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Idiopathic Pulmonary FibrosisPhase 3NCT03955146

Zephyrus I: Evaluation of Efficacy and Safety 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 125 sites in 9 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 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
393 participants
Where
125 sitesin 9 countries
Study dates
18 Jun 2019to 28 Aug 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 (ATS)/European Respiratory Society (ERS)/Japan Radiological Society (JRS)/Latin American Thoracic Association (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 and corrected by hemoglobin (Hb) value ≥25% and ≤90% at screening (determined locally).
  • Not currently receiving treatment for IPF with an approved therapy (that is, 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.
  • 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
  • History of other types of respiratory diseases including diseases or disorders of the airways, lung parenchyma, pleural space, mediastinum, diaphragm, or chest wall.
  • Medical conditions (for example, myocardial infarction [MI]/stroke within the past 6 month), or logistical challenges that in the opinion of the Investigator preclude the participant's adequate participation in the study.
  • Acute IPF exacerbation during screening or randomization.
  • 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 (that is, 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

125 sites in 9 countries.

125 sites in 9 countries

United States60 sites

  • Albany Medical College

    Albany, New York, 12208

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Emory University

    Atlanta, Georgia, 30322

  • University of Colorado Denver

    Aurora, Colorado, 80045

  • Piedmont Healthcare, Inc.

    Austell, Georgia, 30106

  • University of Maryland, Baltimore

    Baltimore, Maryland, 21201

  • University of Alabama at Birmingham Hospital

    Birmingham, Alabama, 35294

  • The University of Vermont

    Burlington, Vermont, 05405

  • Lowcountry Lung and Critical Care, PA

    Charleston, South Carolina, 29406

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • The Lung Research Center, LLC

    Chesterfield, Missouri, 63017

  • Northwestern University

    Chicago, Illinois, 60612

  • University of Cincinnati

    Cincinnati, Ohio, 45267

  • St. Francis Medical Center

    Clearwater, Florida, 33765

  • Ohio State University

    Columbus, Ohio, 43221

  • J&L Research

    Conway, Arkansas, 72032

  • Houston Pulmonary Sleep, Allergy and Asthma Associates

    Cypress, Texas, 77429

  • Baylor Scott and White Research Institute

    Dallas, Texas, 75246

  • University of Texas Southwestern Medical Center

    Dallas, Texas, 75390

  • National Jewish Health

    Denver, Colorado, 80207

  • Henry Ford Hospital

    Detroit, Michigan, 48202

  • University of Florida Pulmonary, Critical Care & Sleep Medicine Division

    Gainesville, Florida, 32610

  • Spectrum Health

    Grand Rapids, Michigan, 49546

  • Pulmonix, LLC

    Greensboro, North Carolina, 27403

  • Tennessee Comprehensive Lung and Sleep Center

    Hendersonville, Tennessee, 37075

  • Penn State Milton S. Hershey Medical Center

    Hershey, Pennsylvania, 17033

  • Baylor College of Medicine

    Houston, Texas, 77030

  • University of Texas - Houston

    Houston, Texas, 77030

  • Indiana University School of Medicine

    Indianapolis, Indiana, 46202

  • University of Florida Health, Jacksonville

    Jacksonville, Florida, 32209

  • Mayo Clinic

    Jacksonville, Florida, 32224

  • The University of Kansas Medical Center

    Kansas City, Kansas, 66160

  • Pulmonary Disease Specialist, PA d/b/a, PDS Research

    Kissimmee, Florida, 34741

  • Dartmouth-Hitchcock Medical Center

    Lebanon, New Hampshire, 03756

  • Pulmonary Health Physicians, PC

    Liverpool, New York, 13088

  • Loma Linda University Health

    Loma Linda, California, 92354

  • David Geffen School of Medicine at UCLA

    Los Angeles, California, 90095

  • Loyola University of Chicago

    Maywood, Illinois, 60153

  • Medical College of Wisconsin

    Milwaukee, Wisconsin, 53226

  • University of Minnesota

    Minneapolis, Minnesota, 55455

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204

  • Yale University School of Medicine

    New Haven, Connecticut, 06510

  • INTEGRIS Baptist Medical Center

    Oklahoma City, Oklahoma, 73112

  • Temple University

    Philadelphia, Pennsylvania, 19140

  • Banner University Medical Center - Phoenix

    Phoenix, Arizona, 85006

  • Norton Thoracic Institute

    Phoenix, Arizona, 85013

  • Pulmonary Associates, PA - Research

    Phoenix, Arizona, 85032

  • Legacy Research Institute

    Portland, Oregon, 97210

  • The Oregon Clinic

    Portland, Oregon, 97220

  • Rhode Island Hospital

    Providence, Rhode Island, 02903

  • UC Davis Medical Center

    Sacramento, California, 95817

  • University of Utah Health

    Salt Lake City, Utah, 84108

  • UT Health San Antonio

    San Antonio, Texas, 78229

  • University of California San Diego

    San Diego, California, 92103

  • University of Washington

    Seattle, Washington, 98195

  • Stanford University Medical Center

    Stanford, California, 94305

  • University of South Florida

    Tampa, Florida, 33606

  • Renovatio Clinical

    The Woodlands, Texas, 77380

  • University of Arizona

    Tucson, Arizona, 85724

  • Medstar Georgetown University Hospital

    Washington D.C., District of Columbia, 20007

Other trials in United States

China22 sites

  • BeiJing Chao-Yang Hospital,Capital medical university

    Beijing, Beijing Municipality, 100020

  • China-Japan friendship hospital

    Beijing, Beijing Municipality, 100029

  • Peking Union Medical College Hospital

    Beijing, Beijing Municipality, 100730

  • The Second Xiangya Hospital of Central South University

    Changsha, Hunan, 410011

  • Huaxi Hospital of Sichuan University.

    Chengdu, Sichuan, 6100141

  • The second hospital of Dalian medical university

    Dalian, Liaoning, 116001

  • Nanfang Hospital of Southern Medical University

    Guangzhou, Guangdong, 510000

  • The First Affiliated Hospital of Guangzhou Medical University

    Guangzhou, Guangdong, 510120

  • Hangzhou First People's Hospital

    Hangzhou, Zhejiang, 310006

  • Second Affiliated Hospital of Anhui Medical University

    Hefei, Anhui, 230000

  • Affiliated Hospital of Inner Mongolia Medical University

    Hohhot, Inner Mongolia, 10010

  • People's Hospital of Inner Mongolia Autonomous Region

    Hohhot, Inner Mongolia, 10020

  • Ruijin Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

    Shanghai, Shanghai Municipality, 200025

  • The First Hospital of China Medical University

    Shenyang, Liaoning, 110001

  • Shenzhen people's hospital

    Shenzhen, Guangdong, 518020

  • General Hospital of Tianjin Medical University

    Tianjin, Tianjin Municipality, 300052

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

    Wuhan, Hubei, 430022

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

    Wuhan, Hubei, 430022

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi, 710004

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia, 750004

  • Henan Provincial People's Hospital

    Zhengzhou, Henan, 450000

  • Henan Provincial chest hospital

    Zhengzhou, Henan, 450003

Other trials in China

Russia10 sites

  • Regional Clinical Hospital #3

    Chelyabinsk, 454106

  • Kazan State Medical University based on Republican Clinical Hospital

    Kazan', 420029

  • Clinical Hospital #3

    Kemerovo, 650000

  • Euromedservice, Clinical and Diagnostic Center

    Moscow, 115419

  • MONIKI

    Moscow, 129110

  • City Clinical Hospital #1 n.a. A.N. Kabanov

    Omsk, 644112

  • Vvedenskaya hospital

    Saint Petersburg, 191180

  • Medical Center "Reavita Med SPb"

    Saint Petersburg, 194354

  • FSBEI HE First Pavlov Medical University

    Saint Petersburg, 197022

  • Medical Association "NEW HOSPITAL"

    Yekaterinburg, 620109

Other trials in Russia

South Korea10 sites

  • Soonchunhyang University Bucheon Hospital

    Bucheon-si, Gyeonggi-do, 14579

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

    Bucheon-si, Gyeonggi-do, 14647

  • Inje University Busan Paik Hospital

    Busan, 47392

  • Gachon University Gil Medical Center

    Incheon, 21565

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggi-do, 13620

  • Korea University Anam Hospital

    Seoul, 2841

  • Seoul National University Hospital

    Seoul, 3080

  • Asan Medical Center

    Seoul, 5505

  • Samsung Medical Centerx

    Seoul, 6351

  • Ajou University Hospital

    Suwon, Gyeonggi-do, 16499

Other trials in South Korea

Argentina9 sites

  • Centro de Investigacion Metabolica 'CINME'

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1027AAP

  • Consultorios Medicos. Organización del Buen Ayre. SRL

    Ciudad Autonoma de Buenos Aires, Buenos Aires, C1425FVH

  • Fundacion Respirar - Centro Médico Dra. De Salvo

    Ciudad Autonoma de Buenos Aires (caba), Buenos Aires, 1426

  • Centro Medico de Enfermedades Respiratorias

    Florida, Buenos Aires, B1602DQD

  • Respira Salud Clinica Integral

    Godoy Cruz, Mendoza Province, M5501GCA

  • Centro Platense en Investigaciones Respiratorias

    La Plata, Buenos Aires, 1900

  • Instituto ave Pulmo Fundacion enfisema

    Mar del Plata, Buenos Aires, B7602DCK

  • INSARES

    Mendoza, Mendoza Province, M5500CCG

  • Investigaciones en Patologias Respiratorias

    San Miguel de Tucumán, Tucumán Province, T4000IAR

Other trials in Argentina

Australia6 sites

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000

  • Box Hill Hospital

    Box Hill, Victoria, 3128

  • The Alfred Hospital

    Melbourne, Victoria, 3004

  • Mater Health Services Adult Hospital

    South Brisbane, Queensland, 4101

  • Royal Prince Alfred Hospital

    Sydney, New South Wales, 2050

  • Westmead Hospital

    Westmead, New South Wales, 2145

Other trials in Australia

Chile4 sites

  • Instituto Nacional del Torax

    Santiago, Santiago Metropolitan, 7500691

  • CIMER

    Santiago, Santiago Metropolitan, 7500692

  • M y F estudios clinicos

    Santiago, Santiago Metropolitan, 7750495

  • Centro Investigacion del Maule CIM

    Talca, Maule Region, 3465586

Other trials in Chile

Hong Kong2 sites

  • Queen Mary Hospital

    Central

  • Tuen Mun Hospital

    Hong Kong

Other trials in Hong Kong

Taiwan2 sites

  • Taichung Veterans General Hospital

    Taichung, 40705

  • Taipei Medical University - Shuang-Ho Hospital, Ministry of Health and Welfare

    Taipei, 23561

Other trials in Taiwan

About this study

Official title: 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 IPF.

Read the detailed description

This is a Phase 3, randomized, double-blind, placebo-controlled, multi-center trial to evaluate the efficacy and safety of pamrevlumab 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.

The study consists of the following study periods:

  • Main (double blind, placebo-controlled) phase:
  • Screening period: Up to 6 weeks
  • Treatment period: 48 weeks
  • Optional, open-label extension (OLE) phase of pamrevlumab:
  • Access to pamrevlumab will be available until the last participant completes 48 weeks of treatment in the OLE phase, or pamrevlumab is commercially available for the indication of IPF, or the Sponsor decides to end the OLE phase, whichever occurs first.
  • Follow-up period/final safety assessments:
  • 28 days after last dose
  • 60 days after last dose: follow-up phone call, for a final safety assessment

During the treatment period, co-administration of an approved IPF therapy (that is, pirfenidone or nintedanib) is acceptable if clinically indicated in the Investigator's opinion, provided that the Investigator assesses the potential risks/benefits of combining approved IPF therapies with blinded study treatment.

Participants who discontinue study treatment for any reason should be encouraged to remain in the study and be followed for all study visits and assessments.

Participants who complete the Week 48 visit of the main study (regardless of the number of study drug infusions received) will be eligible to participate in the optional OLE phase of the study that offers continuing access to pamrevlumab regardless of randomization assignment in the main study.

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

    Pamrevlumab will be administered per dose and schedule specified in the arm description.

  • PlaceboDrug

    Placebo matching to pamrevlumab will be administered per schedule specified in the arm description.

Study groups in NCT03955146
Study groupRoleWhat they receive
Main Study Cohort: PamrevlumabExperimentalParticipants will receive pamrevlumab 30 milligrams (mg)/kilogram (kg) by intravenous (IV) infusion every 3 weeks for up to 48 weeks in the DB period.
Receives: Drug: Pamrevlumab
Main Study Cohort: PlaceboPlacebo comparatorParticipants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks in the DB period.
Receives: Drug: Placebo
Japan Extension Cohort: PamrevlumabExperimentalParticipants will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks.
Receives: Drug: Pamrevlumab
Japan Extension Cohort: PlaceboPlacebo comparatorParticipants will receive placebo matching to pamrevlumab by IV infusion every 3 weeks for up to 48 weeks.
Receives: Drug: Placebo
OLE Period: Pamrevlumab/PamrevlumabExperimentalParticipants who receive pamrevlumab in the DB period will continue to receive the same dose of pamrevlumab for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Receives: Drug: Pamrevlumab
OLE Period: Placebo/PamrevlumabExperimentalParticipants who receive placebo matching to pamrevlumab in the DB period, will receive pamrevlumab 30 mg/kg by IV infusion every 3 weeks for up to 48 weeks in the OLE period or until pamrevlumab is commercially available for the indication of IPF, or the sponsor decides to end the OLE period, whichever occurrs first.
Receives: Drug: Pamrevlumab

What is being measured

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

  1. DB Period (Main Study Cohort): 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 could forcibly be blown out after full inspiration in the upright position, measured in liters. Least square (LS) mean and standard error (SE) were calculated using mixed model for repeated measures (MMRM).

    Measured: Baseline, Week 48

  2. DB Period (Japan Extension Cohort): 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 could forcibly be blown out after full inspiration in the upright position, measured in liters.

    Measured: Baseline, Week 48

Secondary outcomes (6)

  1. DB Period (Main Study Cohort): Time to Disease Progression

    Time to disease progression was defined as the number of weeks from randomization to either the first occurrence of an absolute ≥10% decline from baseline in percent predicted FVC (FVCpp) or all-cause death, whichever occurred first. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  2. DB Period (Main Study Cohort): Time to First Occurrence of Any Component of the Clinical Composite Endpoint

    The components of the clinical composite endpoint included acute IPF exacerbation, respiratory hospitalization, or death. Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  3. DB Period (Main Study Cohort and Japan Extension Cohort): Change From Baseline in Quantitative Lung Fibrosis (QLF) Volume at Week 48

    The QLF volume was calculated as QLF = total lung capacity volume multiplied by percentage (%) of quantitative lung fibrosis for fibrosis of the whole lung. LS mean and SE was calculated using MMRM.

    Measured: Baseline, Week 48

  4. DB Period (Main Study Cohort): Time to First Acute IPF Exacerbation

    Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  5. DB Period (Main Study Cohort): Time to All-Cause Mortality

    Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is longer than the reported timeframe of 48 weeks.

    Measured: Up to Week 48

  6. DB Period (Main Study Cohort): Time to First Respiratory Hospitalizations

    Median Time to Event' is an estimated value, which was calculated based on Kaplan-Meier method. Hence, the 'Median Time to Event' is 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 posted17 May 2019
  2. Study start18 Jun 2019
  3. Primary completion20 Mar 2023
  4. Study completion28 Aug 2023

Why it stopped: Study did not meet its primary endpoint.

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
393 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03955146
Sponsor's protocol ID
FGCL-3019-091
Status last verified
Sep 2024
First submitted
16 May 2019
Last updated
19 Sep 2024
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • Raghu G, Richeldi L, Fernandez Perez ER, De Salvo MC, Silva RS, Song JW, Ogura T, Xu ZJ, Belloli EA, Zhang X, Seid LL, Poole L; ZEPHYRUS-1 Study Investigators. Pamrevlumab for Idiopathic Pulmonary Fibrosis: The ZEPHYRUS-1 Randomized Clinical Trial. JAMA. 2024 Aug 6;332(5):380-389. doi: 10.1001/jama.2024.8693.

    PubMed 38762797

  • Rayego-Mateos S, Morgado-Pascual JL, Lavoz C, Rodrigues-Diez RR, Marquez-Exposito L, Tejera-Munoz A, Tejedor-Santamaria L, Rubio-Soto I, Marchant V, Ruiz-Ortega M. CCN2 Binds to Tubular Epithelial Cells in the Kidney. Biomolecules. 2022 Feb 3;12(2):252. doi: 10.3390/biom12020252.

    PubMed 35204752

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 125 sites in 9 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 19 Sep 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 125 sites in United States, China, Russia, South Korea, Argentina and 4 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

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

Are results available for this study?

Yes. Results are posted in the registry (first posted 19 Sep 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 (Main Study Cohort): Change From Baseline in FVC at Week 48 (time frame: Baseline, Week 48). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03955146, 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 19 Sep 2024.

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