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INTEGUMENT-OLE: Open Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Atopic Dermatitis

Sponsor
Arcutis Biotherapeutics, Inc. (Industry)
Overall Status
Recruiting
CT.gov ID
NCT04804605
Collaborator
(none)
1,500
Enrollment
92
Locations
1
Arm
23.2
Anticipated Duration (Months)
16.3
Patients Per Site
0.7
Patients Per Site Per Month

Study Details

Study Description

Brief 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).

Condition or Disease Intervention/Treatment Phase
  • Drug: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%
 Phase 3

Detailed 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).

Study Design

Study Type:
Interventional
Anticipated Enrollment :
1500 participants
Allocation:
N/A
Intervention Model:
Single Group Assignment
Masking:
None (Open Label)
Primary Purpose:
Treatment
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
Actual Study Start Date :
Feb 25, 2021
Anticipated Primary Completion Date :
Jan 31, 2023
Anticipated Study Completion Date :
Jan 31, 2023

Arms and Interventions

Arm Intervention/Treatment
Experimental: ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

ARQ-151 Cream 0.15% or ARQ-151 Cream 0.05%

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

Outcome Measures

Primary Outcome Measures

  1. 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 [24 or 52 weeks]

    AEs and SAEs

Secondary Outcome Measures

  1. Validated Investigator Global Assessment-Atopic Dermatitis (vIGA-AD) score of 0 or 1 at each assessment [24 or 52 weeks]

    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. vIGA-AD success [24 or 52 weeks]

    Defined as vIGA-AD value of 0 or 1 plus a 2-grade improvement from baseline

  3. WI-NRS score over time [24 or 52 weeks]

    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. EASI score over time [24 or 52 weeks]

    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.

Eligibility Criteria

Criteria

Ages Eligible for Study:
2 Years and Older
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
No
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Arcutis Clinical Site 112 Birmingham Alabama United States 35209
2 Arcutis Clinical Site 73 Birmingham Alabama United States 35244
3 Arcutis Clinical Site 63 Scottsdale Arizona United States 85255
4 Arcutis Clinical Site 106 Bryant Arkansas United States 72022
5 Arcutis Clinical Site 116 Fort Smith Arkansas United States 72916
6 Arcutis Clinical Site 69 Beverly Hills California United States 90212
7 Arcutis Clinical Site 81 Inglewood California United States 90301
8 Clinical Site 08 San Francisco California United States 94132
9 Arcutis Clinical Site 31 Santa Monica California United States 90404
10 Arcutis Clinical Site 130 Thousand Oaks California United States 91320
11 Arcutis Clinical Site 123 Centennial Colorado United States 80112
12 Arcutis Clinical Site 59 Coral Gables Florida United States 33134
13 Arcutis Clinical Site 72 Coral Gables Florida United States 33146
14 Arcutis Clinical Site 79 Delray Beach Florida United States 33484
15 Arcutis Clinical Site 103 Hollywood Florida United States 33021
16 Clinical Site 04 Jacksonville Florida United States 32256
17 Arcutis Clinical Site 15 Largo Florida United States 33770
18 Arcutis Clinical Site 67 Miami Florida United States 33162
19 Arcutis Clinical Site 95 Miami Florida United States 33173
20 Arcutis Clinical Site 68 Miami Florida United States 33174
21 Arcutis Clinical Site 29 Sanford Florida United States 32771
22 Clinical Site 01 Tampa Florida United States 33613
23 Arcutis Clinical Site 138 Wellington Florida United States 33449
24 Arcutis Clinical Site 47 Sandy Springs Georgia United States 30328
25 Arcutis Clinical Site 145 Boise Idaho United States 83706
26 Arcutis Clinical Site 13 Rolling Meadows Illinois United States 33770
27 Arcutis Clinical Site 93 Clarksville Indiana United States 47129
28 Clinical Site 22 Plainfield Indiana United States 46168
29 Arcutis Clinical Site 114 West Lafayette Indiana United States 47906
30 Clinical Site 03 Louisville Kentucky United States 40217
31 Arcutis Clinical Site 80 Covington Louisiana United States 70433
32 Arcutis Clinical Site 85 Lake Charles Louisiana United States 70605
33 Arcutis Clinical Site 24 Metairie Louisiana United States 70006
34 Arcutis Clinical Site 76 Rockville Maryland United States 20850
35 Arcutis Clinical Site 94 Bay City Michigan United States 48706
36 Arcutis Clinical Site 88 Clarkston Michigan United States 48346
37 Arcutis Clinical Site 58 Clinton Township Michigan United States 48038
38 Arcutis Clinical Site 66 Detroit Michigan United States 48202
39 Arcutis Clinical Site 132 Troy Michigan United States 48084
40 Clinical Site 10 New Brighton Minnesota United States 55112
41 Arcutis Clinical Site 102 Saint Joseph Missouri United States 64506
42 Arcutis Clinical Site 62 Reno Nevada United States 89509
43 Arcutis Clinical Site 71 East Windsor New Jersey United States 08520
44 Arcutis Clinical Site 96 Kew Gardens New York United States 11415
45 Arcutis Clinical Site 82 Rochester New York United States 14623
46 Arcutis Clinical Site 19 High Point North Carolina United States 27262
47 Arcutis Clinical Site 17 Gresham Oregon United States 97030
48 Arcutis Clinical Site 108 Portland Oregon United States 97210
49 Arcutis Clinical Site 16 Portland Oregon United States 97223
50 Arcutis Clinical Site 14 Portland Oregon United States 97239
51 Arcutis Clinical Site 53 Hershey Pennsylvania United States 17033
52 Arcutis Clinical Site 64 Newtown Square Pennsylvania United States 19073
53 Arcutis Clinical Site 25 Pittsburgh Pennsylvania United States 15213
54 Arcutis Clinical Site 101 Johnston Rhode Island United States 02919
55 Arcutis Clinical Site 77 Charleston South Carolina United States 29407
56 Arcutis Clinical Site 41 Charleston South Carolina United States 29425
57 Clinical Site 33 North Charleston South Carolina United States 29420
58 Arcutis Clinical Site 91 Summerville South Carolina United States 29486
59 Arcutis Clinical Site 60 Murfreesboro Tennessee United States 37130
60 Arcutis Clinical Site 34 Arlington Texas United States 76011
61 Clinical Site 23 Austin Texas United States 78759
62 Arcutis Clinical Site 84 Bellaire Texas United States 77401
63 Arcutis Clinical Site 21 College Station Texas United States 77845
64 Arcutis Clinical Site 126 Frisco Texas United States 75034
65 Arcutis Clinical Site 118 Grapevine Texas United States 76051
66 Arcutis Clinical Site 48 Houston Texas United States 77030
67 Arcutis Clinical Site 35 Houston Texas United States 77056
68 Arcutis Clinical Site 109 Katy Texas United States 77494
69 Clinical Site 20 San Antonio Texas United States 78213
70 Arcutis Clinical Site 49 San Antonio Texas United States 78218
71 Arcutis Clinical Site 74 Orem Utah United States 84058
72 Arcutis Clinical Site 36 West Jordan Utah United States 84088
73 Arcutis Clinical Site 51 Burke Virginia United States 22015
74 Arcutis Clinical Site 40 Norfolk Virginia United States 23502
75 Arcutis Clinical Site 12 Spokane Washington United States 99202
76 Arcutis Clinical Site 133 Kenosha Wisconsin United States 53142
77 Arcutis Clinical Site 70 Calgary Alberta Canada T2J 7E1
78 Arcutis Clinical Site 27 Surrey British Columbia Canada V3R 6A7
79 Arcutis Clinical Site 55 Winnipeg Manitoba Canada R3M 3Z4
80 Arcutis Clinical Site 50 Fredericton New Brunswick Canada E3B 1G9
81 Arcutis Clinical Site 43 Ajax Ontario Canada L1S 7K8
82 Arcutis Clinical Site 52 London Ontario Canada N6H 5L5
83 Clinical Site 11 Markham Ontario Canada L3P 1X3
84 Clinical Site 46 Mississauga Ontario Canada L5H 1G9
85 Arcutis Clinical Site 46 Montréal Ontario Canada H2X 2V1
86 Arcutis Clinical Site 61 Peterborough Ontario Canada K9J 5K2
87 Arcutis Clinical Site 54 Toronto Ontario Canada M4W 2N4
88 Arcutis Clinical Site 39 Waterloo Ontario Canada N2J 1C4
89 Clinical Site 09 Windsor Ontario Canada N8W 1E6
90 Arcutis Clinical Site 26 Drummondville Quebec Canada J2B 5L4
91 Arcutis Clinical Site 45 Montréal Quebec Canada H2X 2V1
92 Arcutis Clinical Site 56 Montréal Quebec Canada H3Z 2S6

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:
NCT04804605
Other Study ID Numbers:
  • ARQ-151-313
First Posted:
Mar 18, 2021
Last Update Posted:
Aug 8, 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 8, 2022