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Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (Cardigan I)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03836287
Recruitment Status : Completed
First Posted : February 11, 2019
Last Update Posted : January 25, 2022
Sponsor:
Information provided by (Responsible Party):
Fresh Tracks Therapeutics, Inc.

Tracking Information
First Submitted Date  ICMJE February 6, 2019
First Posted Date  ICMJE February 11, 2019
Last Update Posted Date January 25, 2022
Actual Study Start Date  ICMJE October 9, 2020
Actual Primary Completion Date June 25, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 7, 2019)
  • The number of participants with treatment emergent adverse events [ Time Frame: Through study completion (6 weeks). ]
    Summarized by MedDRA LLT with a 3 point severity scale of mild, moderate and severe
  • Change in Hyperhidrosis Disease Severity Measure-Axillary score [ Time Frame: 6 weeks ]
    Change in score from baseline to end of treatment of an 11 question patient reported outcome assessment, each question has a 5 point response (range 0 [better] - 4 [worse]).
  • Gravimetric sweat production [ Time Frame: 6 weeks ]
    Change in the measured weight of axillary sweat production from baseline to end of study.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301)
Official Title  ICMJE 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
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.

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.

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  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Axillary Hyperhidrosis
Intervention  ICMJE
  • Drug: Sofpironium Bromide, 15%
    Active
  • Drug: Vehicle
    Vehicle gel
Study Arms  ICMJE
  • Experimental: Active
    Sofpironium bromide, 15% gel, once per day
    Intervention: Drug: Sofpironium Bromide, 15%
  • Placebo Comparator: Vehicle
    Vehicle gel, once per day
    Intervention: Drug: Vehicle
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: October 9, 2020)
350
Original Estimated Enrollment  ICMJE
 (submitted: February 7, 2019)
496
Actual Study Completion Date  ICMJE June 25, 2021
Actual Primary Completion Date June 25, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 9 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03836287
Other Study ID Numbers  ICMJE BBI-4000-CL-301
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Current Responsible Party Fresh Tracks Therapeutics, Inc.
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Fresh Tracks Therapeutics, Inc.
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Deepak Chadha Fresh Tracks Therapeutics, Inc.
PRS Account Fresh Tracks Therapeutics, Inc.
Verification Date January 2022

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP