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Pulmonary FibrosisPhase 2NCT06329401

A Study Evaluating the Safety and Efficacy of Inhaled AP01 in Participants With Progressive Pulmonary Fibrosis

A Phase 2 study testing AP01 in people with Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Avalyn Pharma Inc. at 154 sites in 14 countries.

Active, not recruiting

Under way, not looking for participants. Everyone needed has enrolled. The study is still running.

Official record
Search all trials

Trial summary

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
AP01
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
398 participants
Where
154 sitesin 14 countries
Study dates
3 Apr 2024to Jun 2027
Phase
Phase 2
Are there results?
Not yet: the study is under way

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 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Participant meets criteria for PPF, as follows:
  • In subjects with interstitial lung disease (ILD) of known or unknown etiology other than idiopathic pulmonary fibrosis (IPF) who have radiological evidence of pulmonary fibrosis, PPF is defined as:
  • Physiological evidence of disease progression with at least 1 of the following criteria despite treatment with approved or unapproved medications commonly used in practice (per Investigator):
  • Relative decline in FVC ≥10% predicted within the previous 24 months based on documented historical spirometry assessments
  • Relative decline in FVC ≥5% to <10% predicted within the previous 24 months based on documented historical spirometry assessments with at least 1 of the 2 following criteria:
  • Worsening respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) OR
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  • Radiological (HRCT) evidence of disease progression per a local or central radiologist (from historical HRCT taken up to 24 months prior to Screening Visit 1), for example:
  • Increased extent or severity of traction bronchiectasis and bronchiolectasis
  • New ground-glass opacity with traction bronchiectasis
  • New fine reticulation
  • Increased extent or increased coarseness of reticular abnormality
  • New or increased honeycombing
  • Increased lobar volume loss
  • Worsening of respiratory symptoms (Note: Changes attributable to comorbidities e.g., infection, heart failure must be excluded) AND radiological (HRCT) evidence of disease progression per a local or central radiologist
  • Meeting all of the following criteria during the Screening Period:
  • FVC ≥45% of predicted normal at Screening Visit 1, b. Forced expiratory volume at 1 second (FEV1)/FVC ≥0.7 or ≥age-adjusted lower limit of normal at Screening Visit 1, c. Diffusing capacity of lung for carbon monoxide (DLCO) ≥30% of predicted, corrected for hemoglobin at Screening Visit 1, d. Acceptability: Participants can perform acceptable spirometry (i.e., meet American Thoracic Society (ATS)/ European Respiratory Society (ERS) acceptability criteria at both Screening Visits).
  • For subjects already on background therapy (nintedanib or nerandomilast 18 mg twice daily [up to 30% of subjects]): Must have been on background therapy for at least 12 weeks prior to Screening with or without dose adjustments and/or drug interruptions during that period. For subjects who have discontinued background therapy prior to Screening: Must have been off for a minimum of 12 weeks.

Who cannot join

  • Current treatment with oral pirfenidone or nerandomilast 9 mg twice daily dose or treatment with oral pirfenidone within 3 months prior to Screening.
  • Elevated liver enzymes and liver injury at Screening defined as:
  • Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ˃ 3 times the upper limit of normal (ULN)
  • Bilirubin >2.0 x ULN
  • Renal disease with a creatinine clearance < 30 mL/min, calculated according to the Chronic Kidney Disease Epidemiology Collaboration formula. Retesting is allowed once.
  • Diagnosis of idiopathic pulmonary fibrosis (IPF) based on the ATS diagnostic algorithm for IPF. UIP that is not idiopathic, for example related to rheumatoid arthritis (RA), familial interstitial lung disease (ILD), or other is not exclusionary.
Show all 9Show fewer
  • Greater extent of emphysema than of fibrotic ILD on HRCT. Note: CT results must be confirmed through the central over read process.
  • Significant clinical worsening of PPF between Screening Visit 1 and Visit 3
  • Participants who cannot meet protocol-specified Baseline stability criteria. FVC Baseline stability is defined as the FVC assessments at Visit 3 being within ±12% of the mean of the FVC assessments obtained at the 2 preceding visits. At Visit 3, if the pre-dose FVC is outside of ±12% range, the participant will not be randomized and will be considered a screen failure.

Trial locations and contacts

154 sites in 14 countries.

154 sites in 14 countries

United States61 sites

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Piedmont Healthcare, Inc.

    Atlanta, Georgia, 30309

  • University of Colorado, Anschutz Medical Campus

    Aurora, Colorado, 80045

  • University of Maryland

    Baltimore, Maryland, 21201

  • Johns Hopkins University

    Baltimore, Maryland, 21224

  • The Oregon Clinic Pulmonary West

    Beaverton, Oregon, 97008

  • Summit Health

    Bend, Oregon, 97701

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35205

  • Beth Israel Deaconess Medical Center

    Boston, Massachusetts, 02215

  • Lowcountry Lung and Critical Care

    Charleston, South Carolina, 29406

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Northwestern University

    Chicago, Illinois, 60611

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Baylor Scott & White Research Institute, Baylor University Medical Center

    Dallas, Texas, 75246

  • UT Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University

    Durham, North Carolina, 27710

  • El Paso Pulmonary Association

    El Paso, Texas, 79902

  • Endeavor Health

    Evanston, Illinois, 60201

  • Inova Healthcare

    Falls Church, Virginia, 22042

  • UCONN Health

    Farmington, Connecticut, 06030

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067

  • Hannibal Regional Healthcare System

    Hannibal, Missouri, 63401

  • The Pennsylvania State University

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • The University of Texas Health Science Center

    Houston, Texas, 77030

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Clinical Site Partners, LCC

    Leesburg, Florida, 34748

  • University of Southern California

    Los Angeles, California, 90033

  • Cedars-Sinai

    Los Angeles, California, 90048

  • UCLA

    Los Angeles, California, 90095

  • Loyola University Medical Center

    Maywood, Illinois, 60153

  • Metroplex Pulmonary and Sleep Center, PA

    McKinney, Texas, 75069

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Northern Westchester Hospital

    Mount Kisco, New York, 10549

  • Northwell Health - Mount Kisco

    Mount Kisco, New York, 10549

  • Intermountain Medical Center

    Murray, Utah, 84157

  • Vanderbilt Lung Institute

    Nashville, Tennessee, 37204

  • Yale University

    New Haven, Connecticut, 06519

  • NYU Langone Health

    New York, New York, 10017

  • Weill Cornell

    New York, New York, 10021

  • Icahn School of Medicine at Mount Sinai

    New York, New York, 10029

  • Columbia University

    New York, New York, 10032

  • Newport Native MD, Inc.

    Newport Beach, California, 92663

  • Renstar Medical Research

    Ocala, Florida, 34470

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • The Oregon Clinic Pulmonary East

    Portland, Oregon, 97220

  • The Oregon Clinic Pulmonary West

    Portland, Oregon, 97225

  • Paradigm Clinical Research - Redding

    Redding, California, 96001

  • Mayo Clinic Rochester

    Rochester, Minnesota, 55905

  • University of Utah Health

    Salt Lake City, Utah, 84108

  • University of California - San Francisco

    San Francisco, California, 94143

  • Mayo Clinic- Scottsdale

    Scottsdale, Arizona, 85259

  • University of Washington

    Seattle, Washington, 98195

  • Piedmont HealthCare, PA

    Statesville, North Carolina, 28625

  • Montefiore Medical Center

    The Bronx, New York, 10467

  • Accellacare

    Wilmington, North Carolina, 28401

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103

  • Clinical Site Partners

    Winter Park, Florida, 32789

Other trials in United States

United Kingdom15 sites

  • Birmingham Heartlands Hospital

    Birmingham, Heartlands, B95SS

  • ILD Unit, University Hospitals Birmingham NHS Foundation Trust Theme

    Birmingham, Midlands, B15 2GW

  • Royal Papworth Hospital

    Cambridge, CB2 0BB

  • Hull University Teaching Hospital NHS Trust

    Cottingham, East Yorkshire, HU16 5JQ

  • Royal Devon

    Exeter, South West, EX2 5DW

  • Leicester Biomedical Research Centre - Respiratory Theme

    Glenfield, Leicester, LE3 9QP

  • St James University Hospital - LTHT

    Leeds, West Yorkshire, LS9 7TF

  • St George's University Hospitals NHS Foundation Trust

    London, London, sw17 0QT

  • Royal Brompton Hospital

    London, SW3 6HP

  • C-TRIC Altnagelvin Hospital

    Londonderry, Northern Ireland, BT46

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT

  • Nottingham University NHS Trust

    Nottingham, NG5 1PB

  • Oxford University Hospitals NHS Foundation Trust

    Oxford, Oxon, OX3 7LE

  • University Hospitals of North Midlands NHS Trust, Royal Stoke University Hospital

    Stoke-on-Trent, ST4 6QG

  • The Royal Wolverhampton NHS Trust, New Cross Hospital, Research and Development

    Wolverhampton, West Midlands, WV10 0QP

Other trials in United Kingdom

Australia10 sites

  • Wallace Street Specialist Centre/Lung Research QLD Pty Ltd

    Brisbane, Queensland, 4032

  • Royal Prince Alfred Hospital

    Camperdown, New South Wales, 2050

  • Canberra Hospital

    Canberra, 2605

  • Lung Research Victoria

    Footscray, Victoria, 3011

  • Nepean Lung & Sleep

    Kingswood, New South Wales, 2745

  • Alfred Health

    Melbourne, Victoria, 3004

  • Institute for Respiratory Health

    Nedlands, Perth West Australia, 6009

  • John Hunter Hospital

    New Lambton, New South Wales, 2305

  • Macquarie University Clinical Trials Unit

    Sydney, New South Wales, 2109

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Spain10 sites

  • Hospital de Sant Pau y la Santa Creu

    Barcelona, Barcelona, 08025

  • Hospital Universitary de Bellvitge

    Barcelona, 08908

  • Hospital Universitario Puerta del Mar - Leon-Jimenez

    Cadiz, 11009

  • Hospital Universitario Virgen de las Nieves

    Granada, Andalusia, 18014

  • Hospital Gregorio Marañon

    Madrid, Madrid, 28007

  • Hospital Universitario Ramon y Cajal

    Madrid, Madrid, 28034

  • Hospital Universitario Virgen de la Victoria

    Málaga, Málaga, 29010

  • Hospital Universitario Central de Asturias

    Oviedo, Principality of Asturias, 33011

  • Hospital Universitario Marqués de Valdecilla

    Santander, Cantabria, 39008

  • Hospital Universitario Virgen del Rocío

    Seville, Sevilla, 41013

Other trials in Spain

Argentina9 sites

  • Fundacion Respirar

    Buenos Aires, Buenos Aires, 1427

  • CINME

    Buenos Aires, Buenos Aires, C1056AB

  • Hospital Italiano de Buenos Aires

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1199ABH

  • Instituto de Medicina Respiratoria

    Córdoba, Córdoba Province, 5003

  • Instituto Ave Pulmo, Fundacion Enfisema

    Mar del Plata, Buenos Aires, 7600

  • Clinica Monte Grande

    Monte Grande, Buenos Aires, 1842

  • Centro Respiratorio Quilmes

    Quilmes, Buenos Aires, B1878

  • CIMER Centro Integral de Medicina Respiratoria

    San Miguel de Tucumán, Tucumán Province, 4000

  • Investigaciones En Patologias Respiratorias

    San Miguel de Tucumán, Tucumán Province, 4000

Other trials in Argentina

France9 sites

  • CHU Angers

    Angers, 49933

  • APHP - Hopital Bicetre

    Le Kremlin-Bicêtre, 94270

  • Louis Pradel Hospital

    Lyon, Lyon, 69677

  • Robert Schuman Hospital UNEOS

    Metz, Lorraine, 57000

  • University of Montpellier

    Montpellier, Montpellier, 34295

  • Hôpital Paris St Jozeph

    Paris, 75014

  • Hôpital Haut-Lévêque

    Pessac, 33604

  • CHU de Rennes

    Rennes, Cedex NA, 35033

  • CHU Tours

    Tours, Indre et Loire, 37000

Other trials in France

Germany9 sites

  • Vivantes Klinikum Neukölln - Klinik für Innere Medizin - Pneumologie und Infektiologie

    Berlin, State of Berlin, 12351

  • Ruhrlandklinik Essen, Klinik fuer Pneumologie

    Essen, North Rhine-Westphalia, 45239

  • Studienzentrum Dr. Claus Keller

    Frankfurt, Main Hessia, 60389

  • Medizinische Hochschule Hannover

    Hanover, Lower Saxony, 30625

  • Uniklinikum Leipzig Medizinische Klinik II - Bereich

    Leipzig, Saxony, 04103

  • Universitätsmedizin Mainz - Zentrum für Thoraxerkrankungen

    Mainz, Rhineland-Palatinate, 55131

  • Muenchen Klinik Bogenhausen - Klinik für Pneumologie und Pneumologische Onkologie

    München, Bavaria, 81925

  • Pneumologisches Studienzentrum München-West

    Munich, Bavaria, 81241

  • RoMed Klinikum Rosenheim

    Rosenheim, Bavaria, 83022

Other trials in Germany

Italy9 sites

  • IRCCS AOU di Bologna - Policlinico Sant' Orsola

    Bologna, Emilia-Romagna, 40138

  • A.O.U. Policlinico G. Rodolico

    Catania, Sicily, 95123

  • Ospedale San Giuseppe

    Milan, Milano, 20123

  • Azienda Ospedaliera dei Colli - Ospedale Monaldi

    Naples, Campania, 80131

  • Università degli Studi di Napoli Federico II - Ospedale Monaldi

    Naples, Campania, 80131

  • Fondazione IRCCS Policlinico San Matteo - UOC Pneumologia

    Pavia, Lombardy, 27100

  • HUMANITAS Research Hospital

    Rozzano, Milano, 20089

  • A.O.U. delle Marche - Ospedale di Torrette

    Torrette, Ancona, 60126

  • Azienda Sanitaria Universitaria Giuliano Isontina

    Venezia, Giulia, 34149

Other trials in Italy

Canada6 sites

  • Dynamic Drug Advancement

    Ajax, Ontario, L1S2J5

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6

  • Research Institute McGill University Health Center

    Montreal, Quebec, H4A 3J1

  • Institut universitaire de cardiologie et de pneumologie de Québec-Université Laval

    Québec, Quebec, G1V4G5

  • CIC Mauricie

    Trois-Rivières, Quebec, G8T7A1

  • Vancouver General Hospital

    Vancouver, British Columbia, V5Z1M9

Other trials in Canada

Poland5 sites

  • Vitamed Galaj I Cichomski sp.j.

    Bydgoszcz, Bydgoszc, 85-079

  • University Hospital in Krakow

    Krakow, Krakow, 30-688

  • Department of Pneumology of the University Hospital No 1

    Lodz, 90-153

  • PRYWATNY GABINET LEKARSKI GINEKOLOGIA I POŁOZNICTWO ULTRASONOGRAFIA Prof. Dr hab. Med. Jacek Suzin

    Lodz, 90-602

  • AppleTreeClinics Network

    Lodz, Łódź Voivodeship, 90-349

Other trials in Poland

New Zealand4 sites

  • Greenlane Clinical Centre

    Auckland, Auckland, 1051

  • Health New Zealand

    Christchurch, Canterbury, 8011

  • Dunedin Hospital

    Dunedin, Dunedine, 9016

  • Bay of Plenty Clinical School

    Tauranga, South Tauranga, 3112

Other trials in New Zealand

Turkey (Türkiye)3 sites

  • Cukurova University Medical Faculty

    Adana, 01240

  • Health Sciences University, Gulhane Faculty of Medicine

    Ankara, 06010

  • Ege University Medical Faculty Hospital

    Bornova, İzmir, 35100

Other trials in Turkey (Türkiye)

Belgium2 sites

  • UZ Leuven

    Leuven, 3000

  • CHU de Liège

    Liège, 4000

Other trials in Belgium

Netherlands2 sites

  • St Antoniusziekenhuis

    Nieuwegein, Utrecht, 3435

  • Erasmus University Medical Center

    Rotterdam, 3015 GD

Other trials in Netherlands

About this study

Official title: A Randomized, Double-Blind, Placebo-Controlled, Phase 2b Study Evaluating the Safety and Efficacy of Pirfenidone Solution for Inhalation (AP01) in Participants With PPF

A randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of inhaled pirfenidone (AP01) versus placebo on top of standard of care in participants with PPF over 52 weeks.

Read the detailed description

This is a randomized, double-blind, placebo-controlled clinical study to evaluate the safety and efficacy of 2 doses of AP01 (pirfenidone solution for inhalation) versus placebo on top of standard of care in participants with PPF over 52 weeks. Up to 300 eligible participants will be randomized to 1 of 3 treatment arms: AP01 high dose, AP01 low dose, or placebo.

Being tested
AP01, Placebo
Keywords
Chronic-Fibrosing-ILD with progressive phenotype, PF-ILD
Medical subject headings
Pulmonary Fibrosis, Lung Diseases, Interstitial, Alveolitis, Extrinsic Allergic

What participants receive

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

  • AP01Drug

    Also called Pirfenidone Solution

    Oral inhalation solution

  • PlaceboOther

    Placebo oral inhalation solution

Study groups in NCT06329401
Study groupRoleWhat they receive
AP01 High Dose BIDExperimentalPirfenidone Solution for Inhalation
Receives: Drug: AP01
AP01 Low Dose BIDExperimentalPirfenidone Solution for Inhalation
Receives: Drug: AP01
Placebo BIDPlacebo comparatorPlacebo solution for inhalation
Receives: Other: Placebo

What is being measured

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

  1. To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID)

    Change from baseline in forced vital capacity (FVC) (mL)

    Measured: Week 52

Secondary outcomes (3)

  1. To evaluate the effect of AP01 high dose and AP01 low dose compared to placebo on disease progression (defined as absolute FVC percent predicted decline of ≥10% prior to Week 52)

    Time to disease progression

    Measured: 52 weeks

  2. To evaluate the effect of AP01 high dose, AP01 low dose compared to placebo on quality of life (QoL)

    Absolute change from Baseline in QoL measurements as assessed by Living with Pulmonary Fibrosis Symptoms and Impact Questionnaire (L-PF) total score. The L-PF is a 44-item questionnaire to assess how impacted a participant is by disease symptoms on a scale from 0 (Not at all) to 4 (Extremely). The higher the summary score, the greater the impairment.

    Measured: 52 weeks

  3. To evaluate the change from baseline in quantitative lung fibrosis score.

    Change in lung fibrosis score.

    Measured: 52 weeks

Timeline

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

  1. First posted25 Mar 2024
  2. Study start3 Apr 2024
  3. Primary completionJun 2027 (estimated)
  4. Study completionJun 2027 (estimated)

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
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
398 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06329401
Sponsor's protocol ID
AP01-007
Status last verified
Jun 2026
First submitted
12 Mar 2024
Last updated
16 Oct 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
No

Publications

  • West A, Chaudhuri N, Barczyk A, Wilsher ML, Hopkins P, Glaspole I, Corte TJ, Sterclova M, Veale A, Jassem E, Wijsenbeek MS, Grainge C, Piotrowski W, Raghu G, Shaffer ML, Nair D, Freeman L, Otto K, Montgomery AB. Inhaled pirfenidone solution (AP01) for IPF: a randomised, open-label, dose-response trial. Thorax. 2023 Sep;78(9):882-889. doi: 10.1136/thorax-2022-219391. Epub 2023 Mar 22.

    PubMed 36948586

  • Kolb M, Corte TJ, Feldman J, Nathan SD, Reisner C, Nair D, Woodhead F, Lazarus H, Conoscenti C. Design of the MIST study: a double-blind, randomised, placebo-controlled phase 2b trial of pirfenidone solution for inhalation in patients with progressive pulmonary fibrosis. BMJ Open Respir Res. 2025 Dec 25;12(1):e003059. doi: 10.1136/bmjresp-2024-003059.

    PubMed 41448793

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing AP01 in people with Pulmonary Fibrosis and Progressive Pulmonary Fibrosis, run by Avalyn Pharma Inc. at 154 sites in 14 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 17 inclusion and 9 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: under way, not looking for participants, as of the sponsor's last update on 16 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 154 sites in United States, United Kingdom, Australia, Spain, Argentina and 9 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?

This study is still under way. Results are not available in the source record yet.

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?

To evaluate the effect of AP01 high dose twice a day (BID) or AP01 low dose twice a day (BID) compared to placebo twice a day (BID) (time frame: Week 52). 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 NCT06329401, 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 16 Oct 2026.

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