Open-Label Extension Trial of PDE4 Inhibition With Roflumilast for the Management of Plaque Psoriasis

Study Overview
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Brief Summary
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This study will assess the safety and efficacy of ARQ-151 cream applied once a day for 24 weeks by subjects with chronic plaque psoriasis

Detailed Description
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This is an open-label study in which ARQ-151 cream is applied once daily x 24 weeks to subjects with psoriasis

Official Title
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A Phase 3, Multicenter, Open-Label Extension Study of the Long-Term Safety of ARQ-151 Cream 0.3% in Subjects With Chronic Plaque Psoriasis

Conditions
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Chronic Plaque Psoriasis

Intervention / Treatment
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* Drug: Topical roflumilast


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Participants legally competent to sign and give informed consent or informed consent of legal guardian, and, if age appropriate, assent by the subject, as required by local laws Males and females ages 2 years and older (inclusive) Subjects with chronic plaque psoriasis who meet eligibility criteria and: Successfully completed a prior ARQ-151 cream study in psoriasis (Cohort 1) or Are naïve to treatment with ARQ-151 cream (Cohort 2) Females of childbearing potential (FOCBP) must have a negative pregnancy test at all study visits. In addition, sexually active FOCBP must agree to use at least one form of highly effective contraception throughout the trial. Exclusion Criteria: Subjects who experienced an ARQ-151 treatment-related AE or a serious AE (SAE) that precluded further treatment with ARQ-151 cream in a prior ARQ-151 cream study. Planned excessive exposure of treated area(s) to either natural or artificial sunlight, tanning bed or other LED. 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 drug abuse within 6 months of initiation of investigational product. 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.

Ages Eligible for Study
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Minimum Age: 2 Years
Maximum Age: 11 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
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: ARQ-151 Cream 0.3%<br> | Drug: Topical roflumilast<br>* Active treatment<br>* Other names: ARQ-151 Cream 0.3%;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Occurrence of treatment emergent AEs (TEAEs) | The occurrence of TEAEs and the occurrence of (Serious Adverse Events) SAEs | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Achievement of an Investigator Global Assessment (IGA) of 'clear' or 'almost clear' over time. |  | 24 weeks | 
| In subjects who achieve a 'clear' IGA time to re-starting investigational product (duration of response). |  | 24 weeks | 
| Achievement of a 50% reduction in (Psoriasis Area Severity Index) PASI over time |  | 24 weeks | 
| Achievement of a 75% reduction in PASI over time |  | 24 weeks | 
| Achievement of a 90% reduction in PASI over time |  | 24 weeks | 
| Achievement of a 100% reduction in PASI over time |  | 24 weeks | 
| Change in Worst Itch Numeric Rating Scale) WI-NRS score over time |  | 24 weeks |