Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Hyperhidrosis is a disorder of abnormal excessive sweating. Primary hyperhidrosis (armpits,
 hands, and feet) affects approximately 4.8% of the US population and is believed to be caused
 by an overactive cholinergic response of the sweat glands.

 Current therapies have limited effectiveness, significant side effects, and can be invasive
 and costly. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the
 topical treatment of hyperhidrosis.

 This Phase 3 study will assess the safety and efficacy of sofpironium bromide, 15% gel versus
 vehicle (2 treatment arms), applied for the treatment of axillary hyperhidrosis.
This is a multicenter, randomized, double-blind, vehicle-controlled study to evaluate the
 safety and efficacy of topically applied sofpironium bromide, 15% gel in subjects with
 axillary hyperhidrosis.

 Safety will be assessed through collection of vital signs, adverse events, local skin
 responses, hematology, serum chemistry laboratory testing and urinalysis.

 A maximum of 350 subjects will be randomized to receive either sofpironium bromide gel, 15%
 or vehicle.

 Adverse events, vital signs, and local tolerability assessments will be collected at visits
 across the study. Urine pregnancy tests will be taken throughout the course of the study for
 women of child bearing potential. Blood and urine samples will be collected and analyzed for
 routine hematology, chemistry, and urinalysis parameters at specified visits.
 Patient-reported outcome assessments will be recorded during the study at predefined time
 points.

 The study will be comprised of a total of 13 scheduled visits to take place over
 approximately 11 to 15 weeks.
Inclusion Criteria:

 -  Male or female subject ≥ 9 years of age.

 -  Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a)
 symptoms of hyperhydrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and
 (c) a minimum GSP of 50 mg is each axilla with a combined total of at least 150 mg.

 -  The ability to understand and follow all study-related procedures including study drug
 administration.

 -  Sexually active female of childbearing potential (FOCBP)* must agree to periodic
 pregnancy testing and use a medically acceptable method of contraception while
 receiving protocol-assigned product.

 Exclusion Criteria:

 -  In the Investigators opinion, any skin or subcutaneous tissue conditions of the
 axilla(s).

 -  Prior use of any prohibited medication(s) or procedure(s) within the specified
 timeframe for the treatment of axillary hyperhidrosis.

 -  Anticholinergic agents used to treat conditions such as, but not limited to,
 hyperhidrosis, asthma, incontinence, gastrointestinal cramps, and muscular spasms by
 any route of administration.

 -  Use of any cholinergic drug (e.g. bethanechol) within 28 days.

 -  Known cause of hyperhidrosis or known history of a condition that may cause
 hyperhidrosis (i.e., hyperhidrosis secondary to any known cause such hyperthyroidism,
 diabetes mellitus, medications, etc.).

 -  Subjects with unstable diabetes mellitus or thyroid disease, history of renal or
 hepatic impairment, malignancy glaucoma, intestinal obstructive or motility disease,
 obstructive uropathy, myasthenia gravis, BPH, neurological or psychiatric conditions,
 Sjögren's or Sicca syndrome, or cardiac abnormalities that may alter or exacerbate
 sweat production by the use of anticholinergics in the investigator's opinion.

 -  Subjects with known hypersensitivity to glycopyrrolate, anticholinergics, or any of
 the components of the topical formulation.

 -  Subject is pregnant, lactating or is planning to become pregnant during the study.