A Safety Study of 188-0551 Spray Versus Reference Listed Drug (RLD) in Adult Subjects With Plaque Psoriasis

Study Overview
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Brief Summary
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Adrenal suppression effects of corticosteroids are among the most important safety concerns for this group of products. This study is to determine and compare the adrenal suppression potential and the pharmacokinetic (PK) properties of 188-0551 Spray versus an FDA-approved drug (also known as a Reference Listed Drug [RLD]) under maximal use conditions when applied twice daily (approximately every 12 hours) in adult subjects with stable, moderate to severe, plaque psoriasis.

Official Title
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An Open Label, Comparative Evaluation of the Adrenal Suppression Potential and Pharmacokinetic Properties of 188-0551 Spray Versus Reference Listed Drug (RLD) Applied Every 12 Hours for 2 Weeks in Subjects With Moderate to Severe Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: 188-0551 Spray
* Drug: RLD


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Subject is a male or non-pregnant female and is at least 18 years of age at the time of informed consent. Subject has provided written informed consent. Subject has moderate or severe psoriasis involving a minimum of 20% Body Surface Area (BSA). Subject has an Investigator's Global Assessment (IGA) score of at least three (3 = moderate) at the Baseline Visit. Exclusion Criteria: Subject is pregnant, lactating, or is planning to become pregnant during the study. Subject has spontaneously improving or rapidly deteriorating plaque psoriasis. Subject has a physical condition which, in the investigator's opinion, might impair evaluation of plaque psoriasis, adrenal axis function or which exposes the subject to an unacceptable risk by study participation. Subject has had prolonged exposure to natural or artificial sources of ultraviolet radiation. Subject is currently enrolled in an investigational drug or device study. Subject has clinically significant abnormal labs at Visit 1/Screening that precludes topical steroid use, in the opinion of the investigator.

Ages Eligible for Study
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Minimum Age: 18 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: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 188-0551 Spray<br>Investigational Topical Spray Product | Drug: 188-0551 Spray<br>* Applied topically twice daily for two weeks<br>|
| Active Comparator: Reference Listed Drug (RLD)<br>FDA Approved Topical Cream | Drug: RLD<br>* Applied topically twice daily for two weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The proportion of subjects to exhibit adrenal suppression as measured by a cortrosyn stimulation test | A subject is considered to have adrenal suppression evidence if post stimulation lab draw result is ≤ 18 µg/dL (497 nmol/L). | Day 15 |