Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

Study Overview
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Brief Summary
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The objective of the study is to evaluate the safety and efficacy of a topical lotion

Detailed Description
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The objective of the study is to evaluate the safety and efficacy of a topical lotion when applied once daily to adult subjects with moderate to severe plaque psoriasis.

Official Title
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A Phase 2, Multicenter, Double-Blind, Randomized, Vehicle Controlled Clinical Study to Assess the Safety and Efficacy of IDP 118 in the Treatment of Plaque Psoriasis

Conditions
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Plaque Psoriasis

Intervention / Treatment
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* Drug: IDP-118 Lotion
* Drug: IDP-118 Monad HP Lotion
* Drug: IDP-118 Monad Taz Lotion
* Drug: IDP-118 Vehicle Lotion


Participation Criteria
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Eligibility Criteria
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Key Inclusion Criteria: Male or female, of any race, at least 18 years of age (inclusive). Freely provides both verbal and written informed consent. Has an area of plaque psoriasis appropriate for topical treatment that covers a BSA of at least 3%, but no more than 12%. The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this calculation. Is willing and able to avoid prolonged exposure of the treatment area to ultraviolet radiation (natural and artificial) for the duration of the study. Has a clinical diagnosis of psoriasis at the Baseline visit with an IGA score of 3 or 4. (The face, scalp, palms, soles, axillae and intertriginous areas are to be excluded in this assessment, if psoriasis is present). Key Exclusion Criteria: Has spontaneously improving or rapidly deteriorating plaque psoriasis or pustular psoriasis, as determined by the investigator. Presents with psoriasis that was treated with prescription medication and failed to respond to treatment, even partially or temporarily, as determined by the investigator. Presents with any concurrent skin condition that could interfere with the evaluation of the treatment areas, as determined by the investigator. Is pregnant, nursing an infant, or planning a pregnancy during the study period. Has received treatment with any investigational drug or device within 60 days or 5 drug half lives (whichever is longer) prior to the Baseline visit, or is concurrently participating in another clinical study with an investigational drug or device.

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: Factorial Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: IDP-118 Lotion<br>halobetasol propionate [HP], tazarotene [Taz] | Drug: IDP-118 Lotion<br>* Lotion<br>* Other names: Lotion;|
| Active Comparator: IDP-118 Monad HP Lotion<br>HP | Drug: IDP-118 Monad HP Lotion<br>* Active Comparator<br>* Other names: HP;|
| Active Comparator: IDP-118 Monad Taz Lotion<br>Taz | Drug: IDP-118 Monad Taz Lotion<br>* Active Comparator<br>* Other names: Taz;|
| Active Comparator: IDP-118 Vehicle Lotion<br>Vehicle | Drug: IDP-118 Vehicle Lotion<br>* Vehicle<br>* Other names: Vehicle;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Week 8 | Treatment success defined as at least a 2-grade improvement from Baseline in the IGA score and an IGA score equating to clear or almost clear at Week 8. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). | 8 weeks | 
| Percentage of Participants With Treatment Success of a 2-Grade IGA Score Improvement From Baseline and an IGA Score of Clear or Almost Clear at Weeks 2, 4, 6, and 12 | Treatment success defined as at least a 2-grade improvement from Baseline in the Investigator's Global Assessment (IGA) score and an IGA score equating to clear or almost clear at Weeks 2, 4, 6, and 12. The IGA score was based on a 5-point scale ranging from 0 to 4 (0=clear, 1=almost clear, 2=mild, 3=moderate, and 4=severe). | Weeks 2, 4, 6, and 12 (4-week follow-up) |