Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis (Integument-PED)

Atopic Dermatitis Eczema Clinical Trial

Official title:

A Phase 3, 4-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-151 Cream 0.05% Administered QD in Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04845620
• Other study ID #: ARQ-151-315
• Status: Completed
• Phase: Phase 3
• Start date: April 7, 2021
• Est. completion date: June 1, 2023

Study information

• Verified date: May 2024
• 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: 652
• Est. completion date: June 1, 2023
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years to 5 Years

Eligibility

Inclusion Criteria:

1. Informed consent by parent(s) or legal guardian as required by local laws.

2. Males and females, ages 2 to 5 years old at time of signing Informed Consent (Screening) and at Baseline (Day 1).

3. Diagnosed with atopic dermatitis for at least 6 weeks, as determined by the Investigator. Stable disease for the past 4 weeks with no significant flares in atopic dermatitis before screening.

4. In good health as judged by the Investigator.

5. 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 for 4 weeks prior to Baseline/Day 1 and during the study.

4. Previous treatment with ARQ-151.

5. 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.

6. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled (in other studies of ARQ-151) 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 0.05% - Active
• ARQ-151 Vehicle
ARQ-151 Cream - Vehicle

Locations

Country	Name	City	State
Canada	Arcutis Clinical Site 73	Burlington	Ontario
Canada	Arcutis Clinical Site 29	Calgary	Alberta
Canada	Arcutis Clinical Site 36	Markham	Ontario
Canada	Arcutis Clinical Site 78	Saskatoon	Saskatchewan
Canada	Arcutis Clinical Site 64	Winnipeg	Manitoba
United States	Arcutis Clinical Site 53	Auburn Hills	Michigan
United States	Arcutis Clinical Site 08	Austin	Texas
United States	Arcutis Clinical Site 84	Baton Rouge	Louisiana
United States	Arcutis Clinical Site 41	Bay City	Michigan
United States	Arcutis Clinical Site 27	Bellaire	Texas
United States	Arcutis Clinical Site 65	Bethlehem	Pennsylvania
United States	Arcutis Clinical Site 14	Birmingham	Alabama
United States	Arcutis Clinical Site 56	Birmingham	Alabama
United States	Arcutis Clinical Site 48	Boca Raton	Florida
United States	Arcutis Clinical Site 82	Boise	Idaho
United States	Arcutis Clinical Site 54	Brooklyn	New York
United States	Arcutis Clinical Site 50	Bryant	Arkansas
United States	Arcutis Clinical Site 06	Burke	Virginia
United States	Arcutis Clinical Site 62	Charleston	South Carolina
United States	Arcutis Clinical Site 76	Charlottesville	Virginia
United States	Arcutis Clinical Site 60	Chicago	Illinois
United States	Arcutis Clinical Site 58	Cincinnati	Ohio
United States	Arcutis Clinical Site 36	Clarkston	Michigan
United States	Arcutis Clinical Site 42	Clarksville	Indiana
United States	Arcutis Clinical Site 77	Columbia	Maryland
United States	Arcutis Clinical Site 12	Coral Gables	Florida
United States	Arcutis Clinical Site 33	Coral Gables	Florida
United States	Arcutis Clinical Site 11	Delray Beach	Florida
United States	Arcutis Clinical Site 59	Fort Smith	Arkansas
United States	Arcutis Clinical Site 74	Fort Worth	Texas
United States	Arcutis Clinical Site 66	Frisco	Texas
United States	Arcutis Clinical Site 68	Gilbert	Arizona
United States	Arcutis Clinical Site 61	Grapevine	Texas
United States	Arcutis Clinical Site 01	Gresham	Oregon
United States	Arcutis Clinical Site 31	Hershey	Pennsylvania
United States	Arcutis Clinical Site 04	Houston	Texas
United States	Arcutis Clinical Site 09	Inglewood	California
United States	Arcutis Clinical Site 34	Lake Charles	Louisiana
United States	Arcutis Clinical Site 28	Largo	Florida
United States	Arcutis Clinical Site 55	Lebanon	New Hampshire
United States	Arcutis Clinical Site 71	Little Rock	Arkansas
United States	Arcutis Clinical Site 22	Louisville	Kentucky
United States	Arcutis Clinical Site 46	Louisville	Kentucky
United States	Arcutis Clinical Site 81	Mason	Ohio
United States	Arcutis Clinical Site 40	Metairie	Louisiana
United States	Arcutis Clinical Site 51	Metairie	Louisiana
United States	Arcutis Clinical Site 43	Miami	Florida
United States	Arcutis Clinical Site 79	Miami	Florida
United States	Arcutis Clinical Site 10	Miami Lakes	Florida
United States	Arcutis Clinical Site 69	Montgomery	Alabama
United States	Arcutis Clinical Site 05	New Brighton	Minnesota
United States	Arcutis Clinical Site 44	New York	New York
United States	Arcutis Clinical Site 24	Newtown Square	Pennsylvania
United States	Arcutis Clinical Site 35	North Miami Beach	Florida
United States	Arcutis Clinical Site 21	Plainfield	Indiana
United States	Arcutis Clinical Site 52	Portland	Oregon
United States	Arcutis Clinical Site 63	Portland	Oregon
United States	Arcutis Clinical Site 45	Rancho Santa Margarita	California
United States	Arcutis Clinical Site 16	Reno	Nevada
United States	Arcutis Clinical Site 32	Rochester	New York
United States	Arcutis Clinical Site 13	Rockville	Maryland
United States	Arcutis Clinical Site 15	Rockville	Maryland
United States	Arcutis Clinical Site 07	Rolling Meadows	Illinois
United States	Arcutis Clinical Site 47	Saint Joseph	Missouri
United States	Arcutis Clinical Site 02	San Antonio	Texas
United States	Arcutis Clinical Site 18	San Antonio	Texas
United States	Arcutis Clinical Site 30	San Diego	California
United States	Arcutis Clinical Site 20	Sandy Springs	Georgia
United States	Arcutis Clinical Site 26	Scottsdale	Arizona
United States	Arcutis Clinical Site 03	South Jordan	Utah
United States	Arcutis Clinical Site 25	Spokane	Washington
United States	Arcutis Clinical Site 39	Summerville	South Carolina
United States	Arcutis Clinical Site 70	Thousand Oaks	California
United States	Arcutis Clinical Site 72	Troy	Michigan
United States	Arcutis Clinical Site 75	Wellington	Florida
United States	Arcutis Clinical Site 57	West Lafayette	Indiana

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	In subjects with vIGA-AD score of 'Moderate' at randomization, IGA 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 vIGA-AD score of 'Moderate' at randomization, achievement of at least 75% 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	In subjects with vIGA-AD score of 'Moderate' at randomization, vIGA-AD score 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 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 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 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