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, France, Greece, Israel, Japan, Korea, Republic of, Mexico, Spain, United States
Conditions

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

Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
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.

IRIS Research and Development LLC, Plantation, Florida

Status

Address

IRIS Research and Development LLC

Plantation, Florida, 33324

DelRicht Clinical Research, LLC, New Orleans, Louisiana

Status

Address

DelRicht Clinical Research, LLC

New Orleans, Louisiana, 70115

Michigan Medicine University of Michigan, Ann Arbor, Michigan

Status

Address

Michigan Medicine University of Michigan

Ann Arbor, Michigan, 48109-5000

Charleston, South Carolina

Status

Address

Medical University of South Carolina - PPDS

Charleston, South Carolina, 29425-8900

Metroplex Clinical Research Center, Dallas, Texas

Status

Address

Metroplex Clinical Research Center

Dallas, Texas, 75231-4345

UT Physicians Rheumatology, Houston, Texas

Status

Address

UT Physicians Rheumatology

Houston, Texas, 77030

International Sites

Clínica Adventista Belgrano, Cuiudad Autónoma De, Buenos Aires, Argentina

Status

Address

Clínica Adventista Belgrano

Cuiudad Autónoma De, Buenos Aires, C1430EGF

Framingham Centro Médico, La Plata, Buenos Aires, Argentina

Status

Address

Framingham Centro Médico

La Plata, Buenos Aires, B1900

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

Status

Address

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, C1406AGA

San Miguel De Tucumán, Tucumán, Argentina

Status

Address

Centro de Investigaciones Médicas Tucumán

San Miguel De Tucumán, Tucumán, T4000AXL

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

Status

Address

Centro de Investigaciones Reumatologicas

San Miguel De Tucumán, Tucumán, T4000AXL

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

Status

Address

Clinica Mayo de U.M.C.B. S.R.L

San Miguel De Tucumán, Tucumán, T4000IHE

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

Status

Address

I.R. Medical Center - Hospital de Dia

Mendoza, , M5500CPH

Bordeaux, Gironde, France

Status

Address

Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin

Bordeaux, Gironde, 33000

Hopital Cochin, Paris, France

Status

Address

Hopital Cochin

Paris, , 75014

Kianous Stavros, Thessaloniki, Greece

Status

Address

Kianous Stavros

Thessaloniki, , 546 36

Thessaloniki, Greece

Status

Address

Ippokratio General Hospital of Thessaloniki

Thessaloniki, , 546 42

Tel Aviv Sourasky Medical Center - PPDS, Tel Aviv-Yafo, Tel-Aviv, Israel

Status

Address

Tel Aviv Sourasky Medical Center - PPDS

Tel Aviv-Yafo, Tel-Aviv, 64239

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

Status

Address

Saitama Medical University Hospital

Iruma-Gun, Saitama, 350-0495

Chonnam National University Hospital, Gwangju, Korea, Republic of

Status

Address

Chonnam National University Hospital

Gwangju, , 61469

Hanyang University Medical Center, Seoul, Korea, Republic of

Status

Address

Hanyang University Medical Center

Seoul, , 4763

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

Burocratas Del Estado, San Luis Potosí, Mexico

Status

Address

Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

Burocratas 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

Hospital Quironsalud Infanta Luisa, Sevilla, Spain

Status

Address

Hospital Quironsalud Infanta Luisa

Sevilla, , 41010