Long-Term Safety of ARQ-154 Foam in Subjects With Seborrheic Dermatitis

• Sponsor: Arcutis Biotherapeutics, Inc. (Industry)
• Overall Status: Active, not recruiting
• CT.gov ID: NCT04445987
• Collaborator: (none)
• Enrollment: 408
• Locations: 39
• Arm: 1
• Anticipated Duration (Months): 27.6
• Patients Per Site: 10.5
• Patients Per Site Per Month: 0.4

Study Details

Study Description

Brief Summary

Open-label, long-term safety study of ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study medication will be applied by the qualifying subjects topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from a prior ARQ-154 trial. Cohort 2 include treatment naive subjects. Periodic clinic visits will include assessments for clinical safety, application site reactions, and disease improvement or progression.

Condition or Disease	Intervention/Treatment	Phase
Seborrheic Dermatitis	Drug: ARQ-154	Phase 2

Study Design

• Study Type: Interventional
• Actual Enrollment: 408 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Intervention Model Description: Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)Subjects that consent to enter this open-label safety study may or may not have previously completed a companion study (ARQ-154 trial)
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis
• Actual Study Start Date: Jun 12, 2020
• Anticipated Primary Completion Date: Oct 1, 2022
• Anticipated Study Completion Date: Oct 1, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Long-term safety of ARQ-154 Open-label, Long-term Safety of ARQ-154	Drug: ARQ-154; ARQ-154 foam 0.3% applied once daily for 52 weeks

Outcome Measures

Primary Outcome Measures

1. Treatment Emergent Adverse Events [52 Weeks]

   Occurrence of treatment emergent adverse events

2. Serious Adverse Events [52 Weeks]

   Occurrence of treatment serious adverse events

Secondary Outcome Measures

1. Investigator Global Assessment [52 Weeks]

   Achievement of an IGA score of 'completely clear' or 'almost clear' as observed over time. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

2. Investigator Global Assessment [52 Weeks]

   A 2-grade improvement in IGA from Baseline as observed over time. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

3. Investigator Global Assessment [52 Weeks]

   Achievement of an IGA score of 'completely clear' or 'almost clear' plus a 2-grade improvement in IGA from baseline as observed at Week 12, Week 24. This global assessment scale has five severity grades reported from 0-4 and defined as Clear (0), Almost Clear (1), Mild (2), Moderate (3), Severe (4).

4. Duration of Response [52 Weeks]

   Duration of IGA Success, defined as the time from the first observation of IGA Success to the last time a subject's disease response meets the criteria for IGA Success. The duration of IGA Success for subjects who end treatment in IGA Success will be censored at the last disease assessment date.

5. Treatment Free Interval [52 Weeks]

   Treatment-free interval, defined among subjects who achieve a 'completely clear' IGA and stop treatment to all lesions, as the time from attainment of a score of 'clear' to re-starting study drug.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Participants legally competent to sign and give informed consent or (for adolescents) assent.

2. Males and females ages 9 years and older (inclusive) at the time of consent.

3. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.

4. Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.

Cohort 1 only:

1. Subjects with seborrheic dermatitis who met eligibility criteria for a prior ARQ-154 study, successfully completed a prior ARQ-154 study through final visit and are able to immediately enroll into this long-term safety study on the final visit of the previous ARQ-154 study.

Cohort 2 subjects that have not participated in a prior ARQ-154 study:

1. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.

2. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

3. An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.

4. Overall Assessment of Erythema and Overall Assessment of Scaling scores of Moderate ('2') at Day 1.

Cohort 2 subjects that have participated in a prior ARQ-154 study:

1. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.

2. Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

Exclusion Criteria:

1. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.

2. Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.

3. Subjects unable to apply investigational product to the scalp due to physical limitation.

4. Known allergies to excipients in ARQ-154 foam.

5. Subjects who cannot discontinue the use of strong P-450 cytochrome inhibitors e.g., indinavir, nelfinavir, ritonavir, clarithromycin, itraconazole, ketoconazole, nefazodone, saquinavir, suboxone and telithromycin during the study period.

6. Known or suspected:

• severe renal insufficiency or moderate to severe hepatic disorders

• history of severe depression, suicidal ideation or C-SSRS indicative of suicidal ideation, whether lifetime or recent/recurrent.

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

2. Subjects with any serious medical condition or laboratory abnormality that would prevent study participation or place the subject at significant risk, as determined by the Investigator.

3. Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.

4. Current or a history of cancer within 5 years with the exception of fully treated skin basal cell carcinoma, cutaneous squamous cell carcinoma or carcinoma in situ of the cervix.

5. 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 that live in the same household of enrolled subjects.

Cohort 1 only:

1. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.

2. Subjects that use any Excluded Medication and Treatments.

Cohort 2 only:

1. Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Day 1 visit and during the study according to Excluded Medications and Treatments.

2. Subjects with PHQ-8 >10 or modified PHQ-A >10 at Screening or Day 1.

Cohort 2 subjects that have participated in a prior ARQ-154 study:

1. Subjects who experienced an ARQ-154 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-154 foam in a prior ARQ-154 study.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Arcutis Biotherapeutics Clinical Site 59	Beverly Hills	California	United States	90212
2	Arcutis Biotherapeutics Clinical Site 51	Encino	California	United States	91436
3	Arcutis Biotherapeutics Clinical Site 75	Fountain Valley	California	United States	92708
4	Arcutis Biotherapeutics Clinical Site 19	Fremont	California	United States	94538
5	Arcutis Biotherapeutics Clinical Site 62	Los Angeles	California	United States	90036
6	Arcutis Biotherapeutics Clinical Site 64	San Diego	California	United States	92123
7	Arcutis Biotherapeutics Clinical Site 21	Santa Monica	California	United States	90404
8	Arcutis Biotherapeutics Clinical Site 53	Aventura	Florida	United States	33180
9	Arcutis Biotherapeutics Clinical Site 42	Coral Gables	Florida	United States	33134
10	Arcutis Biotherapeutics Clinical Site 57	Delray Beach	Florida	United States	33484
11	Arcutis Biotherapeutics Clinical Site 24	Miami	Florida	United States	33144
12	Arcutis Biotherapeutics Clinical Site 65	Sanford	Florida	United States	32771
13	Arcutis Biotherapeutics Clinical Site 12	Tampa	Florida	United States	33613
14	Arcutis Biotherapeutics Clinical Site 10	Rolling Meadows	Illinois	United States	60008
15	Arcutis Biotherapeutics Clinical Site 22	Plainfield	Indiana	United States	46168
16	Arcutis Biotherapeutics Clinical Site 15	Louisville	Kentucky	United States	40217
17	Arcutis Biotherapeutics Clinical Site 52	Metairie	Louisiana	United States	70006
18	Arcutis Biotherapeutics Clinical Site 28	Rockville	Maryland	United States	20850
19	Arcutis Biotherapeutics Clinical Site 73	Brighton	Massachusetts	United States	02135
20	Arcutis Biotherapeutics Clinical Site 40	Clinton Township	Michigan	United States	48038
21	Arcutis Biotherapeutics Clinical Site 20	Detroit	Michigan	United States	48202
22	Arcutis Biotherapeutics Clinical Site 58	Fort Gratiot	Michigan	United States	48059
23	Arcutis Biotherapeutics Clinical Site 14	Fridley	Minnesota	United States	55432
24	Arcutis Biotherapeutics Clinical Site 50	Las Vegas	Nevada	United States	89148
25	Arcutis Biotherapeutics Clinical Site 56	Portsmouth	New Hampshire	United States	03801
26	Arcutis Biotherapeutics Clinical Site 63	Bronx	New York	United States	10462
27	Arcutis Biotherapeutics Clinical Site 55	New York	New York	United States	10029
28	Arcutis Biotherapeutics Clinical Site 23	High Point	North Carolina	United States	27262
29	Arcutis Biotherapeutics Clinical Site 18	Bexley	Ohio	United States	43209
30	Arcutis Biotherapeutics Clinical Site 29	Portland	Oregon	United States	97210
31	Arcutis Biotherapeutics Clinical Site 27	Pittsburgh	Pennsylvania	United States	15213
32	Arcutis Biotherapeutics Clinical Site 76	Charleston	South Carolina	United States	29407
33	Arcutis Biotherapeutics Clinical Site 13	Arlington	Texas	United States	76011
34	Arcutis Biotherapeutics Clinical Site 11	Austin	Texas	United States	78759
35	Arcutis Biotherapeutics Clinical Site 41	College Station	Texas	United States	77845
36	Arcutis Biotherapeutics Clinical Site 25	Houston	Texas	United States	77056
37	Arcutis Biotherapeutics Clinical Site 26	Pflugerville	Texas	United States	78660
38	Arcutis Biotherapeutics Clinical Site 54	San Antonio	Texas	United States	78213
39	Arcutis Biotherapeutics Clinical Site 17	Norfolk	Virginia	United States	23502

Sponsors and Collaborators

• Arcutis Biotherapeutics, Inc.

Investigators

• Study Director: David Berk, MD, Arcutis Biotherapeutics

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Arcutis Biotherapeutics, Inc.
• ClinicalTrials.gov Identifier: NCT04445987
• Other Study ID Numbers: ARQ-154-214
• First Posted: Jun 24, 2020
• Last Update Posted: Aug 8, 2022
• Last Verified: Aug 1, 2022

• Individual Participant Data (IPD) Sharing Statement: No
• Plan to Share IPD: No
• Studies a U.S. FDA-regulated Drug Product: Yes
• Studies a U.S. FDA-regulated Device Product: No
• Additional relevant MeSH terms: Dermatitis; Dermatitis, Seborrheic

Study Results

No Results Posted as of Aug 8, 2022