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

Study Overview
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Brief Summary
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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). Investigational product will be applied topically once daily for 52 weeks. Cohort 1 will be rollover participants from study ARQ-154-203 (NCT04091646) and will roll into treatment in the current study without interruption. Cohort 2 will include participants from ARQ-154-203 who began treatment in the current study after a gap from completing treatment in the prior study.

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

Conditions
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Seborrheic Dermatitis

Intervention / Treatment
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* Drug: ARQ-154


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 9 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Intervention Model: Single Group Assignment
Interventional 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)
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Long-term safety of ARQ-154<br>Open-label, Long-term Safety of ARQ-154 | Drug: ARQ-154<br>* ARQ-154 foam 0.3% applied once daily for 52 weeks<br>* Other names: Roflumilast foam;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Treatment Emergent Adverse Events | Occurrence of treatment emergent adverse events | 52 Weeks | 
| Serious Adverse Events | Occurrence of treatment serious adverse events | 52 Weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment | 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). | 52 Weeks | 
| Investigator Global Assessment | 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). | 52 Weeks | 
| Investigator Global Assessment | 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). | 52 Weeks | 
| Duration of Response | 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. | 52 Weeks | 
| Treatment Free Interval | 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. | 52 Weeks |