Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Cure My Disease

Don't miss your cure!

 Log in / Sign up

Promising IPF drug trial halted midway

NCT ID NCT05032066

Disease control Sponsor: Amgen Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early This study
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Jun 27, 2026

Summary

This study tested an experimental drug called HZN-825 in people with idiopathic pulmonary fibrosis (IPF), a lung disease that causes scarring and makes breathing hard. The trial aimed to see if the drug could slow the decline in lung function over a year. About 153 adults with IPF were randomly assigned to receive one of two doses of HZN-825 or a placebo. The study was terminated early, so results are limited.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

153 people

The number who actually took part.

Started

Jan 2022

Finished

Jan 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Key Inclusion Criteria in Core Phase: 1. Male or female ≥18 years of age at Screening. 2. Current diagnosis of IPF, as defined by American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society (ALAT) guidelines and determined by central review; the date of initial diagnosis of IPF should be ≤7 years prior to Screening. 3. No recent changes or planned changes to the dose or regimen for IPF therapy, defined as: * Receiving a stable dose of IPF-approved therapy (i.e., nintedanib or pirfenidone) for a minimum of 3 months prior to Day 1 with no plans to change the background regimen during trial participation, or * Not currently receiving background IPF-approved therapy at Screening (either naïve to IPF-approved therapy or previously discontinued any IPF-approved therapy at least 4 weeks prior to Day 1 or drug-specific, 5 half-lives elimination period if longer than 4 weeks), and with no current plans to restart treatment during trial participation * Participants receiving any additional agent for IPF therapy must be on a stable regimen for at least 3 months prior to Day 1 with no current plans to change the treatment regimen during trial participation. Any previously discontinued therapy used to treat IPF must have been discontinued at least 4 weeks prior to Day 1 or 5 half-lives for that specific therapy must have elapsed, whichever is longer, with no plans to restart the therapy during trial participation. 4. Lung high-resolution computed tomography (HRCT) historically performed within 6 months prior to the Screening Visit and according to the minimum requirements for IPF diagnosis by central review based on participant's HRCT. If an evaluable HRCT is not available within 6 months prior to Screening, an HRCT will be performed at Screening to determine eligibility, according to the same requirements as the historical HRCT. 5. HRCT shows ≥10% to \<50% parenchymal fibrosis (reticulation) and the extent of fibrotic changes is greater than the extent of emphysema on the most recent HRCT scan (central reviewer determined). 6. Meets all of the following criteria during the Screening Period: 1. FVC ≥45% predicted of normal 2. forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 3. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin is ≥25% and ≤90% predicted of normal 7. Estimated minimum life expectancy of ≥30 months for non-IPF-related disease, in the opinion of the Investigator. 8. Vaccinations are up to date given age, comorbidities and local availability prior to trial drug dosing. 9. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial. Key Inclusion Criteria in Extension Phase: 1. Completed the Double-blind Treatment Period (Week 52) of the Core Phase of the trial; subjects prematurely discontinued from trial drug in the Core Phase of the trial for reasons other than safety or tolerability may be included at the discretion of the Investigator after completing scheduled visits, including Week 52 assessments. 2. Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the Extension Phase of the trial. Key Exclusion Criteria Core Phase: 1. Any of the following cardiovascular diseases: 1. uncontrolled, severe hypertension (≥160/100 mmHg), within 6 months of Screening 2. myocardial infarction within 6 months of Screening 3. unstable cardiac angina within 6 months of Screening 2. Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis and coronavirus disease 2019 \[COVID-19\]), connective tissue disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus, Sjogren's, dermatomyositis, scleroderma), exposures (e.g., radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone). 3. Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease (fungal infections of nail beds are allowed). The participant must be 3 months beyond any acute infection with COVID-19 if there has been a prior infection. 4. Clinically significant pulmonary hypertension requiring chronic medical therapy. 5. Use of any of the following therapies within 4 weeks prior to Screening, during the Screening Period or planned during the trial: prednisone at steady dose \>10 mg/day or equivalent or cyclosporine. Change in regimen or dosage of any immunosuppressant during the Screening Period through the end of trial participation will require consultation with and approval by the trial Medical Monitor. 6. Use of rifampin within 2 weeks prior to Day 1 or planned during the trial. 7. Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 8. Women of childbearing potential (WOCBP) or male subjects not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug. Females must refrain from egg/ova donation for 4 weeks after the last dose of trial drug and males must refrain from sperm donation for 3 months after the last dose of trial drug. 9. Pregnant or lactating women and women who plan to become pregnant or breast feed during the trial and within 4 weeks after the last dose of trial drug. 10. Current drug or alcohol abuse or history of either within the previous 2 years, in the opinion of the Investigator or as reported by the subject. 11. Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial. 12. Known history of positive test for human immunodeficiency virus (HIV). 13. Active hepatitis (hepatitis B: positive hepatitis B surface antigen and positive anti-hepatitis B core antibody \[anti-HBcAb\] and negative hepatitis B surface antibody \[HBsAb\] or positive for HBcAb with a positive test for HBsAb and with presence of hepatitis B virus DNA at Screening; hepatitis C: positive anti-hepatitis C virus \[anti-HCV\] and positive RNA HCV). 14. Current alcoholic liver disease, primary biliary cirrhosis or primary sclerosing cholangitis. 15. Previous organ transplant (including allogeneic and autologous marrow transplant). 16. International normalized ratio \>2, prolonged prothrombin time \>1.5 × the upper limit of normal (ULN) or partial thromboplastin time \>1.5 × ULN at Screening. 17. Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \>2.0 × ULN. 18. Estimated glomerular filtration rate \<30 mL/min/1.73 m\^2 at Screening. 19. Total bilirubin \>1.5 × ULN. Subjects with documented diagnosis of Gilbert's syndrome may be enrolled if their total bilirubin is ≤3.0 mg/dL. 20. Moderate (Child-Pugh B) to severe (Child-Pugh C) hepatic impairment according to the Child-Pugh scoring system. 21. Any confirmed Grade 3 or higher laboratory abnormality. 22. Any laboratory abnormality at Screening that, in the opinion of the Investigator, would preclude the participant's entry in the trial. 23. Exposure to an experimental drug (with the exception of HZN-825) or experimental vaccine within either 30 days, 5 half-lives of the test agent, or twice the duration of the biological effect of the test agent, whichever is the longest, prior to Day 1. 24. Any other condition that, in the opinion of the Investigator, would preclude enrollment in the trial. Key Exclusion Criteria Extension Phase: 1. Anticipated use of another investigational agent for any condition during the course of the trial. 2. New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-303 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 3. Estimated minimum life expectancy ≤18 months, in the opinion of the Investigator.

Get updates

Get notified about this study

Sign up to get updates when this study changes or when new studies for Idiopathic pulmonary fibrosis are added.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

Conditions

The condition(s) this trial relates to.

idiopathic pulmonary fibrosis pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Idiopathic pulmonary fibrosis

Contacts and locations

Locations

  • Asan Medical Center-PPDS

    Seoul, 05505, South Korea

  • Athens Medical Center

    Marousi, Attica, 151 25, Greece

  • Azienda Ospedaliera Universitaria Senese

    Siena, 53100, Italy

  • Box Hill Hospital

    Box Hill, Victoria, 3128, Australia

  • CICUM San Miguel

    Guadalajara, Jalisco, 44160, Mexico

  • Central Florida Pulmonary Group PA

    Orlando, Florida, 32803, United States

  • Centro Medico Dra de Salvo

    Ciudad de Buenos Aires, C1426ABP, Argentina

  • Centro Respiratorio Integral LTDA. (CENRESIN)

    Quillota, Valparaiso, 2260000, Chile

  • Centro de Investigacion del Maule

    Talca, 3465586, Chile

  • Centro de Investigación Curico

    Curicó, Maule Region, 3440000, Chile

  • China Medical University Hospital - PPDS

    Taichung, 404, Taiwan

  • Clinical Research Chile SpA

    Valdivia, 8330033, Chile

  • Clinical Research of Gastonia

    Gastonia, North Carolina, 28054, United States

  • Clinical Research of Rock Hill

    Rock Hill, South Carolina, 29732, United States

  • Clinical Trials Center of Middle Tennessee

    Franklin, Tennessee, 37067, United States

  • Connolly Hospital Blanchardstown

    Liverpool, L9 7AL, United Kingdom

  • DBC Research Corp.

    Tamarac, Florida, 33321, United States

  • Dartmouth Hitchcock Medical Center

    Lebanon, New Hampshire, 03756-1000, United States

  • Dr. Ismail Abdullah Private Practice

    Cape Town, Western Cape, 7764, South Africa

  • Dynamic Drug Advancement Ltd.

    Ajax, Ontario, L1S 2J5, Canada

  • El Paso Pulmonary Association - Elligo

    El Paso, Texas, 79902-1124, United States

  • Enroll SpA

    Providencia, Región-MetropolitanadeSantiago, 7500587, Chile

  • Erasmus MC

    Rotterdam, 3015 GD, Netherlands

  • Evangelismos General Hospital of Athens

    Athens, Attica, 10676, Greece

  • Far Eastern Memorial Hospital

    Taipei, 220, Taiwan

  • GCP Clinical Research

    Tampa, Florida, 33609, United States

  • Hiroshima Prefectural Hospital

    Hiroshima, 734-0004, Japan

  • Hopital Haut Leveque

    Pessac, Gironde, 33604, France

  • Hopital Nord AP-HM

    Marseille, Bouches-du-Rhône, 13915, France

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • Hospital Universitario Dr. Jose Eleuterio González

    Monterrey, Nuevo León, 64460, Mexico

  • Hospital Universitario Quironsalud Madrid

    Pozuelo de Alarcón, Madrid, 28223, Spain

  • Hospital Universitario de Bellvitge

    L'Hospitalet de Llobregat, Barcelona, 08907, Spain

  • Hôpital Bretonneau

    Tours, Indre-et-Loire, 37044, France

  • Instituto Ave Pulmo

    Mar del Plata, Buenos Aires, 7600, Argentina

  • Instituto De Enfermedades Respiratorias E Investigacion Medica

    San Juan Bautista, Buenos Aires, 1888, Argentina

  • Instituto De Patologías Respiratorias

    San Miguel de Tucumán, Tucumán Province, 4000, Argentina

  • Instituto Del Buen Aire

    Santa Fe, 3000, Argentina

  • Kanagawa Cardiovascular and Respiratory Center

    Yokohama, Kanagawa, 235-0041, Japan

  • Kaohsiung Medical University - Chung-Ho Memorial Hospital

    Kaohsiung City, 807, Taiwan

  • Kocaeli University Hospital

    Kocaeli, 41380, Turkey (Türkiye)

  • Korea University Anam Hospital

    Seoul, 02841, South Korea

  • KwaPhila Health Solutions

    Durban, KwaZulu-Natal, 4091, South Africa

  • Lungenklinik Hemer

    Hemer, North Rhine-Westphalia, 58675, Germany

  • MCM Krakow - PRATIA - PPDS

    Krakow, 30-510, Poland

  • MIRES/MYF estudios cli-nicos

    Ñuñoa, Región-MetropolitanadeSantiago, 7750495, Chile

  • Medical Hospital of Tokyo Medical and Dental University

    Tokyo, 113-8519, Japan

  • Meditek Ltda

    Santiago, Región-MetropolitanadeSantiago, 8330008, Chile

  • Metroplex Pulmonary and Sleep Medicine Center

    McKinney, Texas, 75069, United States

  • National Hospital Organization Himeji Medical Center

    Himeji-Shi, Hyôgo, 670-8520, Japan

  • National Hospital Organization Ibarakihigashi National Hospital

    Naka-Gun, Ibaraki, 319-1113, Japan

  • National Hospital Organization Kinki-Chuo Chest Medical Center

    Sakaishi, Ôsaka, 591-8025, Japan

  • Nebraska Pulmonary Specialties LLC

    Lincoln, Nebraska, 68510, United States

  • Northwestern Memorial Hospital

    Milwaukee, Wisconsin, 53226-3522, United States

  • Oaxaca Site management Organization (OSMO)

    Centro, Oaxaca, 68000, Mexico

  • PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

    Katowice, Silesian Voivodeship, 40-752, Poland

  • Palmtree Clinical Research

    Palm Springs, California, 92262, United States

  • Presidio Ospedaliero GB Morgagni L Pierantoni

    Forlì, Emilia-Romagna, 47121, Italy

  • Royal Adelaide Hospital

    Adelaide, South Australia, 5000, Australia

  • STAT Research S.A.

    Ciudad Autónoma de Buenos Aires, Buenos Aires, C1013AAB, Argentina

  • Samsung Medical Center

    Seoul, South Korea

  • Seoul National University Bundang Hospital

    Seongnam-si, Gyeonggido, 13620, South Korea

  • Shelby Clinical Research

    Shelby, North Carolina, 28150, United States

  • Southeastern Research Center

    Winston-Salem, North Carolina, 27103, United States

  • St. Francis Medical Institute

    Clearwater, Florida, 33765, United States

  • St. Joseph's Healthcare Hamilton

    Hamilton, Ontario, L8N 4A6, Canada

  • Stony Brook Medicine Advanced Specialty Care

    Commack, New York, 11725, United States

  • Taipei Veterans General Hospital

    Taipei, Taiwan

  • Temple University Hospital

    Philadelphia, Pennsylvania, 19140-5103, United States

  • The Cleveland Clinic Foundation

    Cleveland, Ohio, 44195, United States

  • Thomas Jefferson University

    Philadelphia, Pennsylvania, 19107, United States

  • Unidad de Investigación Clínica En Medicina SC

    Monterrey, Nuevo León, 64718, Mexico

  • Universidad de Los Andes

    Las Condes, Región-MetropolitanadeSantiago, 7550000, Chile

  • University General Hospital of Heraklion

    Heraklion, 711 10, Greece

  • University General Hospital of Ioannina

    Ioannina, 455 00, Greece

  • University General Hospital of Larissa

    Larissa, 411 10, Greece

  • University General Hospital of Patras

    Pátrai, Achaïa, 265 04, Greece

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35233, United States

  • University of Cape Town Lung Institute (UCTLI)

    Cape Town, Western Cape, 7700, South Africa

  • University of Kansas Medical Center

    Kansas City, Kansas, 66160, United States

  • Uniwersyteckie Centrum Kliniczne

    Gdansk, Pomeranian Voivodeship, Poland

  • Vanderbilt University Medical Center

    Nashville, Tennessee, 37204, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.