Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Last updated: May 31, 2024
Sponsor: Arcutis Biotherapeutics, Inc.
Overall Status: Completed

Phase

3

Condition

Atopic Dermatitis

Allergy

Hives (Urticaria)

Treatment

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Clinical Study ID

NCT04804605
ARQ-151-313
  • Ages > 2
  • All Genders

Study Summary

This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. For adult subjects: Participants legally competent to sign and give informedconsent. For pediatric and adolescent subjects: Informed consent of parent(s) orlegal guardian, and, if age appropriate, assent by the subjects, as required bylocal laws.

  2. Males and females, ages 2 years and older. (Only subjects 18 years and older will beenrolled at sites located in the province of Québec in Canada.)

  3. Subjects with atopic dermatitis who met eligibility criteria for and successfullycompleted one of three preceding studies through Week 4, and are able and eligibleto enroll into this long-term safety study on the Week 4 visit of the precedingstudy.

  4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy testat all study visits. In addition, sexually active FOCBP must agree to use at leastone form of a highly effective or barrier method of contraception throughout thetrial.

  5. Females of non-childbearing potential should either be pre-menarchal, orpost-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausalstatus would have been confirmed with FSH testing in the preceding study) or haveundergone surgical sterilization (permanent sterilization methods includehysterectomy, bilateral oophorectomy, or bilateral salpingectomy).

  6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable ofadhering to the Protocol and visit schedule, according to the judgment of theInvestigator.

Exclusion

Exclusion Criteria:

  1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precludedfurther treatment with ARQ-151 cream in the preceding study.

  2. Subjects that use any Excluded Medications and Treatments.

  3. Subjects with skin conditions other than AD that would interfere with evaluations ofthe effect of the study medication on AD, as determined by the Investigator.Subjects with any condition on the treatment area which, in the opinion of theInvestigator, could confound efficacy measurements.

  4. Subjects with known genetic dermatological conditions that overlap with AD.

  5. Females who are pregnant, wishing to become pregnant during the study, or arebreast-feeding.

  6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read orunderstand the local language(s), or who display another condition, which in theInvestigator's opinion, makes them unsuitable for clinical study participation.

  7. Subjects who are family members of the clinical study site, clinical study staff, orsponsor, or family members of enrolled subjects (subjects enrolled in other studiesof ARQ-151 cream) living in the same house.

Study Design

Total Participants: 1220
Treatment Group(s): 1
Primary Treatment: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Phase: 3
Study Start date:
February 25, 2021
Estimated Completion Date:
May 28, 2024

Study Description

This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Connect with a study center

  • Arcutis Clinical Site 70

    Calgary, Alberta T2J 7E1
    Canada

    Site Not Available

  • Arcutis Clinical Site 27

    Surrey, British Columbia V3R 6A7
    Canada

    Site Not Available

  • Arcutis Clinical Site 55

    Winnipeg, Manitoba R3M 3Z4
    Canada

    Site Not Available

  • Arcutis Clinical Site 50

    Fredericton, New Brunswick E3B 1G9
    Canada

    Site Not Available

  • Arcutis Clinical Site 43

    Ajax, Ontario L1S 7K8
    Canada

    Site Not Available

  • Arcutis Clinical Site 52

    London, Ontario N6H 5L5
    Canada

    Site Not Available

  • Clinical Site 11

    Markham, Ontario L3P 1X3
    Canada

    Site Not Available

  • Clinical Site 46

    Mississauga, Ontario L5H 1G9
    Canada

    Site Not Available

  • Arcutis Clinical Site 46

    Montréal, Ontario H2X 2V1
    Canada

    Site Not Available

  • Arcutis Clinical Site 61

    Peterborough, Ontario K9J 5K2
    Canada

    Site Not Available

  • Arcutis Clinical Site 54

    Toronto, Ontario M4W 2N4
    Canada

    Site Not Available

  • Arcutis Clinical Site 39

    Waterloo, Ontario N2J 1C4
    Canada

    Site Not Available

  • Clinical Site 09

    Windsor, Ontario N8W 1E6
    Canada

    Site Not Available

  • Arcutis Clinical Site 26

    Drummondville, Quebec J2B 5L4
    Canada

    Site Not Available

  • Arcutis Clinical Site 45

    Montréal, Quebec H2X 2V1
    Canada

    Site Not Available

  • Arcutis Clinical Site 56

    Montréal, Quebec H3Z 2S6
    Canada

    Site Not Available

  • Arcutis Clinical Site 112

    Birmingham, Alabama 35209
    United States

    Site Not Available

  • Arcutis Clinical Site 73

    Birmingham, Alabama 35244
    United States

    Site Not Available

  • Arcutis Clinical Site 63

    Scottsdale, Arizona 85255
    United States

    Site Not Available

  • Arcutis Clinical Site 106

    Bryant, Arkansas 72022
    United States

    Site Not Available

  • Arcutis Clinical Site 116

    Fort Smith, Arkansas 72916
    United States

    Site Not Available

  • Arcutis Clinical Site 69

    Beverly Hills, California 90212
    United States

    Site Not Available

  • Arcutis Clinical Site 81

    Inglewood, California 90301
    United States

    Site Not Available

  • Clinical Site 08

    San Francisco, California 94132
    United States

    Site Not Available

  • Arcutis Clinical Site 31

    Santa Monica, California 90404
    United States

    Site Not Available

  • Arcutis Clinical Site 130

    Thousand Oaks, California 91320
    United States

    Site Not Available

  • Arcutis Clinical Site 123

    Centennial, Colorado 80112
    United States

    Site Not Available

  • Arcutis Clinical Site 59

    Coral Gables, Florida 33134
    United States

    Site Not Available

  • Arcutis Clinical Site 72

    Coral Gables, Florida 33146
    United States

    Site Not Available

  • Arcutis Clinical Site 79

    Delray Beach, Florida 33484
    United States

    Site Not Available

  • Arcutis Clinical Site 103

    Hollywood, Florida 33021
    United States

    Site Not Available

  • Clinical Site 04

    Jacksonville, Florida 32256
    United States

    Site Not Available

  • Arcutis Clinical Site 15

    Largo, Florida 33770
    United States

    Site Not Available

  • Arcutis Clinical Site 67

    Miami, Florida 33162
    United States

    Site Not Available

  • Arcutis Clinical Site 68

    Miami, Florida 33174
    United States

    Site Not Available

  • Arcutis Clinical Site 95

    Miami, Florida 33173
    United States

    Site Not Available

  • Arcutis Clinical Site 29

    Sanford, Florida 32771
    United States

    Site Not Available

  • Clinical Site 01

    Tampa, Florida 33613
    United States

    Site Not Available

  • Arcutis Clinical Site 138

    Wellington, Florida 33449
    United States

    Site Not Available

  • Arcutis Clinical Site 47

    Sandy Springs, Georgia 30328
    United States

    Site Not Available

  • Arcutis Clinical Site 145

    Boise, Idaho 83706
    United States

    Site Not Available

  • Arcutis Clinical Site 13

    Rolling Meadows, Illinois 33770
    United States

    Site Not Available

  • Arcutis Clinical Site 93

    Clarksville, Indiana 47129
    United States

    Site Not Available

  • Clinical Site 22

    Plainfield, Indiana 46168
    United States

    Site Not Available

  • Arcutis Clinical Site 114

    West Lafayette, Indiana 47906
    United States

    Site Not Available

  • Clinical Site 03

    Louisville, Kentucky 40217
    United States

    Site Not Available

  • Arcutis Clinical Site 80

    Covington, Louisiana 70433
    United States

    Site Not Available

  • Arcutis Clinical Site 85

    Lake Charles, Louisiana 70605
    United States

    Site Not Available

  • Arcutis Clinical Site 24

    Metairie, Louisiana 70006
    United States

    Site Not Available

  • Arcutis Clinical Site 76

    Rockville, Maryland 20850
    United States

    Site Not Available

  • Arcutis Clinical Site 94

    Bay City, Michigan 48706
    United States

    Site Not Available

  • Arcutis Clinical Site 88

    Clarkston, Michigan 48346
    United States

    Site Not Available

  • Arcutis Clinical Site 58

    Clinton Township, Michigan 48038
    United States

    Site Not Available

  • Arcutis Clinical Site 66

    Detroit, Michigan 48202
    United States

    Site Not Available

  • Arcutis Clinical Site 132

    Troy, Michigan 48084
    United States

    Site Not Available

  • Clinical Site 10

    New Brighton, Minnesota 55112
    United States

    Site Not Available

  • Arcutis Clinical Site 102

    Saint Joseph, Missouri 64506
    United States

    Site Not Available

  • Arcutis Clinical Site 62

    Reno, Nevada 89509
    United States

    Site Not Available

  • Arcutis Clinical Site 71

    East Windsor, New Jersey 08520
    United States

    Site Not Available

  • Arcutis Clinical Site 96

    Kew Gardens, New York 11415
    United States

    Site Not Available

  • Arcutis Clinical Site 82

    Rochester, New York 14623
    United States

    Site Not Available

  • Arcutis Clinical Site 19

    High Point, North Carolina 27262
    United States

    Site Not Available

  • Arcutis Clinical Site 17

    Gresham, Oregon 97030
    United States

    Site Not Available

  • Arcutis Clinical Site 108

    Portland, Oregon 97210
    United States

    Site Not Available

  • Arcutis Clinical Site 14

    Portland, Oregon 97239
    United States

    Site Not Available

  • Arcutis Clinical Site 16

    Portland, Oregon 97223
    United States

    Site Not Available

  • Arcutis Clinical Site 53

    Hershey, Pennsylvania 17033
    United States

    Site Not Available

  • Arcutis Clinical Site 64

    Newtown Square, Pennsylvania 19073
    United States

    Site Not Available

  • Arcutis Clinical Site 25

    Pittsburgh, Pennsylvania 15213
    United States

    Site Not Available

  • Arcutis Clinical Site 101

    Johnston, Rhode Island 02919
    United States

    Site Not Available

  • Arcutis Clinical Site 41

    Charleston, South Carolina 29425
    United States

    Site Not Available

  • Arcutis Clinical Site 77

    Charleston, South Carolina 29407
    United States

    Site Not Available

  • Clinical Site 33

    North Charleston, South Carolina 29420
    United States

    Site Not Available

  • Arcutis Clinical Site 91

    Summerville, South Carolina 29486
    United States

    Site Not Available

  • Arcutis Clinical Site 60

    Murfreesboro, Tennessee 37130
    United States

    Site Not Available

  • Arcutis Clinical Site 34

    Arlington, Texas 76011
    United States

    Site Not Available

  • Clinical Site 23

    Austin, Texas 78759
    United States

    Site Not Available

  • Arcutis Clinical Site 84

    Bellaire, Texas 77401
    United States

    Site Not Available

  • Arcutis Clinical Site 21

    College Station, Texas 77845
    United States

    Site Not Available

  • Arcutis Clinical Site 126

    Frisco, Texas 75034
    United States

    Site Not Available

  • Arcutis Clinical Site 118

    Grapevine, Texas 76051
    United States

    Site Not Available

  • Arcutis Clinical Site 35

    Houston, Texas 77056
    United States

    Site Not Available

  • Arcutis Clinical Site 48

    Houston, Texas 77030
    United States

    Site Not Available

  • Arcutis Clinical Site 109

    Katy, Texas 77494
    United States

    Site Not Available

  • Arcutis Clinical Site 49

    San Antonio, Texas 78218
    United States

    Site Not Available

  • Clinical Site 20

    San Antonio, Texas 78213
    United States

    Site Not Available

  • Arcutis Clinical Site 74

    Orem, Utah 84058
    United States

    Site Not Available

  • Arcutis Clinical Site 36

    West Jordan, Utah 84088
    United States

    Site Not Available

  • Arcutis Clinical Site 51

    Burke, Virginia 22015
    United States

    Site Not Available

  • Arcutis Clinical Site 40

    Norfolk, Virginia 23502
    United States

    Site Not Available

  • Arcutis Clinical Site 12

    Spokane, Washington 99202
    United States

    Site Not Available

  • Arcutis Clinical Site 133

    Kenosha, Wisconsin 53142
    United States

    Site Not Available

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