Primary Axillary HyperhidrosisPhase 3NCT03627468

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

A Phase 3 study testing Sofpironium Bromide Gel, 5% and Sofpironium Bromide Gel, 15% in people with Primary Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 12 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

Who is it for?: Ages 9 to 65 years
Conditions the study is for: Primary Axillary Hyperhidrosis
What is being tested?: Sofpironium Bromide Gel, 5% and Sofpironium Bromide Gel, 15%
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 300 participants
Where: 12 sitesUnited States
Study dates: 5 Sep 2018to 27 Jan 2020
Phase: Phase 3
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 9 to 65 years
All sexes
No healthy volunteers
Child, Adult, Older adult

Who may be able to join

Male or female subject ≥9 years of age in good general health.
Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 3 - 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 Baseline Visit (Visit 2).

Who cannot join

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 6 months of the Baseline Visit (Visit 2). (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 28 days of the Baseline Visit (Visit 2). 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 the Baseline Visit; 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 15 days of Baseline Visit (Visit 2).
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 (e.g., IV, oral, inhaled, topical) within 28 days of the Baseline Visit (Visit 2).
Use of potent oral inhibitors of cytochrome P450 CYP3A \& CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to the Baseline Visit (Visit 2). 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 7 days of the Baseline Visit (Visit 2).
Use of any cholinergic drug (e.g., bethanechol) within 15 days of the Baseline Visit (Visit 2).

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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. (c) Drugs with known anticholinergic side effects (taken within the last 28 days), including dry mouth, blurred vision, may be allowed based on the Principal Investigator's assessment.
NOTE: If anticholinergic side effect(s) are experienced on these medications prior to starting study medication; document the side effect(s) and severities in the source document and the eCRF. The doses of these agents should not be altered during the course of the study.
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.
Participating in a study of or used an investigational drug or device within 28 days prior to the Baseline Visit (Visit 2).
Any major illness within 28 days before the screening examination.
Any other condition, including psychiatric illness (depression and/or anxiety) that would interfere with study participation and/or evaluation of study endpoints or laboratory abnormality that, in the opinion of the Investigator, would put the subject at unacceptable risk for participation in the study or may interfere with the assessments included in the study.
History or presence of supraventricular tachycardia, ventricular arrhythmias, atrial fibrillation or atrial flutter.

Trial locations and contacts

12 sites in 1 country.

City, postcode or hospital

12 sites in 1 country

United States12 sites

Center for Clinical and Cosmetic Research
Aventura, Florida, 33180
Skin Care Research, Inc.
Boca Raton, Florida, 33486
J&S Studies, Inc.
College Station, Texas, 77845
Minnesota Clinical Study Center
Fridley, Minnesota, 55432
Baumann Cosmetic & Research Institute
Miami, Florida, 33137
Coastal Clinical Research, Inc.
Mobile, Alabama, 36608
Tennessee Clinical Research Center
Nashville, Tennessee, 37215
Tory Sullivan MD PA
North Miami Beach, Florida, 33162
Austin Institute for Clinical Research
Pflugerville, Texas, 78660
Northwest Arkansas Clinical Trials Center
Rogers, Arkansas, 72758
Grekin Skin Institute
Warren, Michigan, 48088
Research Institute of the Southeast, LLC
West Palm Beach, Florida, 33401

Other trials in United States

About this study

Official title: A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study of Topically Applied Sofpironium Bromide (BBI-4000) Gel, 5% and 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 long-term safety, tolerability, and efficacy of sofpironium bromide gel applied topically to subjects with axillary hyperhidrosis.

Read the detailed description

This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability and efficacy of sofpironium bromide gel when applied topically to the axillae.

Subjects will apply the gel once daily at bedtime, to both axillae.

A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations.

Adverse events, vital signs, and local tolerability assessments will be collected at each visit. 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 17 scheduled visits to take place over a 52 week period.

Conditions: Primary Axillary Hyperhidrosis
Being tested: Sofpironium Bromide Gel, 5%, Sofpironium Bromide Gel, 15%

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Sofpironium Bromide Gel, 5%Drug
Also called BBI-4000
Sofpironium Bromide Gel, 5%
Sofpironium Bromide Gel, 15%Drug
Also called BBI-4000
Sofpironium Bromide Gel, 15%

Study groups in NCT03627468
Study group	Role	What they receive
Gel, 5%	Experimental	Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks Receives: Drug: Sofpironium Bromide Gel, 5%
Gel, 15%	Experimental	Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks Receives: Drug: Sofpironium Bromide Gel, 15%

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity
The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe
Measured: All safety subjects, reaching week 48 or not
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety)
Number of participants reporting: local tolerability symptoms and severity (worst) symptom ratings; Incidence by subject report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rated either as Absent or Minimal, Mild, Moderate or Severe.
Measured: All Safety Subject, Baseline-Through study completion (48 weeks) or Not

Secondary outcomes (3)

The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease in subjects with axillary hyperhidrosis. Two questions measured frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).
The individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11total scores) reflected improvement in HDSM-Ax-11© score and condition.
Measured: From baseline to each visit through study completion (48 weeks)
The Number (%) of Subjects Achieving (-) ≥ 1.5 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).
The individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.
Measured: From baseline to each visit through study completion (48 weeks)
The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
HDSM-Ax-11 is 11-question tool used to measure effect of BBI-4000 gel, 5% and 15 % on disease in subjects with axillary hyperhidrosis. Two questions measured the frequency (since yesterday) of underarm sweating outcomes. The range of responses included increasing frequency scale: None of the time (0); A little of the time (1); Some of the time (2); Most of the time (3); All of the time (4). The next seven questions measured the severity of underarm sweating outcomes. Range in increasing severity: I did not experience this (0); Mild (1); Moderate (2); Severe (3); Very Severe (4). The last two questions measured the need to change or clean from underarm sweating. Range in increasing degree of need: Not at all (0); Slight (1); Moderate (2); Strong (3); Very Strong (4).
The individual mean was derived by taking the total score and dividing by the number of questions answered. A negative change (difference of mean HDSM-Ax-11scores) reflected improvement in HDSM-Ax-11© score and condition.
Measured: From baseline to each visit through study completion (48 weeks)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Sep 201827 Jan 2020

First posted13 Aug 2018
Study start5 Sep 2018
Primary completion27 Jan 2020
Study completion27 Jan 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Primary Axillary HyperhidrosisStudies of the same condition, open and under way.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 3
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 300 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03627468
Sponsor's protocol ID: BBI-4000-CL-303
Status last verified: Apr 2023
First submitted: 2 Aug 2018
Last updated: 19 May 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Study at a glance

From the registry record, last updated by the sponsor on 19 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Multicenter, Randomized, Open-label, Phase 3 Long-term Safety Study of Topically Applied Sofpironium Bromide (BBI-4000) Gel, 5% and 15% in Subjects With Axillary Hyperhidrosis
ClinicalTrials.gov ID: NCT03627468
Acronym / sponsor ID: BBI-4000-CL-303
Conditions: Primary Axillary Hyperhidrosis
Phase: Phase 3
Study type: Interventional
Recruitment status: Completed
Enrolment: 300 participants (actual)
Lead sponsor: Botanix PharmaceuticalsIndustry (pharma, biotech, devices)
Study start: 5 Sep 2018 (actual)
Primary completion: 27 Jan 2020 (actual)
Study completion: 27 Jan 2020 (actual)
First posted: 13 Aug 2018 (actual)
Results: Posted 19 May 2023

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This is a randomized, open-label, phase 3 long-term study designed to evaluate the safety, local tolerability and efficacy of sofpironium bromide gel when applied topically to the axillae.

Subjects will apply the gel once daily at bedtime, to both axillae.

A maximum of 300 subjects, will be randomized to receive one of two sofpironium bromide gel concentrations.

The study will be comprised of a total of 17 scheduled visits to take place over a 52 week period.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Gel, 5%	Experimental	Drug: Sofpironium Bromide Gel, 5%Sofpironium Bromide Gel, 5%, applied topically to each axilla once daily for 48 weeks
Gel, 15%	Experimental	Drug: Sofpironium Bromide Gel, 15%Sofpironium Bromide Gel, 15%, applied topically to each axilla once daily for 48 weeks

Who may qualify

Ages: 9 to 65 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Child, Adult, Older adult

Key inclusion criteria (2 listed)

Male or female subject ≥9 years of age in good general health.
Diagnosis of primary axillary hyperhidrosis that meets all the following criteria: (a) HDSM-Ax of 3 - 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 Baseline Visit (Visit 2).

Key exclusion criteria (17 listed)

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 6 months of the Baseline Visit (Visit 2). (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 28 days of the Baseline Visit (Visit 2). 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 the Baseline Visit; 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 15 days of Baseline Visit (Visit 2).
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 (e.g., IV, oral, inhaled, topical) within 28 days of the Baseline Visit (Visit 2).
Use of potent oral inhibitors of cytochrome P450 CYP3A \& CYP2D6 and transporter inhibitors (OCT2/MATE1/MATE2) 14 days prior to the Baseline Visit (Visit 2). 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 7 days of the Baseline Visit (Visit 2).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Sofpironium Bromide Gel, 5%Also: BBI-4000Sofpironium Bromide Gel, 5%	Drug	Gel, 5%
Sofpironium Bromide Gel, 15%Also: BBI-4000Sofpironium Bromide Gel, 15%	Drug	Gel, 15%

Primary outcome

The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity
Time frame: All safety subjects, reaching week 48 or not
The number of participants with treatment emergent adverse events cumulative to week 48 by maximum severity based on a 3 point increasing severity scale of: mild, moderate and severe
Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety)
Time frame: All Safety Subject, Baseline-Through study completion (48 weeks) or Not
Number of participants reporting: local tolerability symptoms and severity (worst) symptom ratings; Incidence by subject report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rated either as Absent or Minimal, Mild, Moderate or Severe.

3 secondary outcomes

The Number (%) of Subjects Achieving (-) ≥ 1point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
Time frame: From baseline to each visit through study completion (48 weeks)
The Number (%) of Subjects Achieving (-) ≥ 1.5 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
Time frame: From baseline to each visit through study completion (48 weeks)
The Number (%) of Subjects Achieving (-) ≥ 2 Point (Negative) Change (or Decrease) in the Hyperhidrosis Disease Severity Measure-Axillary 11-item (HDSM-Ax-11©) Score
Time frame: From baseline to each visit through study completion (48 weeks)

Results and safety

Results posted to the registry on 19 May 2023, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Gel, 5%	103	72
Gel, 15%	197	118

Primary outcome: The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity

Time frame: All safety subjects, reaching week 48 or not. Count of participants. Unit: Participants

Measure	Gel, 5% n = 102	Gel, 15% n = 197
Mild Severity	27	55
Moderate Severity	29	58
Severe Severity	2	17
Missing	0	0
No TEAE Reported	44	67

Population analysed: Overall number of participants analyzed included the Safety Population. Subunits: Subjects reporting any TEAE made up the overall number of units analyzed.

Primary outcome: Number of Participants With Post-baseline Local Tolerability Assessments Results by Treatment Group (Population: Safety)

Time frame: All Safety Subject, Baseline-Through study completion (48 weeks) or Not. Number. Unit: participants

Measure	Gel, 5% n = 102	Gel, 15% n = 197
Absent	31	59
Minimal	34	41
Mild	20	37
Moderate	12	38
Severe	4	19
Subject Tolerability Assessment not Performed	1	3

Population analysed: Safety population, units analyzed: subject incidence of report of any local symptom type (including Burning, Stinging, Itching, Scaling, Erythema) and local symptom worst severity rating either as Absent or Minimal, Mild, Moderate or Severe. Subjects where local tolerability assessment was not completed were also included.

3 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each Subject's AE data was collected over approximately 52 weeks of participation, including 48 weeks of investigational treatment.. Other adverse events reported at 2% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Gel, 5%	1 of 102 (1%)	58 of 102 (56.9%)	1 of 102
Gel, 15%	4 of 197 (2%)	131 of 197 (66.5%)	0 of 197

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Patricia Walker, MD PhD study director

Botanix Pharmaceuticals

12 sites in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Sofpironium Bromide Gel, 5% and Sofpironium Bromide Gel, 15% in people with Primary Axillary Hyperhidrosis, run by Botanix Pharmaceuticals at 12 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 2 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 19 May 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 12 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 May 2023). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

The Number of Participants With Treatment Emergent Adverse Events Cumulative to Week 48 by Maximum Severity (time frame: All safety subjects, reaching week 48 or not). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03627468.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 May 2023.