Eosinophilic AsthmaPhase 2EXHALE-1NCT04046939

Dexpramipexole Dose-Ranging Biomarker Study in Subjects With Eosinophilic Asthma

A Phase 2 study testing Dexpramipexole in people with Eosinophilic Asthma and Asthma, run by Knopp Biosciences at 36 sites in United States.

Completed

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

Official record

Search all trials

Trial summary

This is a randomized, double-blind, placebo-controlled, parallel-group, dose-ranging, multi-center study to evaluate the clinical effects of oral administration of dexpramipexole for 12 weeks on peripheral blood eosinophil count in subjects with eosinophilic asthma. Read more about this study

Who is it for?: Ages 18 to 74 years
Conditions the study is for: Eosinophilic Asthma, Asthma
What is being tested?: Dexpramipexole
Type of treatment: Pill or oral medicine
Could I receive a placebo?: Yes, some participants may receive a placebo
How many people: 534 participants
Where: 36 sitesUnited States
Study dates: 15 Aug 2019to 2 Mar 2021
Phase: Phase 2
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 18 to 74 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Male or female ≥18 and <75 years of age at the time of consent
Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global Initiative for Asthma (GINA) 2018 Guidelines
Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in combination with a long-acting β2 agonist, on a stable dose for at least 1 month before Screening
Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15 to 25 minutes following inhalation of albuterol at Screening
Pre-bronchodilator FEV1 ≥40% and <80% of predicted at Screening and Baseline
AEC ≥0.30 x10^9/L at the Screening visit

Show all 9Show fewer

ACQ-7 ≥1.5 at Screening
Negative pregnancy test at Baseline
Adherence ≥85% with twice-daily placebo taken during the Run-in Period

Who cannot join

Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit
Treatment with systemic corticosteroids in the 8 weeks prior to Screening
Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline
Treatment with selected drugs known to have a substantial risk of neutropenia
Absolute neutrophil count <2.0x10^9/L at Screening, or any documented history of absolute neutrophil count <2.0x10^9/L.
Renal dysfunction, defined as an estimated glomerular filtration rate (eGFR) <60 mL/min/1.73m^2 at Screening

Show all 11Show fewer

Clinically significant abnormal laboratory or ECG values
Other medically significant illness
Use of any smoke or inhaled nicotine delivery device within 1 year prior to Screening
Pregnant women or women breastfeeding
Currently taking pramipexole or other dopamine agonists

Trial locations and contacts

36 sites in 1 country.

City, postcode or hospital

36 sites in 1 country

United States36 sites

Research Site
Allen, Texas, 75013
Research Site
Anderson, South Carolina, 29621
Research Site
Boerne, Texas, 78006
Research Site
Boise, Idaho, 83706
Research Site
Cincinnati, Ohio, 45231
Research Site
Cincinnati, Ohio, 45242
Research Site
Columbus, Ohio, 43235
Research Site
Corning, New York, 14830
Research Site
Dallas, Texas, 75240
Research Site
Daytona Beach, Florida, 32117
Research Site
Denver, Colorado, 80230
Research Site
Dublin, Ohio, 43016
Research Site
Edmond, Oklahoma, 73034
Research Site
El Paso, Texas, 79902
Research Site
Farmington Hills, Michigan, 48336
Research Site
Las Vegas, Nevada, 89119
Research Site
Lawrenceville, Georgia, 30046
Research Site
Los Angeles, California, 90048
Research Site
Medford, Oregon, 97504
Research Site
Miami, Florida, 33186
Research Site
Mission Viejo, California, 92691
Research Site
New Brunswick, New Jersey, 08901
Research Site
New Hyde Park, New York, 11042
Research Site
North Charleston, South Carolina, 29406
Research Site
Orlando, Florida, 32803
Research Site
Pittsburgh, Pennsylvania, 15205
Research site
Plymouth, Minnesota, 55441
Research Site
Portland, Oregon, 97202
Research Site
Raleigh, North Carolina, 27607
Research Site
St Louis, Missouri, 63110
Research Site
St Louis, Missouri, 63141
Research Site
Tampa, Florida, 33612
Research Site
Tampa, Florida, 33634
Research Site
Westminster, California, 92683
Research Site
Winder, Georgia, 30680
Research Site
Winston-Salem, North Carolina, 27103

Other trials in United States

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma

Read the detailed description

One hundred subjects will receive study drug or matching placebo over 12 weeks of consecutive dosing. Following a short Run-in Period, eligible subjects will enter the Primary Assessment Period and receive twice-daily dosing of study drug or placebo for 12 weeks. Following 12 weeks of treatment, subjects will enter a 12-week Eosinophil Recovery Period. The primary endpoint for the study is the change in blood absolute eosinophil count from Baseline to Week 12.

Conditions: Eosinophilic Asthma, Asthma
Being tested: Dexpramipexole, Placebo
Keywords: Eosinophilic Asthma, Asthma, dexpramipexole
Medical subject headings: Pulmonary Eosinophilia, Asthma

What participants receive

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

DexpramipexoleDrug
Also called KNS-760704, BIIB050
dexpramipexole twice daily oral dosing for up to 12 weeks
PlaceboDrug
Also called PBO
placebo twice daily oral dosing for up to 12 weeks

Study groups in NCT04046939
Study group	Role	What they receive
placebo BID	Placebo comparator	Following a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks. Receives: Drug: Placebo
37.5 mg BID dexpramipexole	Active comparator	Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks. Receives: Drug: Dexpramipexole
75 mg BID dexpramipexole	Active comparator	Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks. Receives: Drug: Dexpramipexole
150 mg BID dexpramipexole	Active comparator	Following a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks. Receives: Drug: Dexpramipexole

What is being measured

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

Change in Blood Absolute Eosinophil Count From Baseline to Week 12
The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus the log10 transformed baseline value. The estimates of Geometric LS Means and their ratios were obtained by back transforming the corresponding estimates of LS means and their differences to the original scale.
Measured: Baseline, 12 Weeks

Secondary outcomes (9)

Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12
FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation.
Measured: Baseline, 12 Weeks
Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12
ACQ-6 is simple questionnaire to measure the adequacy of asthma control and change in asthma control which occurs either spontaneously or as a result of treatment. The 6-point self-administered scale has items measuring asthma symptoms and rescue inhaler use. The ACQ score is the mean of the questions and therefore between 0 (totally controlled) and 6 (severely uncontrolled). The original protocol planned to analyze the ACQ-7 score. As a result of FEV1 testing restrictions imposed on the study during the COVID-19 pandemic, the analysis was prospectively modified to the ACQ-6 score prior to database lock. The ACQ-6 is a validated questionnaire and is identical to the ACQ-7, with the exception of FEV1 data that is also utilized in the ACQ-7 questionnaire total score calculation.
Measured: Baseline, 12 Weeks
Change in Post-bronchodilator FEV1 From Baseline to Week 12
Post-bronchodilator FEV1 is defined as the amount of air that can be forcibly exhaled from the lungs in the first second of a forced exhalation, after treatment with inhaled albuterol.
Measured: Baseline, 12 Weeks
Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12
The AQLQ is a 32-item asthma specific questionnaire designed to measure functional impairments that are most important to patients with asthma. The 32 questions in the AQLQ are divided into four domains; activity limitations, symptoms, emotional function, and environmental stimuli. Individual questions are equally weighted. The overall AQLQ score is the mean of the responses to each of the 32 questions and ranges from 1 to 7. A score 7.0 indicates that the patient has no impairments due to asthma and score 1.0 indicates severe impairment.
Measured: Baseline, 12 Weeks
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Number of Participants with Potentially Clinically Significant Hematology Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Measured: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Number of Participants with Potentially Clinically Significant Blood Chemistry Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Measured: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
Number of Participants with Potentially Clinically Significant Urinalysis Results (glycosuria, ketonuria, or proteinuria) by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline urinalysis value in each treatment group. Patients are only counted once per criterion per laboratory test. The number of participants with potential clinical important urinalysis findings at any post-baseline visit were reported.
Measured: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Number of Participants with Potentially Clinically Significant Vital Signs Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Measured: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
Number of Participants with Potentially Clinically Significant ECG Results by Treatment Group. Percentages based on number of patients with at least one non-missing post-baseline value in each treatment group. Patients are only counted once per criterion per laboratory test.
Measured: Immediately post-baseline up to Week 12

Timeline

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

15 Aug 20192 Mar 2021

First posted6 Aug 2019
Study start15 Aug 2019
Primary completion3 Dec 2020
Study completion2 Mar 2021

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 Eosinophilic AsthmaStudies 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 2
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Model description: Four-arm parallel assignment
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 534 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04046939
Sponsor's protocol ID: KNS-760704-AS201
Acronym: EXHALE-1
Status last verified: Apr 2023
First submitted: 30 Jul 2019
Last updated: 13 Apr 2023
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 13 Apr 2023. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: A Randomized, Double-Blind, Placebo-Controlled Dose-Ranging Biomarker Study of the Effects of Dexpramipexole on Eosinophils in Subjects With Eosinophilic Asthma
ClinicalTrials.gov ID: NCT04046939
Acronym / sponsor ID: EXHALE-1 / KNS-760704-AS201
Conditions: Eosinophilic Asthma, Asthma
Keywords: Eosinophilic Asthma, Asthma, dexpramipexole
Phase: Phase 2
Study type: Interventional
Recruitment status: Completed
Enrolment: 534 participants (actual)
Lead sponsor: Knopp BiosciencesIndustry (pharma, biotech, devices)
Study start: 15 Aug 2019 (actual)
Primary completion: 3 Dec 2020 (actual)
Study completion: 2 Mar 2021 (actual)
First posted: 6 Aug 2019 (actual)
Results: Posted 22 Dec 2021

Clinical summary

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

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 4
Model description: Four-arm parallel assignment

Arm	Type	Receives
placebo BID	Placebo comparator	Drug: PlaceboFollowing a 2-4 week placebo run-in, randomized subjects received 1 tablet placebo twice daily for 12 weeks.
37.5 mg BID dexpramipexole	Active comparator	Drug: DexpramipexoleFollowing a 2-4 week placebo run-in, randomized subjects received 1 tablet of 37.5 mg dexpramipexole twice daily for 12 weeks.
75 mg BID dexpramipexole	Active comparator	Drug: DexpramipexoleFollowing a 2-4 week placebo run-in, randomized subjects received 1 tablet of 75 mg dexpramipexole twice daily for 12 weeks.
150 mg BID dexpramipexole	Active comparator	Drug: DexpramipexoleFollowing a 2-4 week placebo run-in, randomized subjects received 1 tablet of 150 mg dexpramipexole twice daily for 12 weeks.

Who may qualify

Ages: 18 to 74 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (9 listed)

Male or female ≥18 and <75 years of age at the time of consent
Physician diagnosis of asthma for ≥12 months (relative to Baseline) based on Global Initiative for Asthma (GINA) 2018 Guidelines
Asthma requiring treatment with, at a minimum, low dose inhaled corticosteroids in combination with a long-acting β2 agonist, on a stable dose for at least 1 month before Screening
Bronchodilator reversibility, as evidenced by ≥12% and ≥200 mL improvement in FEV1 15 to 25 minutes following inhalation of albuterol at Screening
Pre-bronchodilator FEV1 ≥40% and <80% of predicted at Screening and Baseline

Key exclusion criteria (11 listed)

Treatment for an asthma exacerbation within 8 weeks prior to Baseline visit
Treatment with systemic corticosteroids in the 8 weeks prior to Screening
Treatment with monoclonal antibody therapy, within 5-half-lives prior to Baseline
Treatment with selected drugs known to have a substantial risk of neutropenia
Absolute neutrophil count <2.0x10^9/L at Screening, or any documented history of absolute neutrophil count <2.0x10^9/L.

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
DexpramipexoleAlso: KNS-760704, BIIB050dexpramipexole twice daily oral dosing for up to 12 weeks	Drug	150 mg BID dexpramipexole, 37.5 mg BID dexpramipexole, 75 mg BID dexpramipexole
PlaceboAlso: PBOplacebo twice daily oral dosing for up to 12 weeks	Drug	placebo BID

Primary outcome

Change in Blood Absolute Eosinophil Count From Baseline to Week 12
Time frame: Baseline, 12 Weeks
The primary endpoint of this study was the change in AEC from Baseline to Week 12 on a ratio scale. The analysis used a mixed effects model repeated-measures (MMRM) with terms for log10 transformed baseline, GINA treatment step, treatment, visit, treatment by visit interaction, and log10 transformed baseline by visit interaction as fixed effects, and subject as a random effect. An unstructured covariance matrix was used. The response variable was the log10 transformed post-baseline value minus the log10 transformed baseline value. The estimates of Geometric LS Means and their ratios were obtained by back transforming the corresponding estimates of LS means and their differences to the original scale.

9 secondary outcomes

Change in Pre-bronchodilator FEV1 (Liters) From Baseline to Week 12
Time frame: Baseline, 12 Weeks
Change in Asthma Control Questionnaire (ACQ-6) Score From Baseline to Week 12
Time frame: Baseline, 12 Weeks
Change in Post-bronchodilator FEV1 From Baseline to Week 12
Time frame: Baseline, 12 Weeks
Change in Quality of Life, as Measured by the Asthma Quality of Life Questionnaire (AQLQ) From Baseline to Week 12
Time frame: Baseline, 12 Weeks
Number of Participants With Potentially Clinically Significant Hematology Results by Treatment Group Post Randomization Through Week 12
Time frame: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant Blood Chemistry Results by Treatment Group Post Randomization Through Week 12
Time frame: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant Urinalysis Results by Treatment Group Post Randomization Through Week 12
Time frame: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant Vital Signs Results by Treatment Group Post Randomization Through Week 12
Time frame: Immediately post-baseline up to Week 12
Number of Participants With Potentially Clinically Significant ECG Results by Treatment Group Post Randomization Through Week 12
Time frame: Immediately post-baseline up to Week 12

Results and safety

Results posted to the registry on 22 Dec 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Placebo BID	534	103
37.5 mg BID Dexpramipexole	0	0
75 mg BID Dexpramipexole	0	0
150 mg BID Dexpramipexole	0	0

Primary outcome: Change in Blood Absolute Eosinophil Count From Baseline to Week 12

Time frame: Baseline, 12 Weeks. Geometric least squares mean (Standard Error). Unit: ratio to baseline

Measure	Placebo BID n = 25	37.5 mg BID Dexpramipexole n = 22	75 mg BID Dexpramipexole n = 24	150 mg BID Dexpramipexole n = 28
Value	0.8980 (1.26)	0.4031 (1.28)	0.3056 (1.27)	0.2051 (1.25)

Placebo BID vs 150 mg BID Dexpramipexole: Ratio to PBO of the ratios to baseline: 0.2283 (95% CI 0.121 to 0.431), p <.0001, Mixed Models Analysis
Placebo BID vs 75 mg BID Dexpramipexole: Ratio to PBO of the ratios to baseline: 0.3403 (95% CI 0.177 to 0.653), p = 0.0014, Mixed Models Analysis
Placebo BID vs 37.5 mg BID Dexpramipexole: Ratio to PBO of the ratios to baseline: 0.4489 (95% CI 0.231 to 0.874), p = 0.0190, Mixed Models Analysis

Population analysed: The efficacy population will be a modified intent-to-treat sample and consist of all subjects in the safety population (all subjects who were randomized and received at least one dose of randomized study drug) and who have at least one post-randomization AEC evaluation.

9 secondary outcomes are reported in the full results.

Adverse events

Time frame: Placebo Run-in Period = from enrollment to Randomization (2-4 weeks); Primary Assessment Period = from Randomization through the Week 12 visit, plus 30 days following the last dose; Eosinophil Recovery Period = all visits occurring from 30 days following the last dose through the end of study (Week 24 post-Randomization). Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Screening Period	0 of 103 (0%)	6 of 103 (5.8%)	0 of 103
Primary Assessment Period: Placebo BID	0 of 27 (0%)	9 of 27 (33.3%)	0 of 27
Primary Assessment Period: 37.5 mg BID	0 of 22 (0%)	7 of 22 (31.8%)	0 of 22
Primary Assessment Period: 75 mg BID	0 of 26 (0%)	12 of 26 (46.2%)	0 of 26
Primary Assessment Period: 150 mg BID	0 of 28 (0%)	12 of 28 (42.9%)	0 of 28
Eosinophil Recovery Period: Assigned to Placebo BID During Primary Assessment Period	0 of 25 (0%)	2 of 25 (8%)	0 of 25
Eosinophil Recovery Period: Assigned to 37.5 mg BID During Primary Assessment Period	0 of 22 (0%)	3 of 22 (13.6%)	0 of 22
Eosinophil Recovery Period: Assigned to 75 mg BID During Primary Assessment Period	0 of 24 (0%)	5 of 24 (20.8%)	0 of 24
Eosinophil Recovery Period: Assigned to 150 mg BID During Primary Assessment Period	0 of 28 (0%)	10 of 28 (35.7%)	0 of 28

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 13 Apr 2023.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

Related trials for Eosinophilic Asthma

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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dexpramipexole in people with Eosinophilic Asthma and Asthma, run by Knopp Biosciences at 36 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 9 inclusion and 11 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 13 Apr 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 36 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. Some participants in this study may receive a placebo. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

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 22 Dec 2021). 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?

Change in Blood Absolute Eosinophil Count From Baseline to Week 12 (time frame: Baseline, 12 Weeks). 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 NCT04046939.

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 13 Apr 2023.