Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Atopic Dermatitis Eczema Clinical Trial

— INTEGUMENT-OLE  

Official title:

A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.15% and ARQ-151 Cream 0.05% in Subjects With Atopic Dermatitis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04804605
• Other study ID #: ARQ-151-313
• Status: Completed
• Phase: Phase 3
• Start date: February 25, 2021
• Est. completion date: May 28, 2024

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 applied once a day for 52 weeks by subjects with atopic dermatitis (eczema).

Description:

This is an open-label study in which ARQ-151 cream is applied once daily x 52 weeks to subjects with atopic dermatitis (eczema).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1220
• Est. completion date: May 28, 2024
• Est. primary completion date: May 28, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. For adult subjects: Participants legally competent to sign and give informed consent. For pediatric and adolescent subjects: Informed consent of parent(s) or legal guardian, and, if age appropriate, assent by the subjects, as required by local laws.

2. Males and females, ages 2 years and older. (Only subjects 18 years and older will be enrolled at sites located in the province of Québec in Canada.)

3. Subjects with atopic dermatitis who met eligibility criteria for and successfully completed one of three preceding studies through Week 4, and are able and eligible to enroll into this long-term safety study on the Week 4 visit of the preceding study.

4. Females of childbearing potential (FOCBP) must have a negative urine pregnancy test at all study visits. 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. Females of non-childbearing potential should either be pre-menarchal, or post-menopausal with spontaneous amenorrhea for at least 12 months (post-menopausal status would have been confirmed with FSH testing in the preceding study) or have undergone surgical sterilization (permanent sterilization methods include hysterectomy, bilateral oophorectomy, or bilateral salpingectomy).

6. Subjects and parent(s)/legal guardian(s) are considered reliable and capable of adhering to the Protocol and visit schedule, according to the judgment of the Investigator.

Exclusion Criteria:

1. Subjects who experienced a treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in the preceding study.

2. Subjects that use any Excluded Medications and Treatments.

3. Subjects with skin conditions other than AD that would interfere with evaluations of the effect of the study medication on AD, as determined by the Investigator. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.

4. Subjects with known genetic dermatological conditions that overlap with AD.

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

6. Subjects and parent(s)/legal guardian(s) who are unable to communicate, read or understand the local language(s), or who display another condition, which in the Investigator's opinion, makes them unsuitable for clinical study participation.

7. Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members of enrolled subjects (subjects enrolled in other studies of ARQ-151 cream) living in the same house.

Related Conditions & MeSH terms

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

Intervention

Drug:
• ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
ARQ-151 Cream

Locations

Country	Name	City	State
Canada	Arcutis Clinical Site 43	Ajax	Ontario
Canada	Arcutis Clinical Site 70	Calgary	Alberta
Canada	Arcutis Clinical Site 26	Drummondville	Quebec
Canada	Arcutis Clinical Site 50	Fredericton	New Brunswick
Canada	Arcutis Clinical Site 52	London	Ontario
Canada	Clinical Site 11	Markham	Ontario
Canada	Clinical Site 46	Mississauga	Ontario
Canada	Arcutis Clinical Site 45	Montréal	Quebec
Canada	Arcutis Clinical Site 46	Montréal	Ontario
Canada	Arcutis Clinical Site 56	Montréal	Quebec
Canada	Arcutis Clinical Site 61	Peterborough	Ontario
Canada	Arcutis Clinical Site 27	Surrey	British Columbia
Canada	Arcutis Clinical Site 54	Toronto	Ontario
Canada	Arcutis Clinical Site 39	Waterloo	Ontario
Canada	Clinical Site 09	Windsor	Ontario
Canada	Arcutis Clinical Site 55	Winnipeg	Manitoba
United States	Arcutis Clinical Site 34	Arlington	Texas
United States	Clinical Site 23	Austin	Texas
United States	Arcutis Clinical Site 94	Bay City	Michigan
United States	Arcutis Clinical Site 84	Bellaire	Texas
United States	Arcutis Clinical Site 69	Beverly Hills	California
United States	Arcutis Clinical Site 112	Birmingham	Alabama
United States	Arcutis Clinical Site 73	Birmingham	Alabama
United States	Arcutis Clinical Site 145	Boise	Idaho
United States	Arcutis Clinical Site 106	Bryant	Arkansas
United States	Arcutis Clinical Site 51	Burke	Virginia
United States	Arcutis Clinical Site 123	Centennial	Colorado
United States	Arcutis Clinical Site 41	Charleston	South Carolina
United States	Arcutis Clinical Site 77	Charleston	South Carolina
United States	Arcutis Clinical Site 88	Clarkston	Michigan
United States	Arcutis Clinical Site 93	Clarksville	Indiana
United States	Arcutis Clinical Site 58	Clinton Township	Michigan
United States	Arcutis Clinical Site 21	College Station	Texas
United States	Arcutis Clinical Site 59	Coral Gables	Florida
United States	Arcutis Clinical Site 72	Coral Gables	Florida
United States	Arcutis Clinical Site 80	Covington	Louisiana
United States	Arcutis Clinical Site 79	Delray Beach	Florida
United States	Arcutis Clinical Site 66	Detroit	Michigan
United States	Arcutis Clinical Site 71	East Windsor	New Jersey
United States	Arcutis Clinical Site 116	Fort Smith	Arkansas
United States	Arcutis Clinical Site 126	Frisco	Texas
United States	Arcutis Clinical Site 118	Grapevine	Texas
United States	Arcutis Clinical Site 17	Gresham	Oregon
United States	Arcutis Clinical Site 53	Hershey	Pennsylvania
United States	Arcutis Clinical Site 19	High Point	North Carolina
United States	Arcutis Clinical Site 103	Hollywood	Florida
United States	Arcutis Clinical Site 35	Houston	Texas
United States	Arcutis Clinical Site 48	Houston	Texas
United States	Arcutis Clinical Site 81	Inglewood	California
United States	Clinical Site 04	Jacksonville	Florida
United States	Arcutis Clinical Site 101	Johnston	Rhode Island
United States	Arcutis Clinical Site 109	Katy	Texas
United States	Arcutis Clinical Site 133	Kenosha	Wisconsin
United States	Arcutis Clinical Site 96	Kew Gardens	New York
United States	Arcutis Clinical Site 85	Lake Charles	Louisiana
United States	Arcutis Clinical Site 15	Largo	Florida
United States	Clinical Site 03	Louisville	Kentucky
United States	Arcutis Clinical Site 24	Metairie	Louisiana
United States	Arcutis Clinical Site 67	Miami	Florida
United States	Arcutis Clinical Site 68	Miami	Florida
United States	Arcutis Clinical Site 95	Miami	Florida
United States	Arcutis Clinical Site 60	Murfreesboro	Tennessee
United States	Clinical Site 10	New Brighton	Minnesota
United States	Arcutis Clinical Site 64	Newtown Square	Pennsylvania
United States	Arcutis Clinical Site 40	Norfolk	Virginia
United States	Clinical Site 33	North Charleston	South Carolina
United States	Arcutis Clinical Site 74	Orem	Utah
United States	Arcutis Clinical Site 25	Pittsburgh	Pennsylvania
United States	Clinical Site 22	Plainfield	Indiana
United States	Arcutis Clinical Site 108	Portland	Oregon
United States	Arcutis Clinical Site 14	Portland	Oregon
United States	Arcutis Clinical Site 16	Portland	Oregon
United States	Arcutis Clinical Site 62	Reno	Nevada
United States	Arcutis Clinical Site 82	Rochester	New York
United States	Arcutis Clinical Site 76	Rockville	Maryland
United States	Arcutis Clinical Site 13	Rolling Meadows	Illinois
United States	Arcutis Clinical Site 102	Saint Joseph	Missouri
United States	Arcutis Clinical Site 49	San Antonio	Texas
United States	Clinical Site 20	San Antonio	Texas
United States	Clinical Site 08	San Francisco	California
United States	Arcutis Clinical Site 47	Sandy Springs	Georgia
United States	Arcutis Clinical Site 29	Sanford	Florida
United States	Arcutis Clinical Site 31	Santa Monica	California
United States	Arcutis Clinical Site 63	Scottsdale	Arizona
United States	Arcutis Clinical Site 12	Spokane	Washington
United States	Arcutis Clinical Site 91	Summerville	South Carolina
United States	Clinical Site 01	Tampa	Florida
United States	Arcutis Clinical Site 130	Thousand Oaks	California
United States	Arcutis Clinical Site 132	Troy	Michigan
United States	Arcutis Clinical Site 138	Wellington	Florida
United States	Arcutis Clinical Site 36	West Jordan	Utah
United States	Arcutis Clinical Site 114	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	To assess long-term safety in a multicenter, open-label, single-arm, 52-week study in subjects with atopic dermatitis treated with ARQ-151 cream: AEs and SAEs	AEs and SAEs	24 or 52 weeks
Secondary	Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment	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).	24 or 52 weeks
Secondary	vIGA-AD success	Defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline	24 or 52 weeks
Secondary	WI-NRS score over time	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").	24 or 52 weeks
Secondary	EASI score over time	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.	24 or 52 weeks