A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Study Overview
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Brief Summary
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The objectives of this study are to assess the safety and efficacy of Olumacostat Glasaretil Gel compared to vehicle in patients with acne vulgaris

Official Title
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A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Olumacostat Glasaretil Gel, 5.0%
* Other: Olumacostat Glasaretil Gel, Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent and, for subjects under legal adult age, signed assent Age ≥ 9 years Clinical diagnosis of facial acne vulgaris defined as: At least 20 inflammatory lesions, and At least 20 non-inflammatory lesions, and Investigator Global Assessment of 3 or greater Exclusion Criteria: Active cystic acne or acne conglobata, acne fulminans, and secondary acne Two or more active nodulocystic lesions on the face Clinically significant abnormal laboratory or ECG result Subjects who are actively participating in an experimental therapy study or who have received experimental therapy within 30 days or 5 half-lives (whichever is longer) of the Baseline visit Treatment with over-the-counter topical medications for the treatment of acne vulgaris including benzoyl peroxide, topical anti-inflammatory medications, corticosteroids, α-hydroxy/glycolic acid on the face within 2 weeks prior to Baseline Treatment with systemic antibiotics or systemic anti-acne drugs or topical retinoid within 4 weeks prior to Baseline Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline (hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills). Use of androgen receptor blockers (such as spironolactone or flutamide) within 2 weeks prior to Baseline. Oral retinoid use (e.g., isotretinoin) within 12 months prior to Baseline or vitamin A supplements greater than 10,000 units/day within 6 months prior to Baseline Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks

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 |
| --- | --- |
| Experimental: Olumacostat Glasaretil Gel, 5.0%<br>Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks | Drug: Olumacostat Glasaretil Gel, 5.0%<br>* Gel containing Olumacostat Glasaretil<br>* Other names: DRM01;|
| Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle<br>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | Other: Olumacostat Glasaretil Gel, Vehicle<br>* Vehicle (placebo) gel<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 | Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12 | Baseline and Week 12 | 
| Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 | Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12 | Baseline and Week 12 | 
| Percentage of Subjects Who Achieved ≥ 2-grade Improvement and a Grade of 0 or 1 in the Investigator Global Assessment of Acne (IGA) From Baseline to Week 12 | Percentage of subjects who achieved ≥ 2-grade improvement and a grade of 0 or 1 in the investigator global assessment of acne (IGA) from baseline to Week 12 Scoring Criteria for Investigator Global Assessment 0 - Clear skin with no inflammatory or noninflammatory lesions - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions) - Moderate severity; greater than Grade 2; up to many noninflammatory lesions and may have some inflammatory lesions, but no more than one small nodular lesion - Severe; greater than Grade 3; up to many noninflammatory and inflammatory lesions, but no more than a few nodular lesions | Baseline and Week 12 |