A Dose-ranging Study of DRM01 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 DRM01 Topical Gel compared to vehicle in patients with acne vulgaris.

Official Title
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A Phase 2, Randomized, Double-blind, Vehicle-controlled, Dose-ranging Study of DRM01B Topical Gel in Subjects With Acne Vulgaris

Conditions
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Acne Vulgaris

Intervention / Treatment
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* Drug: Olumacostat Glasaretil
* Other: Vehicle


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Signed informed consent. Male or non-pregnant, non-lactating females. Age ≥ 18 years. Clinical diagnosis of facial acne vulgaris defined as: At least 20 inflammatory lesions At least 20 non-inflammatory lesions 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. Screening clinical chemistry or hematology laboratory value that is considered clinically significant, in the opinion of the Investigator. Abnormal findings on screening ECG, deemed clinically significant, by the Investigator. 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. Subjects who are a poor medical risk because of other systemic diseases or active uncontrolled infections, in the opinion of the investigator. 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 corticosteroids (use of intranasal and inhaled corticosteroids allowed for seasonal allergies and asthma) within 4 weeks prior to Baseline. Treatment with systemic antibiotics or systemic anti-acne drugs or systemic anti-inflammatory drugs within 4 weeks prior to Baseline. Prescription topical retinoid use on the face within 4 weeks of Baseline (e.g., tretinoin, tazarotene, adapalene). Treatment with a new hormonal therapy or dose change to existing hormonal therapy within 12 weeks prior to Baseline. Dose and frequency of use of any hormonal therapy started more than 12 weeks prior to Baseline must remain unchanged throughout the study. Hormonal therapies include, but are not limited to, estrogenic and progestational agents such as birth control pills. Prior use of androgen receptor blockers (such as spironolactone or flutamide). 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 of Baseline. Facial procedures (chemical or laser peel, microdermabrasion, etc.) within the past 8 weeks or during the study.

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: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle QD<br>Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks | Other: Vehicle<br> <br> |
| Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle BID<br>Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks | Other: Vehicle<br> <br> |
| Experimental: Olumacostat Glasaretil Gel, 4.0% QD<br>Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks | Drug: Olumacostat Glasaretil<br> <br> * Other names: DRM01B;|
| Experimental: Olumacostat Glasaretil Gel, 7.5% QD<br>Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks | Drug: Olumacostat Glasaretil<br> <br> * Other names: DRM01B;|
| Experimental: Olumacostat Glasaretil Gel, 7.5% BID<br>Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks | Drug: Olumacostat Glasaretil<br> <br> * Other names: DRM01B;|

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 |