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Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

NCT ID: NCT05028582

Last Updated: 2025-07-17

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE3

Total Enrollment

432 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-08-24

Study Completion Date

2022-06-03

Brief Summary

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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.

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Detailed Description

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Conditions

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Scalp Psoriasis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Roflumilast Foam 0.3%

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

Group Type ACTIVE_COMPARATOR

Roflumilast Foam 0.3%

Intervention Type DRUG

Roflumilast foam 0.3%

Vehicle Foam

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

Group Type PLACEBO_COMPARATOR

Vehicle Foam

Intervention Type DRUG

Vehicle foam matched to roflumilast 0.3% foam.

Interventions

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Roflumilast Foam 0.3%

Roflumilast foam 0.3%

Intervention Type DRUG

Vehicle Foam

Vehicle foam matched to roflumilast 0.3% foam.

Intervention Type DRUG

Other Intervention Names

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ARQ-154 0.3%

Eligibility Criteria

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Inclusion Criteria

* 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.

Exclusion Criteria

* 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.
Minimum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Arcutis Biotherapeutics, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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David Berk, MD

Role: STUDY_DIRECTOR

Arcutis Biotherapeutics, Inc.

Locations

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Arcutis Biotherapeutics Clinical Site 01

Scottsdale, Arizona, United States

Site Status

Arcutis Biotherapeutics Clinical Site 50

Beverly Hills, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 45

Encinitas, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 64

San Diego, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 72

Santa Ana, California, United States

Site Status

Arcutis Biotherapeutics Clinical Site 21

Santa Monica, California, United States

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Arcutis Biotherapeutics Clinical Site 33

Clearwater, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 42

Coral Gables, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 57

Delray Beach, Florida, United States

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Arcutis Biotherapeutics Clinical Site 31

North Miami Beach, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 05

Orlando, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 65

Sanford, Florida, United States

Site Status

Arcutis Biotherapeutics Clinical Site 12

Tampa, Florida, United States

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Arcutis Biotherapeutics Clinical Site 22

Plainfield, Illinois, United States

Site Status

Arcutis Biotherapeutics Clinical Site 10

Rolling Meadows, Illinois, United States

Site Status

Arcutis Biotherapeutics Clinical Site 15

Louisville, Kentucky, United States

Site Status

Arcutis Biotherapeutics Clinical Site 04

Lake Charles, Louisiana, United States

Site Status

Arcutis Biotherapeutics Clinical Site 02

Rockville, Maryland, United States

Site Status

Arcutis Biotherapeutics Clinical Site 28

Rockville, Maryland, United States

Site Status

Arcutis Biotherapeutics Clinical Site 20

Detroit, Michigan, United States

Site Status

Arcutis Biotherapeutics Clinical Site 14

New Brighton, Minnesota, United States

Site Status

Arcutis Biotherapeutics Clinical Site 44

Saint Joseph, Missouri, United States

Site Status

Arcutis Biotherapeutics Clinical Site 34

East Windsor, New Jersey, United States

Site Status

Arcutis Biotherapeutics Clinical Site 51

Rochester, New York, United States

Site Status

Arcutis Biotherapeutics Clinical Site 63

The Bronx, New York, United States

Site Status

Arcutis Biotherapeutics Clinical Site 23

High Point, North Carolina, United States

Site Status

Arcutis Biotherapeutics Clinical Site 25

Portland, Oregon, United States

Site Status

Arcutis Biotherapeutics Clinical Site 27

Pittsburgh, Pennsylvania, United States

Site Status

Arcutis Biotherapeutics Clinical Site 06

Knoxville, Tennessee, United States

Site Status

Arcutis Biotherapeutics Clinical Site 13

Arlington, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 11

Austin, Texas, United States

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Arcutis Biotherapeutics Clinical Site 41

College Station, Texas, United States

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Arcutis Biotherapeutics Clinical Site 54

San Antonio, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 24

San Antonio, Texas, United States

Site Status

Arcutis Biotherapeutics Clinical Site 07

West Jordan, Utah, United States

Site Status

Arcutis Biotherapeutics Clinical Site 17

Norfolk, Virginia, United States

Site Status

Arcutis Biotherapeutics Clinical Site 35

Calgary, Alberta, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 37

Surrey, British Columbia, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 47

Winnepeg, Manitoba, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 43

Fredericton, New Brunswick, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 38

Ajax, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 16

London, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 29

Mississauga, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 30

North Bay, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 32

Peterborough, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 71

Toronto, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 36

Waterloo, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 49

Windsor, Ontario, Canada

Site Status

Arcutis Biotherapeutics Clinical Site 09

Montreal, Quebec, Canada

Site Status

Countries

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United States Canada

References

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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.

Reference Type DERIVED
PMID: 40332898 (View on PubMed)

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

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ARQ-154-309

Identifier Type: -

Identifier Source: org_study_id

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