing) or have undergone surgical sterilization according to Contraception Requirements for the protocol. Prepubescent females must agree to be abstinent during the study.
• Subjects in good health as judged by the Investigator, based on medical history, physical examination, vital signs, serum chemistry labs, hematology values, and urinalysis.

You may not qualify if:

• Subjects who cannot discontinue treatment with therapies for the treatment of psoriasis vulgaris prior to the Baseline visit and during the study.
• Planned excessive exposure to treated area(s) to either natural or artificial sunlight, tanning bed, or other LED.
• Previous treatment with ARQ-151 or ARQ-154.
• Females who are pregnant, wishing to become pregnant during the study, or are breast feeding.
• Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.
• Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members residing in the same household of enrolled subjects.
• Any condition that in the Investigator's assessment would preclude the subject from participating in the study.

Sponsors & Collaborators

• Arcutis Biotherapeutics, Inc.: lead

Study Sites (49)

Arcutis Biotherapeutics Clinical Site 01

Scottsdale, Arizona, 85255, United States

Location

Arcutis Biotherapeutics Clinical Site 50

Beverly Hills, California, 90212, United States

Location

Arcutis Biotherapeutics Clinical Site 45

Encinitas, California, 92024, United States

Location

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, 92123, United States

Location

Arcutis Biotherapeutics Clinical Site 72

Santa Ana, California, 92701, United States

Location

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, 90404, United States

Location

Arcutis Biotherapeutics Clinical Site 33

Clearwater, Florida, 33756, 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 31

North Miami Beach, Florida, 33162, United States

Location

Arcutis Biotherapeutics Clinical Site 05

Orlando, Florida, 32819, 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 22

Plainfield, Illinois, 46168, United States

Location

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, 60008, 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 20

Detroit, Michigan, 48202, United States

Location

Arcutis Biotherapeutics Clinical Site 14

New Brighton, Minnesota, 55112, United States

Location

Arcutis Biotherapeutics Clinical Site 44

Saint Joseph, Missouri, 64506, United States

Location

Arcutis Biotherapeutics Clinical Site 34

East Windsor, New Jersey, 08520, United States

Location

Arcutis Biotherapeutics Clinical Site 51

Rochester, New York, 14623, United States

Location

Arcutis Biotherapeutics Clinical Site 63

The Bronx, New York, 10462, United States

Location

Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, 27262, United States

Location

Arcutis Biotherapeutics Clinical Site 25

Portland, Oregon, 97223, 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 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, V3V0C6, Canada

Location

Arcutis Biotherapeutics Clinical Site 47

Winnepeg, Manitoba, R3M 3Z4, Canada

Location

Arcutis Biotherapeutics Clinical Site 43

Fredericton, New Brunswick, E3B 1G9, Canada

Location

Arcutis Biotherapeutics Clinical Site 38

Ajax, Ontario, L1S 7K8, 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 71

Toronto, Ontario, M4W 2N2, Canada

Location

Arcutis Biotherapeutics Clinical Site 36

Waterloo, Ontario, N2J 1C4, Canada

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Arcutis Biotherapeutics Clinical Site 49

Windsor, Ontario, N8W 1E6, Canada

Location

Arcutis Biotherapeutics Clinical Site 09

Montreal, Quebec, H3Z 2S6, Canada

Location

Related Publications (1)

• Gooderham MJ, Alonso-Llamazares J, Bagel J, Bhatia N, Bukhalo M, DuBois J, Ferris LK, Green L, Kircik LH, Lockshin B, Loo WJ, Papp KA, Soung J, Seal MS, Snyder S, Kato S, Krupa D, Burnett P, Berk DR, Chu DH. Roflumilast Foam, 0.3%, for Psoriasis of the Scalp and Body: The ARRECTOR Phase 3 Randomized Clinical Trial. JAMA Dermatol. 2025 Jul 1;161(7):698-706. doi: 10.1001/jamadermatol.2025.1136.

  PMID: 40332898 DERIVED

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: August 25, 2021
• First Posted: August 31, 2021
• Study Start: August 24, 2021
• Primary Completion: June 3, 2022
• Study Completion: June 3, 2022
• Last Updated: July 17, 2025
• Results First Posted: July 17, 2025

Record last verified: 2025-07

Data Sharing

• IPD Sharing: Will not share

Locations

CA (13); US (36)