Trial of PDE4 Inhibition With Roflumilast for the Management of Seborrheic Dermatitis (STRATUM)

Study Overview
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Brief Summary
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The study will assess the safety and efficacy of ARQ-154 foam vs vehicle applied once for 8 weeks by subjects with seborrheic dermatitis.

Detailed Description
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This is a parallel group, double blind, vehicle-controlled study in which ARQ-154 foam or vehicle is applied once daily for 8 weeks to subjects with seborrheic dermatitis.

Official Title
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A Phase 3, 8-Week, Parallel Group, Double Blind, Vehicle-Controlled Study of the Safety and Efficacy of ARQ-154 Foam 0.3% Administered QD in Subjects With Seborrheic Dermatitis

Conditions
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Seborrheic Dermatitis

Intervention / Treatment
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* Drug: ARQ-154 - Active
* Drug: ARQ-154 Vehicle


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Participants legally competent to sign and give informed consent and, if appropriate, assent as required by local laws. Males and females ages 9 years and older at the time of consent. Clinical diagnosis of seborrheic dermatitis of at least 3 months duration at Screening as determined by the Investigator. Stable disease for the past 4 weeks. Seborrheic dermatitis up to 20% BSA involvement. Involvement may be of the scalp and/or face and/or trunk and/or intertriginous areas. An Investigator Global Assessment (IGA) disease severity of at least Moderate ('3') at Baseline. Overall Assessment of Erythema and Overall Assessment of Scaling scores of at least Moderate ('2') at Baseline. Females of childbearing potential (FOCBP) must have a negative serum pregnancy test at Screening (Visit 1) and a negative urine pregnancy test at Baseline (Visit 2). Females of non-childbearing potential must either be post-menopausal with spontaneous amenorrhea for at least 12 months or have undergone surgical sterilization. Subjects in good health as judged by the Investigator. Subjects are considered reliable and capable of adhering to the Protocol and visit schedule according to the Investigator judgment. Key Exclusion Criteria: Subjects who cannot discontinue treatment with therapies for the treatment of seborrheic dermatitis prior to the Baseline visit and during the study. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. Previous treatment with ARQ-154 or ARQ-151. Subjects with any serious medical condition or clinically significant abnormality that would prevent study participation or place the subject at significant risk, as judged by the Investigator. Females who are pregnant, wishing to become pregnant during the study, or are breast-feeding. Subjects with a history of chronic alcohol or drug abuse within 6 months prior to Screening. Subjects, parent(s)/legal guardian(s) who are unable to communicate, read, or understand the local language(s). Subjects who are family members of the clinical study site, clinical study staff, or sponsor, or family members living in the same house of enrolled subjects.

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
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental: ARQ-154 Foam 0.3%<br> | Drug: ARQ-154 - Active<br>* ARQ-154 Foam 0.3% - Active<br>|
| Placebo Comparator: Placebo Comparator: ARQ-154 Vehicle Foam<br> | Drug: ARQ-154 Vehicle<br>* ARQ-154 Foam - Vehicle<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Investigator Global Assessment Scale (IGA) Score Change | IGA Success, defined as an IGA score of 'clear' or 'almost clear' plus a 2-point improvement at Week 8. 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). | Week 8 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. | WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' (no itch to worst imaginable itch). | Week 8 | 
| In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. | WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' (no itch to worst imaginable itch). | Week 4 | 
| In subjects with a Baseline WI-NRS pruritus score of ≥ 4, WI-NRS Success, defined as achievement of a ≥ 4-point improvement from Baseline. | WI-NRS is a subject-reported severity of itch at its highest intensity during the previous 24-hour period. The scale is from '0 to 10' (no itch to worst imaginable itch). | Week 2 | 
| IGA Success | 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). | Week 4 | 
| Overall Assessment of Scaling Score | Achievement of an Overall Assessment of Scaling score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3). | Week 8 | 
| Overall Assessment of Erythema Score | Achievement of an Overall Assessment of Erythema score of 0. This assessment scale has four severity grades reported from 0-3 and defined as None (0), Mild (1), Moderate (2), Severe (3). | Week 8 | 
| Investigator Global Assessment Scale (IGA) Score Change | Achievement of an IGA score of 'clear'. 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). | Week 8 | 
| IGA Success | 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). | Week 2 |