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Atopic Dermatitis EczemaPhase 3NCT04773600

Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)

A Phase 3 study testing Roflumilast Cream in people with Atopic Dermatitis Eczema, run by Arcutis Biotherapeutics, Inc. at 53 sites in 2 countries.

Completed

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

Official record
Search all trials

Trial summary

This study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with… 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
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
683 participants
Where
53 sitesin 2 countries
Study dates
24 Feb 2021to 29 Sep 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

53 sites in 2 countries.

53 sites in 2 countries

United States44 sites

  • Clinical Site 05

    Austin, Texas, 78759

  • Arcutis Clinical Site 63

    Baton Rouge, Louisiana, 70808

  • Arcutis Clinical Site 31

    Birmingham, Alabama, 35244

  • Arcutis Clinical Site 55

    Boca Raton, Florida, 33486

  • Arcutis Clinical Site 62

    Boise, Idaho, 83706

  • Arcutis Clinical Site 22

    Burke, Virginia, 22015

  • Arcutis Clinical Site 54

    Centennial, Colorado, 80112

  • Arcutis Clinical Site 35

    Charleston, South Carolina, 29407

  • Arcutis Clinical Site 18

    Charleston, South Carolina, 29425

  • Arcutis Clinical Site 29

    Clinton Township, Michigan, 48038

  • Arcutis Clinical Site 03

    College Station, Texas, 77845

  • Arcutis Clinical Site 30

    Coral Gables, Florida, 33146

  • Arcutis Clinical Site 37

    Delray Beach, Florida, 33484

  • Arcutis Clinical Site 21

    Fort Gratiot, Michigan, 48059

  • Arcutis Clinical Site 51

    Fort Smith, Arkansas, 72916

  • Arcutis Clinical Site 59

    Frisco, Texas, 75034

  • Arcutis Clinical Site 250

    Grapevine, Texas, 76051

  • Arcutis Clinical Site 24

    Hershey, Pennsylvania, 17033

  • Arcutis Clinical Site 01

    High Point, North Carolina, 27262

  • Arcutis Clinical Site 46

    Inglewood, California, 90301

  • Arcutis Clinical Site 42

    Lake Charles, Louisiana, 70605

  • Arcutis Clinical Site 43

    Louisville, Kentucky, 40241

  • Arcutis Clinical Site 38

    Mandeville, Louisiana, 70448

  • Arcutis Clinical Site 06

    Metairie, Louisiana, 70006

  • Arcutis Clinical Site 58

    Miami, Florida, 33137

  • Arcutis Clinical Site 41

    Miami, Florida, 33144

  • Arcutis Clinical Site 53

    New York, New York, 11415

  • Arcutis Clinical Site 17

    Norfolk, Virginia, 23502

  • Arcutis Clinical Site 15

    North Charleston, South Carolina, 29420

  • Arcutis Clinical Site 32

    Orem, Utah, 84058

  • Arcutis Clinical Site 52

    Pflugerville, Texas, 78660

  • Arcutis Clinical Site 07

    Pittsburgh, Pennsylvania, 15213

  • Clinical Site 04

    Plainfield, Indiana, 46168

  • Arcutis Clinical Site 39

    Rochester, New York, 14623

  • Arcutis Clinical Site 34

    Rockville, Maryland, 20850

  • Arcutis Clinical Site 245

    Saint Joseph, Missouri, 64506

  • Arcutis Clinical Site 02

    San Antonio, Texas, 78213

  • Arcutis Clinical Site 19

    San Diego, California, 92123

  • Arcutis Clinical Site 36

    San Diego, California, 92123

  • Arcutis Clinical Site 11

    Sanford, Florida, 32771

  • Arcutis Clinical Site 13

    Santa Monica, California, 90404

  • Arcutis Clinical Site 33

    Stony Brook, New York, 11790

  • Arcutis Clinical Site 61

    Troy, Michigan, 48084

  • Arcutis Clinical Site 57

    West Palm Beach, Florida, 33406

Other trials in United States

Canada9 sites

  • Arcutis Clinical Site 20

    Ajax, Ontario, L1S 7K8

  • Arcutis Clinical Site 12

    Calgary, Alberta, T2G 1B1

  • Arcutis Clinical Site 08

    Drummondville, Quebec, J2B 5L4

  • Arcutis Clinical Site 23

    London, Ontario, N6H 5L5

  • Arcutis Clinical Site 27

    Québec, Quebec, H3Z 2S6

  • Arcutis Clinical Site 09

    Surrey, British Columbia, V3R 6A7

  • Arcutis Clinical Site 25

    Toronto, Ontario, M4W 2N4

  • Arcutis Clinical Site 16

    Waterloo, Ontario, N2J 1C4

  • Arcutis Clinical Site 26

    Winnipeg, Manitoba, R3M 3Z4

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 study will assess the safety and efficacy of ARQ-151 cream vs vehicle applied once a day for 4 weeks by subjects with atopic dermatitis (eczema). This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 0.15% cream or vehicle is applied once daily (qd) for 4 weeks by participants with atopic dermatitis.

Being tested
Roflumilast Cream, Vehicle cream

What participants receive

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

  • Roflumilast CreamDrug

    Also called ARQ-151

    Roflumilast cream 0.15% for topical application

  • Vehicle creamDrug

    Vehicle cream for topical application

Study groups in NCT04773600
Study groupRoleWhat they receive
Roflumilast Cream 0.15%ExperimentalParticipants apply roflumilast cream 0.15% once daily (qd) for 4 weeks.
Receives: Drug: Roflumilast Cream
Vehicle CreamPlacebo comparatorParticipants apply 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. vIGA-AD Success at Week 2

    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 2

  3. vIGA-AD Success at Week 1

    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 1

  4. Achievement of a 4-point Reduction at Week 4 in the Average, Weekly Worst Itch Numeric Rating Scale (WI-NRS) in Participants With Baseline WI-NRS Score ≥4

    The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success 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

  5. Achievement of a 4-point Reduction at Week 2 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4

    The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success 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

  6. Achievement of a 4-point Reduction at Week 1 in the WI-NRS in Participants With Baseline WI-NRS Score ≥4

    The percentage of participants with a baseline WI-NRS ≥ 4 achieving WI-NRS success 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

  7. Achievement of ≥75% Decrease From Baseline at Week 4 in the Eczema Area and Severity Index (EASI-75)

    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

  8. 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 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

  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 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 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 start24 Feb 2021
  3. Primary completion29 Sep 2022
  4. Study completion29 Sep 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
683 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04773600
Sponsor's protocol ID
ARQ-151-312
Status last verified
Sep 2024
First submitted
24 Feb 2021
Last updated
4 Oct 2024
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 in people with Atopic Dermatitis Eczema, run by Arcutis Biotherapeutics, Inc. at 53 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 4 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 53 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 4 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 NCT04773600, 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 4 Oct 2024.

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