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

Atopic Dermatitis Eczema Clinical Trial

— INTEGUMENT-I  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773587
• Other study ID #: ARQ-151-311
• Status: Completed
• Phase: Phase 3
• Start date: January 27, 2021
• Est. completion date: August 30, 2022

Study information

• Verified date: July 2023
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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).

Description:

This is a parallel group, double blind, vehicle-controlled study in which ARQ-151 cream or vehicle is applied once daily for 4 weeks to subjects with atopic dermatitis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 654
• Est. completion date: August 30, 2022
• Est. primary completion date: August 30, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 6 Years and older

Eligibility

Inclusion Criteria:

1. Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws.

2. 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.

3. 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.

4. 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.

5. In good health as judged by the Investigator.

6. Subjects considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. 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

2. Has unstable AD or any consistent requirement for high potency topical steroids.

3. 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.

4. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.

5. Previous treatment with ARQ-151.

6. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening.

7. 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.

8. 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.

Related Conditions & MeSH terms

• Atopic Dermatitis Eczema
• Dermatitis
• Dermatitis, Atopic
• Eczema

Intervention

Drug:
• ARQ-151 Active
ARQ-151 Cream 0.15% - Active
• ARQ-151 Vehicle
ARQ-151 Cream - Vehicle

Locations

Country	Name	City	State
Canada	Arcutis Clinical Site 41	Calgary	Alberta
Canada	Arcutis Clinical Site 29	Fredericton	New Brunswick
Canada	Arcutis Clinical Site 11	Markham	Ontario
Canada	Clinical Site 25	Mississauga	Ontario
Canada	Arcutis Clinical Site 24	Montréal	Quebec
Canada	Arcutis Clinical Site 32	Peterborough	Ontario
Canada	Arcutis Clinical Site 09	Windsor	Ontario
United States	Arcutis Clinical Site 19	Arlington	Texas
United States	Arcutis Clinical Site 55	Auburn Hills	Michigan
United States	Arcutis Clinical Site 54	Bay City	Michigan
United States	Arcutis Clinical Site 43	Bellaire	Texas
United States	Arcutis Clinical Site 40	Beverly Hills	California
United States	Arcutis Clinical Site 46	Clarkston	Michigan
United States	Arcutis Clinical Site 48	Clarksville	Indiana
United States	Arcutis Clinical Site 30	Coral Gables	Florida
United States	Arcutis Clinical Site 37	Detroit	Michigan
United States	Arcutis Clinical Site 42	East Windsor	New Jersey
United States	Arcutis Clinical Site 06	Encinitas	California
United States	Arcutis Clinical Site 17	Gresham	Oregon
United States	Arcutis Clinical Site 20	Houston	Texas
United States	Arcutis Clinical Site 27	Houston	Texas
United States	Arcutis Clinical Site 02	Indianapolis	Indiana
United States	Arcutis Clinical Site 04	Jacksonville	Florida
United States	Arcutis Clinical Site 101	Johnston	Rhode Island
United States	Arcutis Clinical Site 15	Largo	Florida
United States	Arcutis Clinical Site 58	Little Rock	Arkansas
United States	Arcutis Clinical Site 52	Los Angeles	California
United States	Arcutis Clinical Site 03	Louisville	Kentucky
United States	Arcutis Clinical Site 39	Miami Lakes	Florida
United States	Arcutis Clinical Site 57	Montgomery	Alabama
United States	Arcutis Clinical Site 31	Murfreesboro	Tennessee
United States	Arcutis Clinical Site 10	New Brighton	Minnesota
United States	Arcutis Clinical Site 35	Newtown Square	Pennsylvania
United States	Arcutis Clinical Site 38	North Miami Beach	Florida
United States	Arcutis Clinical Site 14	Portland	Oregon
United States	Arcutis Clinical Site 16	Portland	Oregon
United States	Arcutis Clinical Site 33	Reno	Nevada
United States	Arcutis Clinical Site 36	Rockville	Maryland
United States	Arcutis Clinical Site 13	Rolling Meadows	Illinois
United States	Arcutis Clinical Site 28	San Antonio	Texas
United States	Arcutis Clinical Site 05	San Diego	California
United States	Arcutis Clinical Site 08	San Francisco	California
United States	Arcutis Clinical Site 26	Sandy Springs	Georgia
United States	Arcutis Clinical Site 34	Scottsdale	Arizona
United States	Arcutis Clinical Site 21	South Jordan	Utah
United States	Arcutis Clinical Site 12	Spokane	Washington
United States	Arcutis Clinical Site 01	Tampa	Florida
United States	Arcutis Clinical Site 62	Thousand Oaks	California
United States	Arcutis Clinical Site 61	Wellington	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Arcutis Biotherapeutics, Inc.

Countries where clinical trial is conducted

United States,  Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at 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).	Week 4
Secondary	Subjects with a vIGA-AD score of 'Moderate' at randomization, vIGA-AD Success at 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).	Week 4
Secondary	In subjects with baseline WI-NRS = 4, achievement of a 4 point reduction in the WI-NRS at 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").	Week 4
Secondary	In subjects with baseline WI-NRS = 4, achievement of a 4 point reduction in the WI-NRS at 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").	Week 2
Secondary	In subjects with baseline WI-NRS = 4, achievement of a 4 point reduction in the WI-NRS at 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").	Week 1
Secondary	Achievement of at least a 75% (percent) reduction in the Eczema Area and Severity Index (EASI-75) at 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.	Week 4
Secondary	vIGA-AD of 'clear' or 'almost clear' at 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).	Week 4
Secondary	vIGA-AD success at 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).	Week 2
Secondary	vIGA-AD success at 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).	Week 1
Secondary	vIGA-AD of 'clear' or 'almost clear' at 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).	Week 2
Secondary	vIGA-AD of 'clear' or 'almost clear' at 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).	Week 1