An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
About this trial
This is an interventional treatment trial for Diffuse Cutaneous Systemic Sclerosis focused on measuring Scleroderma, Forced vital capacity
Eligibility 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: Anticipated use of another investigational agent for any condition during the course of the trial. 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). 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. 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. Pregnant or lactating women. 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.
Sites / Locations
- IRIS Research and Development LLC
- DelRicht Clinical Research, LLC
- Michigan Medicine University of Michigan
- Medical University of South Carolina - PPDS
- Metroplex Clinical Research Center
- UT Physicians Rheumatology
- Clínica Adventista Belgrano
- Framingham Centro Médico
- Aprillus Asistencia e Investigacion de Arcis Salud SRL
- Centro de Investigaciones Médicas Tucumán
- Centro de Investigaciones Reumatologicas
- Centre Hospitalier Universitaire de Bordeaux, Hopital Pellegrin
- Hopital Cochin
- Kianous Stavros
- Tel Aviv Sourasky Medical Center - PPDS
- Chonnam National University Hospital
- Hanyang University Medical Center
- Centro de Investigación y Tratamiento Reumatológico S.C
- Centro de Estudios de Investigacion Basica Y Clinica SC
- Centro Integral Reumatologia SA de CV
- Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
- Clinica de Investigacion en Reumatologia y Obesidad
- Unidad de Atencion Medica e Investigacion en Salud
Arms of the Study
Arm 1
Experimental
HZN-825
HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks