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Idiopathic Pulmonary FibrosisPhase 3NCT04419558

Zephyrus II: Efficacy and Safety Study of Pamrevlumab in Participants With Idiopathic Pulmonary Fibrosis (IPF)

A Phase 3 study testing Pamrevlumab in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 157 sites in 25 countries.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
Search all trials

Trial summary

This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). Read more about this study

Who is it for?
Ages 40 to 85 years
Conditions the study is for
Idiopathic Pulmonary Fibrosis
What is being tested?
Pamrevlumab
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
372 participants
Where
157 sitesin 25 countries
Study dates
30 Sep 2020to 4 Sep 2023
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 40 to 85 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Diagnosis of IPF as defined by American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Association (ATS/ERS/JRS/ALAT) guidelines within the past 7 years prior to study participation.
  • High-resolution computed tomography (HRCT) scan at Screening, with ≥10% to <50% parenchymal fibrosis (reticulation) and <25% honeycombing.
  • FVCpp value >45% and <95% at Screening and Day 1 (prior to randomization).
  • Diffusing capacity of the lungs for carbon monoxide (DLCO) percent predicted ≥25% and ≤90%.
  • Not currently receiving treatment for IPF with an approved therapy for IPF (such as, pirfenidone or nintedanib) for any reason, including prior intolerance or lack of response to an approved IPF therapy, or choice to forego treatment with an approved IPF therapy after a full discussion with the Investigator regarding risks/benefits of such therapy.

Who cannot join

  • Previous exposure to pamrevlumab.
  • Evidence of significant obstructive lung disease, as evidenced by spirometry or HRCT.
  • Female participants who are pregnant or nursing.
  • Smoking within 3 months of Screening and/or unwilling to avoid smoking throughout the study.
  • Interstitial lung disease other than IPF.
  • Sustained improvement in the severity of IPF during the 12 months prior to screening.
Show all 11Show fewer
  • Other types of respiratory diseases that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study, including diseases of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
  • Certain medical conditions, that, in the opinion of the Investigator, would impact the primary protocol endpoint or otherwise preclude participation in the study (such as, myocardial infarction/stroke, severe chronic heart failure, pulmonary hypertension, or cancers).
  • Acute IPF exacerbation during Screening or Randomization including hospitalization due to acute IPF exacerbation within 4 weeks prior to or during screening.
  • Use of any investigational drugs or unapproved therapies, or participation in any clinical trial with an investigational new drug within 30 days prior to screening. Or use of approved IPF therapies (such as, pirfenidone or nintedanib) within 1 week prior to screening.
  • History of allergic or anaphylactic reaction to human, humanized, chimeric or murine monoclonal antibodies, or to any component of the excipient.

Trial locations and contacts

157 sites in 25 countries.

157 sites in 25 countries

United States23 sites

  • Emory University/The Emory Clinic

    Atlanta, Georgia, 30324

  • University of Maryland Medical Center

    Baltimore, Maryland, 21201

  • UAB Lung Health Center

    Birmingham, Alabama, 35294

  • The General Hospital Corporation d/b/a Massachusetts General Hospital

    Boston, Massachusetts, 02114

  • The University of Vermont

    Burlington, Vermont, 05405

  • Low Country Lung and Critical Care, PA

    Charleston, South Carolina, 29406

  • St. Francis Medical Center

    Clearwater, Florida, 33765

  • Ohio State University

    Columbus, Ohio, 43221

  • National Jewish Health

    Denver, Colorado, 80206

  • Duke University Medical Center

    Durham, North Carolina, 27710

  • Spectrum Health

    Grand Rapids, Michigan, 49504

  • PulmonIx, LLC

    Greensboro, North Carolina, 27403

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • University of Iowa

    Iowa City, Iowa, 52242

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Pulmonary Disease Specialists d/b/a PDS Research

    Kissimmee, Florida, 34741

  • University of Wisconsin Clinical Research

    Madison, Wisconsin, 53706

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Yale University

    New Haven, Connecticut, 06520

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Mayo Clinic

    Rochester, Minnesota, 55905

  • UC San Francisco

    San Francisco, California, 94143

  • TGH/USF Center for Advanced Lung Disease and Lung Transplant

    Tampa, Florida, 33606

Other trials in United States

China15 sites

  • BeiJing Chao-Yang Hospital,Capital Medical University

    Beijing

  • Beijing Frindship hosiptal capital Medical University

    Beijing

  • China Japan Friendship hospital

    Beijing

  • Peking Union Medical College Hospital

    Beijing

  • Sichuan People's Hospital

    Chengdu

  • Guangdong Provincial People's Hospital

    Guangzhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Ruijin Hospital, Shanghai Jiaotong University School of Medicine

    Shanghai

  • Shanghai Oriental Hospital

    Shanghai

  • The First Hospital of China Medical University

    Shenyang

  • General Hospital of Tianjin Medical University

    Tianjing

  • Tongji Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology

    Wuhan

  • Union Hospital Tongji Medical College Huazhong University of Science and Technology

    Wuhan

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • General Hospital of Ningxia Medical University

    Yinchuan

Other trials in China

South Korea15 sites

  • Soonchunhyang University Hospital Bucheon

    Bucheon-si, 14584

  • The Catholic University of Korea Bucheon St. Mary's Hospital

    Bucheon-si, 14647

  • Inje University Haeundae Paik Hospital

    Busan, 48108

  • Inje University Hospital Iisan Paik Hospital

    Goyang, 10380

  • Myongji Hospital

    Goyang-si, Gyeonggi-do, 10475

  • Chonnam National University Hospital

    Gwangju, 61469

  • Gachon University Gil Medical Centre

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam, 13620

  • Seoul National University Hospital

    Seoul, 03080

  • Kyunghee University Medical Center

    Seoul, 17104

  • Severance hospital

    Seoul, 3722

  • Soonchunhyang University Hospital Seoul

    Seoul, 4401

  • Asan Medical Center

    Seoul, 5505

  • The Catholic University of Korea, Yeouido ST. Mary's Hospital

    Seoul, 7345

  • Ulsan University Hospital

    Ulsan, 44033

Other trials in South Korea

Italy11 sites

  • Gaspare Rodiloco Hospital

    Catania, 95123

  • Ospedale G.B.Morgagni L.Pierantoni - Azienda Unita Sanitaria Locale (AUSL) di Forli

    Forlì, 47121

  • Ospedale San Giuseppe

    Milan, 20123

  • AOU Policlinico di Modena

    Modena, 41124

  • Monaldi Hospital

    Naples, 80131

  • Azienda Ospedaliera Universitaria di Padova

    Padova, 35128

  • IRCCS Fondazione San Matteo di Pavia

    Pavia, 27100

  • Agostina Gemelli University Polyclinic

    Rome, 00168

  • Azienda Ospedaliera Universitaria Senese, Policlinico "Le Scotte"

    Siena, 53100

  • Azienda Ospedaliera Citta' della Salute e delle Scienza di Torino

    Torino, 0126

  • Azienda Ospedaliero-Universitaria "Ospedali Riuniti di Ancona"

    Torrette, 60126

Other trials in Italy

France10 sites

  • University Hospital Avicenne

    Bobigny, 93000

  • Hôpital Cardio-Vasculaire et Pneumologique Louis Pradel

    Bron, 69677

  • CHU de Caen

    Caen, 14033

  • Centre Memoire Ressources Recherche, Hopital F. MITTERRAND

    Dijon, 21079

  • C.H.R.U. de Montpellier - Hôpital Lapeyronie

    Montpellier, 34295

  • CHU de Nice Hôpital Pasteur

    Nice, 06000

  • Hôpital Bichat - Claude Bernard

    Paris, 75018

  • CHU de Reims Hopital Maison Blanche

    Reims, 51092

  • CHU de Rennes Hôpital Pontchaillou

    Rennes, 35033

  • Service de Néphrologie, Hôpital Bretonneau, CHRU de Tours

    Tours, 37044

Other trials in France

Brazil9 sites

  • Hospital das Clínicas da UFMG - Centro de Pesquisas Clínicas do Hospital das Clínicas da Universidade Federal de Minas Gerais - CPC HC/UFMG

    Belo Horizonte, Minas Gerais, 30130-100

  • Hospital Dia do Pulmão

    Blumenau, Santa Catarina, 89030-101

  • Unidade de Pesquisa Clínica da Faculdade de Medicina de Botucatu - UPECLIN - UNESP

    Botucatu, São Paulo, 18618-686

  • Irmandade da Santa Casa de Misericórdia de Porto Alegre

    Porto Alegre, Rio Grande do Sul, 90020-090

  • HSL-PUCRS Hospital São Lucas da Pontifícia Universidade Católica do Rio Grande do Sul

    Porto Alegre, Rio Grande do Sul, 90610-000

  • CEMEC - Centro Multidisciplinar de Estudos Clínicos LTDA EPP

    São Bernardo do Campo, São Paulo, 09715-090

  • CPQuali Pesquisa Clínica Ltda.

    São Paulo, 01228-000

  • Hospital Alemao Oswaldo Cruz

    São Paulo, 01323-001

  • INCOR - Instituto do Coração Centro de Pesquisa Prof. Dr. Fulvio Pileggi Hospital das Clínicas da Faculdade de Medicina da USP - HCFMUSP

    São Paulo, 05403-000

Other trials in Brazil

Spain8 sites

  • Hospital Universitario de Bellvitge

    Barcelona, 08907

  • Hospital Clinic de Barcelona

    Barcelona, 8036

  • Hospital Universitaio de La Princesa

    Madrid, 28006

  • Hospital General Universitario Gregorio Maranon

    Madrid, 28007

  • Hospital Clinico San Carlos-Madrid C/Martin Lagos s/n

    Madrid, 28040

  • Hospital Universitario Quironsalud Madrid

    Madrid, 28223

  • Hospital Universitario Marques de Valdecilla

    Santander, 39008

  • Hospital Universitario Nuestra Senora de Valme

    Seville, 41014

Other trials in Spain

United Kingdom8 sites

  • Queen Elizabeth Hospital, University Hospitals Birmingham NHS Foundation Trust

    Birmingham, B15 2TH

  • Papworth Hospital NHS Foundation Trust, Advanced Heart Failure Unit

    Cambridge, CB2 0AY

  • Medway NHS Foundation Trust

    Gillingham, Kent, ME7 5NY

  • The Princess Alexandra Hospital NHS Trust

    Harlow, CM20 1QX

  • Royal Brompton Hospital

    London, SW3 6NP

  • University College London

    London, WC1E 6JF

  • Manchester University NHS Foundation Trust

    Manchester, M23 9LT

  • Southampton General Hospital

    Southampton, SO16 6YD

Other trials in United Kingdom

Germany7 sites

  • Ruhrlandklinik-Universitaetsmedizin Essen

    Essen, 45239

  • Klinik Schillerhoehe

    Gerlingen, 70839

  • Agaplesion Evangelisches Krankenhaus Mittelhessen

    Giessen, 035398

  • Universitätsklinikum Hamburg-Eppendorf

    Hamburg, 20246

  • University of Munich

    Munich, 81377

  • RoMed Klinikum Rosenheim

    Rosenheim, 83022

  • Institut fur Pneumologie an der Universitat zu Koln

    Solingen, 83022

Other trials in Germany

Mexico6 sites

  • Instituto Nacional de Enfermedades Respiratorias INER

    México, 14080

  • Unidad Medica para la Salud Integral (UMSI)

    México, 66465

  • Medical Care and Research S.A. de C.V.

    México, 97070

  • St. Lucas Clinical Research Center SA de CV

    México, CP97217

  • Centro Regional para el estudio del Adulto Mayor, Servicio de Geriatria, Hospital Universitario Dr Jose Eleuterio Gonzalez

    Monterrey, 64460

  • Oaxaca Site Management Organization S.C. (OSMO)

    Oaxaca City, 68000

Other trials in Mexico

Peru6 sites

  • Clinica Internacional

    Lima, 15001

  • Clinica San Pablo

    Lima, 150140

  • Clinica Providencia

    Lima, 15088

  • Hospital Nacional Cayetano Heredia / Servicio de Inmunología y Reumatología

    Lima, 15102

  • Centro de Investigacion Ricardo Palma

    San Isidro, 150131

  • Clinica La luz

    Santa Beatriz, 15046

Other trials in Peru

Netherlands5 sites

  • Dept. of Pulmonary Diseases

    Amsterdam, 30.033

  • Catharina Hospital

    Eindhoven, 5623 EJ

  • Longarts - Opleider Longziekten Zuyderland MC

    Heerlen, 6419

  • St. Antonius Ziekenhuis BV

    Nieuwegein, 3435

  • Canisius-Wilhelmina Ziekenhuis

    Nieuwegein, 6533

Other trials in Netherlands

Poland5 sites

  • Centrum Dentystyczno-Lekarskie Promedica Joanna Markiewicz

    Będzin, 42-500

  • Centrum Medycyny Oddechowej Mroz SJ

    Bialystok, 15-044

  • Gornoslaskie Centrum Medyczne im. prof. Leszka Gieca Slaskiego Uniwersytetu Medycznego w Katowicach

    Katowice, 40-635

  • University Hospital No1

    Lodz, 90-153

  • Instytut Gruzlicy i Chorob Pluc

    Warsaw, 01-138

Other trials in Poland

Hungary4 sites

  • Semmelweis University Clinic of Pulmonology

    Budapest, 1083

  • Orszagos Koranyi Tbc es Pulmonologiai Intezet, IV. Tudobelosztaly

    Budapest, 1121

  • Fejer Megyei Szent Gyorgy kh

    Székesfehérvár, 8000

  • Pulmonology Hospital

    Törökbálint, 2045

Other trials in Hungary

Serbia4 sites

  • Municipal Institute for Lung Diseases and Tuberculosis

    Belgrade, 11000

  • University Clinical Center of Serbia

    Belgrade, 11000

  • Institute for Pulmonary Diseases of Vojvodina

    Kamenitz, 21204

  • University Clinical Center of Nis

    Niš, 18000

Other trials in Serbia

Colombia3 sites

  • Fundación Santa Fe de Bogotá

    Bogotá, 110121

  • Fundación Neumológica Colombiana

    Bogotá, 110131

  • Healthy Medical Center S.A.S

    Zipaquirá, 250252

Other trials in Colombia

Czechia3 sites

  • Fakultní nemocnice Brno

    Brno, 625 00

  • Nemocnice Jihlava

    Jihlava, 586 33

  • Nemocnice Na Bulovce, Klinika pneumologie

    Prague, 18081

Other trials in Czechia

Lebanon3 sites

  • American University of beirut medical center

    Beirut

  • Hotel Dieu De France

    Beirut

  • Rafik Hariri University Hospital (Clinical Research Unit)

    Bir Hassan

Other trials in Lebanon

Ukraine3 sites

  • Communal non-profit enterprise "City clinical hospital #16" of Dnipro Сit Сouncil

    Dnipro, 49069

  • Ivano-Frankivsk Regional Phthisiology-Pulmonology Center of Ivano-Frankivsk regional council

    Ivano-Frankivsk, 76018

  • National Institute of Phthisiology and Pulmonology named after F. G. Yanovskyi NAMS of Ukraine, Clinical and Functional Department

    Kyiv, 03680

Other trials in Ukraine

Denmark2 sites

  • Aarhus Universitets Hospital

    Aarhus, DK-8200

  • Odense University Hospital

    Odense, 5000

Other trials in Denmark

Dominican Republic2 sites

  • Centro de Obstetricia y Ginecologia

    Santo Domingo, 10205

  • Centro Medico Dominicano

    Santo Domingo, 456

Other trials in Dominican Republic

Georgia2 sites

  • Research Institute Of Clinical Medicine Todua Clinic

    Tbilisi, 0112

  • Clinic Diacor

    Tbilisi, 0159

Other trials in Georgia

Argentina1 site

  • Fundacion Respirar - Centro Médico Dra. De Salvo

    Ciudad Autonoma de Buenos Aires (caba)

Other trials in Argentina

Ireland1 site

  • Royal College of Surgeons in Ireland

    Dublin, D09YD60

Other trials in Ireland

Switzerland1 site

  • Universitätsklinik für Pneumologie

    Bern, 3010

Other trials in Switzerland

About this study

Official title: Zephyrus II: A Phase 3, Randomized, Double-Blind, Placebo-Controlled Efficacy and Safety Study of Pamrevlumab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

This is a Phase 3 trial to evaluate the efficacy and safety of 30 milligrams (mg)/kilogram (kg) intravenous (IV) infusions of pamrevlumab administered every 3 weeks as compared to placebo in participants with Idiopathic Pulmonary Fibrosis (IPF). There is a 48-week randomized treatment phase followed by an optional, open-label extension phase.

Read the detailed description

The intent of this study is to evaluate the efficacy and safety of pamrevlumab as monotherapy in participants with IPF. Participants who are not being treated with approved IPF therapies (that is, nintedanib or pirfenidone) may be eligible for screening. Examples of reasons participants may not be treated with approved IPF therapies include but are not limited to:

  • Intolerant or not responsive to approved IPF therapies
  • Ineligible to receive these therapies
  • Participant voluntarily declines to receive approved IPF therapies after being fully informed of the potential benefits/risks

NOTE: No participant should discontinue an approved IPF therapy for the purpose of enrolling in this study.

During the 48-week treatment phase of the study, co-administration of an approved IPF therapy (such as, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, after assessment of potential risks/benefits of such combination with blinded study treatment.

Participants who complete the 48-week study will be eligible for an optional, open-label extension phase with continued access to pamrevlumab, regardless of their randomized assignment.

Being tested
Pamrevlumab, Placebo
Keywords
Idiopathic Pulmonary Fibrosis, IPF, Idiopathic Interstitial Pneumonia, Interstitial Lung Disease, Lung Fibrosis
Medical subject headings
Idiopathic Pulmonary Fibrosis, Idiopathic Interstitial Pneumonias, Lung Diseases, Interstitial, Pulmonary Fibrosis

What participants receive

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

  • PamrevlumabDrug

    Also called FG-3019

    Sterile solution for injection

  • PlaceboDrug

    Sterile solution for injection

Study groups in NCT04419558
Study groupRoleWhat they receive
PamrevlumabExperimentalTreatment phase: Pamrevlumab 30 mg/kg administered by IV infusion, every 3 weeks, for a total of up to 17 infusions over 48 weeks. Open-label extension phase: Pamrevlumab 30 mg/kg administered by intravenous infusion, every 3 weeks for up to 48 weeks
Receives: Drug: Pamrevlumab
PlaceboExperimentalPamrevlumab-matching placebo administered by IV infusion every 3 weeks for a total of up to 17 infusions over 48 weeks
Receives: Drug: Placebo

What is being measured

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

  1. DB Period: Change From Baseline in FVC at Week 48

    FVC is a standard pulmonary function test used to quantify respiratory muscle weakness. FVC was the volume of air that can forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were analyzed using mixed model repeated measures (MMRM).

    Measured: Baseline, Week 48

Secondary outcomes (6)

  1. DB Period: Time to Disease Progression

    Time to disease progression was defined as time from randomization to either the first occurrence of an absolute FVC percent predicted (FVCpp) decline of ≥10% from baseline or death, whichever occurred first. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  2. DB Period: Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48

    The QLF volume is calculated as QLF=total lung capacity volume (TLC) * % of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE were analyzed using MMRM.

    Measured: Baseline, Week 48

  3. DB Period: Time to First Occurrence of Any Component of the Clinical Composite Endpoint, Whichever Occurred First

    The components of the clinical composite endpoints included acute idiopathic pulmonary fibrosis (IPF) exacerbation, respiratory hospitalization, or death. 'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  4. DB Period: Time to First Acute IPF Exacerbation

    'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  5. DB Period: Time to All-Cause Mortality

    'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  6. DB Period: Time to First Respiratory Hospitalization

    'Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. For an endpoint in which less than half of the participants have encountered the events, the 'Median Time to Event' might be longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

Timeline

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

  1. First posted5 Jun 2020
  2. Study start30 Sep 2020
  3. Primary completion4 Sep 2023
  4. Study completion4 Sep 2023

Why it stopped: Sponsor Decision

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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
372 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04419558
Sponsor's protocol ID
FGCL-3019-095
Status last verified
Aug 2024
First submitted
3 Jun 2020
Last updated
12 Aug 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Pamrevlumab in people with Idiopathic Pulmonary Fibrosis, run by Kyntra Bio at 157 sites in 25 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 5 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: stopped early, as of the sponsor's last update on 12 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 157 sites in United States, China, South Korea, Italy, France and 20 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. 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 12 Aug 2024). 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?

DB Period: Change From Baseline in FVC at Week 48 (time frame: Baseline, Week 48). 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 NCT04419558.

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 12 Aug 2024.

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