Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (INTEGUMENT-II)
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| ClinicalTrials.gov Identifier: NCT04773600 |
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Recruitment Status :
Completed
First Posted : February 26, 2021
Last Update Posted : October 31, 2022
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Sponsor:
Arcutis Biotherapeutics, Inc.
Information provided by (Responsible Party):
Arcutis Biotherapeutics, Inc.
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Brief 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).
| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Atopic Dermatitis Eczema | Drug: ARQ-151 Active Drug: ARQ-151 Vehicle Cream | Phase 3 |
| Study Type : | Interventional (Clinical Trial) |
| Actual Enrollment : | 683 participants |
| Allocation: | Randomized |
| Intervention Model: | Parallel Assignment |
| Masking: | Triple (Participant, Care Provider, Investigator) |
| Primary Purpose: | Treatment |
| 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 |
| Actual Study Start Date : | February 24, 2021 |
| Actual Primary Completion Date : | September 29, 2022 |
| Actual Study Completion Date : | September 29, 2022 |
Resource links provided by the National Library of Medicine
MedlinePlus Genetics related topics:
Atopic dermatitis
MedlinePlus related topics:
Eczema
| Arm | Intervention/treatment |
|---|---|
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Active Comparator: ARQ-151 Cream 0.15%
Active comparator
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Drug: ARQ-151 Active
ARQ-151 Cream 0.15% - Active |
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Placebo Comparator: ARQ-151 Vehicle Cream
Placebo comparator
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Drug: ARQ-151 Vehicle Cream
ARQ-151 Cream - Vehicle |
Primary Outcome Measures :
- IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4. [ Time Frame: Week 4 ]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).
Secondary Outcome Measures :
- Subjects with a vIGA-AD score of 'Moderate' at randomization, vIGA-AD Success at Week 4 [ Time Frame: Week 4 ]IGA Success, 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).
- In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction inthe WI-NRS at Week 4 [ Time Frame: Week 4 ]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").
- In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction inthe WI-NRS at Week 2 [ Time Frame: Week 2 ]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").
- In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction inthe WI-NRS at Week 1 [ Time Frame: Week 1 ]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").
- Achievement of at least a 75% (percent) reduction in the Eczema Area andSeverity Index (EASI-75) at Week 4 [ Time Frame: Week 4 ]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.
- vIGA-AD of 'clear' or 'almost clear' at Week 4 [ Time Frame: Week 4 ]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).
- vIGA-AD success at Week 2 [ Time Frame: Week 2 ]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).
- vIGA-AD success at Week 1 [ Time Frame: Week 1 ]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).
- vIGA-AD of 'clear' or 'almost clear' at Week 2 [ Time Frame: Week 2 ]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).
- vIGA-AD of 'clear' or 'almost clear' at Week 1 [ Time Frame: Week 1 ]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).
Information from the National Library of Medicine
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| Ages Eligible for Study: | 6 Years and older (Child, Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Criteria
Inclusion Criteria:
- 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.
Exclusion Criteria:
- 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.
Information from the National Library of Medicine
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04773600
Locations
Show 53 study locations
Sponsors and Collaborators
Arcutis Biotherapeutics, Inc.
Investigators
| Study Director: | David Berk, MD | Arcutis Biotherapeutics, Inc. |
| Responsible Party: | Arcutis Biotherapeutics, Inc. |
| ClinicalTrials.gov Identifier: | NCT04773600 |
| Other Study ID Numbers: |
ARQ-151-312 |
| First Posted: | February 26, 2021 Key Record Dates |
| Last Update Posted: | October 31, 2022 |
| Last Verified: | October 2022 |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
Additional relevant MeSH terms:
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Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |