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

Seborrheic Dermatitis Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04445987
• Other study ID #: ARQ-154-214
• Status: Completed
• Phase: Phase 2
• Start date: June 12, 2020
• Est. completion date: November 19, 2022

Study information

• Verified date: May 2024
• Source: Arcutis Biotherapeutics, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open-label, long-term safety study of roflumilast ARQ-154 foam 0.3% in subjects with seborrheic dermatitis involving up to 20% total Body Surface Area (BSA). Study was applied topically once daily for 52 weeks. Cohort 1 subjects are rollover subjects from study ARQ-154-203 (NCT04091646) and were rolled into treatment in the current study without interruption. Cohort 2 includes participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 408
• Est. completion date: November 19, 2022
• Est. primary completion date: November 19, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 9 Years and older

Eligibility

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:

5. 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:

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

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

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

9. 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:

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

11. 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.

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

8. 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.

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

10. 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.

11. 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.

12. 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:

13. 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.

14. Subjects that use any Excluded Medication and Treatments.

Cohort 2 only:

15. 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.

16. 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:

17. 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.

Related Conditions & MeSH terms

• Dermatitis
• Dermatitis, Seborrheic
• Seborrheic Dermatitis

Intervention

Drug:
• ARQ-154
ARQ-154 foam 0.3% applied once daily for 52 weeks

Locations

Country	Name	City	State
United States	Arcutis Biotherapeutics Clinical Site 13	Arlington	Texas
United States	Arcutis Biotherapeutics Clinical Site 11	Austin	Texas
United States	Arcutis Biotherapeutics Clinical Site 53	Aventura	Florida
United States	Arcutis Biotherapeutics Clinical Site 59	Beverly Hills	California
United States	Arcutis Biotherapeutics Clinical Site 18	Bexley	Ohio
United States	Arcutis Biotherapeutics Clinical Site 73	Brighton	Massachusetts
United States	Arcutis Biotherapeutics Clinical Site 63	Bronx	New York
United States	Arcutis Biotherapeutics Clinical Site 76	Charleston	South Carolina
United States	Arcutis Biotherapeutics Clinical Site 40	Clinton Township	Michigan
United States	Arcutis Biotherapeutics Clinical Site 41	College Station	Texas
United States	Arcutis Biotherapeutics Clinical Site 42	Coral Gables	Florida
United States	Arcutis Biotherapeutics Clinical Site 57	Delray Beach	Florida
United States	Arcutis Biotherapeutics Clinical Site 20	Detroit	Michigan
United States	Arcutis Biotherapeutics Clinical Site 51	Encino	California
United States	Arcutis Biotherapeutics Clinical Site 58	Fort Gratiot	Michigan
United States	Arcutis Biotherapeutics Clinical Site 75	Fountain Valley	California
United States	Arcutis Biotherapeutics Clinical Site 19	Fremont	California
United States	Arcutis Biotherapeutics Clinical Site 14	Fridley	Minnesota
United States	Arcutis Biotherapeutics Clinical Site 23	High Point	North Carolina
United States	Arcutis Biotherapeutics Clinical Site 25	Houston	Texas
United States	Arcutis Biotherapeutics Clinical Site 50	Las Vegas	Nevada
United States	Arcutis Biotherapeutics Clinical Site 62	Los Angeles	California
United States	Arcutis Biotherapeutics Clinical Site 15	Louisville	Kentucky
United States	Arcutis Biotherapeutics Clinical Site 52	Metairie	Louisiana
United States	Arcutis Biotherapeutics Clinical Site 24	Miami	Florida
United States	Arcutis Biotherapeutics Clinical Site 55	New York	New York
United States	Arcutis Biotherapeutics Clinical Site 17	Norfolk	Virginia
United States	Arcutis Biotherapeutics Clinical Site 26	Pflugerville	Texas
United States	Arcutis Biotherapeutics Clinical Site 27	Pittsburgh	Pennsylvania
United States	Arcutis Biotherapeutics Clinical Site 22	Plainfield	Indiana
United States	Arcutis Biotherapeutics Clinical Site 29	Portland	Oregon
United States	Arcutis Biotherapeutics Clinical Site 56	Portsmouth	New Hampshire
United States	Arcutis Biotherapeutics Clinical Site 28	Rockville	Maryland
United States	Arcutis Biotherapeutics Clinical Site 10	Rolling Meadows	Illinois
United States	Arcutis Biotherapeutics Clinical Site 54	San Antonio	Texas
United States	Arcutis Biotherapeutics Clinical Site 64	San Diego	California
United States	Arcutis Biotherapeutics Clinical Site 65	Sanford	Florida
United States	Arcutis Biotherapeutics Clinical Site 21	Santa Monica	California
United States	Arcutis Biotherapeutics Clinical Site 12	Tampa	Florida

Sponsors (1)

Lead Sponsor	Collaborator
Arcutis Biotherapeutics, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Participants With =1 Adverse Event (AE)	The number of participants with treatment-emergent AEs is reported. An AE is any untoward or unfavorable medical occurrence in a human participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to participation in the research. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	Up to 52 weeks
Primary	Number of Participants With =1 Serious Adverse Event (SAE)	The number of participants with treatment-emergent SAEs is reported. An SAE is any AE that results in death, is life-threatening (places the subject at immediate risk of death from the event as it occurred), requires inpatient hospitalization or prolongation of existing hospitalization, results in a persistent or significant disability/incapacity, results in a congenital anomaly/birth defect, or is any other adverse event that, based upon appropriate medical judgment, may jeopardize the subject's health. Data are presented according to cohort group assigned as treatment were identical in this study regardless of the treatment received in the prior study.	Up to 52 weeks
Secondary	Number of Participants With an Investigator Global Assessment (IGA) Score of Completely Clear or Almost Clear	The number of participants with an IGA score of 0 ('completely clear') or 1 ('almost clear') is presented. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.	Weeks 4, 12, 24, 36, and 52
Secondary	Achievement of IGA Success	The number of participants achieving "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a =2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity.	Weeks 4, 12, 24, 36, and 52
Secondary	Duration of IGA Success	The duration of "success" in IGA assessment of disease severity is presented. Success was defined as achievement of an IGA score of 0 ('clear') or 1 ('almost clear') at Week 8, accompanied by a =2-grade improvement from baseline IGA score. The IGA is a 5-point scale assessing the severity of seborrheic dermatitis, with scores ranging from 0 ('clear') to 4 ('severe'), and higher scores indicate greater symptom severity. The time from first observation of IGA success to the first subsequent time a participant's disease response did not meet the criteria for IGA success is presented. The duration of IGA success for subjects who ended treatment in IGA success was censored at the last disease assessment date.	Weeks 4, 12, 24, 36, and 52
Secondary	IGA Treatment-Free Interval	The treatment-free interval is defined as time from when the participant achieves disease clearance (IGA score of 0 ["completely clear"]) and stops treatment of all lesions until the time of restarting treatment.	Weeks 4, 12, 24, 36, and 52