Psoriasis Clinical Trial

Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Summary

This study will assess the safety and efficacy of ARQ-154 foam vs vehicle applied once daily for 8 weeks by subjects with scalp and body psoriasis.

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Full Description

This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle foam is applied once daily for 8 weeks to subjects with scalp and body psoriasis.

View Eligibility Criteria

Eligibility Criteria

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.

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

432

Study ID:

NCT05028582

Recruitment Status:

Completed

Sponsor:

Arcutis Biotherapeutics, Inc.

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There are 48 Locations for this study

See Locations Near You

Arcutis Biotherapeutics Clinical Site 01
Scottsdale Arizona, 85255, United States
Arcutis Biotherapeutics Clinical Site 50
Beverly Hills California, 90212, United States
Arcutis Biotherapeutics Clinical Site 45
Encinitas California, 92024, United States
Arcutis Biotherapeutics Clinical Site 64
San Diego California, 92123, United States
Arcutis Biotherapeutics Clinical Site 72
Santa Ana California, 92701, United States
Arcutis Biotherapeutics Clinical Site 21
Santa Monica California, 90404, United States
Arcutis Biotherapeutics Clinical Site 33
Clearwater Florida, 33756, United States
Arcutis Biotherapeutics Clinical Site 42
Coral Gables Florida, 33134, United States
Arcutis Biotherapeutics Clinical Site 57
Delray Beach Florida, 33484, United States
Arcutis Biotherapeutics Clinical Site 31
North Miami Beach Florida, 33162, United States
Arcutis Biotherapeutics Clinical Site 05
Orlando Florida, 32819, United States
Arcutis Biotherapeutics Clinical Site 65
Sanford Florida, 32771, United States
Arcutis Biotherapeutics Clinical Site 12
Tampa Florida, 33613, United States
Arcutis Biotherapeutics Clinical Site 22
Plainfield Illinois, 46168, United States
Arcutis Biotherapeutics Clinical Site 10
Rolling Meadows Illinois, 60008, United States
Arcutis Biotherapeutics Clinical Site 15
Louisville Kentucky, 40217, United States
Arcutis Biotherapeutics Clinical Site 04
Lake Charles Louisiana, 70605, United States
Arcutis Biotherapeutics Clinical Site 02
Rockville Maryland, 20850, United States
Arcutis Biotherapeutics Clinical Site 28
Rockville Maryland, 20850, United States
Arcutis Biotherapeutics Clinical Site 20
Detroit Michigan, 48202, United States
Arcutis Biotherapeutics Clinical Site 14
New Brighton Minnesota, 55112, United States
Arcutis Biotherapeutics Clinical Site 44
Saint Joseph Missouri, 64506, United States
Arcutis Biotherapeutics Clinical Site 34
East Windsor New Jersey, 08520, United States
Arcutis Biotherapeutics Clinical Site 63
Bronx New York, 10462, United States
Arcutis Biotherapeutics Clinical Site 51
Rochester New York, 14623, United States
Arcutis Biotherapeutics Clinical Site 23
High Point North Carolina, 27262, United States
Arcutis Biotherapeutics Clinical Site 25
Portland Oregon, 97223, United States
Arcutis Biotherapeutics Clinical Site 27
Pittsburgh Pennsylvania, 15213, United States
Arcutis Biotherapeutics Clinical Site 06
Knoxville Tennessee, 37922, United States
Arcutis Biotherapeutics Clinical Site 13
Arlington Texas, 76011, United States
Arcutis Biotherapeutics Clinical Site 11
Austin Texas, 78759, United States
Arcutis Biotherapeutics Clinical Site 41
College Station Texas, 77845, United States
Arcutis Biotherapeutics Clinical Site 54
San Antonio Texas, 78213, United States
Arcutis Biotherapeutics Clinical Site 24
San Antonio Texas, 78218, United States
Arcutis Biotherapeutics Clinical Site 07
West Jordan Utah, 84088, United States
Arcutis Biotherapeutics Clinical Site 17
Norfolk Virginia, 23502, United States
Arcutis Biotherapeutics Clinical Site 35
Calgary Alberta, T2J 7, Canada
Arcutis Biotherapeutics Clinical Site 37
Surrey British Columbia, V3V0C, Canada
Arcutis Biotherapeutics Clinical Site 47
Winnepeg Manitoba, R3M 3, Canada
Arcutis Biotherapeutics Clinical Site 43
Fredericton New Brunswick, E3B 1, Canada
Arcutis Biotherapeutics Clinical Site 38
Ajax Ontario, L1S 7, Canada
Arcutis Biotherapeutics Clinical Site 16
London Ontario, N6H 5, Canada
Arcutis Biotherapeutics Clinical Site 29
Mississauga Ontario, L5H 1, Canada
Arcutis Biotherapeutics Clinical Site 30
North Bay Ontario, P1B 3, Canada
Arcutis Biotherapeutics Clinical Site 32
Peterborough Ontario, K9J 5, Canada
Arcutis Biotherapeutics Clinical Site 71
Toronto Ontario, M4W 2, Canada
Arcutis Biotherapeutics Clinical Site 36
Waterloo Ontario, N2J 1, Canada
Arcutis Biotherapeutics Clinical Site 49
Windsor Ontario, N8W 1, Canada
Arcutis Biotherapeutics Clinical Site 09
Montreal Quebec, H3Z 2, Canada

How clear is this clinincal trial information?

Study is for people with:

Psoriasis

Phase:

Phase 3

Estimated Enrollment:

432

Study ID:

NCT05028582

Recruitment Status:

Completed

Sponsor:


Arcutis Biotherapeutics, Inc.

How clear is this clinincal trial information?

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