Trial Outcomes & Findings for A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris (NCT NCT03073486)
NCT ID: NCT03073486
Last Updated: 2021-07-20
Results Overview
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
744 participants
Primary outcome timeframe
Baseline and Week 12
Results posted on
2021-07-20
Participant Flow
Participant milestones
| Measure |
Olumacostat Glasaretil Gel, 5.0%
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Overall Study
STARTED
|
493
|
251
|
|
Overall Study
COMPLETED
|
405
|
207
|
|
Overall Study
NOT COMPLETED
|
88
|
44
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=493 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=251 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Total
n=744 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.2 Years
STANDARD_DEVIATION 6.98 • n=5 Participants
|
19.2 Years
STANDARD_DEVIATION 7.26 • n=7 Participants
|
19.2 Years
STANDARD_DEVIATION 7.07 • n=5 Participants
|
|
Sex: Female, Male
Female
|
294 Participants
n=5 Participants
|
145 Participants
n=7 Participants
|
439 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
199 Participants
n=5 Participants
|
106 Participants
n=7 Participants
|
305 Participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
304 Participants
n=5 Participants
|
147 Participants
n=7 Participants
|
451 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
189 Participants
n=5 Participants
|
104 Participants
n=7 Participants
|
293 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
88 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
140 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
393 Participants
n=5 Participants
|
196 Participants
n=7 Participants
|
589 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
12 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
15 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
4 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
35 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
44 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
90 Participants
n=5 Participants
|
54 Participants
n=7 Participants
|
144 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
342 Participants
n=5 Participants
|
178 Participants
n=7 Participants
|
520 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
21 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
Canada
|
44 participants
n=5 Participants
|
22 participants
n=7 Participants
|
66 participants
n=5 Participants
|
|
Region of Enrollment
United States
|
393 participants
n=5 Participants
|
200 participants
n=7 Participants
|
593 participants
n=5 Participants
|
|
Region of Enrollment
Australia
|
56 participants
n=5 Participants
|
29 participants
n=7 Participants
|
85 participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type I
|
33 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
46 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type II
|
99 Participants
n=5 Participants
|
61 Participants
n=7 Participants
|
160 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type III
|
133 Participants
n=5 Participants
|
58 Participants
n=7 Participants
|
191 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
112 Participants
n=5 Participants
|
57 Participants
n=7 Participants
|
169 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type V
|
51 Participants
n=5 Participants
|
26 Participants
n=7 Participants
|
77 Participants
n=5 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
65 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
101 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Mean absolute change in acne lesion counts (inflammatory) from baseline to Week 12
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=493 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=251 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Mean Absolute Change in Acne Lesion Counts (Inflammatory) From Baseline to Week 12
|
-17.0 Lesions
Standard Deviation 12.16
|
-15.4 Lesions
Standard Deviation 11.95
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
Mean absolute change in acne lesion counts (non-inflammatory) from baseline to Week 12
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=493 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=251 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Mean Absolute Change in Acne Lesion Counts (Non-inflammatory) From Baseline to Week 12
|
-18.0 Lesions
Standard Deviation 23.37
|
-17.6 Lesions
Standard Deviation 22.64
|
PRIMARY outcome
Timeframe: Baseline and Week 12Population: Intent-to-Treat
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
Outcome measures
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=493 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=251 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
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
Success
|
80 Participants
|
30 Participants
|
|
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
Failure
|
413 Participants
|
221 Participants
|
Adverse Events
Olumacostat Glasaretil Gel, 5.0%
Serious events: 1 serious events
Other events: 108 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, Vehicle
Serious events: 0 serious events
Other events: 28 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=491 participants at risk
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=248 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Psychiatric disorders
Suicidal ideation
|
0.20%
1/491 • Baseline to Week 12
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.
|
0.00%
0/248 • Baseline to Week 12
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.
|
Other adverse events
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=491 participants at risk
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=248 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
General disorders
Application site dryness
|
3.1%
15/491 • Baseline to Week 12
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.
|
0.81%
2/248 • Baseline to Week 12
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.
|
|
General disorders
Application site erythema
|
5.7%
28/491 • Baseline to Week 12
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.
|
1.2%
3/248 • Baseline to Week 12
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.
|
|
General disorders
Application site pain
|
6.1%
30/491 • Baseline to Week 12
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.
|
2.4%
6/248 • Baseline to Week 12
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.
|
|
General disorders
Application site pruritus
|
7.7%
38/491 • Baseline to Week 12
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.
|
6.9%
17/248 • Baseline to Week 12
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.
|
|
Infections and infestations
Nasopharyngitis
|
1.8%
9/491 • Baseline to Week 12
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.
|
2.8%
7/248 • Baseline to Week 12
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.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.1%
20/491 • Baseline to Week 12
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.
|
2.0%
5/248 • Baseline to Week 12
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.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place