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

Completed · Phase 2

Conditions studied: Seborrheic Dermatitis

In brief

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.

Key facts

Study ID

NCT04445987

Run by

Arcutis Biotherapeutics, Inc.

People needed

408

Starts

2020-06-12

Expected to finish

2022-11-19

Last updated by the study team

2024-06-11

Who can join

Age: 9 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Participants legally competent to sign and give informed consent or (for adolescents) assent.
• Males and females ages 9 years and older (inclusive) at the time of consent.
• Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at all study visits.
• Post-menopausal women with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization.
• Cohort 1 only:
• 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:
• Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator. Stable disease for the past 4 weeks.
• Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.
• An Investigator Global Assessment (IGA) of disease severity of at least Moderate ('3') at Day 1.
• 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:
• Clinical diagnosis of seborrheic dermatitis of at least 3 months duration as determined by the Investigator.
• Seborrheic dermatitis of the scalp and/or face and/or trunk and/or intertriginous areas up to ≤20% BSA involvement.

You may not qualify if…

• Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED.
• Subjects with any condition on the treatment area which, in the opinion of the Investigator, could confound efficacy measurements.
• Subjects unable to apply investigational product to the scalp due to physical limitation.
• Known allergies to excipients in ARQ-154 foam.
• 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.
• 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.
• Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding.
• 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.
• Subjects with a history of chronic alcohol or drugs abuse within 6 months of initiation of investigational product.
• 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.
• 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.
• 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:
• 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.
• Subjects that use any Excluded Medication and Treatments.
• Cohort 2 only:
• 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.
• 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:
• 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.

Where it is running

• Arcutis Biotherapeutics Clinical Site 15 — Louisville, Kentucky, United States
• Arcutis Biotherapeutics Clinical Site 52 — Metairie, Louisiana, United States
• Arcutis Biotherapeutics Clinical Site 28 — Rockville, Maryland, United States
• Arcutis Biotherapeutics Clinical Site 73 — Brighton, Massachusetts, United States
• Arcutis Biotherapeutics Clinical Site 40 — Clinton Township, Michigan, United States
• Arcutis Biotherapeutics Clinical Site 20 — Detroit, Michigan, United States
• Arcutis Biotherapeutics Clinical Site 58 — Fort Gratiot, Michigan, United States
• Arcutis Biotherapeutics Clinical Site 14 — Fridley, Minnesota, United States
• Arcutis Biotherapeutics Clinical Site 50 — Las Vegas, Nevada, United States
• Arcutis Biotherapeutics Clinical Site 56 — Portsmouth, New Hampshire, United States
• Arcutis Biotherapeutics Clinical Site 55 — New York, New York, United States
• Arcutis Biotherapeutics Clinical Site 63 — The Bronx, New York, United States
• Arcutis Biotherapeutics Clinical Site 23 — High Point, North Carolina, United States
• Arcutis Biotherapeutics Clinical Site 18 — Bexley, Ohio, United States
• Arcutis Biotherapeutics Clinical Site 29 — Portland, Oregon, United States
• Arcutis Biotherapeutics Clinical Site 27 — Pittsburgh, Pennsylvania, United States
• Arcutis Biotherapeutics Clinical Site 76 — Charleston, South Carolina, United States
• Arcutis Biotherapeutics Clinical Site 13 — Arlington, Texas, United States
• Arcutis Biotherapeutics Clinical Site 11 — Austin, Texas, United States
• Arcutis Biotherapeutics Clinical Site 41 — College Station, Texas, United States
• Arcutis Biotherapeutics Clinical Site 25 — Houston, Texas, United States
• Arcutis Biotherapeutics Clinical Site 26 — Pflugerville, Texas, United States
• Arcutis Biotherapeutics Clinical Site 54 — San Antonio, Texas, United States
• Arcutis Biotherapeutics Clinical Site 17 — Norfolk, Virginia, United States
• Arcutis Biotherapeutics Clinical Site 59 — Beverly Hills, California, United States

Full record on ClinicalTrials.gov

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