Trial Outcomes & Findings for Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis (NCT NCT02553798)

NCT ID: NCT02553798

Last Updated: 2021-08-25

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 564 participants
• Primary outcome timeframe: Day 1 - Week 44
• Results posted on: 2021-08-25

Participant Flow

Participant milestones

Measure	Glycopyrronium Glycopyrronium Topical Wipes
Overall Study STARTED	564
Overall Study COMPLETED	226
Overall Study NOT COMPLETED	338

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Long-term Safety Study of Glycopyrronium in Subjects With Primary Axillary Hyperhidrosis

Baseline characteristics by cohort

Measure	Glycopyrronium n=564 Participants Glycopyrronium Topical Wipes
Age, Categorical <=18 years	60 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	499 Participants n=5 Participants
Age, Categorical >=65 years	5 Participants n=5 Participants
Sex: Female, Male Female	309 Participants n=5 Participants
Sex: Female, Male Male	255 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	97 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	467 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	3 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	1 Participants n=5 Participants
Race (NIH/OMB) Black or African American	64 Participants n=5 Participants
Race (NIH/OMB) White	470 Participants n=5 Participants
Race (NIH/OMB) More than one race	24 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants

PRIMARY outcome

Timeframe: Day 1 - Week 44

Population: Participant

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.

Outcome measures

Measure	Glycopyrronium n=550 Participants Glycopyrronium Topical Wipes
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions Mild AEs	148 Adverse Events and Local Skin Reactions
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions Moderate AEs	153 Adverse Events and Local Skin Reactions
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions Severe AEs	28 Adverse Events and Local Skin Reactions
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions Mild LSRs	120 Adverse Events and Local Skin Reactions
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions Moderate LSRs	44 Adverse Events and Local Skin Reactions
Long-term Safety Assessed Through Adverse Events and Local Skin Reactions Severe LSRs	15 Adverse Events and Local Skin Reactions

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Population: Participant

Subjects are acclimated to the environment for 30 minutes. Dry gauze is weighed. The dry gauze is then applied to the subject's axilla with the arm down by the subject's side or on their lap during the 5-minute period of sweat production. The gauze with the sweat is then weighed. The difference between the Weight of the gauze with sweat and the dry gauze is the gravimetric sweat measurement in mg/5min.

Outcome measures

Measure	Glycopyrronium n=430 Participants Glycopyrronium Topical Wipes
Mean Absolute Change From Baseline in Gravimetrically-measured Sweat Production at Week 4	-95.68 mg/5 min Standard Deviation 140.806

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Population: Participant

Hyperhidrosis Disease Severity Scale (HDSS) is a disease specific diagnostic tool that provides a qualitative measure of the severity of the subjects' condition based on how it affects daily activities.

Outcome measures

Measure	Glycopyrronium n=437 Participants Glycopyrronium Topical Wipes
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) 3 - point improvement	72 participants
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) 2 - point improvement	204 participants
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) 1 - point improvement	135 participants
Grade Improvement in Hyperhidrosis Disease Severity Scale (HDSS) no improvement	26 participants

OTHER_PRE_SPECIFIED outcome

Timeframe: Baseline (from DRM04-HH04 (NCT02530281) or DRM04-HH05 (NCT02530294) study) - Week 44/ET

Population: Participant

The Dermatology Life Quality Index DLQI is a ten question questionnaire, used to measure the impact of skin disease on the quality of life of an affected person. The scoring of each question is as follows: Very much (3), A lot (2), A little (1), Not at all (0), Not relevant (0). Is calculated by summing the score of each question resulting in a max of 30 and a min of 0. Higher the score the more Quality of life is impaired.

Outcome measures

Measure	Glycopyrronium n=406 Participants Glycopyrronium Topical Wipes
Change From Baseline in Dermatology Life Quality Index (DLQI) at Week 44/ET	-8.7 scores on a scale Standard Deviation 6.24

Adverse Events

Glycopyrronium

Serious events: 7 serious events

Other events: 178 other events

Deaths: 0 deaths

Serious adverse events

Measure	Glycopyrronium n=550 participants at risk Glycopyrronium Topical Wipes Glycopyrronium Topical Wipes: Glycopyrronium Topical Wipes
Infections and infestations Diverticulitis	0.18% 1/550 • up to 45 weeks 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 Infectious colitis	0.18% 1/550 • up to 45 weeks 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 Affective disorder	0.18% 1/550 • up to 45 weeks 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 Suicide attempt	0.18% 1/550 • up to 45 weeks 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.
Eye disorders Mydriasis	0.18% 1/550 • up to 45 weeks 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 Chest pain	0.18% 1/550 • up to 45 weeks 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.
Injury, poisoning and procedural complications Concussion	0.18% 1/550 • up to 45 weeks 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	Glycopyrronium n=550 participants at risk Glycopyrronium Topical Wipes Glycopyrronium Topical Wipes: Glycopyrronium Topical Wipes
Gastrointestinal disorders Dry Mouth	16.9% 93/550 • up to 45 weeks 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	5.8% 32/550 • up to 45 weeks 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	6.4% 35/550 • up to 45 weeks 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.
Eye disorders Vision blurred	6.7% 37/550 • up to 45 weeks 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.
Eye disorders Mydriasis	5.1% 28/550 • up to 45 weeks 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

Eugene A. Bauer, MD, Chief Medical Officer

Dermira, Inc.

Phone: 650-421-7202

Email: eugene.bauer@dermira.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place