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A Dose-ranging Study of DRM01 in Subjects With Acne Vulgaris

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02431052
Recruitment Status : Completed
First Posted : April 30, 2015
Results First Posted : February 26, 2019
Last Update Posted : July 20, 2021
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company ( Dermira, Inc. )

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Triple (Participant, Investigator, Outcomes Assessor);   Primary Purpose: Treatment
Condition Acne Vulgaris
Interventions Drug: Olumacostat Glasaretil
Other: Vehicle
Enrollment 420
Recruitment Details  
Pre-assignment Details  
Arm/Group Title Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Hide Arm/Group Description Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Period Title: Overall Study
Started 53 50 106 110 101
Completed 42 46 94 94 86
Not Completed 11 4 12 16 15
Arm/Group Title Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID Total
Hide Arm/Group Description Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks Total of all reporting groups
Overall Number of Baseline Participants 52 50 106 110 101 419
Hide Baseline Analysis Population Description
Intent-to-Treat
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
<=18 years
6
  11.5%
3
   6.0%
10
   9.4%
15
  13.6%
14
  13.9%
48
  11.5%
Between 18 and 65 years
46
  88.5%
47
  94.0%
96
  90.6%
95
  86.4%
87
  86.1%
371
  88.5%
>=65 years
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
26.8  (7.65) 26.7  (7.04) 27  (8.13) 26.4  (7.96) 25.9  (8.26) 26.5  (7.90)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
Female
38
  73.1%
39
  78.0%
77
  72.6%
83
  75.5%
79
  78.2%
316
  75.4%
Male
14
  26.9%
11
  22.0%
29
  27.4%
27
  24.5%
22
  21.8%
103
  24.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
Hispanic or Latino
12
  23.1%
9
  18.0%
24
  22.6%
27
  24.5%
32
  31.7%
104
  24.8%
Not Hispanic or Latino
38
  73.1%
41
  82.0%
81
  76.4%
83
  75.5%
68
  67.3%
311
  74.2%
Unknown or Not Reported
2
   3.8%
0
   0.0%
1
   0.9%
0
   0.0%
1
   1.0%
4
   1.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
American Indian or Alaska Native
2
   3.8%
1
   2.0%
1
   0.9%
1
   0.9%
0
   0.0%
5
   1.2%
Asian
1
   1.9%
2
   4.0%
4
   3.8%
6
   5.5%
6
   5.9%
19
   4.5%
Native Hawaiian or Other Pacific Islander
1
   1.9%
0
   0.0%
2
   1.9%
1
   0.9%
0
   0.0%
4
   1.0%
Black or African American
16
  30.8%
12
  24.0%
27
  25.5%
24
  21.8%
20
  19.8%
99
  23.6%
White
28
  53.8%
33
  66.0%
69
  65.1%
75
  68.2%
72
  71.3%
277
  66.1%
More than one race
4
   7.7%
2
   4.0%
3
   2.8%
3
   2.7%
3
   3.0%
15
   3.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
Canada
11
  21.2%
12
  24.0%
25
  23.6%
25
  22.7%
24
  23.8%
97
  23.2%
United States
41
  78.8%
38
  76.0%
81
  76.4%
85
  77.3%
77
  76.2%
322
  76.8%
Fitzpatrick Skin Type   [1] 
Measure Type: Count of Participants
Unit of measure:  Participants
 Number Analyzed 52 participants 50 participants 106 participants 110 participants 101 participants 419 participants
Type I
1
   1.9%
2
   4.0%
7
   6.6%
12
  10.9%
5
   5.0%
27
   6.4%
Type II
9
  17.3%
7
  14.0%
17
  16.0%
23
  20.9%
20
  19.8%
76
  18.1%
Type III
12
  23.1%
17
  34.0%
26
  24.5%
28
  25.5%
30
  29.7%
113
  27.0%
Type IV
15
  28.8%
13
  26.0%
25
  23.6%
22
  20.0%
23
  22.8%
98
  23.4%
Type V
8
  15.4%
4
   8.0%
9
   8.5%
12
  10.9%
13
  12.9%
46
  11.0%
Type VI
7
  13.5%
7
  14.0%
22
  20.8%
13
  11.8%
10
   9.9%
59
  14.1%
[1]
Measure Description:

Fitzpatrick Skin Type is a scale to numerically classify skin color, defined by the response to ultraviolet (UV) light with the following categories:

Type I Burns easily, rarely tans Type II Burns easily, tans minimally Type III Burns moderately, tans gradually Type IV Burns minimally, tans well Type V Rarely burns, tans profusely Type VI Never burns, deeply pigmented
1.Primary Outcome
Title Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
Hide Description Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Hide Arm/Group Description:

Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks

Olumacostat Glasaretil

Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks

Olumacostat Glasaretil

Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks

Olumacostat Glasaretil

Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks

Vehicle

Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks

Vehicle
Overall Number of Participants Analyzed 52 50 106 110 101
Least Squares Mean (Standard Deviation)
Unit of Measure: Lesions
-10.5  (9.79) -11.0  (9.04) -14.6  (9.22) -14.5  (9.49) -15.0  (9.35)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, Vehicle QD, Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% QD, Olumacostat Glasaretil Gel, 7.5% BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0006
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.
2.Primary Outcome
Title Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
Hide Description Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Time Frame Baseline and Week 12
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-To-Treat
Arm/Group Title Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Overall Number of Participants Analyzed 52 50 106 110 101
Least Squares Mean (Standard Deviation)
Unit of Measure: Lesions
-9.3  (15.62) -9.3  (15.07) -15.3  (15.17) -13.4  (15.42) -17.5  (15.15)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, Vehicle QD, Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% QD, Olumacostat Glasaretil Gel, 7.5% BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0002
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments ANCOVA with factors of treatment group (combined vehicle as one group) and baseline count as covariate.
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
Hide 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

  1. - Almost clear; rare noninflammatory lesions with no more than one small inflammatory lesion
  2. - Mild severity; greater than Grade 1; some noninflammatory lesions with no more than a few inflammatory lesions (papules/pustules only, no nodular lesions)
  3. - 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
  4. - 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-Treat
Arm/Group Title Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Hide Arm/Group Description:
Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks
Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
Overall Number of Participants Analyzed 52 50 106 110 101
Measure Type: Count of Participants
Unit of Measure: Participants
Success
4
   7.7%
6
  12.0%
23
  21.7%
21
  19.1%
26
  25.7%
Failure
48
  92.3%
44
  88.0%
83
  78.3%
89
  80.9%
75
  74.3%
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection Olumacostat Glasaretil Gel, Vehicle QD, Olumacostat Glasaretil Gel, Vehicle BID, Olumacostat Glasaretil Gel, 4.0% QD, Olumacostat Glasaretil Gel, 7.5% QD, Olumacostat Glasaretil Gel, 7.5% BID
Comments [Not Specified]
Type of Statistical Test Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.0055
Comments [Not Specified]
Method Cochran-Mantel-Haenszel
Comments Cochran-Mantel-Haenszel test (vehicle treatment groups included as single combined treatment group).
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, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Hide Arm/Group Description Olumacostat Glasaretil Gel, Vehicle, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks Olumacostat Glasaretil Gel, 4.0%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5%, applied once daily to the face for 12 weeks Olumacostat Glasaretil Gel, 7.5%, applied twice daily to the face for 12 weeks
All-Cause Mortality
Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/50 (0.00%)   0/106 (0.00%)   0/109 (0.00%)   0/101 (0.00%) 
Hide Serious Adverse Events
Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/50 (0.00%)   0/106 (0.00%)   1/109 (0.92%)   0/101 (0.00%) 
Neoplasms benign, malignant and unspecified (incl cysts and polyps)           
Uterine Leiomyoma †  0/52 (0.00%)  0/50 (0.00%)  0/106 (0.00%)  1/109 (0.92%)  0/101 (0.00%) 
†
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Olumacostat Glasaretil Gel, Vehicle QD Olumacostat Glasaretil Gel, Vehicle BID Olumacostat Glasaretil Gel, 4.0% QD Olumacostat Glasaretil Gel, 7.5% QD Olumacostat Glasaretil Gel, 7.5% BID
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   0/52 (0.00%)   0/50 (0.00%)   4/106 (3.77%)   6/109 (5.50%)   7/101 (6.93%) 
Infections and infestations           
Nasopharyngitis †  0/52 (0.00%)  0/50 (0.00%)  4/106 (3.77%)  6/109 (5.50%)  7/101 (6.93%) 
†
Indicates events were collected by systematic assessment
[Not Specified]
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.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company.
Phone: 800-545-5979
EMail: ClinicalTrials.gov@lilly.com
Layout table for additonal information
Responsible Party: Eli Lilly and Company ( Dermira, Inc. )
ClinicalTrials.gov Identifier: NCT02431052    
Other Study ID Numbers: DRM01B-ACN02
First Submitted: April 27, 2015
First Posted: April 30, 2015
Results First Submitted: January 31, 2019
Results First Posted: February 26, 2019
Last Update Posted: July 20, 2021