A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris

• Sponsor: Dermira, Inc. (Industry)
• Overall Status: Completed
• CT.gov ID: NCT03028363
• Collaborator: (none)
• Enrollment: 759
• Locations: 49
• Arms: 2
• Actual Duration (Months): 11
• Patients Per Site: 15.5
• Patients Per Site Per Month: 1.4

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Acne Vulgaris	Drug: Olumacostat Glasaretil Gel, 5.0%; Other: Olumacostat Glasaretil Gel, Vehicle	Phase 3

Study Design

• Study Type: Interventional
• Actual Enrollment: 759 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Primary Purpose: Treatment
• Official Title: A Randomized, Double-blind, Vehicle Controlled, Efficacy and Safety Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
• Actual Study Start Date: Dec 27, 2016
• Actual Primary Completion Date: Nov 28, 2017
• Actual Study Completion Date: Nov 28, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Olumacostat Glasaretil Gel, 5.0% Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Drug: Olumacostat Glasaretil Gel, 5.0%; Gel containing Olumacostat Glasaretil; Other Names: DRM01
Placebo Comparator: Olumacostat Glasaretil Gel, Vehicle Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Other: Olumacostat Glasaretil Gel, Vehicle; Vehicle (placebo) gel

Outcome Measures

Primary Outcome Measures

1. Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12 [Baseline and Week 12]

   Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12

2. Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12 [Baseline and Week 12]

   Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12

3. 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 [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 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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 9 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Alliance Dermatology & MOHS Center	Phoenix	Arizona	United States	85032
2	Anaheim Clinical Trials	Anaheim	California	United States	92801
3	Dermatology Research Associates	Los Angeles	California	United States	90045
4	Rady Children's Hospital UCSD Pediatric and Adolescent Derm	San Diego	California	United States	92123
5	University Clinical Trials Inc.	San Diego	California	United States	92123
6	Horizons Clinical Research Center, LLC	Denver	Colorado	United States	80220
7	Dermatology Physicians of CT	Shelton	Connecticut	United States	06484
8	Finlay Medical Research	Miami	Florida	United States	33126
9	Health Awareness, Inc	Port Saint Lucie	Florida	United States	34952
10	International Clinical Research-US, LLC	Sanford	Florida	United States	32771
11	Lenus Research & Medical Group	Sweetwater	Florida	United States	33172
12	Research Institute of the Southeast, LLC	West Palm Beach	Florida	United States	33401
13	Arlington Dermatology	Arlington Heights	Illinois	United States	60005
14	Forefront Dermatology	Carmel	Indiana	United States	46032
15	Kansas City Dermatology, PA	Overland Park	Kansas	United States	66215
16	Skin Sciences, PLLC	Louisville	Kentucky	United States	40217
17	Lawrence Jeffrey Green MD, LLC	Rockville	Maryland	United States	20850
18	Great Lakes Research Group, Inc	Bay City	Michigan	United States	48706
19	Minnesota Clinical Study Center	Fridley	Minnesota	United States	55432
20	Mercy Research	Washington	Missouri	United States	63090
21	Meridian Clinical Research, LLC	Norfolk	Nebraska	United States	68701
22	Quality Clinical Research Inc	Omaha	Nebraska	United States	68114
23	Meridian Clinical Research	Omaha	Nebraska	United States	68134
24	Acne Treatment & Research Center	Morristown	New Jersey	United States	07960
25	Schweiger Dermatology, PLLC	New York	New York	United States	10022
26	DermResearchCenter of New York, Inc.	Stony Brook	New York	United States	11790
27	Cyn3rgy Research	Gresham	Oregon	United States	97030
28	Clinical Partners, LLC	Johnston	Rhode Island	United States	02919
29	Meridian Clincial Research	Dakota Dunes	South Dakota	United States	57049
30	International Clinical Research - Tennessee LLC	Murfreesboro	Tennessee	United States	37130
31	International Clinical Research-Tennesse LLC	Murfreesboro	Tennessee	United States	37130
32	DermResearch	Austin	Texas	United States	78759
33	J &S Studies, Inc	College Station	Texas	United States	77845
34	Synexus US, LP, dba, Research Across America	Murphy	Texas	United States	75094
35	Progressive Clinical Research, PA	San Antonio	Texas	United States	78213
36	Clinical Trials of Texas, Inc.	San Antonio	Texas	United States	78229
37	Dermatology Clinical Research Center of San Antonio	San Antonio	Texas	United States	78229
38	Virginia Clinical Research, Inc.	Norfolk	Virginia	United States	23507
39	Woden Dermatology	Phillip	Australian Capital Territory	Australia	2606
40	St George Dermatology and Skin Cancer Centre	Kogarah	New South Wales	Australia	2217
41	North Eastern Health Specialists	Hectorville	South Australia	Australia	5073
42	Skin & Cancer Foundation Inc.	Carlton	Victoria	Australia	3053
43	Fremantle Dermatology	Fremantle	Western Australia	Australia	6160
44	Institute for Skin Advancement	Calgary	Alberta	Canada	T3A 2N1
45	SimcoDerm Medical and Surgical Dermatology Center	Barrie	Ontario	Canada	L4M 7G1
46	Lynderm Research Inc.	Markham	Ontario	Canada	L3P 1X2
47	North Bay Dermatology Centre	North Bay	Ontario	Canada	P1B 3Z7
48	Research Toronto	Toronto	Ontario	Canada	M4W 2N2
49	Windsor Research Inc.	Windsor	Ontario	Canada	N8W 5L7

Sponsors and Collaborators

• Dermira, Inc.

Investigators

• Study Director: Beth Zib, Dermira, Inc.

Study Documents (Full-Text)

• Study Protocol - Oct 6, 2016
• Statistical Analysis Plan - Jan 19, 2018

More Information

Publications

None provided.

• Responsible Party: Dermira, Inc.
• ClinicalTrials.gov Identifier: NCT03028363
• Other Study ID Numbers: DRM01B-ACN03
• First Posted: Jan 23, 2017
• Last Update Posted: Jul 20, 2021
• Last Verified: Jul 1, 2021

• Additional relevant MeSH terms: Acne Vulgaris

Study Results

Participant Flow

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Period Title: Overall Study
STARTED	498	261
COMPLETED	420	228
NOT COMPLETED	78	33

Baseline Characteristics

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle	Total
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks	Total of all reporting groups
Overall Participants	498	261	759
Age (Count of Participants)
<=18 years	289 58%	140 53.6%	429 56.5%
Between 18 and 65 years	209 42%	121 46.4%	330 43.5%
>=65 years	0 0%	0 0%	0 0%
Age (Years) [Mean (Standard Deviation) ]
Mean (Standard Deviation) [Years]	19.4 (6.58)	20.1 (7.14)	19.7 (6.78)
Sex: Female, Male (Count of Participants)
Female	286 57.4%	152 58.2%	438 57.7%
Male	212 42.6%	109 41.8%	321 42.3%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	150 30.1%	68 26.1%	218 28.7%
Not Hispanic or Latino	346 69.5%	193 73.9%	539 71%
Unknown or Not Reported	2 0.4%	0 0%	2 0.3%
Race (NIH/OMB) (Count of Participants)
American Indian or Alaska Native	3 0.6%	3 1.1%	6 0.8%
Asian	13 2.6%	11 4.2%	24 3.2%
Native Hawaiian or Other Pacific Islander	3 0.6%	0 0%	3 0.4%
Black or African American	79 15.9%	43 16.5%	122 16.1%
White	373 74.9%	191 73.2%	564 74.3%
More than one race	27 5.4%	13 5%	40 5.3%
Unknown or Not Reported	0 0%	0 0%	0 0%
Region of Enrollment (Count of Participants)
Canada	32 6.4%	16 6.1%	48 6.3%
United States	431 86.5%	226 86.6%	657 86.6%
Australia	35 7%	19 7.3%	54 7.1%
Fitzpatrick Skin Type (Count of Participants)
Type I	28 5.6%	16 6.1%	44 5.8%
Type II	94 18.9%	55 21.1%	149 19.6%
Type III	125 25.1%	75 28.7%	200 26.4%
Type IV	115 23.1%	55 21.1%	170 22.4%
Type V	79 15.9%	29 11.1%	108 14.2%
Type VI	57 11.4%	31 11.9%	88 11.6%

Outcome Measures

1. Primary Outcome

Title	Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Description	Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Measure Participants	498	261
Least Squares Mean (Standard Deviation) [Lesions]	-14.5 (14.85)	-13.5 (14.54)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.3430
	Comments
	Method	ANCOVA
	Comments	Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation

2. Primary Outcome

Title	Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Description	Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Measure Participants	498	261
Least Squares Mean (Standard Deviation) [Lesions]	-14.1 (21.05)	-11.8 (20.28)

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.1260
	Comments
	Method	ANCOVA
	Comments	Ranked ANCOVA, Markov Chain Monte Carlo (MCMC) Multiple Imputation

3. Primary Outcome

Title	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
Description	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
Time Frame	Baseline and Week 12

Outcome Measure Data

Analysis Population Description

Intent-to-Treat

Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%	Olumacostat Glasaretil Gel, Vehicle
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks	Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Measure Participants	498	261
Success	95 19.1%	54 20.7%
Failure	403 80.9%	207 79.3%

Statistical Analysis 1

Statistical Analysis Overview	Comparison Group Selection	Olumacostat Glasaretil Gel, 5.0%, Olumacostat Glasaretil Gel, Vehicle
	Comments
	Type of Statistical Test	Other
	Comments
Statistical Test of Hypothesis	p-Value	0.5247
	Comments
	Method	Regression, Logistic
	Comments	Logistic Regression (Firth's Penalized Likelihood), MCMC Multiple Imputation

Adverse Events

Time Frame	Baseline to Week 12
Adverse Event Reporting Description	The Total Participants at risk are based on the Safety Population defined as Participants who were randomized and received at least one confirmed dose of study drug.
Arm/Group Title	Olumacostat Glasaretil Gel, 5.0%		Olumacostat Glasaretil Gel, Vehicle
Arm/Group Description	Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks		Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
All Cause Mortality
	Olumacostat Glasaretil Gel, 5.0%		Olumacostat Glasaretil Gel, Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	0/485 (0%)		0/258 (0%)
Serious Adverse Events
	Olumacostat Glasaretil Gel, 5.0%		Olumacostat Glasaretil Gel, Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	1/485 (0.2%)		3/258 (1.2%)
Gastrointestinal disorders
Constipation	0/485 (0%)		1/258 (0.4%)
Infections and infestations
Appendicitis	0/485 (0%)		1/258 (0.4%)
Nervous system disorders
Epilepsy	1/485 (0.2%)		0/258 (0%)
Psychiatric disorders
Bipolar disorder	0/485 (0%)		1/258 (0.4%)
Other (Not Including Serious) Adverse Events
	Olumacostat Glasaretil Gel, 5.0%		Olumacostat Glasaretil Gel, Vehicle
	Affected / at Risk (%)	# Events	Affected / at Risk (%)	# Events
Total	89/485 (18.4%)		33/258 (12.8%)
General disorders
Application site dryness	13/485 (2.7%)		2/258 (0.8%)
Application site erythema	13/485 (2.7%)		3/258 (1.2%)
Application site pain	19/485 (3.9%)		11/258 (4.3%)
Application site pruritus	13/485 (2.7%)		4/258 (1.6%)
Infections and infestations
Nasopharyngitis	15/485 (3.1%)		5/258 (1.9%)
Upper respiratory tract infection	16/485 (3.3%)		8/258 (3.1%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

Principal Investigators are NOT employed by the organization sponsoring the study.

There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.