Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-OLE)

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

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).

Study Overview

• Status: Active, not recruiting
• Conditions: Atopic Dermatitis Eczema
• Intervention / Treatment: Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

Detailed 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).

• Study Type: Interventional
• Enrollment (Actual): 1220
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Arcutis Medical Information; Phone Number: 1-844-692-6729; Email: medinfo@arcutis.com

Study Locations

• Canada
  • Alberta
    • Calgary, Alberta, Canada, T2J 7E1
      • Arcutis Clinical Site 70
  • British Columbia
    • Surrey, British Columbia, Canada, V3R 6A7
      • Arcutis Clinical Site 27
  • Manitoba
    • Winnipeg, Manitoba, Canada, R3M 3Z4
      • Arcutis Clinical Site 55
  • New Brunswick
    • Fredericton, New Brunswick, Canada, E3B 1G9
      • Arcutis Clinical Site 50
  • Ontario
    • Ajax, Ontario, Canada, L1S 7K8
      • Arcutis Clinical Site 43
    • London, Ontario, Canada, N6H 5L5
      • Arcutis Clinical Site 52
    • Markham, Ontario, Canada, L3P 1X3
      • Clinical site 11
    • Mississauga, Ontario, Canada, L5H 1G9
      • Clinical Site 46
    • Montréal, Ontario, Canada, H2X 2V1
      • Arcutis Clinical Site 46
    • Peterborough, Ontario, Canada, K9J 5K2
      • Arcutis Clinical Site 61
    • Toronto, Ontario, Canada, M4W 2N4
      • Arcutis Clinical Site 54
    • Waterloo, Ontario, Canada, N2J 1C4
      • Arcutis Clinical Site 39
    • Windsor, Ontario, Canada, N8W 1E6
      • Clinical Site 09
  • Quebec
    • Drummondville, Quebec, Canada, J2B 5L4
      • Arcutis Clinical Site 26
    • Montréal, Quebec, Canada, H2X 2V1
      • Arcutis Clinical Site 45
    • Montréal, Quebec, Canada, H3Z 2S6
      • Arcutis Clinical Site 56
• United States
  • Alabama
    • Birmingham, Alabama, United States, 35209
      • Arcutis Clinical Site 112
    • Birmingham, Alabama, United States, 35244
      • Arcutis Clinical Site 73
  • Arizona
    • Scottsdale, Arizona, United States, 85255
      • Arcutis Clinical Site 63
  • Arkansas
    • Bryant, Arkansas, United States, 72022
      • Arcutis Clinical Site 106
    • Fort Smith, Arkansas, United States, 72916
      • Arcutis Clinical Site 116
  • California
    • Beverly Hills, California, United States, 90212
      • Arcutis Clinical Site 69
    • Inglewood, California, United States, 90301
      • Arcutis Clinical Site 81
    • San Francisco, California, United States, 94132
      • Clinical Site 08
    • Santa Monica, California, United States, 90404
      • Arcutis Clinical Site 31
    • Thousand Oaks, California, United States, 91320
      • Arcutis Clinical Site 130
  • Colorado
    • Centennial, Colorado, United States, 80112
      • Arcutis Clinical Site 123
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Arcutis Clinical Site 59
    • Coral Gables, Florida, United States, 33146
      • Arcutis Clinical Site 72
    • Delray Beach, Florida, United States, 33484
      • Arcutis Clinical Site 79
    • Hollywood, Florida, United States, 33021
      • Arcutis Clinical Site 103
    • Jacksonville, Florida, United States, 32256
      • Clinical Site 04
    • Largo, Florida, United States, 33770
      • Arcutis Clinical Site 15
    • Miami, Florida, United States, 33162
      • Arcutis Clinical Site 67
    • Miami, Florida, United States, 33173
      • Arcutis Clinical Site 95
    • Miami, Florida, United States, 33174
      • Arcutis Clinical Site 68
    • Sanford, Florida, United States, 32771
      • Arcutis Clinical Site 29
    • Tampa, Florida, United States, 33613
      • Clinical site 01
    • Wellington, Florida, United States, 33449
      • Arcutis Clinical Site 138
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Arcutis Clinical Site 47
  • Idaho
    • Boise, Idaho, United States, 83706
      • Arcutis Clinical Site 145
  • Illinois
    • Rolling Meadows, Illinois, United States, 33770
      • Arcutis Clinical Site 13
  • Indiana
    • Clarksville, Indiana, United States, 47129
      • Arcutis Clinical Site 93
    • Plainfield, Indiana, United States, 46168
      • Clinical Site 22
    • West Lafayette, Indiana, United States, 47906
      • Arcutis Clinical Site 114
  • Kentucky
    • Louisville, Kentucky, United States, 40217
      • Clinical Site 03
  • Louisiana
    • Covington, Louisiana, United States, 70433
      • Arcutis Clinical Site 80
    • Lake Charles, Louisiana, United States, 70605
      • Arcutis Clinical Site 85
    • Metairie, Louisiana, United States, 70006
      • Arcutis Clinical Site 24
  • Maryland
    • Rockville, Maryland, United States, 20850
      • Arcutis Clinical Site 76
  • Michigan
    • Bay City, Michigan, United States, 48706
      • Arcutis Clinical Site 94
    • Clarkston, Michigan, United States, 48346
      • Arcutis Clinical Site 88
    • Clinton Township, Michigan, United States, 48038
      • Arcutis Clinical Site 58
    • Detroit, Michigan, United States, 48202
      • Arcutis Clinical Site 66
    • Troy, Michigan, United States, 48084
      • Arcutis Clinical Site 132
  • Minnesota
    • New Brighton, Minnesota, United States, 55112
      • Clinical Site 10
  • Missouri
    • Saint Joseph, Missouri, United States, 64506
      • Arcutis Clinical Site 102
  • Nevada
    • Reno, Nevada, United States, 89509
      • Arcutis Clinical Site 62
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Arcutis Clinical Site 71
  • New York
    • Kew Gardens, New York, United States, 11415
      • Arcutis Clinical Site 96
    • Rochester, New York, United States, 14623
      • Arcutis Clinical Site 82
  • North Carolina
    • High Point, North Carolina, United States, 27262
      • Arcutis Clinical Site 19
  • Oregon
    • Gresham, Oregon, United States, 97030
      • Arcutis Clinical Site 17
    • Portland, Oregon, United States, 97223
      • Arcutis Clinical Site 16
    • Portland, Oregon, United States, 97239
      • Arcutis Clinical Site 14
    • Portland, Oregon, United States, 97210
      • Arcutis Clinical Site 108
  • Pennsylvania
    • Hershey, Pennsylvania, United States, 17033
      • Arcutis Clinical Site 53
    • Newtown Square, Pennsylvania, United States, 19073
      • Arcutis Clinical Site 64
    • Pittsburgh, Pennsylvania, United States, 15213
      • Arcutis Clinical Site 25
  • Rhode Island
    • Johnston, Rhode Island, United States, 02919
      • Arcutis Clinical Site 101
  • South Carolina
    • Charleston, South Carolina, United States, 29407
      • Arcutis Clinical Site 77
    • Charleston, South Carolina, United States, 29425
      • Arcutis Clinical Site 41
    • North Charleston, South Carolina, United States, 29420
      • Clinical Site 33
    • Summerville, South Carolina, United States, 29486
      • Arcutis Clinical Site 91
  • Tennessee
    • Murfreesboro, Tennessee, United States, 37130
      • Arcutis Clinical Site 60
  • Texas
    • Arlington, Texas, United States, 76011
      • Arcutis Clinical Site 34
    • Austin, Texas, United States, 78759
      • Clinical Site 23
    • Bellaire, Texas, United States, 77401
      • Arcutis Clinical Site 84
    • College Station, Texas, United States, 77845
      • Arcutis Clinical Site 21
    • Frisco, Texas, United States, 75034
      • Arcutis Clinical Site 126
    • Grapevine, Texas, United States, 76051
      • Arcutis Clinical Site 118
    • Houston, Texas, United States, 77030
      • Arcutis Clinical Site 48
    • Houston, Texas, United States, 77056
      • Arcutis Clinical Site 35
    • Katy, Texas, United States, 77494
      • Arcutis Clinical Site 109
    • San Antonio, Texas, United States, 78213
      • Clinical Site 20
    • San Antonio, Texas, United States, 78218
      • Arcutis Clinical Site 49
  • Utah
    • Orem, Utah, United States, 84058
      • Arcutis Clinical Site 74
    • West Jordan, Utah, United States, 84088
      • Arcutis Clinical Site 36
  • Virginia
    • Burke, Virginia, United States, 22015
      • Arcutis Clinical Site 51
    • Norfolk, Virginia, United States, 23502
      • Arcutis Clinical Site 40
  • Washington
    • Spokane, Washington, United States, 99202
      • Arcutis Clinical Site 12
  • Wisconsin
    • Kenosha, Wisconsin, United States, 53142
      • Arcutis Clinical Site 133

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.
2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)
3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.
4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of a highly effective or barrier method of contraception throughout the trial.
5. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).
6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further 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 of the 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 the Investigator, 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 are breast-feeding.
6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.
7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%	Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%; ARQ-151 Cream

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs	AEs and SAEs	24 or 52 weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment	The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (reported only in integers of 0 to 4 where 0 is clear).	24 or 52 weeks
vIGA-AD success	Defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline	24 or 52 weeks
WI-NRS score over time	WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' ("no itch" to "worst imaginable itch").	24 or 52 weeks
EASI score over time	EASI combines the assessment of the severity of lesions and the area affected into a single total score in the range 0 (no disease) to 72 (maximal disease). To calculate the EASI, the sum of the severity rating (0 to 3 with 3 being the most severe) for four clinical signs are multiplied with the numerical value of the area affected and with the percentage of the four body areas.	24 or 52 weeks

Collaborators and Investigators

• Sponsor: Arcutis Biotherapeutics, Inc.
• Investigators: Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study record dates

Study Major Dates

• Study Start (Actual): February 25, 2021
• Primary Completion (Estimated): May 31, 2024
• Study Completion (Estimated): May 31, 2024

Study Registration Dates

• First Submitted: March 16, 2021
• First Submitted That Met QC Criteria: March 17, 2021
• First Posted (Actual): March 18, 2021

Study Record Updates

• Last Update Posted (Estimated): December 1, 2023
• Last Update Submitted That Met QC Criteria: November 29, 2023
• Last Verified: November 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Immune System Diseases; Hypersensitivity, Immediate; Genetic Diseases, Inborn; Skin Diseases, Genetic; Hypersensitivity; Skin Diseases, Eczematous; Dermatitis; Eczema; Dermatitis, Atopic
• Other Study ID Numbers: ARQ-151-313

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No