INTEGUMENT-I: Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

• Sponsor: Arcutis Biotherapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04773587
• Collaborator: (none)
• Enrollment: 654
• Locations: 49
• Arms: 2
• Anticipated Duration (Months): 21.1
• Patients Per Site: 13.3
• Patients Per Site Per Month: 0.6

Study Details

Study Description

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	Phase 3

Detailed 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.

Study Design

• Study Type: Interventional
• Actual Enrollment: 654 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: Jan 27, 2021
• Anticipated Primary Completion Date: Nov 1, 2022
• Anticipated Study Completion Date: Nov 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: ARQ-151 Cream 0.15% Active comparator	Drug: ARQ-151 Active; ARQ-151 Cream 0.15% - Active
Placebo Comparator: ARQ-151 Vehicle Cream Placebo comparator	Drug: ARQ-151 Vehicle; ARQ-151 Cream - Vehicle

Outcome Measures

Primary Outcome Measures

1. IGA Success, defined as a vIGA-AD score of 'clear' or 'almost clear' PLUS a 2-grade improvement from Baseline at Week 4. [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

1. Subjects with a vIGA-AD score of 'Moderate' at randomization, vIGA-AD Success at Week 4 [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).

2. In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 4 [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").

3. In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 2 [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").

4. In subjects with baseline WI-NRS ≥ 4, achievement of a 4 point reduction in the WI-NRS at Week 1 [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").

5. Achievement of at least a 75% (percent) reduction in the Eczema Area and Severity Index (EASI-75) at Week 4 [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.

6. vIGA-AD of 'clear' or 'almost clear' at Week 4 [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).

7. vIGA-AD success at Week 2 [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).

8. vIGA-AD success at Week 1 [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).

9. vIGA-AD of 'clear' or 'almost clear' at Week 2 [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).

10. vIGA-AD of 'clear' or 'almost clear' at Week 1 [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arcutis Clinical Site 57	Montgomery	Alabama	United States	36117
2	Arcutis Clinical Site 34	Scottsdale	Arizona	United States	85255
3	Arcutis Clinical Site 58	Little Rock	Arkansas	United States	72212
4	Arcutis Clinical Site 40	Beverly Hills	California	United States	90212
5	Arcutis Clinical Site 06	Encinitas	California	United States	92024
6	Arcutis Clinical Site 52	Los Angeles	California	United States	90056
7	Arcutis Clinical Site 05	San Diego	California	United States	92123
8	Arcutis Clinical Site 08	San Francisco	California	United States	94132
9	Arcutis Clinical Site 62	Thousand Oaks	California	United States	91320
10	Arcutis Clinical Site 30	Coral Gables	Florida	United States	33134
11	Arcutis Clinical Site 04	Jacksonville	Florida	United States	32256
12	Arcutis Clinical Site 15	Largo	Florida	United States	33770
13	Arcutis Clinical Site 39	Miami Lakes	Florida	United States	33014
14	Arcutis Clinical Site 38	North Miami Beach	Florida	United States	33162
15	Arcutis Clinical Site 01	Tampa	Florida	United States	33613
16	Arcutis Clinical Site 61	Wellington	Florida	United States	33449
17	Arcutis Clinical Site 26	Sandy Springs	Georgia	United States	30328
18	Arcutis Clinical Site 13	Rolling Meadows	Illinois	United States	33770
19	Arcutis Clinical Site 48	Clarksville	Indiana	United States	47129
20	Arcutis Clinical Site 02	Indianapolis	Indiana	United States	46250
21	Arcutis Clinical Site 03	Louisville	Kentucky	United States	40217
22	Arcutis Clinical Site 36	Rockville	Maryland	United States	20850
23	Arcutis Clinical Site 55	Auburn Hills	Michigan	United States	48326
24	Arcutis Clinical Site 54	Bay City	Michigan	United States	48706
25	Arcutis Clinical Site 46	Clarkston	Michigan	United States	48346
26	Arcutis Clinical Site 37	Detroit	Michigan	United States	48202
27	Arcutis Clinical Site 10	New Brighton	Minnesota	United States	55112
28	Arcutis Clinical Site 33	Reno	Nevada	United States	89509
29	Arcutis Clinical Site 42	East Windsor	New Jersey	United States	08520
30	Arcutis Clinical Site 17	Gresham	Oregon	United States	97030
31	Arcutis Clinical Site 16	Portland	Oregon	United States	97223
32	Arcutis Clinical Site 14	Portland	Oregon	United States	97239
33	Arcutis Clinical Site 35	Newtown Square	Pennsylvania	United States	19073
34	Arcutis Clinical Site 101	Johnston	Rhode Island	United States	02919
35	Arcutis Clinical Site 31	Murfreesboro	Tennessee	United States	37130
36	Arcutis Clinical Site 19	Arlington	Texas	United States	76011
37	Arcutis Clinical Site 43	Bellaire	Texas	United States	77401
38	Arcutis Clinical Site 27	Houston	Texas	United States	77030
39	Arcutis Clinical Site 20	Houston	Texas	United States	77056
40	Arcutis Clinical Site 28	San Antonio	Texas	United States	78218
41	Arcutis Clinical Site 21	South Jordan	Utah	United States	84095
42	Arcutis Clinical Site 12	Spokane	Washington	United States	99202
43	Arcutis Clinical Site 41	Calgary	Alberta	Canada	T2J 7E1
44	Arcutis Clinical Site 29	Fredericton	New Brunswick	Canada	E3B 1G9
45	Arcutis Clinical Site 11	Markham	Ontario	Canada	L3P 1X3
46	Clinical Site 25	Mississauga	Ontario	Canada	L5H 1G9
47	Arcutis Clinical Site 32	Peterborough	Ontario	Canada	K9J 5K2
48	Arcutis Clinical Site 09	Windsor	Ontario	Canada	N8W 1E6
49	Arcutis Clinical Site 24	Montréal	Quebec	Canada	H2X 2V1

Sponsors and Collaborators

• Arcutis Biotherapeutics, Inc.

Investigators

• Study Director: David Berk, MD, Arcutis Biotherapeutics, Inc.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arcutis Biotherapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04773587
• Other Study ID Numbers: ARQ-151-311
• First Posted: Feb 26, 2021
• Last Update Posted: Aug 12, 2022
• Last Verified: Aug 1, 2022

• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis, Atopic; Dermatitis; Eczema

Study Results

No Results Posted as of Aug 12, 2022