A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis

NCT05032066 | Terminated Phase 2 Results DMC FDA Drug

• 2 other identifiers: HZNP-HZN-825-3032023-509784-24-00
• Study Type: interventional
• Target: 153
• Locations: 19 countries
• Sites: 82

Brief Summary

HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors:

1. 1.Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no
2. 2.Forced vital capacity (FVC) % predicted at Baseline: ≥70% or \<70%

Conditions

Idiopathic Pulmonary Fibrosis

Keywords

Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis

Outcome Measures

Primary Outcomes (2)

• Core Phase: Change in FVC % Predicted From Baseline to Week 52

  FVC was assessed using a blowing device provided by the Sponsor. The best of 3 efforts was defined as the highest FVC, obtained on any of the 3 blows meeting the ATS/ERS criteria with a maximum of 8 maneuvers. FVC % predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.

  Baseline and Week 52

• Extension Phase: Change in FVC % Predicted From OLE Baseline to Week 104

  OLE baseline was defined as the latest measurement prior to the first dose of HZN-825 in the extension phase. FVC was assessed using a blowing device provided by the Sponsor. The best of 3 efforts was defined as the highest FVC, obtained on any of the 3 blows meeting the ATS/ERS criteria with a maximum of 8 maneuvers. FVC % predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.

  OLE baseline (Week 52) and Week 104

Secondary Outcomes (9)

• Core Phase: Number of Participants With a Decline in FVC % Predicted ≥10% From Baseline at Week 52

  Baseline and Week 52

• Core Phase: Change in the 6-Minute Walk Test (6MWT) Results From Baseline to Week 52

  Baseline and Week 52

• Core Phase: Change in King's Brief Interstitial Lung Disease (K-BILD) Questionnaire Scores From Baseline to Week 52

  Baseline and Week 52

• Core Phase: Change in Living With IPF (L-IPF) Scores From Baseline to Week 52

  Baseline and Week 52

• Core Phase: Change in Leicester Cough Questionnaire (LCQ) Scores From Baseline to Week 52

  Baseline to Week 52

Study Arms (3)

HZN-825 300 mg once daily (QD)

EXPERIMENTAL

Two 150 mg oral tablets given in the morning with a meal and two matching placebo tablets given in the evening with a meal; total daily dose 300 mg HZN-825.

Drug: HZN-825

HZN-825-300 mg twice daily (BID)

EXPERIMENTAL

Two 150 mg oral tablets given in the morning with a meal and two 150 mg oral tablets given in the evening with a meal; total daily dose 600 mg HZN-825.

Drug: HZN-825

Placebo BID

PLACEBO COMPARATOR

Matching placebo tablets (2) given in the morning with a meal and matching placebo tablets (2) given in the evening with a meal; total dose 4 placebo tablets.

Drug: Placebo

Interventions

HZN-825 DRUG

Core Phase: Participants will receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally in the morning and evening with a meal for 52 weeks according to randomization schema. Extension Phase: Participants will receive open-label HZN-825 150 mg orally in the morning and evening with a meal for 52 weeks.

HZN-825 300 mg once daily (QD); HZN-825-300 mg twice daily (BID)

Placebo DRUG

Core Phase: Participants will receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally in the morning and evening with a meal for 52 weeks according to randomization schema. Extension Phase: Participants who received matching placebo in the Core Phase will receive open-label HZN-825 150 mg orally in the morning and evening with a meal for 52 weeks.

Placebo BID

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female ≥18 years of age at Screening.
• 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.
• 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.
• 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.
• 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).
• Meets all of the following criteria during the Screening Period:
• FVC ≥45% predicted of normal
• forced expiratory volume in 1 second (FEV1)/FVC ≥0.7
• Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin is ≥25% and ≤90% predicted of normal
• Estimated minimum life expectancy of ≥30 months for non-IPF-related disease, in the opinion of the Investigator.
• Vaccinations are up to date given age, comorbidities and local availability prior to trial drug dosing.
• Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial.

You may not qualify if:

• Any of the following cardiovascular diseases:
• uncontrolled, severe hypertension (≥160/100 mmHg), within 6 months of Screening
• myocardial infarction within 6 months of Screening
• unstable cardiac angina within 6 months of Screening
• 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).
• 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.
• Clinically significant pulmonary hypertension requiring chronic medical therapy.
• 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.
• Use of rifampin within 2 weeks prior to Day 1 or planned during the trial.
• Malignant condition in the past 5 years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ).
• 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.
• 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.
• 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.
• Previous enrollment in this trial or participation in a prior HZN-825 or SAR100842 clinical trial.
• Known history of positive test for human immunodeficiency virus (HIV).

Sponsors & Collaborators

• Amgen: lead

Study Sites (82)

University of Alabama at Birmingham

Birmingham, Alabama, 35233, United States

Location

Palmtree Clinical Research

Palm Springs, California, 92262, United States

Location

St. Francis Medical Institute

Clearwater, Florida, 33765, United States

Location

Central Florida Pulmonary Group PA

Orlando, Florida, 32803, United States

Location

DBC Research Corp.

Tamarac, Florida, 33321, United States

Location

GCP Clinical Research

Tampa, Florida, 33609, United States

Location

University of Kansas Medical Center

Kansas City, Kansas, 66160, United States

Location

Nebraska Pulmonary Specialties LLC

Lincoln, Nebraska, 68510, United States

Location

Dartmouth Hitchcock Medical Center

Lebanon, New Hampshire, 03756-1000, United States

Location

Stony Brook Medicine Advanced Specialty Care

Commack, New York, 11725, United States

Location

Clinical Research of Gastonia

Gastonia, North Carolina, 28054, United States

Location

Shelby Clinical Research

Shelby, North Carolina, 28150, United States

Location

Southeastern Research Center

Winston-Salem, North Carolina, 27103, United States

Location

The Cleveland Clinic Foundation

Cleveland, Ohio, 44195, United States

Location

Thomas Jefferson University

Philadelphia, Pennsylvania, 19107, United States

Location

Temple University Hospital

Philadelphia, Pennsylvania, 19140-5103, United States

Location

Clinical Research of Rock Hill

Rock Hill, South Carolina, 29732, United States

Location

Clinical Trials Center of Middle Tennessee

Franklin, Tennessee, 37067, United States

Location

Vanderbilt University Medical Center

Nashville, Tennessee, 37204, United States

Location

El Paso Pulmonary Association - Elligo

El Paso, Texas, 79902-1124, United States

Location

Metroplex Pulmonary and Sleep Medicine Center

McKinney, Texas, 75069, United States

Location

Northwestern Memorial Hospital

Milwaukee, Wisconsin, 53226-3522, United States

Location

STAT Research S.A.

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

Location

Instituto Ave Pulmo

Mar del Plata, Buenos Aires, 7600, Argentina

Location

Instituto De Enfermedades Respiratorias E Investigacion Medica

San Juan Bautista, Buenos Aires, 1888, Argentina

Location

Instituto De Patologías Respiratorias

San Miguel de Tucumán, Tucumán Province, 4000, Argentina

Location

Centro Medico Dra de Salvo

Ciudad de Buenos Aires, C1426ABP, Argentina

Location

Instituto Del Buen Aire

Santa Fe, 3000, Argentina

Location

Royal Adelaide Hospital

Adelaide, South Australia, 5000, Australia

Location

Box Hill Hospital

Box Hill, Victoria, 3128, Australia

Location

Dynamic Drug Advancement Ltd.

Ajax, Ontario, L1S 2J5, Canada

Location

St. Joseph's Healthcare Hamilton

Hamilton, Ontario, L8N 4A6, Canada

Location

Centro de Investigación Curico

Curicó, Maule Region, 3440000, Chile

Location

Centro Respiratorio Integral LTDA. (CENRESIN)

Quillota, Región de Valparaíso, 2260000, Chile

Location

Universidad de Los Andes

Las Condes, Región-MetropolitanadeSantiago, 7550000, Chile

Location

MIRES/MYF estudios cli-nicos

Ñuñoa, Región-MetropolitanadeSantiago, 7750495, Chile

Location

Enroll SpA

Providencia, Región-MetropolitanadeSantiago, 7500587, Chile

Location

Meditek Ltda

Santiago, Región-MetropolitanadeSantiago, 8330008, Chile

Location

Centro de Investigacion del Maule

Talca, 3465586, Chile

Location

Clinical Research Chile SpA

Valdivia, 8330033, Chile

Location

Hopital Nord AP-HM

Marseille, Bouches-du-Rhône, 13915, France

Location

Hopital Haut Leveque

Pessac, Gironde, 33604, France

Location

Hôpital Bretonneau

Tours, Indre-et-Loire, 37044, France

Location

Lungenklinik Hemer

Hemer, North Rhine-Westphalia, 58675, Germany

Location

University General Hospital of Patras

Pátrai, Achaïa, 265 04, Greece

Location

Evangelismos General Hospital of Athens

Athens, Attica, 10676, Greece

Location

Athens Medical Center

Marousi, Attica, 151 25, Greece

Location

University General Hospital of Heraklion

Heraklion, 711 10, Greece

Location

University General Hospital of Ioannina

Ioannina, 455 00, Greece

Location

University General Hospital of Larissa

Larissa, 411 10, Greece

Location

Presidio Ospedaliero GB Morgagni L Pierantoni

Forlì, Emilia-Romagna, 47121, Italy

Location

Azienda Ospedaliera Universitaria Senese

Siena, 53100, Italy

Location

National Hospital Organization Himeji Medical Center

Himeji-Shi, Hyôgo, 670-8520, Japan

Location

National Hospital Organization Ibarakihigashi National Hospital

Naka-Gun, Ibaraki, 319-1113, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Yokohama, Kanagawa, 235-0041, Japan

Location

Hiroshima Prefectural Hospital

Hiroshima, 734-0004, Japan

Location

Medical Hospital of Tokyo Medical and Dental University

Tokyo, 113-8519, Japan

Location

National Hospital Organization Kinki-Chuo Chest Medical Center

Sakaishi, Ôsaka, 591-8025, Japan

Location

CICUM San Miguel

Guadalajara, Jalisco, 44160, Mexico

Location

Hospital Universitario Dr. Jose Eleuterio González

Monterrey, Nuevo León, 64460, Mexico

Location

Unidad de Investigación Clínica En Medicina SC

Monterrey, Nuevo León, 64718, Mexico

Location

Oaxaca Site management Organization (OSMO)

Centro, Oaxaca, 68000, Mexico

Location

Erasmus MC

Rotterdam, 3015 GD, Netherlands

Location

Uniwersyteckie Centrum Kliniczne

Gdansk, Pomeranian Voivodeship, Poland

Location

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna

Katowice, Silesian Voivodeship, 40-752, Poland

Location

MCM Krakow - PRATIA - PPDS

Krakow, 30-510, Poland

Location

KwaPhila Health Solutions

Durban, KwaZulu-Natal, 4091, South Africa

Location

University of Cape Town Lung Institute (UCTLI)

Cape Town, Western Cape, 7700, South Africa

Location

Dr. Ismail Abdullah Private Practice

Cape Town, Western Cape, 7764, South Africa

Location

Seoul National University Bundang Hospital

Seongnam-si, Gyeonggido, 13620, South Korea

Location

Korea University Anam Hospital

Seoul, 02841, South Korea

Location

Asan Medical Center-PPDS

Seoul, 05505, South Korea

Location

Samsung Medical Center

Seoul, South Korea

Location

Hospital Universitario de Bellvitge

L'Hospitalet de Llobregat, Barcelona, 08907, Spain

Location

Hospital Universitario Quironsalud Madrid

Pozuelo de Alarcón, Madrid, 28223, Spain

Location

Hospital Universitario 12 de Octubre

Madrid, 28041, Spain

Location

Kaohsiung Medical University - Chung-Ho Memorial Hospital

Kaohsiung City, 807, Taiwan

Location

China Medical University Hospital - PPDS

Taichung, 404, Taiwan

Location

Far Eastern Memorial Hospital

Taipei, 220, Taiwan

Location

Taipei Veterans General Hospital

Taipei, Taiwan

Location

Kocaeli University Hospital

Kocaeli, 41380, Turkey (Türkiye)

Location

Connolly Hospital Blanchardstown

Liverpool, L9 7AL, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Idiopathic Pulmonary Fibrosis; Pulmonary Fibrosis

Condition Hierarchy (Ancestors)

Lung Diseases, Interstitial; Lung Diseases; Respiratory Tract Diseases; Fibrosis; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Limitations and Caveats

The trial was terminated due to not meeting primary or key secondary endpoints.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 27, 2021
• First Posted: September 2, 2021
• Study Start: January 20, 2022
• Primary Completion: July 22, 2024
• Study Completion: January 2, 2025
• Last Updated: December 3, 2025
• Results First Posted: December 3, 2025

Record last verified: 2025-11

Locations

DE (1); ES (3); JP (6); PL (3); FR (3); TW (4); ZA (3); AR (6); TU (1); IT (2); GR (6); US (22); GB (1); CA (2); AU (2); CL (8); ME (4); NL (1); KR (4)