Trial Outcomes & Findings for An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris (NCT NCT02682264)
NCT ID: NCT02682264
Last Updated: 2020-11-17
Results Overview
Number of participants with any local and systemic treatment emergent AEs (TEAEs)
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
609 participants
Primary outcome timeframe
up to 52 weeks
Results posted on
2020-11-17
Participant Flow
There were 609 subjects who were rolled over (i.e., enrolled) from the two Phase 3 pivotal studies (CB-03-01/25 \[NCT02608450\] and CB-03-01/26 \[NCT02608476\]) into this long-term, safety study. However, two (2) subjects in the original vehicle cream were not treated with test article and thus were excluded from the study population (Safety set).
Participant milestones
| Measure |
CB-03-01 Cream, 1%
Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
|
CB-03-01 Cream, 1% (Vehicle Arm)
Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
|
|---|---|---|
|
Overall Study
STARTED
|
317
|
290
|
|
Overall Study
COMPLETED
|
179
|
168
|
|
Overall Study
NOT COMPLETED
|
138
|
122
|
Reasons for withdrawal
| Measure |
CB-03-01 Cream, 1%
Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a 1% cream for the topical treatment of acne vulgaris.
|
CB-03-01 Cream, 1% (Vehicle Arm)
Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
|
|---|---|---|
|
Overall Study
Withdrawal by Subject
|
56
|
45
|
|
Overall Study
Lost to Follow-up
|
49
|
41
|
|
Overall Study
Lack of Efficacy
|
14
|
16
|
|
Overall Study
Withdrawal by Parent
|
6
|
7
|
|
Overall Study
Adverse Event
|
9
|
0
|
|
Overall Study
Noncompliance with study drug
|
1
|
4
|
|
Overall Study
Pregnancy
|
1
|
2
|
|
Overall Study
Recovery
|
1
|
2
|
|
Overall Study
Progressive Disease
|
1
|
0
|
|
Overall Study
Technical Problems
|
0
|
1
|
|
Overall Study
Moved abroad and unable to continue
|
0
|
3
|
|
Overall Study
Stopped test article application
|
0
|
1
|
Baseline Characteristics
An Open-Label, Long-Term Extension Study to Evaluate the Safety of CB-03-01 Cream, 1% in Participants With Acne Vulgaris
Baseline characteristics by cohort
| Measure |
CB-03-01 Cream, 1%
n=317 Participants
Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a
1% cream for the topical treatment of acne vulgaris.
|
CB-03-01 Cream, 1% (Vehicle Arm)
n=290 Participants
Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
|
Total
n=607 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
19.2 years
STANDARD_DEVIATION 5.8 • n=5 Participants
|
19.3 years
STANDARD_DEVIATION 6.7 • n=7 Participants
|
19.2 years
STANDARD_DEVIATION 6.3 • n=5 Participants
|
|
Sex: Female, Male
Female
|
198 Participants
n=5 Participants
|
183 Participants
n=7 Participants
|
381 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
119 Participants
n=5 Participants
|
107 Participants
n=7 Participants
|
226 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
27 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
42 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
290 Participants
n=5 Participants
|
275 Participants
n=7 Participants
|
565 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
1 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
6 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
17 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
35 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
283 Participants
n=5 Participants
|
256 Participants
n=7 Participants
|
539 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
4 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
10 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: up to 52 weeksPopulation: Safety dataset population.
Number of participants with any local and systemic treatment emergent AEs (TEAEs)
Outcome measures
| Measure |
CB-03-01 Cream, 1%
n=317 Participants
Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a
1% cream for the topical treatment of acne vulgaris.
|
CB-03-01 Cream, 1% (Vehicle Arm)
n=290 Participants
Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
|
|---|---|---|
|
Number of Participants With Any Local and Systemic Treatment Emergent Adverse Events
|
58 Participants
|
52 Participants
|
Adverse Events
CB-03-01 Cream, 1%
Serious events: 3 serious events
Other events: 21 other events
Deaths: 0 deaths
CB-03-01 Cream, 1% (Vehicle Arm)
Serious events: 3 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
CB-03-01 Cream, 1%
n=317 participants at risk
Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a
1% cream for the topical treatment of acne vulgaris.
|
CB-03-01 Cream, 1% (Vehicle Arm)
n=290 participants at risk
Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
|
|---|---|---|
|
Psychiatric disorders
Depression
|
0.32%
1/317 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.00%
0/290 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Psychiatric disorders
Suicide attempt
|
0.32%
1/317 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.00%
0/290 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Gastrointestinal disorders
Gastroenteritis eosinophilic
|
0.32%
1/317 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.00%
0/290 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
General disorders
Fatigue
|
0.00%
0/317 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.34%
1/290 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Nervous system disorders
Dizziness
|
0.32%
1/317 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.00%
0/290 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Surgical and medical procedures
Abortion induced
|
0.00%
0/317 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.34%
1/290 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Vascular disorders
Coronary artery dissection
|
0.00%
0/317 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.34%
1/290 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
Other adverse events
| Measure |
CB-03-01 Cream, 1%
n=317 participants at risk
Subjects in this arm received CB-03-01 (cortexolone 17α-propionate) Cream, 1% in the pivotal study and continued their CB-03-01 cream treatment in this open-label safety extension study. Subjects were instructed to apply CB-03-01 Cream, 1%, twice daily to whole face (about 1 gram) and affected areas of trunk (if applicable) for up to an additional 9 months. Over the course of the study, treatment on the face and/or trunk may be discontinued if/when acne clears and re-started if/when acne worsens, according to the assessment of the investigator for each respective treatment area.
Cortexolone 17α-propionate (USAN/INN: clascoterone) is a steroidal antiandrogen that is being developed as a
1% cream for the topical treatment of acne vulgaris.
|
CB-03-01 Cream, 1% (Vehicle Arm)
n=290 participants at risk
Subjects in this arm received vehicle cream in the pivotal study and CB-03-01 cream in this open-label safety extension study.
|
|---|---|---|
|
Infections and infestations
Nasopharyngitis
|
1.9%
6/317 • Number of events 7 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
3.4%
10/290 • Number of events 13 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Infections and infestations
Upper respiratory tract infection
|
2.2%
7/317 • Number of events 8 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.34%
1/290 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Infections and infestations
Respiratory tract infection viral
|
0.32%
1/317 • Number of events 1 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
1.4%
4/290 • Number of events 4 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
Infections and infestations
Sinusitis
|
0.95%
3/317 • Number of events 3 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.69%
2/290 • Number of events 2 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
|
General disorders
Application site acne
|
1.3%
4/317 • Number of events 4 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
0.00%
0/290 • Treatment emergent adverse events (TEAEs) and serious adverse events (SAEs) were collected from the time the subject exited the pivotal study (i.e., Week 13 or day 1 of the Long-term extension study) and up to 52 weeks after entry into the pivotal study (i.e., up to week 39 or early termination of the long term extension study).
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Sponsor has first right to publish pooled study data. In the event that such manuscript has not been submitted for publication within 18 months from study completion/termination at all participating sites, the PI shall have the right to single center publications provided they submit any data for presentation, oral or written, to the Sponsor for review 60 days prior to public disclosure. The PI may not disclose previously undisclosed confidential information other than study results.
- Publication restrictions are in place
Restriction type: OTHER