Trial Outcomes & Findings for A Study of Olumacostat Glasaretil Gel in Subjects With Acne Vulgaris (NCT NCT03028363)
NCT ID: NCT03028363
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
759 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
|
498
|
261
|
|
Overall Study
COMPLETED
|
420
|
228
|
|
Overall Study
NOT COMPLETED
|
78
|
33
|
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=498 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=261 Participants
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
Total
n=759 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Categorical
<=18 years
|
289 Participants
n=99 Participants
|
140 Participants
n=107 Participants
|
429 Participants
n=206 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
209 Participants
n=99 Participants
|
121 Participants
n=107 Participants
|
330 Participants
n=206 Participants
|
|
Age, Categorical
>=65 years
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Age, Continuous
|
19.4 Years
STANDARD_DEVIATION 6.58 • n=99 Participants
|
20.1 Years
STANDARD_DEVIATION 7.14 • n=107 Participants
|
19.7 Years
STANDARD_DEVIATION 6.78 • n=206 Participants
|
|
Sex: Female, Male
Female
|
286 Participants
n=99 Participants
|
152 Participants
n=107 Participants
|
438 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
212 Participants
n=99 Participants
|
109 Participants
n=107 Participants
|
321 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
150 Participants
n=99 Participants
|
68 Participants
n=107 Participants
|
218 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
346 Participants
n=99 Participants
|
193 Participants
n=107 Participants
|
539 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
3 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
6 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
13 Participants
n=99 Participants
|
11 Participants
n=107 Participants
|
24 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
3 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
3 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
79 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
122 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
373 Participants
n=99 Participants
|
191 Participants
n=107 Participants
|
564 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
27 Participants
n=99 Participants
|
13 Participants
n=107 Participants
|
40 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Region of Enrollment
Canada
|
32 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
48 Participants
n=206 Participants
|
|
Region of Enrollment
United States
|
431 Participants
n=99 Participants
|
226 Participants
n=107 Participants
|
657 Participants
n=206 Participants
|
|
Region of Enrollment
Australia
|
35 Participants
n=99 Participants
|
19 Participants
n=107 Participants
|
54 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type I
|
28 Participants
n=99 Participants
|
16 Participants
n=107 Participants
|
44 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type II
|
94 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
149 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type III
|
125 Participants
n=99 Participants
|
75 Participants
n=107 Participants
|
200 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type IV
|
115 Participants
n=99 Participants
|
55 Participants
n=107 Participants
|
170 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type V
|
79 Participants
n=99 Participants
|
29 Participants
n=107 Participants
|
108 Participants
n=206 Participants
|
|
Fitzpatrick Skin Type
Type VI
|
57 Participants
n=99 Participants
|
31 Participants
n=107 Participants
|
88 Participants
n=206 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=498 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=261 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
|
-14.5 Lesions
Standard Deviation 14.85
|
-13.5 Lesions
Standard Deviation 14.54
|
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=498 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=261 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
|
-14.1 Lesions
Standard Deviation 21.05
|
-11.8 Lesions
Standard Deviation 20.28
|
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=498 Participants
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=261 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
|
95 Participants
|
54 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
|
403 Participants
|
207 Participants
|
Adverse Events
Olumacostat Glasaretil Gel, 5.0%
Serious events: 1 serious events
Other events: 89 other events
Deaths: 0 deaths
Olumacostat Glasaretil Gel, Vehicle
Serious events: 3 serious events
Other events: 33 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Olumacostat Glasaretil Gel, 5.0%
n=485 participants at risk
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=258 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/485 • 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.
|
0.39%
1/258 • 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
Appendicitis
|
0.00%
0/485 • 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.
|
0.39%
1/258 • 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.
|
|
Nervous system disorders
Epilepsy
|
0.21%
1/485 • 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%
0/258 • 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.
|
|
Psychiatric disorders
Bipolar disorder
|
0.00%
0/485 • 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.
|
0.39%
1/258 • 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=485 participants at risk
Olumacostat Glasaretil Gel, 5.0%, applied twice daily to the face for 12 weeks
|
Olumacostat Glasaretil Gel, Vehicle
n=258 participants at risk
Olumacostat Glasaretil Gel, Vehicle, applied twice daily to the face for 12 weeks
|
|---|---|---|
|
General disorders
Application site dryness
|
2.7%
13/485 • 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.
|
0.78%
2/258 • 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
|
2.7%
13/485 • 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%
3/258 • 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
|
3.9%
19/485 • 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.
|
4.3%
11/258 • 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
|
2.7%
13/485 • 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.
|
1.6%
4/258 • 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
|
3.1%
15/485 • 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.
|
1.9%
5/258 • 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
|
3.3%
16/485 • 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.
|
3.1%
8/258 • 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