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Atopic Dermatitis EczemaPhase 3INTEGUMENT-INCT04773587

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

A Phase 3 study testing Roflumilast Cream 0.15% in people with Atopic Dermatitis Eczema, run by Arcutis Biotherapeutics, Inc. at 49 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 is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema). Read more about this study

Who is it for?
Ages 6 years and older
Conditions the study is for
Atopic Dermatitis Eczema
What is being tested?
Roflumilast Cream 0.15%
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
654 participants
Where
49 sitesin 2 countries
Study dates
27 Jan 2021to 30 Aug 2022
Phase
Phase 3
Are there results?
Yes, posted in the registrySummary in the doctors' view

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

Who may be able to join

  • Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.
  • Males and females, ages 6 years and older at time of signing Informed Consent (Screening). Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.
  • Diagnosed with atopic dermatitis 6 months duration (3 months for children), as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.
  • Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening and a negative urine pregnancy test at Baseline/Day 1. 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.
  • In good health as judged by the Investigator.
  • Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Who cannot join

  • Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator
  • Has unstable AD or any consistent requirement for high potency topical steroids.
  • Subjects who are unwilling to refrain from prolonged sun exposure and from using a tanning bed or other artificial light emitting devices (LEDs) for 4 weeks prior to Baseline/Day 1 and during the study.
  • Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
  • Previous treatment with ARQ-151.
  • Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.
  • Parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are unable to communicate, read or understand the local language, 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 living in the same house.

Trial locations and contacts

49 sites in 2 countries.

49 sites in 2 countries

United States42 sites

  • Arcutis Clinical Site 19

    Arlington, Texas, 76011

  • Arcutis Clinical Site 55

    Auburn Hills, Michigan, 48326

  • Arcutis Clinical Site 54

    Bay City, Michigan, 48706

  • Arcutis Clinical Site 43

    Bellaire, Texas, 77401

  • Arcutis Clinical Site 40

    Beverly Hills, California, 90212

  • Arcutis Clinical Site 46

    Clarkston, Michigan, 48346

  • Arcutis Clinical Site 48

    Clarksville, Indiana, 47129

  • Arcutis Clinical Site 30

    Coral Gables, Florida, 33134

  • Arcutis Clinical Site 37

    Detroit, Michigan, 48202

  • Arcutis Clinical Site 42

    East Windsor, New Jersey, 08520

  • Arcutis Clinical Site 06

    Encinitas, California, 92024

  • Arcutis Clinical Site 17

    Gresham, Oregon, 97030

  • Arcutis Clinical Site 27

    Houston, Texas, 77030

  • Arcutis Clinical Site 20

    Houston, Texas, 77056

  • Arcutis Clinical Site 02

    Indianapolis, Indiana, 46250

  • Arcutis Clinical Site 04

    Jacksonville, Florida, 32256

  • Arcutis Clinical Site 101

    Johnston, Rhode Island, 02919

  • Arcutis Clinical Site 15

    Largo, Florida, 33770

  • Arcutis Clinical Site 58

    Little Rock, Arkansas, 72212

  • Arcutis Clinical Site 52

    Los Angeles, California, 90056

  • Arcutis Clinical Site 03

    Louisville, Kentucky, 40217

  • Arcutis Clinical Site 39

    Miami Lakes, Florida, 33014

  • Arcutis Clinical Site 57

    Montgomery, Alabama, 36117

  • Arcutis Clinical Site 31

    Murfreesboro, Tennessee, 37130

  • Arcutis Clinical Site 10

    New Brighton, Minnesota, 55112

  • Arcutis Clinical Site 35

    Newtown Square, Pennsylvania, 19073

  • Arcutis Clinical Site 38

    North Miami Beach, Florida, 33162

  • Arcutis Clinical Site 16

    Portland, Oregon, 97223

  • Arcutis Clinical Site 14

    Portland, Oregon, 97239

  • Arcutis Clinical Site 33

    Reno, Nevada, 89509

  • Arcutis Clinical Site 36

    Rockville, Maryland, 20850

  • Arcutis Clinical Site 13

    Rolling Meadows, Illinois, 33770

  • Arcutis Clinical Site 28

    San Antonio, Texas, 78218

  • Arcutis Clinical Site 05

    San Diego, California, 92123

  • Arcutis Clinical Site 08

    San Francisco, California, 94132

  • Arcutis Clinical Site 26

    Sandy Springs, Georgia, 30328

  • Arcutis Clinical Site 34

    Scottsdale, Arizona, 85255

  • Arcutis Clinical Site 21

    South Jordan, Utah, 84095

  • Arcutis Clinical Site 12

    Spokane, Washington, 99202

  • Arcutis Clinical Site 01

    Tampa, Florida, 33613

  • Arcutis Clinical Site 62

    Thousand Oaks, California, 91320

  • Arcutis Clinical Site 61

    Wellington, Florida, 33449

Other trials in United States

Canada7 sites

  • Arcutis Clinical Site 41

    Calgary, Alberta, T2J 7E1

  • Arcutis Clinical Site 29

    Fredericton, New Brunswick, E3B 1G9

  • Arcutis Clinical Site 11

    Markham, Ontario, L3P 1X3

  • Clinical Site 25

    Mississauga, Ontario, L5H 1G9

  • Arcutis Clinical Site 24

    Montreal, Quebec, H2X 2V1

  • Arcutis Clinical Site 32

    Peterborough, Ontario, K9J 5K2

  • Arcutis Clinical Site 09

    Windsor, Ontario, N8W 1E6

Other trials in Canada

About this study

Official title: A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.15% Administered QD in Subjects With Atopic Dermatitis

This is a parallel group, double blind, vehicle-controlled study to assess the safety and efficacy of roflumilast (ARQ-151) cream vs vehicle applied once daily (qd) for 4 weeks by participants with atopic dermatitis (eczema).

Being tested
Roflumilast Cream 0.15%, Vehicle Cream

What participants receive

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

  • Roflumilast Cream 0.15%Drug

    Also called ARQ-151

    Roflumilast Cream 0.15% - Active

  • Vehicle CreamDrug

    Cream - Vehicle

Study groups in NCT04773587
Study groupRoleWhat they receive
Roflumilast Cream 0.15%ExperimentalParticipants with mild to moderate AD apply roflumilast cream 0.15% QD for 4 weeks.
Receives: Drug: Roflumilast Cream 0.15%
Vehicle CreamPlacebo comparatorParticipants with mild to moderate AD applied vehicle cream QD for 4 weeks.
Receives: Drug: Vehicle Cream

What is being measured

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

  1. Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4

    The percentage of participants achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. 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), with higher scores indicative of greater symptom severity.

    Measured: Week 4

Secondary outcomes (10)

  1. Achievement of vIGA-AD Success at Week 4 in Participants With "Moderate" Baseline Scores

    The percentage of participants with moderate baseline scores achieving vIGA-AD "success" is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline in participants with a 'moderate' baseline vIGA-AD score. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Measured: Week 4

  2. Achievement of a 4-Point Reduction in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) at Week 4 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 4 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

    Measured: Week 4

  3. Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 2 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 2 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

    Measured: Week 2

  4. Achievement of a 4-Point Reduction in the Average, Weekly WI-NRS at Week 1 in Participants ≥12 Years of Age With Baseline WI-NRS ≥ 4

    The percentage of participants ≥12 years of age with a baseline WI-NRS ≥4 achieving WI-NRS success at Week 1 is presented with multiple imputation of missing observations. The WI-NRS is a simple, single item scale to assess the subject-reported severity of this symptom, on a scale ranging from 0 ("no itch") to 10 ("worst imaginable itch") the participant experienced in the previous 24 hours (higher scores indicate higher itch severity).

    Measured: Week 1

  5. Achievement of ≥ 75% Reduction in the Eczema Area and Severity Index (EASI-75) at Week 4

    The percentage of participants achieving EASI-75 is presented with multiple imputation of missing observations. EASI-75 is a ≥75% reduction from the baseline EASI score. 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.

    Measured: Week 4

  6. Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 4

    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Measured: Week 4

  7. Achievement of vIGA-AD Success at Week 2

    The percentage of participants achieving "success" on the VIGA-AD at Week 2 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Measured: Week 2

  8. Achievement of vIGA-AD Success at Week 1

    The percentage of participants achieving "success" on the VIGA-AD at Week 1 is presented with multiple imputation of missing observations. vIGA-AD "success" is defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Measured: Week 1

  9. Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 2

    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Measured: Week 2

  10. Achievement of vIGA-AD Score of 'Clear' or 'Almost Clear' at Week 1

    The percentage of participants scoring 'clear' or 'almost clear' on vIGA-AD at Week 4 is presented with multiple imputation of missing observations. The vIGA-AD is a static evaluation of qualitative overall AD severity. This global assessment scale is an ordinal scale with five severity grades (0 'clear' to 4 'severe'), with higher scores indicative of greater symptom severity.

    Measured: Week 1

Timeline

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

  1. First posted26 Feb 2021
  2. Study start27 Jan 2021
  3. Primary completion30 Aug 2022
  4. Study completion30 Aug 2022

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
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
654 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773587
Sponsor's protocol ID
ARQ-151-311
Acronym
INTEGUMENT-I
Status last verified
Sep 2024
First submitted
24 Feb 2021
Last updated
9 Oct 2024
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No

Publications

  • Simpson EL, Eichenfield LF, Alonso-Llamazares J, Draelos ZD, Ferris LK, Forman SB, Gooderham M, Gonzalez ME, Hebert AA, Kircik LH, Lomaga M, Moore A, Papp KA, Prajapati VH, Hanna D, Snyder S, Krupa D, Burnett P, Almaraz E, Higham RC, Chu DH, Berk DR. Roflumilast Cream, 0.15%, for Atopic Dermatitis in Adults and Children: INTEGUMENT-1 and INTEGUMENT-2 Randomized Clinical Trials. JAMA Dermatol. 2024 Nov 1;160(11):1161-1170. doi: 10.1001/jamadermatol.2024.3121.

    PubMed 39292443

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Roflumilast Cream 0.15% in people with Atopic Dermatitis Eczema, run by Arcutis Biotherapeutics, Inc. at 49 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 9 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 49 sites in United States, Canada. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 9 Oct 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Achievement of Validated Investigator Global Assessment for Atopic Dermatitis (vIGA-AD) Success at Week 4 (time frame: Week 4). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04773587, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Oct 2024.

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