Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-302) (CARDIGANII)

A Multicenter, Randomized, Double-Blinded, Vehicle-Controlled Study to Evaluate the Safety and Efficacy of Topically Applied Sofpironium Bromide Gel, 15% in Subjects With Axillary Hyperhidrosis

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.

Study Overview

• Status: Completed
• Conditions: Axillary Hyperhidrosis
• Intervention / Treatment: Drug: Sofpironium Bromide, 15%; Drug: Vehicle

Detailed Description

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.

• Study Type: Interventional
• Enrollment (Actual): 351
• Phase: Phase 3

Contacts and Locations

Study Locations

• United States
  • Alabama
    • Birmingham, Alabama, United States, 35244
      • Cahaba Dermatology Skin & Health Center
  • Arizona
    • Glendale, Arizona, United States, 85308
      • Advanced Research Associates
  • Arkansas
    • North Little Rock, Arkansas, United States, 72117
      • Arkansas Research Trials
  • California
    • Fountain Valley, California, United States, 92708
      • First OC Dermatology
  • Colorado
    • Centennial, Colorado, United States, 80111
      • CoDerm Research
    • Denver, Colorado, United States, 80210
      • Colorado Medical Research Center
  • Connecticut
    • Cromwell, Connecticut, United States, 06416
      • CCD Research, PLLC
  • District of Columbia
    • Washington, District of Columbia, United States, 20037
      • The GW Medical Faculty Associates
  • Florida
    • Coral Gables, Florida, United States, 33134
      • Driven Research, LLC
    • Coral Gables, Florida, United States, 33134
      • Florida Academic Dermatology Centers Research & Education, LLC
    • Margate, Florida, United States, 33063
      • Gsi Clinical Research
    • Miami, Florida, United States, 33155
      • Cordova Research Institute
    • Tampa, Florida, United States, 33609
      • MOORE Clinical Research, Inc.
  • Georgia
    • Sandy Springs, Georgia, United States, 30328
      • Advanced Medical Research PC
  • Illinois
    • Chicago, Illinois, United States, 60611
      • DeNova Research
  • Indiana
    • Evansville, Indiana, United States, 47715
      • Qualmedica Research, LLC
  • Kansas
    • Wichita, Kansas, United States, 67205
      • Heartland Research Asssociates - AMR Company
  • Louisiana
    • Baton Rouge, Louisiana, United States, 70809
      • DelRicht Research
    • New Orleans, Louisiana, United States, 70130
      • Etre, Cosmetic Dermatology and Laser Center
    • New Orleans, Louisiana, United States, 70124
      • Lupo Center for Aesthetic and General Dermatology
    • New Orleans, Louisiana, United States, 70116
      • DelRicht Research
  • Maryland
    • Rockville, Maryland, United States, 20850
      • DermAssociates
  • Massachusetts
    • Watertown, Massachusetts, United States, 02472
      • Bay State Clinical Trials, Inc.
  • Michigan
    • Clinton Township, Michigan, United States, 48038
      • Michigan Center for Skin Care Research
    • Fort Gratiot, Michigan, United States, 48059
      • Hamzavi Dermatology, Inc.
  • Missouri
    • Saint Louis, Missouri, United States, 63122
      • Saint Louis University, Department of Dermatology
  • Nebraska
    • Omaha, Nebraska, United States, 68134
      • Meridian Clinical Research, LLC
  • Nevada
    • Las Vegas, Nevada, United States, 89148
      • JDR Dermatology Research
  • New Jersey
    • East Windsor, New Jersey, United States, 08520
      • Psoriasis Treatment Center of Central New Jersey
  • New York
    • Rochester, New York, United States, 14623
      • SkinSearch of Rochester
  • North Carolina
    • Charlotte, North Carolina, United States, 28207
      • Dermatology, Laser and Vein Specialists of the Carolinas
  • Ohio
    • Dublin, Ohio, United States, 43016
      • Aventiv Research Inc.
  • Pennsylvania
    • Morrisville, Pennsylvania, United States, 19067
      • Yardley Dermatology Associates, PC
  • Texas
    • Austin, Texas, United States, 78746
      • Westlake Dermatology & Cosmetic Surgery
    • Bellaire, Texas, United States, 77401
      • Bellaire Dermatology Associates
    • College Station, Texas, United States, 77845
      • J&S Studies, Inc.
    • Dallas, Texas, United States, 75231
      • Modern Research Associates
    • Houston, Texas, United States, 77030
      • University of Texas Health Science Center at Houston
    • Houston, Texas, United States, 77056
      • Suzanne Bruce and Associates, P.A.
    • San Antonio, Texas, United States, 78229
      • Dermatology Clinical Research Center of San Antonio
    • Webster, Texas, United States, 77598
      • Center for Clinical Studies, LTD.LLP
  • Washington
    • Spokane, Washington, United States, 99216
      • Valley Dermatology and Skin Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 9 years and older (Child, Adult, Older Adult)
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Male or female subject ≥ 9 years of age.
• Diagnosis of primary axillary hyperhidrosis that meets the following criteria: (a) symptoms of hyperhidrosis for at least 6 months' duration, (b) HDSM-Ax of 3 - 4 and (c) a minimum GSP of 50 mg in 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(e).
• 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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Active; Sofpironium bromide, 15% gel, once per day	Drug: Sofpironium Bromide, 15%; Active; Other Names: BBI-4000, 15%
Placebo Comparator: Vehicle; Vehicle gel, once per day	Drug: Vehicle; Vehicle gel; Other Names: BBI-4000, 0%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	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).	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.
Observed Change in Participant (Vehicle Arm vs SB Gel 15% Arm) Ranked Gravimetric Sweat Production From Baseline to End of Treatment	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.	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.

Collaborators and Investigators

• Sponsor: Botanix Pharmaceuticals
• Investigators: Study Director: Patricia Walker, MD PhD, Botanix Pharmaceuticals

Study record dates

Study Major Dates

• Study Start (Actual): December 4, 2020
• Primary Completion (Actual): August 13, 2021
• Study Completion (Actual): August 13, 2021

Study Registration Dates

• First Submitted: May 10, 2019
• First Submitted That Met QC Criteria: May 10, 2019
• First Posted (Actual): May 14, 2019

Study Record Updates

• Last Update Posted (Actual): May 21, 2024
• Last Update Submitted That Met QC Criteria: May 10, 2024
• Last Verified: May 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Sweat Gland Diseases; Skin Diseases; Hyperhidrosis; Anticonvulsants; Bromides
• Other Study ID Numbers: BBI-4000-CL-302

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No