An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
Stopped early · Phase 2
Conditions studied: Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
In brief
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.
Key facts
- Study ID
- NCT05626751
- Run by
- Amgen
- People needed
- 174
- Starts
- 2022-11-04
- Expected to finish
- 2025-02-24
- Last updated by the study team
- 2026-01-05
Who can join
Age: 18 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
Where it is running
- UCLA Medical Center — Los Angeles, California, United States
- University of Miami Miller School of Medicine — Miami, Florida, United States
- IRIS Research and Development LLC — Plantation, Florida, United States
- DelRicht Clinical Research, LLC - Internal - Covington - PPDS — New Orleans, Louisiana, United States
- Boston University School Of Medicine — Boston, Massachusetts, United States
- Michigan Medicine University of Michigan — Ann Arbor, Michigan, United States
- Mayo Clinic - Cancer Center - Rochester - PPDS — Rochester, Minnesota, United States
- Duke University Medical Center — Durham, North Carolina, United States
- Medical University of South Carolina (MUSC) - PPDS — Charleston, South Carolina, United States
- UT Physicians Rheumatology — Houston, Texas, United States
- Framingham Centro Médico — La Plata, Buenos Aires, Argentina
- Consultorio Médico Dra. Rivera — Buenos Aires, Ciudad Autónoma de BuenosAires, Argentina
- Centro de Investigaciones Médicas Tucumán - PPDS — San Miguel de Tucumán, Tucumán Province, Argentina
- Centro de Investigaciones Reumatológicas — San Miguel de Tucumán, Tucumán Province, Argentina
- Clínica Mayo de U.M.C.B. S.R.L — San Miguel de Tucumán, Tucumán Province, Argentina
- Aprillus Asistencia e Investigacion de Arcis Salud SRL — Buenos Aires, Argentina
- Clínica Adventista Belgrano — Cuiudad Autónoma de Buenos Aires, Argentina
- I.R. Medical Center - Hospital de Dia — Mendoza, Argentina
- Prosalud y Cia Ltda. — Santiago, Región-MetropolitanadeSantiago, Chile
- Laiko General Hospital of Athens — Athens, Attica, Greece
- Euromedica Kianous Stavros — Thessaloniki, Greece
- General Hospital of Thessaloniki ''Hippokratio'' — Thessaloniki, Greece
- The Chaim Sheba Medical Center - PPDS — Ramat Gan, Tel Aviv, Israel
- Tel Aviv Sourasky Medical Center Ichilov - PPDS — Tel Aviv, Tel Aviv, Israel
- Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd — Phoenix, Arizona, United States
Full record on ClinicalTrials.gov
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