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AsthmaPhase 2NCT02918019

A Study to Assess the Efficacy and Safety of MSTT1041A in Participants With Uncontrolled Severe Asthma

A Phase 2 study testing MSTT1041A in people with Asthma, run by Hoffmann-La Roche at 138 sites in 15 countries.

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 Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid… Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
Asthma
What is being tested?
MSTT1041A
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
517 participants
Where
138 sitesin 15 countries
Study dates
20 Sep 2016to 26 Jul 2019
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 75 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Body mass index (BMI) of 18 to 38 kilogram/square meter (kg/m^2) and weight >= 40 kg at screening
  • Documented physician-diagnosed asthma
  • On high dose inhaled corticosteroid (ICS) therapy plus at least one additional allowed controller medication
  • Forced expiratory volume in 1 second (FEV1) of 40% to 80% of predicted
  • Evidence of uncontrolled asthma
  • Use of contraceptive measures

Who cannot join

  • Diagnosis of mimics of asthma
  • Diagnosis of occupational asthma, aspirin-sensitive asthma, asthma chronic obstructive pulmonary disease overlap syndrome, or bronchiolitis, as determined by the investigator
  • Pregnant or lactating, or intending to become pregnant during the study or within 20 weeks after the last dose of MSTT1041A
  • Recent history of smoking
  • History or evidence of substance abuse that would pose a risk to participants safety, interfere with the conduct of the study, have an impact on the study results
  • Asthma exacerbation within 4 weeks prior to screening
Show all 10Show fewer
  • Intubation for respiratory failure due to asthma within 12 months prior to screening
  • Comorbid conditions that may interfere with evaluation of investigational medicinal product
  • Known sensitivity to any of the active substances or their excipients to be administered during dosing
  • Positive pregnancy test

Trial locations and contacts

138 sites in 15 countries.

138 sites in 15 countries

United States43 sites

  • Kern Allergy Med Clinic, Inc.

    Bakersfield, California, 93301

  • Asthma, Allergy & Sinus Center

    Baltimore, Maryland, 21236

  • Chesapeake Clinical Research Inc - CRN

    Baltimore, Maryland, 21236

  • The Allergy and Asthma Center

    Bellevue, Nebraska, 68123

  • Alabama Allergy & Asthma

    Birmingham, Alabama, 35209

  • TTS Research

    Boerne, Texas, 78006

  • Allergy & Respiratory Center

    Canton, Ohio, 44718

  • IMMUNOe Research Centers

    Centennial, Colorado, 80112

  • American Health Research Inc.

    Charlotte, North Carolina, 28277

  • Asthma & Allergy; Associates, P.C.

    Colorado Springs, Colorado, 80907

  • Elliot J. Ginchansky, MD, PA

    Dallas, Texas, 75230

  • Genesis Clinical Research & Consulting, LLC

    Fall River, Massachusetts, 02720

  • Pioneer Research Solutions

    Houston, Texas, 077099

  • Clinical Research Solutions PC

    Knoxville, Tennessee, 37920

  • Allergy & Asthma Care Center of Southern California

    Long Beach, California, 90808

  • CA Allergy & Asthma Med Grp; Medical Group, Inc.

    Los Angeles, California, 90025

  • Jonathan Corren MD, Inc.

    Los Angeles, California, 90025

  • Office of Robert N Wolfe MD

    Los Angeles, California, 90048

  • Metroplex Pulmonology & Sleep Center

    McKinney, Texas, 75069

  • Allergy Associates of Utah

    Murray, Utah, 84107

  • Meharry Medical College; Clinical Trials Office

    Nashville, Tennessee, 37208

  • Yale University School Of Medicine

    New Haven, Connecticut, 06519

  • Infinity Medical Research Inc

    North Dartmouth, Massachusetts, 02747

  • Integrity People Services Research Company

    Oklahoma City, Oklahoma, 73103

  • Emerald Coast Research Associates

    Panama City, Florida, 32405

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140

  • Advances in Medicine

    Rancho Mirage, California, 92270

  • Allergy & Asthma Consultants

    Redwood City, California, 94063

  • Commonwealth Clinical Research Specialists

    Richmond, Virginia, 23226

  • Allergy & Asthma Research Center

    San Antonio, Texas, 78229

  • Washington Univ School of Med

    Seattle, Washington, 98195

  • Spartanburg Medical Research

    Spartanburg, South Carolina, 29303

  • Midwest Clinical Research LLC

    St Louis, Missouri, 63141

  • Atlanta Allergy & Asth Clin PC

    Stockbridge, Georgia, 30281

  • Bensch Research Associates

    Stockton, California, 95207

  • Montefiore Medical Center

    The Bronx, New York, 10461

  • Del Sol Research Management

    Tucson, Arizona, 85710

  • Vital Prospects Clin Res Pc

    Tulsa, Oklahoma, 74136

  • Asthma & Allergy of Idaho

    Twin Falls, Idaho, 83301

  • Allergy and Asthma Clinical Research, Inc.

    Walnut Creek, California, 94598

  • Asthma & Allergy Physicians of Rhode Island Clinical Research Institute (AAPRI CRI)

    Warwick, Rhode Island, 02865

  • Western States Clinical Research, Inc

    Wheat Ridge, Colorado, 80033

  • Florida Premier Research Institute

    Winter Park, Florida, 32789

Other trials in United States

Russia13 sites

  • City Hospital #5

    Barnaul, 656045

  • Municipal Healthcare Institution City Clinical Hospital #3 named after M.A. Podgorbunskogo

    Kemerovo, 650099

  • LLC - ABC Medicina

    Moscow, Sankt-Peterburg, 117574

  • I.M. Sechenov Moscow State Medical University the Ministry of Health and Social Development of RF

    Moscow, 115446

  • Novosibirsk Municipal Clinical Hospital For Emergency Medicine #2

    Novosibirsk, 630008

  • City Clinical Hospital #2

    Novosibirsk, 630051

  • Ryazan State Medical University Named after I.P.Pavlov

    Ryazan, 390026

  • Clinic Reavita LLC

    Saint Petersburg, 194295

  • SHI Ctr Occupational Pathology

    Saint Petersburg, 195271

  • St. Petersburg State Medical University n.a. I.P. Pavlov

    Saint Petersburg, 197089

  • City Hospital #40 of Resort Administrative District

    Saint Petersburg, 197706

  • Siberian State Medical University

    Tomsk, 634050

  • Clinical Emergency Hospital n.a.N.V. Soloviev

    Yaroslavl, Moscow Oblast, 150003

Other trials in Russia

Ukraine13 sites

  • Regional Municipal Institution Chernivtsi Regional Clinical Hospital

    Chernivtsi, Chernihiv Governorate, 58005

  • Public Institution City Clinical Hospital # 6 of Dnipropetrovsk Regional Board

    Dnipro, 49000

  • Ukrainian State Institute of Medical and Social Problems of Disability

    Dnipropetrovsk, 49027

  • Regional Phthisiology and Pulmonology Center

    Ivano-Frankivsk, 76018

  • SI Institute of Therapy n.a. L.T. Mala of National Academy of Medical Sciences of Ukraine

    Kharkiv, 61039

  • Kyiv City Tuberculosis Hospital #1; Department of Differential Diagnosis of Lung Diseases

    Kyiv, KIEV Governorate, 02091

  • SI National Institute of Phthisiology and Pulmonology n.a. F.G.Yanovskyi under NAMS of Ukraine

    Kyiv, 03680

  • Municipal Institution of Kyiv Regional Council Kyiv Regional Clinical Hospital

    Kyiv, 04107

  • Kyiv City Clinical Hospital #8

    Kyiv, 04201

  • City Hospital #1

    Mykolaiv, 54003

  • Municipal Institution Odesa Regional Clinical Hospital

    Odesa, 65025

  • Small Business Private Enterprise Medical Centre Pulse

    Vinnytsia, 21001

  • Municipal institution; City hospital #1; Department of Therapy

    Zaporizhzhya, Kherson Governorate, 69104

Other trials in Ukraine

Bulgaria12 sites

  • Military Medical Academy HBAT

    Pleven, 5800

  • SHATPPD Dr. Dimitar Gramatikov, Ruse Ltd.

    Rousse, 7002

  • Medical Centre Mladost Med 1 EOOD

    Sofia, 1000

  • First MHAT; Clinic of Neurology

    Sofia, 1142

  • Fifth MHAT - Sofia EAD

    Sofia, 1233

  • National Multiprofile Hospital Tsar Boris III

    Sofia, 1233

  • Specialised Hospital for Active Treatment of Pulmonary Deseases "Sv. Sofia", Third Clinic for Non-Sp

    Sofia, 1431

  • Uni. Multiprofile Hosp. for Active Treatment-Aleksandrovska

    Sofia, 1431

  • Medical Center N.I. Pirogov EOOD

    Sofia, 1606

  • Alitera - Med - Medical Center EOOD

    Sofia, 1618

  • Medical Center "Nov Rehabilitatsionen Tsentar", EOOD

    Stara Zagora, 6000

  • Medical Center Tara OOD

    Veliko Tarnovo, 5000

Other trials in Bulgaria

Argentina10 sites

  • Fundacion Cidea

    Buenos Aires, C1121ABE

  • INAER

    Buenos Aires, C1425BEN

  • Fundacion Scherbovsky

    Mendoza, M5500AYB

  • INSARES

    Mendoza, Mendoza City, M5500CCG

  • Centro Respiratorio Quilmes

    Quilmes, B1878FNR

  • Instituto Especialidades de la Salud Rosario

    Rosario, S2000DBS

  • Instituto de Diagnóstico ABC; Servicio de Investigación de Patologías Alérgicas

    Rosario, S2000JKE

  • Centro Modelo de Cardiologia

    San Miguel de Tucumán, 4000

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, T4000IAR

  • CEMER Centro Medico de Enfermedades Respiratorias

    Vicente López, B1602DQD

Other trials in Argentina

Poland10 sites

  • Centrum Medycyny Oddechowej Robert M. Mróz

    Bialystok, 15-003

  • Centrum Medyczne ALL-MED

    Krakow, 30-033

  • Malopolskie Centrum Alergologii

    Krakow, 31-624

  • Niepubliczny Zaklad Opieki Zdrowotnej Centrum Medyczne ProMiMed sp z o.o. sp.k.

    Krakow, 31-637

  • SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im. Norberta Barlickiego Uniwersytetu Medycznego w Lodzi

    Lodz, 90-153

  • Specjalistyczna Poradnia Pulmonologiczna

    Ostrów Wielkopolski, 63-400

  • Przedsiebiorstwo Podmiotu Leczniczego Poradnie Specjalistyczne MAGMED

    Radom, 26-600

  • ALERGO-MED Specjalistyczna Przychodnia Lekarska Sp. z o. o

    Tarnów, 33-100

  • Ewa Pisarczyk-Bogacka Specjalistyczna Praktyka Lekarska

    Wroclaw, 53-301

  • NZOZ Lekarze Specjaliści J. Małolepszy i Partnerzy

    Wroclaw, 54-239

Other trials in Poland

Peru6 sites

  • Clinica Internacional

    Lima, Lima 1

  • Abk Reuma Srl- Medicentro

    Lima, Lima 21

  • Clinica Ricardo Palma; THORAX

    Lima, Lima 27

  • Instituto Peruano de Investigacion en Ciencias Medicas

    Lima, Lima 32

  • Clinica San Borja

    Lima, Lima 41

  • Hospital Santa Rosa Piura

    Piura, 20001

Other trials in Peru

Canada5 sites

  • Aggarwal and Associates

    Brampton, Ontario, L6T 0G1

  • Cheema Research

    Mississauga, Ontario, L5A 3V4

  • Inspiration Research

    Toronto, Ontario, M5T 3A9

  • C.I.C. Mauricie

    Trois-Rivières, Quebec, G8T 7A1

  • Anil Dhar Professional Medicine Corporation

    Windsor, Ontario, N8X 5A6

Other trials in Canada

Czechia5 sites

  • MediTrial s.r.o.

    Jindřichův Hradec, 377 01

  • EUC Klinika Ostrava a.s.

    Ostrava-Poruba, 708 00

  • Ordinace pro tuberkulozu a respiracni nemoci

    Strakonice, 38601

  • KASMED s.r.o.

    Tábor, 390 01

  • Alergologie Teplice, s.r.o.

    Teplice, 415 01

Other trials in Czechia

Romania5 sites

  • Theramed SRL

    Brasov, 16

  • Spitalul Clinic de Pneumoftiziologie Leon Daniello Cluj-Napoca, Sectia Clinica Pneumologie I

    Cluj-Napoca, 400371

  • Spitalul Clinic de Boli Infectioase si Pneumoftiziologie Victor Babes Craiova

    Craiova, 200515

  • Fundatia CardioPrevent

    Timișoara, 300134

  • Dr. Victor Babes Pneumology and Infectious Diseases Clinical Hospital

    Timișoara, 300310

Other trials in Romania

South Africa5 sites

  • Tiervalei Trial Centre

    Cape Town, 7530

  • University of Cape Town Lung Institute; Lung Clinical Research

    Cape Town, 7700

  • St Augustines Hospital; Infectoilogy

    Durban, 4001

  • Vawda Z.Fa Practice

    Durban, 4091

  • Aliwal Shoal Medical Center

    eMkhomazi, 4170

Other trials in South Africa

Germany4 sites

  • Pneumologisches Forschungsinstitut Hohegeest

    Geesthacht, 21502

  • POIS Leipzig Gbr

    Leipzig, 04357

  • Universitätsmedizin der Johannes Gutenberg-Universität Mainz, Medizinische Klinik, Pneumologie

    Mainz, 55131

  • Universitatsklinikum Munster

    Münster, 48149

Other trials in Germany

South Korea3 sites

  • Seoul National University Hospital

    Seoul, 03080

  • Severance Hospital, Yonsei University Health System

    Seoul, 03722

  • Asan Medical Center

    Seoul, 05505

Other trials in South Korea

Belgium2 sites

  • Cliniques Universitaires St-Luc

    Brussels, 1200

  • Private Practice Dr Jean Benoit Martinot

    Erpent, 5101

Other trials in Belgium

New Zealand2 sites

  • Greenlane Clinical Centre

    Auckland, 1051

  • Medical Research Institute of New Zealand

    Wellington, 6021

Other trials in New Zealand

About this study

Official title: A Phase IIb, Randomized, Double-Blind, Placebo-Controlled, Multicenter, Dose-Ranging Study to Assess the Efficacy and Safety of MSTT1041A in Patients With Uncontrolled Severe Asthma

This is a Phase IIb, randomized, placebo-controlled, double-blind, multicenter, multi-arm study which will evaluate efficacy, safety, and pharmacokinetic of MSTT1041A compared with placebo as add-on therapy in participants with severe, uncontrolled asthma who are receiving medium- or high-dose inhaled corticosteroid (ICS) therapy and at least one of the following additional controller medications: long-acting beta-agonists (LABA), leukotriene modifier (LTM), long-acting muscarinic antagonist (LAMA), or long-acting theophylline preparation. The total duration of this study for each participant is approximately 70 weeks including screening, run-in, treatment, and follow-up.

Conditions
Asthma
Being tested
MSTT1041A, Placebo
Medical subject headings
Asthma

What participants receive

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

  • MSTT1041ADrug

    Also called RO7187807

    MSTT1041A will be administered as subcutaneous injections.

  • PlaceboDrug

    Placebo matched with MSTT1041A.

Study groups in NCT02918019
Study groupRoleWhat they receive
MSTT1041A 210 mgExperimentalParticipants will receive MSTT1041A 210 milligrams (mg), subcutaneously every 4 weeks from randomization through Week 50.
Receives: Drug: MSTT1041A
MSTT1041A 490 mgExperimentalParticipants will receive MSTT1041A 490 mg, subcutaneously every 4 weeks from randomization through Week 50.
Receives: Drug: MSTT1041A
MSTT1041A 70 mgExperimentalParticipants will receive MSTT1041A 70 mg, subcutaneously every 4 weeks from randomization through Week 50.
Receives: Drug: MSTT1041A
PlaceboPlacebo comparatorParticipants will receive placebo matched with MSTT1041A, subcutaneously every 4 weeks from randomization through Week 50.
Receives: Drug: Placebo

What is being measured

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

  1. Reduction in Rate of Asthma Exacerbations

    Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.

    Adjusted rates for the overall mITT population (all participants that received at least one dose of study drug) were estimated using Poisson regression and adjusted for blood eosinophil level at the first visit, the number of asthma exacerbations requiring systemic corticosteroids in the 12 months prior to study entry, the total daily ICS dose at the first visit, and geographic region, with patient time at risk used as an offset term.

    Measured: Baseline to Week 54

Secondary outcomes (10)

  1. Absolute Change in Pre-Bronchodilator Forced Expiratory Volume in 1 Second (FEV1)

    FEV1 measures how much air a person can exhale during the first second of a forced breath.

    Adjusted means are reported.

    Measured: Baseline to Week 54

  2. Time to First Asthma Exacerbation

    Asthma exacerbation was defined as new or increased asthma symptoms (wheezing, coughing, dyspnea, chest tightness, and/or nighttime awakenings due to these symptoms) that result in one or both of the following: Hospitalization or emergency department visit with administration of systemic corticosteroid treatment; Treatment with systemic corticosteroids for at least 3 days, or a long-acting depot corticosteroid preparation with a therapeutic effectiveness of at least 3 days.

    Measured: 52 Weeks

  3. Achievement in Improvement in Standardized Asthma Quality-of-Life Questionnaire (AQLQ(S)) Score

    The AQLQ measures the functional problems (physical, emotional, social, and occupational) most troublesome to adults (17-70 years) with asthma. There are 32 questions in 4 domains - symptoms, activity limitation, emotional function, and environmental stimuli - scored on a 7 point scale, with 7= no impairment and 1= severely impaired. For this study, improvement achievement was defined as an increase of at least 0.5 points from baseline to week 54.

    Adjusted rates are reported.

    Measured: Week 54

  4. Absolute Change in Patient-Reported Use of Short-Acting Rescue Therapy

    Adjusted mean values are all equal to zero.

    Measured: Baseline to Week 54

  5. Proportion of Weeks Without Patient-Reported Asthma-Related Nighttime Awakenings

    The adjusted mean proportion of weeks without a nighttime awakening from baseline through week 54 are reported. The proportion of weeks is expressed as a percentage.

    Measured: Baseline through Week 54

  6. Absolute Change in Patient-Reported Daytime Asthma Symptom Severity as Measured by the Asthma Daily Symptom Diary (ADSD)

    The ADSD is a 6-item daily measure of asthma symptom severity that assesses three core categories of asthma symptoms: breathing symptoms, chest symptoms, and cough. Symptoms are rated at their worst using an 11-point numeric rating scale ranging from 0 (no symptoms) to 10 (the worst symptoms imaginable).

    Adjusted means are reported.

    Measured: Baseline to Week 54

  7. Percentage of Participants With Adverse Events

    An adverse event is any untoward medical occurrence in a participant administered a pharmaceutical product and which does not necessarily have to have a causal relationship with the treatment. An adverse event can therefore be any unfavorable and unintended sign (including an abnormal laboratory finding, for example), symptom, or disease temporally associated with the use of a pharmaceutical product, whether or not considered related to the pharmaceutical product. Preexisting conditions which worsen during a study are also considered as adverse events.

    Measured: Baseline to Week 54

  8. Percentage of Participants With Anti-Drug Antibodies (ADAs)

    The prevalence of ADAs at baseline was defined as the proportion of the evaluable participant population in a study that is ADA positive at baseline.

    Measured: Baseline

  9. Serum Concentration of Astegolimab (MSTT1041A)

    Measured: Weeks 26 and 54

  10. Percentage of Participants With Treatment-Emergent ADAs

    The incidence of ADAs at post-baseline timepoints was defined as the proportion of the study population found to have developed treatment-emergent ADAs.

    Measured: From baseline to the first appearance of ADAs at any point post-baseline (up to Week 54)

Timeline

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

  1. First posted28 Sep 2016 (estimated)
  2. Study start20 Sep 2016
  3. Primary completion5 Apr 2019
  4. Study completion26 Jul 2019

Resources

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
Masking
Double blind
Who is masked
Participant, Investigator
Enrolment
517 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02918019
Sponsor's protocol ID
GB39242
Other IDs
2016-001549-13, 2016
Status last verified
Nov 2022
First submitted
27 Sep 2016
Last updated
28 Dec 2022
Data monitoring committee
Yes

Publications

  • Yin Z, Zhou Y, Turnquist HR, Liu Q. Neuro-epithelial-ILC2 crosstalk in barrier tissues. Trends Immunol. 2022 Nov;43(11):901-916. doi: 10.1016/j.it.2022.09.006. Epub 2022 Oct 14.

    PubMed 36253275

  • Kelsen SG, Agache IO, Soong W, Israel E, Chupp GL, Cheung DS, Theess W, Yang X, Staton TL, Choy DF, Fong A, Dash A, Dolton M, Pappu R, Brightling CE. Astegolimab (anti-ST2) efficacy and safety in adults with severe asthma: A randomized clinical trial. J Allergy Clin Immunol. 2021 Sep;148(3):790-798. doi: 10.1016/j.jaci.2021.03.044. Epub 2021 Apr 16.

    PubMed 33872652

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing MSTT1041A in people with Asthma, run by Hoffmann-La Roche at 138 sites in 15 countries.

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 6 inclusion and 10 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 28 Dec 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 138 sites in United States, Russia, Ukraine, Bulgaria, Argentina and 10 more countries. 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 28 Dec 2022). 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?

Reduction in Rate of Asthma Exacerbations (time frame: Baseline to Week 54). 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 NCT02918019, which also lists 2 linked publications.

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 28 Dec 2022.

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