Safety and Efficacy Study of Sofpironium Bromide in Subjects With Axillary Hyperhidrosis (BBI-4000-CL-301) (Cardigan I)
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| ClinicalTrials.gov Identifier: NCT03836287 |
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Recruitment Status :
Completed
First Posted : February 11, 2019
Last Update Posted : January 25, 2022
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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 |
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 (Clinical Trial) |
| Actual 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 : | October 9, 2020 |
| Actual Primary Completion Date : | June 25, 2021 |
| Actual Study Completion Date : | June 25, 2021 |
| Arm | Intervention/treatment |
|---|---|
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Experimental: Active
Sofpironium bromide, 15% gel, once per day
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Drug: Sofpironium Bromide, 15%
Active |
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Placebo Comparator: Vehicle
Vehicle gel, once per day
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Drug: Vehicle
Vehicle gel |
- 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.
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
| 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.
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 ClinicalTrials.gov identifier (NCT number): NCT03836287
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| Study Director: | Deepak Chadha | Brickell Biotech, Inc. |
| Responsible Party: | Brickell Biotech, Inc. |
| ClinicalTrials.gov Identifier: | NCT03836287 |
| Other Study ID Numbers: |
BBI-4000-CL-301 |
| First Posted: | February 11, 2019 Key Record Dates |
| Last Update Posted: | January 25, 2022 |
| Last Verified: | January 2022 |
| Individual Participant Data (IPD) Sharing Statement: | |
| Plan to Share IPD: | No |
| Studies a U.S. FDA-regulated Drug Product: | Yes |
| Studies a U.S. FDA-regulated Device Product: | No |
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Hyperhidrosis Sweat Gland Diseases Skin Diseases Bromides Anticonvulsants |