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

A Phase 2, Multicenter, Open-Label Study of the Long-Term Safety of ARQ-154 Foam 0.3% in Subjects With Seborrheic Dermatitis

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.

Study Overview

• Status: Completed
• Conditions: Seborrheic Dermatitis
• Intervention / Treatment: Drug: ARQ-154

• Study Type: Interventional
• Enrollment (Actual): 408
• Phase: Phase 2

Contacts and Locations

Study Locations

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

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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; Other Names: Roflumilast foam

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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
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
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

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): June 12, 2020
• Primary Completion (Actual): November 19, 2022
• Study Completion (Actual): November 19, 2022

Study Registration Dates

• First Submitted: June 22, 2020
• First Submitted That Met QC Criteria: June 22, 2020
• First Posted (Actual): June 24, 2020

Study Record Updates

• Last Update Posted (Actual): June 11, 2024
• Last Update Submitted That Met QC Criteria: May 13, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Skin Diseases, Papulosquamous; Skin Diseases, Eczematous; Sebaceous Gland Diseases; Dermatitis; Dermatitis, Seborrheic
• Other Study ID Numbers: ARQ-154-214

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No