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Atopic Dermatitis EczemaPhase 3INTEGUMENT-OLENCT04804605

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

A Phase 3 study testing ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05% in people with Atopic Dermatitis Eczema, run by Arcutis Biotherapeutics, Inc. at 92 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Read more about this study

Who is it for?
Ages 2 years and older
Conditions the study is for
Atopic Dermatitis Eczema
What is being tested?
ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
Could I receive a placebo?
No, everyone receives an active treatment
How many people
1,220 participants
Where
92 sitesin 2 countries
Study dates
25 Feb 2021to 28 May 2024
Phase
Phase 3

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 2 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.
  • 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.)
  • 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.
  • 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.
  • 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).
  • 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.

Who cannot join

  • Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.
  • Subjects that use any Excluded Medications and Treatments.
  • 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.
  • Subjects with known genetic dermatological conditions that overlap with AD.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • 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.
  • 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.

Trial locations and contacts

92 sites in 2 countries.

92 sites in 2 countries

United States76 sites

  • Arcutis Clinical Site 34

    Arlington, Texas, 76011

  • Clinical Site 23

    Austin, Texas, 78759

  • Arcutis Clinical Site 94

    Bay City, Michigan, 48706

  • Arcutis Clinical Site 84

    Bellaire, Texas, 77401

  • Arcutis Clinical Site 69

    Beverly Hills, California, 90212

  • Arcutis Clinical Site 112

    Birmingham, Alabama, 35209

  • Arcutis Clinical Site 73

    Birmingham, Alabama, 35244

  • Arcutis Clinical Site 145

    Boise, Idaho, 83706

  • Arcutis Clinical Site 106

    Bryant, Arkansas, 72022

  • Arcutis Clinical Site 51

    Burke, Virginia, 22015

  • Arcutis Clinical Site 123

    Centennial, Colorado, 80112

  • Arcutis Clinical Site 77

    Charleston, South Carolina, 29407

  • Arcutis Clinical Site 41

    Charleston, South Carolina, 29425

  • Arcutis Clinical Site 88

    Clarkston, Michigan, 48346

  • Arcutis Clinical Site 93

    Clarksville, Indiana, 47129

  • Arcutis Clinical Site 58

    Clinton Township, Michigan, 48038

  • Arcutis Clinical Site 21

    College Station, Texas, 77845

  • Arcutis Clinical Site 59

    Coral Gables, Florida, 33134

  • Arcutis Clinical Site 72

    Coral Gables, Florida, 33146

  • Arcutis Clinical Site 80

    Covington, Louisiana, 70433

  • Arcutis Clinical Site 79

    Delray Beach, Florida, 33484

  • Arcutis Clinical Site 66

    Detroit, Michigan, 48202

  • Arcutis Clinical Site 71

    East Windsor, New Jersey, 08520

  • Arcutis Clinical Site 116

    Fort Smith, Arkansas, 72916

  • Arcutis Clinical Site 126

    Frisco, Texas, 75034

  • Arcutis Clinical Site 118

    Grapevine, Texas, 76051

  • Arcutis Clinical Site 17

    Gresham, Oregon, 97030

  • Arcutis Clinical Site 53

    Hershey, Pennsylvania, 17033

  • Arcutis Clinical Site 19

    High Point, North Carolina, 27262

  • Arcutis Clinical Site 103

    Hollywood, Florida, 33021

  • Arcutis Clinical Site 48

    Houston, Texas, 77030

  • Arcutis Clinical Site 35

    Houston, Texas, 77056

  • Arcutis Clinical Site 81

    Inglewood, California, 90301

  • Clinical Site 04

    Jacksonville, Florida, 32256

  • Arcutis Clinical Site 101

    Johnston, Rhode Island, 02919

  • Arcutis Clinical Site 109

    Katy, Texas, 77494

  • Arcutis Clinical Site 133

    Kenosha, Wisconsin, 53142

  • Arcutis Clinical Site 96

    Kew Gardens, New York, 11415

  • Arcutis Clinical Site 85

    Lake Charles, Louisiana, 70605

  • Arcutis Clinical Site 15

    Largo, Florida, 33770

  • Clinical Site 03

    Louisville, Kentucky, 40217

  • Arcutis Clinical Site 24

    Metairie, Louisiana, 70006

  • Arcutis Clinical Site 67

    Miami, Florida, 33162

  • Arcutis Clinical Site 95

    Miami, Florida, 33173

  • Arcutis Clinical Site 68

    Miami, Florida, 33174

  • Arcutis Clinical Site 60

    Murfreesboro, Tennessee, 37130

  • Clinical Site 10

    New Brighton, Minnesota, 55112

  • Arcutis Clinical Site 64

    Newtown Square, Pennsylvania, 19073

  • Arcutis Clinical Site 40

    Norfolk, Virginia, 23502

  • Clinical Site 33

    North Charleston, South Carolina, 29420

  • Arcutis Clinical Site 74

    Orem, Utah, 84058

  • Arcutis Clinical Site 25

    Pittsburgh, Pennsylvania, 15213

  • Clinical Site 22

    Plainfield, Indiana, 46168

  • Arcutis Clinical Site 108

    Portland, Oregon, 97210

  • Arcutis Clinical Site 16

    Portland, Oregon, 97223

  • Arcutis Clinical Site 14

    Portland, Oregon, 97239

  • Arcutis Clinical Site 62

    Reno, Nevada, 89509

  • Arcutis Clinical Site 82

    Rochester, New York, 14623

  • Arcutis Clinical Site 76

    Rockville, Maryland, 20850

  • Arcutis Clinical Site 13

    Rolling Meadows, Illinois, 33770

  • Arcutis Clinical Site 102

    Saint Joseph, Missouri, 64506

  • Clinical Site 20

    San Antonio, Texas, 78213

  • Arcutis Clinical Site 49

    San Antonio, Texas, 78218

  • Clinical Site 08

    San Francisco, California, 94132

  • Arcutis Clinical Site 47

    Sandy Springs, Georgia, 30328

  • Arcutis Clinical Site 29

    Sanford, Florida, 32771

  • Arcutis Clinical Site 31

    Santa Monica, California, 90404

  • Arcutis Clinical Site 63

    Scottsdale, Arizona, 85255

  • Arcutis Clinical Site 12

    Spokane, Washington, 99202

  • Arcutis Clinical Site 91

    Summerville, South Carolina, 29486

  • Clinical Site 01

    Tampa, Florida, 33613

  • Arcutis Clinical Site 130

    Thousand Oaks, California, 91320

  • Arcutis Clinical Site 132

    Troy, Michigan, 48084

  • Arcutis Clinical Site 138

    Wellington, Florida, 33449

  • Arcutis Clinical Site 36

    West Jordan, Utah, 84088

  • Arcutis Clinical Site 114

    West Lafayette, Indiana, 47906

Other trials in United States

Canada16 sites

  • Arcutis Clinical Site 43

    Ajax, Ontario, L1S 7K8

  • Arcutis Clinical Site 70

    Calgary, Alberta, T2J 7E1

  • Arcutis Clinical Site 26

    Drummondville, Quebec, J2B 5L4

  • Arcutis Clinical Site 50

    Fredericton, New Brunswick, E3B 1G9

  • Arcutis Clinical Site 52

    London, Ontario, N6H 5L5

  • Clinical Site 11

    Markham, Ontario, L3P 1X3

  • Clinical Site 46

    Mississauga, Ontario, L5H 1G9

  • Arcutis Clinical Site 45

    Montreal, Quebec, H2X 2V1

  • Arcutis Clinical Site 56

    Montreal, Quebec, H3Z 2S6

  • Arcutis Clinical Site 46

    Montréal, Ontario, H2X 2V1

  • Arcutis Clinical Site 61

    Peterborough, Ontario, K9J 5K2

  • Arcutis Clinical Site 27

    Surrey, British Columbia, V3R 6A7

  • Arcutis Clinical Site 54

    Toronto, Ontario, M4W 2N4

  • Arcutis Clinical Site 39

    Waterloo, Ontario, N2J 1C4

  • Clinical Site 09

    Windsor, Ontario, N8W 1E6

  • Arcutis Clinical Site 55

    Winnipeg, Manitoba, R3M 3Z4

Other trials in Canada

About this study

Official title: 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 was a Phase 3, multicenter, open-label extension study of the long-term safety of roflumilast cream 0.15% (completers of studies ARQ-151-311 or ARQ-151-312 aged ≥6 years and ARQ-151-315 rollovers who turned 6 years of age on study) or roflumilast cream 0.05% (ARQ-151-315 rollovers aged 2 to 5 years). Participants with mild to moderate atopic dermatitis (AD) applied roflumilast cream once daily (qd) for up to 52 weeks.

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

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

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

    Also called Roflumilast

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

Study groups in NCT04804605
Study groupRoleWhat they receive
ARQ-151 Cream 0.05%ExperimentalParticipants applied ARQ-151 Cream 0.05% once daily (qd) for up to 52 weeks.
Receives: Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Participants With ≥1 Treatment-emergent Adverse Event (TEAE)

    The number of participants with ≥1 TEAE(s) is reported.

    Measured: Up to 52 weeks

Secondary outcomes (4)

  1. 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 as score of 0 'clear' to 4 'severe' ), with lower scores indicating reduced symptom severity and vice versa. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.

    Measured: Weeks 4, 12, 24, 36, and 52

  2. Percentage of Participants With vIGA-AD Success

    The percentage of participants with vIGA-AD "success" is presented. Success is defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline. Multiple imputation was used to handle missing data up to Week 24 or 52 for 24- and 52-week cohorts.

    Measured: Weeks 4, 12, 24, 36, and 52

  3. Change From Baseline in Worst Itch-Numeric Rating Scale (WI-NRS) Score Over Time in Participants ≥12 Years of Age in Parent Study

    Change from baseline in WI-NRS score is reported. 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"), with lower scores indicating reduced symptom severity and vice versa.

    Measured: Weeks 4, 12, 24, 36, and 52

  4. Percent Change From Baseline in EASI Score

    EASI is an instrument to measure the severity and extent of AD. The body is first divided into 4 areas: head (10% of skin), arms (20%), trunk (30%), and legs (40%). Then, the area affected is scored from 0 (0% involvement) to 6 (90%-100% involvement), and severity is scored from 0 ('none') to 3 ('severe'). EASI combines the area affected and severity ratings to get a final composite score ranging from 0 (no disease) to 72 (severe disease). Note that palms and soles were treated as appropriate but were not counted towards any measurements of EASI.

    Measured: Weeks 4, 12, 24, 36, and 52

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Mar 2021
  2. Study start25 Feb 2021
  3. Primary completion28 May 2024
  4. Study completion28 May 2024

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
1,220 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04804605
Sponsor's protocol ID
ARQ-151-313
Acronym
INTEGUMENT-OLE
Status last verified
Dec 2025
First submitted
16 Mar 2021
Last updated
23 Dec 2025
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

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