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

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 0.15% Administered QD in Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04773600
• Other study ID #: ARQ-151-312
• Status: Completed
• Phase: Phase 3
• Start date: February 24, 2021
• Est. completion date: September 29, 2022

Study information

• Verified date: September 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: 683
• Est. completion date: September 29, 2022
• Est. primary completion date: September 29, 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:
• Roflumilast (ARQ-151) cream
Roflumilast (ARQ-151) cream 0.15% - Active
• Vehicle cream
Vehicle cream

Locations

Country	Name	City	State
Canada	Arcutis Clinical Site 20	Ajax	Ontario
Canada	Arcutis Clinical Site 12	Calgary	Alberta
Canada	Arcutis Clinical Site 08	Drummondville	Quebec
Canada	Arcutis Clinical Site 23	London	Ontario
Canada	Arcutis Clinical Site 27	Québec	Quebec
Canada	Arcutis Clinical Site 09	Surrey	British Columbia
Canada	Arcutis Clinical Site 25	Toronto	Ontario
Canada	Arcutis Clinical Site 16	Waterloo	Ontario
Canada	Arcutis Clinical Site 26	Winnipeg	Manitoba
United States	Clinical Site 05	Austin	Texas
United States	Arcutis Clinical Site 63	Baton Rouge	Louisiana
United States	Arcutis Clinical Site 31	Birmingham	Alabama
United States	Arcutis Clinical Site 55	Boca Raton	Florida
United States	Arcutis Clinical Site 62	Boise	Idaho
United States	Arcutis Clinical Site 22	Burke	Virginia
United States	Arcutis Clinical Site 54	Centennial	Colorado
United States	Arcutis Clinical Site 18	Charleston	South Carolina
United States	Arcutis Clinical Site 35	Charleston	South Carolina
United States	Arcutis Clinical Site 29	Clinton Township	Michigan
United States	Arcutis Clinical Site 03	College Station	Texas
United States	Arcutis Clinical Site 30	Coral Gables	Florida
United States	Arcutis Clinical Site 37	Delray Beach	Florida
United States	Arcutis Clinical Site 21	Fort Gratiot	Michigan
United States	Arcutis Clinical Site 51	Fort Smith	Arkansas
United States	Arcutis Clinical Site 59	Frisco	Texas
United States	Arcutis Clinical Site 250	Grapevine	Texas
United States	Arcutis Clinical Site 24	Hershey	Pennsylvania
United States	Arcutis Clinical Site 01	High Point	North Carolina
United States	Arcutis Clinical Site 46	Inglewood	California
United States	Arcutis Clinical Site 42	Lake Charles	Louisiana
United States	Arcutis Clinical Site 43	Louisville	Kentucky
United States	Arcutis Clinical Site 38	Mandeville	Louisiana
United States	Arcutis Clinical Site 06	Metairie	Louisiana
United States	Arcutis Clinical Site 41	Miami	Florida
United States	Arcutis Clinical Site 58	Miami	Florida
United States	Arcutis Clinical Site 53	New York	New York
United States	Arcutis Clinical Site 17	Norfolk	Virginia
United States	Arcutis Clinical Site 15	North Charleston	South Carolina
United States	Arcutis Clinical Site 32	Orem	Utah
United States	Arcutis Clinical Site 52	Pflugerville	Texas
United States	Arcutis Clinical Site 07	Pittsburgh	Pennsylvania
United States	Clinical Site 04	Plainfield	Indiana
United States	Arcutis Clinical Site 39	Rochester	New York
United States	Arcutis Clinical Site 34	Rockville	Maryland
United States	Arcutis Clinical Site 245	Saint Joseph	Missouri
United States	Arcutis Clinical Site 02	San Antonio	Texas
United States	Arcutis Clinical Site 19	San Diego	California
United States	Arcutis Clinical Site 36	San Diego	California
United States	Arcutis Clinical Site 11	Sanford	Florida
United States	Arcutis Clinical Site 13	Santa Monica	California
United States	Arcutis Clinical Site 33	Stony Brook	New York
United States	Arcutis Clinical Site 61	Troy	Michigan
United States	Arcutis Clinical Site 57	West Palm Beach	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 inthe 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 inthe 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 inthe 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 andSeverity 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