A Safety Study of BBI-4000 Gel in Pediatric Patients With Axillary Hyperhidrosis

NCT03785587 | Completed Phase 2 Results FDA Drug

• 1 other identifier: BBI-4000-CL-108
• Study Type: interventional
• Target: 21
• Locations: 1 country
• Sites: 1

Brief 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. Sofpironium bromide (BBI-4000) is a novel soft-drug in development for the topical treatment of hyperhidrosis. This Phase 2 study will assess the long-term safety, tolerability, pharmacokinetics and efficacy of sofpironium bromide gel applied topically to pediatric subjects with axillary hyperhidrosis.

Conditions

Primary Axillary Hyperhidrosis

Outcome Measures

Primary Outcomes (3)

• The Number of Participants With Treatment Emergent Adverse Events (All TEAEs).

  Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe.

  Through study completion (24 weeks).

• The Number of Participants With Dermal Tolerability Symptoms of Burning, Stinging, Itching, Scaling or Erythema to the Axillae.

  Summary of local site tolerability by maximum severity symptom rating on a 5-point scale (0=absent, 1=minimal, 2=mild,-3=moderate, 4=severe)-Safety Population

  Through study completion (24 weeks).

• The Systemic Exposure (Ctrough) of Sofpironium and Its Primary Metabolite (BBI-4010)

  Trough levels of sofpironium based on sampling schedule.

  Through study completion (24 weeks).

Study Arms (1)

Gel, 15%

EXPERIMENTAL

Sofpironium Bromide Gel, 15%, applied once daily to each axilla for 24 weeks

Drug: Sofpironium Bromide Gel, 15%

Interventions

Sofpironium Bromide Gel, 15% DRUG

Sofpironium Bromide Gel, 15%

Also known as: BBI-4000

Gel, 15%

Eligibility Criteria

• Age: 9 Years - 16 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• Male or female subject ≥9 to \<17 years of age in good general health.
• Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 2 - 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 enrollment.

You may not qualify if:

• 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 9 months of enrollment. (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 30 days of enrollment. 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 enrollment; 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 3 days of enrollment.
• Anticholinergic agents \[with the exception of sofpironium bromide\] 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 30 days of the enrollment.
• Use of potent oral inhibitors of cytochrome P450 CYP3A \& CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to enrollment. 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 14 days of enrollment.
• Use of any cholinergic drug (e.g., bethanechol) within 30 days of enrollment.
• 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 for 3 months. (c) Drugs with known anticholinergic side effects (taken within the last 30 days), including dry mouth, blurred vision, may be allowed based on the Principal Investigator's assessment.
• 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.
• Unable or unwilling to undergo multiple venipunctures.

Sponsors & Collaborators

• Botanix Pharmaceuticals: lead

Study Sites (1)

Northwest Arkansas Clinical Trials Center

Rogers, Arkansas, 72758, United States

Location

Results Point of Contact

• Title: Anthony Robinson MS CRNP
• Organization: Botanix Pharmaceuticals

trials@botanixpharma.com

+1 (445) 300-3403

Study Officials

• Patricia Walker, MD PhD

  Botanix Pharmaceuticals

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 17, 2018
• First Posted: December 24, 2018
• Study Start: December 21, 2018
• Primary Completion: September 6, 2019
• Study Completion: September 6, 2019
• Last Updated: March 14, 2023
• Results First Posted: March 14, 2023

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)