Trial Outcomes & Findings for Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (NCT NCT03836287)
NCT ID: NCT03836287
Last Updated: 2024-06-06
Results Overview
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 \[better\] - 4 \[worse\]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment \[6 weeks\] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
350 participants
Primary outcome timeframe
Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.
Results posted on
2024-06-06
Participant Flow
Participant milestones
| Measure |
Active
Sofpironium bromide, 15% gel, once per day
Sofpironium Bromide Gel, 15%: Active
|
Vehicle
Vehicle gel, once per day
Vehicle: Vehicle gel
|
|---|---|---|
|
Overall Study
STARTED
|
173
|
177
|
|
Overall Study
COMPLETED
|
150
|
162
|
|
Overall Study
NOT COMPLETED
|
23
|
15
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Baseline characteristics by cohort
| Measure |
Active
n=173 Participants
Sofpironium bromide, 15% gel, once per day
Sofpironium Bromide Gel, 15%: Active
|
Vehicle
n=177 Participants
Vehicle gel, once per day
Vehicle: Vehicle gel
|
Total
n=350 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.9 years
STANDARD_DEVIATION 11.63 • n=99 Participants
|
32.4 years
STANDARD_DEVIATION 10.86 • n=107 Participants
|
32.7 years
STANDARD_DEVIATION 11.21 • n=206 Participants
|
|
Age, Customized
9-12 years
|
2 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Age, Customized
13-16 years
|
7 Participants
n=99 Participants
|
9 Participants
n=107 Participants
|
16 Participants
n=206 Participants
|
|
Age, Customized
17-30 years
|
70 Participants
n=99 Participants
|
73 Participants
n=107 Participants
|
143 Participants
n=206 Participants
|
|
Age, Customized
≥31 years
|
94 Participants
n=99 Participants
|
95 Participants
n=107 Participants
|
189 Participants
n=206 Participants
|
|
Sex: Female, Male
Female
|
98 Participants
n=99 Participants
|
99 Participants
n=107 Participants
|
197 Participants
n=206 Participants
|
|
Sex: Female, Male
Male
|
75 Participants
n=99 Participants
|
78 Participants
n=107 Participants
|
153 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
61 Participants
n=99 Participants
|
60 Participants
n=107 Participants
|
121 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
111 Participants
n=99 Participants
|
117 Participants
n=107 Participants
|
228 Participants
n=206 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
1 Participants
n=206 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Asian
|
1 Participants
n=99 Participants
|
3 Participants
n=107 Participants
|
4 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Black or African American
|
31 Participants
n=99 Participants
|
43 Participants
n=107 Participants
|
74 Participants
n=206 Participants
|
|
Race (NIH/OMB)
White
|
140 Participants
n=99 Participants
|
130 Participants
n=107 Participants
|
270 Participants
n=206 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=99 Participants
|
0 Participants
n=107 Participants
|
0 Participants
n=206 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=99 Participants
|
1 Participants
n=107 Participants
|
2 Participants
n=206 Participants
|
|
Time Since Start of Axillary Hyperhidrosis Symptoms
|
179.29 Months
STANDARD_DEVIATION 115.155 • n=99 Participants
|
184.42 Months
STANDARD_DEVIATION 116.898 • n=107 Participants
|
181.86 Months
STANDARD_DEVIATION 115.708 • n=206 Participants
|
PRIMARY outcome
Timeframe: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.Population: Intent-to-treat
Change in score from baseline to end of treatment of 7 questions from the patient reported outcome assessment - Hyperhidrosis Disease Severity Measure-Axillary-7; each question had a 5-point response (range 0 \[better\] - 4 \[worse\]). Total scores were calculated by averaging the score of all items, resulting in an axillary hyperhidrosis symptom range of 0 (no sweating) to 4 (worst possible sweating). Improvement corresponded to a ≥2-point reduction of individual participant score from baseline to end of treatment (end of treatment \[6 weeks\] score minus baseline score). Treatment arms compared included vehicle and Sofpironium Bromide Gel, 15%. Counts of participants (per treatment arm) with and without an observed ≥2-point improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score from baseline to end of treatment were used as the outcome value(s).
Outcome measures
| Measure |
Active
n=157 Participants
Sofpironium bromide, 15% gel, once per day
Sofpironium Bromide Gel, 15%: Active
|
Vehicle
n=166 Participants
Vehicle gel, once per day
Vehicle: Vehicle gel
|
|---|---|---|
|
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Number of Participants YES Observed ≥2-point improvement
|
84 Participants
|
54 Participants
|
|
Number of Participants (Vehicle Arm vs. Sofpironium Bromide Gel, 15%) With and Without an Observed ≥2-point Improvement in Hyperhidrosis Disease Severity Measure-Axillary-7 Item Total Score From Baseline to End of Treatment
Number of Participants NO Observed ≥2-point improvement
|
73 Participants
|
112 Participants
|
PRIMARY outcome
Timeframe: Total Trial Participation was approximately 11-15 weeks; outcome measure time frame: Baseline (and treatment start) through to end of treatment, taking approximately 6 weeks.Population: Intent-to-Treat
Individual gravimetric sweat production values were reported as the combined measured weight (mg) of axillary (right+left axillae) sweat production at each visit. Gravimetric sweat production values were rank-transformed. Baseline GSP was the median rank of GSP measurements obtained on Visit 2, Visit 3, and Visit 4. End of Treatment GSP was the median rank of GSP measurements obtained on Visit 10, Visit 11, and Visit 12. The difference in ranked GSP from baseline to end of treatment (ranked GSP at end of treatment \[6 weeks\] minus ranked GSP at baseline) was used as the outcome value.
Outcome measures
| Measure |
Active
n=157 Participants
Sofpironium bromide, 15% gel, once per day
Sofpironium Bromide Gel, 15%: Active
|
Vehicle
n=165 Participants
Vehicle gel, once per day
Vehicle: Vehicle gel
|
|---|---|---|
|
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment
|
-27.88 milligrams
Standard Deviation 94.670
|
-7.24 milligrams
Standard Deviation 99.695
|
Adverse Events
Active
Serious events: 1 serious events
Other events: 58 other events
Deaths: 0 deaths
Vehicle
Serious events: 0 serious events
Other events: 6 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Active
n=173 participants at risk
Sofpironium bromide, 15% gel, once per day
Sofpironium Bromide Gel, 15%: Active
|
Vehicle
n=176 participants at risk
Vehicle gel, once per day
Vehicle: Vehicle gel
|
|---|---|---|
|
Gastrointestinal disorders
SMALL BOWEL OBSTRUCTION
|
0.58%
1/173 • Number of events 1 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.00%
0/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
Other adverse events
| Measure |
Active
n=173 participants at risk
Sofpironium bromide, 15% gel, once per day
Sofpironium Bromide Gel, 15%: Active
|
Vehicle
n=176 participants at risk
Vehicle gel, once per day
Vehicle: Vehicle gel
|
|---|---|---|
|
General disorders
APPLICATION SITE PAIN
|
6.4%
11/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
1.7%
3/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
|
General disorders
APPLICATION SITE PRURITUS
|
6.4%
11/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.57%
1/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
|
General disorders
APPLICATION SITE DERMATITIS
|
5.8%
10/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.57%
1/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
|
General disorders
APPLICATION SITE ERYTHEMA
|
5.2%
9/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.57%
1/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
|
Gastrointestinal disorders
DRY MOUTH
|
11.6%
20/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.00%
0/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
|
Eye disorders
MYDRIASIS
|
7.5%
13/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.00%
0/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
|
Eye disorders
VISION BLURRED
|
5.2%
9/173 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
0.00%
0/176 • 11-15 weeks
A total of 350 participants were randomized into the study, 173 participants to sofpironium bromide gel,15% and 177 participants to vehicle gel (placebo). All except one participant (349 participants total) received at least one dose of study drug. A subject in the vehicle group was withdrawn from the study before receiving any study treatment because the subject did not meet eligibility criteria.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Agreement terms prioritized a multi-center publication at the study end. Should such a publication not be completed, an investigator right to individually publish results of his/her study (limited to his/her site data) was included, if for purely scientific or educational purposes; not for any commercial purposes. PI(s) were to submit draft materials to the Sponsor 60 days prior to Investigator release of individual abstract or manuscript. Additional disclosure restrictions and terms applied.
- Publication restrictions are in place
Restriction type: OTHER