An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Study Purpose

Primary Objectives: 1. The primary efficacy objective is to assess the efficacy of 52 weeks of open-label treatment with HZN-825 in participants with diffuse cutaneous systemic sclerosis, as measured by change from both baselines in forced vital capacity percent (FVC %) predicted. 2. The primary safety objective is to examine the safety and tolerability of 52 weeks of open-label treatment with HZN-825, inclusive of, but not limited to, adverse events (AEs), serious AEs (SAEs) and the adverse event of special interest (AESI), from Day 1 to 4 weeks after last dose.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

Interventional
Eligible Ages 18 Years - 75 Years
Gender All
More Inclusion & Exclusion Criteria

Key

Inclusion Criteria:

1. Completed the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301; participants prematurely discontinued from trial drug in Trial HZNP-HZN-825-301 for reasons other than safety or toxicity can be included at the discretion of the Investigator after completing Trial HZNP-HZN-825-301 scheduled visits, including Week 52 assessments. Key

Exclusion Criteria:

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-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ). 3. Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol. 4. Any new development with the participant's disease or condition or any significant laboratory test abnormality during the course of Trial HZNP-HZN-825-301 that, in the opinion of the Investigator, would potentially put the subject at unacceptable risk. 5. Pregnant or lactating women. 6. Participants will be ineligible if, in the opinion of the Investigator, they are unlikely to comply with the trial protocol or have a concomitant disease or condition that could interfere with the conduct of the trial.

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

NCT05626751
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

Amgen
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

MD
Principal Investigator Affiliation Amgen
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

Industry
Overall Status Enrolling by invitation
Countries Argentina, Chile, Greece, Israel, Italy, Japan, Korea, Republic of, Mexico, Poland, Portugal, Romania, Serbia, Spain, United Kingdom, United States
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
Study Website: View Trial Website
Additional Details

This is an open-label, repeat-dose, multicenter extension trial of HZNP-HZN-825-301. Participants who complete the double-blind Treatment Period (Week 52) in Trial HZNP-HZN-825-301 will be eligible to enter this 52-week extension trial. Participants entering this extension trial will complete the Week 52 Visit activities in HZNP-HZN-825-301 and will not complete the Safety Follow-up Visit 4 weeks after the last dose of trial drug in HZNP-HZN-825-301. Acquired from Horizon in 2024.

Arms & Interventions

Arms

Experimental: HZN-825

HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks

Interventions

Drug: - HZN-825

HZN-825 will be administered BID for 52 weeks

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

Phoenix, Arizona

Status

Address

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, 85032-9306

UCLA Medical Center, Los Angeles, California

Status

Address

UCLA Medical Center

Los Angeles, California, 90095-8344

Miami, Florida

Status

Address

University of Miami Miller School of Medicine

Miami, Florida, 33136-1005

IRIS Research and Development LLC, Plantation, Florida

Status

Address

IRIS Research and Development LLC

Plantation, Florida, 33324-2736

New Orleans, Louisiana

Status

Address

DelRicht Clinical Research, LLC - Internal - Covington - PPDS

New Orleans, Louisiana, 70115-3584

Boston University School Of Medicine, Boston, Massachusetts

Status

Address

Boston University School Of Medicine

Boston, Massachusetts, 02118-2642

Michigan Medicine University of Michigan, Ann Arbor, Michigan

Status

Address

Michigan Medicine University of Michigan

Ann Arbor, Michigan, 48109-5000

Rochester, Minnesota

Status

Address

Mayo Clinic - Cancer Center - Rochester - PPDS

Rochester, Minnesota, 55905

Duke University Medical Center, Durham, North Carolina

Status

Address

Duke University Medical Center

Durham, North Carolina, 27710-3037

Charleston, South Carolina

Status

Address

Medical University of South Carolina (MUSC) - PPDS

Charleston, South Carolina, 29425-8900

UT Physicians Rheumatology, Houston, Texas

Status

Address

UT Physicians Rheumatology

Houston, Texas, 77030-5400

International Sites

Framingham Centro Médico, La Plata, Buenos Aires, Argentina

Status

Address

Framingham Centro Médico

La Plata, Buenos Aires, B1900

Consultorio Médico Dra. Rivera, Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

Status

Address

Consultorio Médico Dra. Rivera

Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, C1426

San Miguel De Tucumán, Tucumán, Argentina

Status

Address

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel De Tucumán, Tucumán, T4000AXL

Centro de Investigaciones Reumatológicas, San Miguel De Tucumán, Tucumán, Argentina

Status

Address

Centro de Investigaciones Reumatológicas

San Miguel De Tucumán, Tucumán, T4000AXL

Clínica Mayo de U.M.C.B. S.R.L, San Miguel De Tucumán, Tucumán, Argentina

Status

Address

Clínica Mayo de U.M.C.B. S.R.L

San Miguel De Tucumán, Tucumán, T4000IHE

Ciudad Autónoma de Buenos Aires, Argentina

Status

Address

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Ciudad Autónoma de Buenos Aires, , C1406AGA

Clínica Adventista Belgrano, Cuiudad Autónoma De Buenos Aires, Argentina

Status

Address

Clínica Adventista Belgrano

Cuiudad Autónoma De Buenos Aires, , C1430EGF

I.R. Medical Center - Hospital de Dia, Mendoza, Argentina

Status

Address

I.R. Medical Center - Hospital de Dia

Mendoza, , M5500CPH

Prosalud y Cia Ltda., Santiago, Región-MetropolitanadeSantiago, Chile

Status

Address

Prosalud y Cia Ltda.

Santiago, Región-MetropolitanadeSantiago, 7510047

Laiko General Hospital of Athens, Athens, Attiki, Greece

Status

Address

Laiko General Hospital of Athens

Athens, Attiki, 115 27

Euromedica Kianous Stavros, Thessaloniki, Greece

Status

Address

Euromedica Kianous Stavros

Thessaloniki, , 546 36

Thessaloniki, Greece

Status

Address

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, , 546 42

The Chaim Sheba Medical Center - PPDS, Ramat Gan, Tel-Aviv, Israel

Status

Address

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Tel-Aviv, 52621

Tel Aviv-Yafo, Tel-Aviv, Israel

Status

Address

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv-Yafo, Tel-Aviv, 64239

Rambam Health Care Campus - PPDS, Haifa, Israel

Status

Address

Rambam Health Care Campus - PPDS

Haifa, , 31096

Rabin Medical Center - PPDS, Petah Tiqva, Israel

Status

Address

Rabin Medical Center - PPDS

Petah Tiqva, , 4910000

Udine, Friuli-Venezia Giulia, Italy

Status

Address

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia

Udine, Friuli-Venezia Giulia, 33100

Hokkaido University Hospital, Sapporo-Shi, Hokkaidô, Japan

Status

Address

Hokkaido University Hospital

Sapporo-Shi, Hokkaidô, 060-848

Sapporo Medical University Hospital, Sapporo, Hokkaidô, Japan

Status

Address

Sapporo Medical University Hospital

Sapporo, Hokkaidô, 060-8543

Nagasaki University Hospital, Nagasaki-Shi, Nagasaki, Japan

Status

Address

Nagasaki University Hospital

Nagasaki-Shi, Nagasaki, 852-8102

Saitama Medical University Hospital, Iruma-Gun, Saitama, Japan

Status

Address

Saitama Medical University Hospital

Iruma-Gun, Saitama, 350-0495

Juntendo University Hospital, Bunkyo-Ku, Tokyo, Japan

Status

Address

Juntendo University Hospital

Bunkyo-Ku, Tokyo, 113-8431

Nippon Medical School Hospital, Bunkyo-Ku, Tokyo, Japan

Status

Address

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo, 113-8603

Takatsuki-Shi, Ôsaka, Japan

Status

Address

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-Shi, Ôsaka, 569-8686

Chonnam National University Hospital, Gwangju, Gwangju Gwang'yeogsi, Korea, Republic of

Status

Address

Chonnam National University Hospital

Gwangju, Gwangju Gwang'yeogsi, 61469

Seongnam, Gyeonggido, Korea, Republic of

Status

Address

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 13620

Hanyang University Seoul Hospital, Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of

Status

Address

Hanyang University Seoul Hospital

Seongdong-gu, Seoul Teugbyeolsi, 04763

Seoul, Korea, Republic of

Status

Address

Gangnam Severance Hospital, Yonsei University Health System

Seoul, , 06273

Mexico City, Distrito Federal, Mexico

Status

Address

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Distrito Federal, 14000

San Miguel Chapultepec, Distrito Federal, Mexico

Status

Address

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel Chapultepec, Distrito Federal, 11850

Guadalajara, Jalisco, Mexico

Status

Address

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco, 44690

Centro Integral Reumatologia SA de CV, Guadalajara, Jalisco, Mexico

Status

Address

Centro Integral Reumatologia SA de CV

Guadalajara, Jalisco, ZC 44160

Burócratas del Estado, San Luis Potosí, Mexico

Status

Address

Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

Burócratas del Estado, San Luis Potosí, 78213

Guadalajara, Mexico

Status

Address

Clinica de Investigacion en Reumatologia y Obesidad

Guadalajara, , 44600

Merida, Mexico

Status

Address

Unidad de Atencion Medica e Investigacion en Salud

Merida, , 97000

Mexico, Mexico

Status

Address

CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV

Mexico, , 6700

Twoja Przychodnia NCM, Nowa Sól, Lubuskie, Poland

Status

Address

Twoja Przychodnia NCM

Nowa Sól, Lubuskie, 67-100

Malopolskie Centrum Kliniczne, Kraków, Malopolskie, Poland

Status

Address

Malopolskie Centrum Kliniczne

Kraków, Malopolskie, 30-149

Warszawa, Mazowieckie, Poland

Status

Address

Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS

Warszawa, Mazowieckie, 00-874

Centrum Medyczne Reuma Park NZOZ, Warszawa, Mazowieckie, Poland

Status

Address

Centrum Medyczne Reuma Park NZOZ

Warszawa, Mazowieckie, 02-665

Lisboa, Portugal

Status

Address

Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS

Lisboa, , 1649-035

Sf.Maria Clinical Hospital, Bucharest, Bucuresti, Romania

Status

Address

Sf.Maria Clinical Hospital

Bucharest, Bucuresti, 011172

Dr I Cantacuzino Clinical Hospital, Bucharest, Bucuresti, Romania

Status

Address

Dr I Cantacuzino Clinical Hospital

Bucharest, Bucuresti, 20475

Brasov, Romania

Status

Address

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

Brasov, , 500283

Institute of Rheumatology - PPDS, Belgrade, Serbia

Status

Address

Institute of Rheumatology - PPDS

Belgrade, , 11000

Niška Banja, Serbia

Status

Address

Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, , 708120

Santander, Cantabria, Spain

Status

Address

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008

Hospital Universitario A Coruña, a Coruña, Spain

Status

Address

Hospital Universitario A Coruña

a Coruña, , 15006

Barcelona, Spain

Status

Address

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, , 08035

Hospital de La Santa Creu i Sant Pau, Barcelona, Spain

Status

Address

Hospital de La Santa Creu i Sant Pau

Barcelona, , 08041

Madrid, Spain

Status

Address

Hospital General Universitario Gregorio Marañon

Madrid, , 28009

Hospital Quironsalud Infanta Luisa, Sevilla, Spain

Status

Address

Hospital Quironsalud Infanta Luisa

Sevilla, , 41010

Hospital Universitario Doctor Peset, Valencia, Spain

Status

Address

Hospital Universitario Doctor Peset

Valencia, , 46017

Royal Free Hospital, London, London, City Of, United Kingdom

Status

Address

Royal Free Hospital

London, London, City Of, NW3 2QG