Topical Roflumilast to Treat Scalp and Body Psoriasis (ARRECTOR)

Last updated: April 21, 2023
Sponsor: Arcutis Biotherapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Rosacea

Psoriasis And Psoriatic Disorders

Warts

Treatment

N/A

Clinical Study ID

NCT05028582
ARQ-154-309
  • Ages > 12
  • All Genders

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • For adult subjects: Participants legally competent to read, write, and sign and giveinformed consent. For adolescent subjects: Informed consent of a parent(s) or legalguardian, and assent by the subjects, as required by local laws.
  • Males and females ages 12 years and older (inclusive) at the time of consent orassent.
  • 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 asdetermined by the Investigator. Stable disease for the past 4 weeks.
  • Total overall psoriasis involvement on scalp and non-scalp areas ≤ 25% BSA (notincluding palms/soles) at Baseline. Total non-scalp BSA should not exceed 20%.
  • Female subject of childbearing potential (FOCBP) must have a negative serum pregnancytest 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 highlyeffective contraception or a barrier method of contraception throughout the studyaccording to Contraception Requirements for the protocol.
  • Females of non-childbearing potential must either be premenarchal, post-menopausalwith spontaneous amenorrhea for at least 12 months (post-menopausal status will beconfirmed with FSH testing) or have undergone surgical sterilization according toContraception Requirements for the protocol. Prepubescent females must agree to beabstinent 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, andurinalysis.

Exclusion

Exclusion Criteria:

  • Subjects who cannot discontinue treatment with therapies for the treatment ofpsoriasis vulgaris prior to the Baseline visit and during the study.
  • Planned excessive exposure to treated area(s) to either natural or artificialsunlight, 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 breastfeeding.
  • Subjects with any serious medical condition or laboratory abnormality that wouldprevent study participation or place the subject at significant risk, as determined bythe Investigator.
  • Subjects who are family members of the clinical study site, clinical study staff, orsponsor, or family members residing in the same household of enrolled subjects.
  • Any condition that in the Investigator's assessment would preclude the subject fromparticipating in the study.

Study Design

Total Participants: 432
Study Start date:
August 24, 2021
Estimated Completion Date:
June 03, 2022

Study 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.

Connect with a study center

  • Arcutis Biotherapeutics Clinical Site 35

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 37

    Surrey, British Columbia V3V0C6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 47

    Winnepeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 43

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 38

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 16

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 29

    Mississauga, Ontario L5H 1G9
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 30

    North Bay, Ontario P1B 3Z7
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 32

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 71

    Toronto, Ontario M4W 2N2
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 36

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 49

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 09

    Montreal, Quebec H3Z 2S6
    Canada

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 01

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 50

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 45

    Encinitas, California 92024
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 64

    San Diego, California 92123
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 72

    Santa Ana, California 92701
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 21

    Santa Monica, California 90404
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 33

    Clearwater, Florida 33756
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 42

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 57

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 31

    North Miami Beach, Florida 33162
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 05

    Orlando, Florida 32819
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 65

    Sanford, Florida 32771
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 12

    Tampa, Florida 33613
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 22

    Plainfield, Illinois 46168
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 10

    Rolling Meadows, Illinois 60008
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 15

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 04

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 02

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 28

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 20

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 14

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 44

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 34

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 63

    Bronx, New York 10462
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 51

    Rochester, New York 14623
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 23

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 25

    Portland, Oregon 97223
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 27

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 06

    Knoxville, Tennessee 37922
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 13

    Arlington, Texas 76011
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 11

    Austin, Texas 78759
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 41

    College Station, Texas 77845
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 24

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 54

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 07

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Arcutis Biotherapeutics Clinical Site 17

    Norfolk, Virginia 23502
    United States

    Site Not Available

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