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

PHASE2TerminatedINTERVENTIONAL
Enrollment

153

Participants

Timeline

Start Date

August 25, 2021

Primary Completion Date

July 22, 2024

Study Completion Date

January 2, 2025

Conditions
Idiopathic Pulmonary Fibrosis
Interventions
DRUG

HZN-825

"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."

DRUG

Placebo

"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."

Trial Locations (82)

220

Far Eastern Memorial Hospital, Taipei

404

China Medical University Hospital - PPDS, Taichung

807

Kaohsiung Medical University - Chung-Ho Memorial Hospital, Kaohsiung City

1888

Instituto De Enfermedades Respiratorias E Investigacion Medica, San Juan Bautista

3000

Instituto Del Buen Aire, Santa Fe

3128

Box Hill Hospital, Box Hill

4000

Instituto De Patologías Respiratorias, San Miguel de Tucumán

4091

KwaPhila Health Solutions, Durban

5000

Royal Adelaide Hospital, Adelaide

7600

Instituto Ave Pulmo, Mar del Plata

7700

University of Cape Town Lung Institute (UCTLI), Cape Town

7764

Dr. Ismail Abdullah Private Practice, Cape Town

10676

Evangelismos General Hospital of Athens, Athens

11725

Stony Brook Medicine Advanced Specialty Care, Commack

13620

Seoul National University Bundang Hospital, Seongnam-si

13915

Hopital Nord AP-HM, Marseille

19107

Thomas Jefferson University, Philadelphia

27103

Southeastern Research Center, Winston-Salem

28041

Hospital Universitario 12 de Octubre, Madrid

28054

Clinical Research of Gastonia, Gastonia

28150

Shelby Clinical Research, Shelby

28223

Hospital Universitario Quironsalud Madrid, Pozuelo de Alarcón

29732

Clinical Research of Rock Hill, Rock Hill

32803

Central Florida Pulmonary Group PA, Orlando

33321

DBC Research Corp., Tamarac

33604

Hopital Haut Leveque, Pessac

33609

GCP Clinical Research, Tampa

33765

St. Francis Medical Institute, Clearwater

35233

University of Alabama at Birmingham, Birmingham

37044

Hôpital Bretonneau, Tours

37067

Clinical Trials Center of Middle Tennessee, Franklin

37204

Vanderbilt University Medical Center, Nashville

41380

Kocaeli University Hospital, Kocaeli

44160

CICUM San Miguel, Guadalajara

44195

The Cleveland Clinic Foundation, Cleveland

47121

Presidio Ospedaliero GB Morgagni L Pierantoni, Forlì

53100

Azienda Ospedaliera Universitaria Senese, Siena

58675

Lungenklinik Hemer, Hemer

64460

Hospital Universitario Dr. Jose Eleuterio González, Monterrey

64718

Unidad de Investigación Clínica En Medicina SC, Monterrey

66160

University of Kansas Medical Center, Kansas City

68000

Oaxaca Site management Organization (OSMO), Centro

68510

Nebraska Pulmonary Specialties LLC, Lincoln

75069

Metroplex Pulmonary and Sleep Medicine Center, McKinney

92262

Palmtree Clinical Research, Palm Springs

2260000

Centro Respiratorio Integral LTDA. (CENRESIN), Quillota

3440000

Centro de Investigación Curico, Curicó

3465586

Centro de Investigacion del Maule, Talca

7500587

Enroll SpA, Providencia

7550000

Universidad de Los Andes, Las Condes

7750495

MIRES/MYF estudios cli-nicos, Ñuñoa

8330008

Meditek Ltda, Santiago

8330033

Clinical Research Chile SpA, Valdivia

03756-1000

Dartmouth Hitchcock Medical Center, Lebanon

19140-5103

Temple University Hospital, Philadelphia

79902-1124

El Paso Pulmonary Association - Elligo, El Paso

53226-3522

Northwestern Memorial Hospital, Milwaukee

C1013AAB

STAT Research S.A., Ciudad Autónoma de Buenos Aires

C1426ABP

Centro Medico Dra de Salvo, Ciudad de Buenos Aires

L1S 2J5

Dynamic Drug Advancement Ltd., Ajax

L8N 4A6

St. Joseph's Healthcare Hamilton, Hamilton

265 04

University General Hospital of Patras, Pátrai

151 25

Athens Medical Center, Marousi

711 10

University General Hospital of Heraklion, Heraklion

455 00

University General Hospital of Ioannina, Ioannina

411 10

University General Hospital of Larissa, Larissa

670-8520

National Hospital Organization Himeji Medical Center, Himeji-Shi

319-1113

National Hospital Organization Ibarakihigashi National Hospital, Naka-Gun

235-0041

Kanagawa Cardiovascular and Respiratory Center, Yokohama

734-0004

Hiroshima Prefectural Hospital, Hiroshima

113-8519

Medical Hospital of Tokyo Medical and Dental University, Tokyo

591-8025

National Hospital Organization Kinki-Chuo Chest Medical Center, Sakaishi

3015 GD

Erasmus MC, Rotterdam

Unknown

Uniwersyteckie Centrum Kliniczne, Gdansk

Samsung Medical Center, Seoul

Taipei Veterans General Hospital, Taipei

40-752

PULMAG Grzegorz Gasior Marzena Kociolek Spolka Cywilna, Katowice

30-510

MCM Krakow - PRATIA - PPDS, Krakow

02841

Korea University Anam Hospital, Seoul

05505

Asan Medical Center-PPDS, Seoul

08907

Hospital Universitario de Bellvitge, L'Hospitalet de Llobregat

L9 7AL

Connolly Hospital Blanchardstown, Liverpool

Sponsors

Lead Sponsor

All Listed Sponsors
lead

Amgen

INDUSTRY

NCT05032066 - A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis | Biotech Hunter | Biotech Hunter