A Safety Study of BBI-4000 Gel in Patients With Axillary Hyperhidrosis
Condition: Primary Axillary Hyperhidrosis
MeSH terms: Hyperhidrosis
Intervention: Sofpironium Bromide Gel, 5%; Sofpironium Bromide Gel, 15%
Intervention description: Sofpironium Bromide Gel, 5%; Sofpironium Bromide Gel, 15%
Intervention MeSH terms: Bromides
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 300.0
Sex: All
Minimum age: 9 Years
Maximum age: 65 Years
Healthy volunteers: No

Summary:

      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 long-term safety, tolerability, and efficacy of
      sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Male or female subject ≥9 years of age in good general health.

          -  Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a)
             HDSM-Ax of 3 - 4 inclusive at both the Screening Visit (Visit 1) and Baseline Visit
             (Visit 2). (b) Symptoms of axillary hyperhidrosis for greater than or equal to 6
             months' duration prior to Baseline Visit (Visit 2).

        Exclusion Criteria:

          -  In the Investigator's opinion, any skin or subcutaneous tissue conditions of the
             axilla(e), (i.e., the axillary area should be deemed otherwise "normal", besides the
             hyperhidrosis diagnosis, and free of blisters, large boils or sinus tracts,
             significant scarring or open wounds).

          -  Prior use of any prohibited medication(s) or procedure(s) within the specified
             timeframe for the treatment of axillary hyperhidrosis: (a) Botulinum toxin to the
             axillary area within 6 months of the Baseline Visit (Visit 2). (b) Axillary
             thermolysis, sympathectomy or surgical procedures of the axillary area at any time in
             the past. (c) Serotonergic agonist (or drugs that increase serotonin activity
             including SSRIs), beta-blocker, alpha-adrenergic agonist (clonidine), dopamine partial
             agonist or tricyclic antidepressant treatment within 28 days of the Baseline Visit
             (Visit 2). However, if a subject has been on a stable dose (in the opinion of the PI)
             of any of these medications and has not had a recent change in hyperhidrosis frequency
             or severity for 3 months prior to the Baseline Visit; they may be included. Doses of
             these agents should not be altered during the course of the study. (d) Any topical
             treatment for hyperhidrosis, requiring a prescription, within 15 days of Baseline
             Visit (Visit 2).

          -  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 (e.g., IV, oral, inhaled, topical) within 28 days of the
             Baseline Visit (Visit 2).

          -  Use of potent oral inhibitors of cytochrome P450 CYP3A & CYP2D6 and transporter
             inhibitors (OCT2/MATE1/MATE2) 14 days prior to the Baseline Visit (Visit 2). The use
             of topical antifungal medications is permitted if not applied in the treatment area.

          -  Any oral or topical homeopathic or herbal treatment (i.e., alternative therapies such
             as sage tablets, chamomile, valerian root and St. John's Wort) within 7 days of the
             Baseline Visit (Visit 2).

          -  Use of any cholinergic drug (e.g., bethanechol) within 15 days of the Baseline Visit
             (Visit 2).

          -  Use of any anti-anxiety and/or anti-depressant, amphetamine product or drugs with
             known anticholinergic side effects is prohibited with the following exceptions: (a) If
             a subject has been on a stable dose of an anti-anxiety and/or anti-depressant drug and
             has not had a recent change in hyperhidrosis frequency or severity for 3 months; they
             may be included. (b) An amphetamine product may be allowed if the dose has been stable
             for greater than or equal to 6 months without change in hyperhidrosis frequency or
             severity. (c) Drugs with known anticholinergic side effects (taken within the last 28
             days), including dry mouth, blurred vision, may be allowed based on the Principal
             Investigator's assessment.

        NOTE: If anticholinergic side effect(s) are experienced on these medications prior to
        starting study medication; document the side effect(s) and severities in the source
        document and the eCRF. The doses of these agents should not be altered during the course of
        the study.

          -  Known causes 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 hyperhidrosis symptoms initiated or exacerbated with menopause.

          -  Subjects with unstable type 1 or type 2 diabetes mellitus or thyroid disease, history
             of renal impairment, hepatic impairment, malignancy, glaucoma, intestinal obstructive
             or motility disease, obstructive uropathy, myasthenia gravis, benign prostatic
             hyperplasia (BPH), neurological conditions, psychiatric conditions, Sjögren's
             syndrome, Sicca syndrome, or cardiac abnormalities that may alter normal sweat
             production or may be exacerbated by the use of anticholinergics in the Investigator's
             opinion.

          -  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.

          -  Participating in a study of or used an investigational drug or device within 28 days
             prior to the Baseline Visit (Visit 2).

          -  Any major illness within 28 days before the screening examination.

          -  Any other condition, including psychiatric illness (depression and/or anxiety) that
             would interfere with study participation and/or evaluation of study endpoints or
             laboratory abnormality that, in the opinion of the Investigator, would put the subject
             at unacceptable risk for participation in the study or may interfere with the
             assessments included in the study.

          -  History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial
             fibrillation or atrial flutter.