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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT03948646
Recruitment Status : Recruiting
First Posted : May 14, 2019
Last Update Posted : March 10, 2021
Information provided by (Responsible Party):
Brickell Biotech, Inc.

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.

Condition or disease Intervention/treatment Phase
Axillary Hyperhidrosis Drug: Sofpironium Bromide, 15% Drug: Vehicle Phase 3

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 350 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: 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
Actual Study Start Date : December 4, 2020
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : September 2021

Arm Intervention/treatment
Experimental: Active
Sofpironium bromide, 15% gel, once per day
Drug: Sofpironium Bromide, 15%

Placebo Comparator: Vehicle
Vehicle gel, once per day
Drug: Vehicle
Vehicle gel

Primary Outcome Measures :
  1. 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

  2. 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]).

  3. Gravimetric sweat production [ Time Frame: 6 weeks ]
    Change in the measured weight of axillary sweat production from baseline to end of study.

Information from the National Library of Medicine

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Ages Eligible for Study:   9 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT03948646

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Contact: Deepak Chadha 720-505-4755

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Sponsors and Collaborators
Brickell Biotech, Inc.
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Study Director: Deepa Chadha Brickell Biotech, Inc.
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Responsible Party: Brickell Biotech, Inc. Identifier: NCT03948646    
Other Study ID Numbers: BBI-4000-CL-302
First Posted: May 14, 2019    Key Record Dates
Last Update Posted: March 10, 2021
Last Verified: March 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Sweat Gland Diseases
Skin Diseases