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Clinical Trial Details — Status: Enrolling by invitation

Administrative data

NCT number NCT05626751
Other study ID # HZNP-HZN-825-302
Secondary ID 2021-006271-42
Status Enrolling by invitation
Phase Phase 2
First received
Last updated
Start date November 4, 2022
Est. completion date September 29, 2026

Study information

Verified date June 2024
Source Amgen
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

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.


Description:

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.


Recruitment information / eligibility

Status Enrolling by invitation
Enrollment 246
Est. completion date September 29, 2026
Est. primary completion date September 29, 2026
Accepts healthy volunteers No
Gender All
Age group 18 Years to 75 Years
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
HZN-825
HZN-825 will be administered BID for 52 weeks

Locations

Country Name City State
Argentina Aprillus Asistencia e Investigacion de Arcis Salud SRL Ciudad Autónoma de Buenos Aires
Argentina Framingham Centro Médico La Plata Buenos Aires
Argentina I.R. Medical Center - Hospital de Dia Mendoza
Argentina Centro de Investigaciones Reumatológicas San Miguel De Tucumán Tucumán
Argentina Clínica Mayo de U.M.C.B. S.R.L San Miguel De Tucumán Tucumán
Austria Medizinische Universität Graz-Auenbruggerplatz 52 Graz Steiermark
France CHU de Bordeaux - Hôpital Pellegrin Bordeaux Gironde
France AP-HP - Hôpital Cochin - Port-Royal, site Cochin Paris
Germany Charité - Universitätsmedizin Berlin Berlin
Germany Universitatsklinikum Erlangen-Universitätsstr. 21-23 Erlangen Bayern
Germany Universitätsklinikum Würzburg Würzburg Bayern
Greece General Hospital of Thessaloniki ''Hippokratio'' Thessaloniki
Israel Rambam Health Care Campus - PPDS Haifa
Japan Juntendo University Hospital Bunkyo-Ku Tokyo
Japan Nippon Medical School Hospital Bunkyo-Ku Tokyo
Japan Saitama Medical University Hospital Iruma-Gun Saitama
Japan Nagasaki University Hospital Nagasaki-Shi Nagasaki
Japan Sapporo Medical University Hospital Sapporo Hokkaidô
Japan Hokkaido University Hospital Sapporo-Shi Hokkaidô
Korea, Republic of Chonnam National University Hospital Gwangju Gwangju Gwang'yeogsi
Korea, Republic of Gangnam Severance Hospital, Yonsei University Health System Seoul
Korea, Republic of Hanyang University Seoul Hospital Seoul
Mexico Centro Integral Reumatologia SA de CV Americana Jalisco
Mexico Centro de Estudios de Investigacion Basica Y Clinica SC Guadalajara Jalisco
Mexico Clinica de Investigacion en Reumatologia y Obesidad Guadalajara
Mexico CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV Mexico Distrito Federal
Mexico Centro de Investigación y Tratamiento Reumatológico S.C San Miguel Chapultepec I Sección
Poland Twoja Przychodnia NCM Nowa Sól Lubuskie
Poland Medicover Integrated Clinical Services sp. z o.o - PPDS Warszawa Mazowieckie
Spain Hospital General Universitario Gregorio Marañon Madrid
Spain Hospital Universitario Doctor Peset Valencia
United Kingdom Royal Free Hospital London London, City Of
United States Boston University School Of Medicine Boston Massachusetts
United States Medical University of South Carolina (MUSC) - PPDS Charleston South Carolina
United States Duke University Medical Center Durham North Carolina
United States UT Physicians Rheumatology Houston Texas
United States UCLA Medical Center Los Angeles California
United States DelRicht Clinical Research, LLC - Internal - Covington - PPDS New Orleans Louisiana
United States IRIS Research and Development LLC Plantation Florida
United States Mayo Clinic - Cancer Center - Rochester - PPDS Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
Amgen

Countries where clinical trial is conducted

United States,  Argentina,  Austria,  France,  Germany,  Greece,  Israel,  Japan,  Korea, Republic of,  Mexico,  Poland,  Spain,  United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted As measured by a pulmonary function test called a spirometry. Baseline to Week 52
Primary Change from HZN-825 Baseline, defined as the latest measurement prior to the first dose of HZN-825 in either trial HZNP-HZN-825-301 or this extension trial in FVC % predicted As measured by a pulmonary function test called a spirometry. Baseline to Week 52
Primary Incidence of treatment emergent adverse events (TEAEs) Day 1 to Week 56
Primary Incidence of adverse events of special interest (AESI) orthostatic hypotension Day 1 to Week 52
Primary Incidence and frequency of use of concomitant medication Day 1 to Week 56
Primary Change from trial baseline in vital signs as reported as TEAEs Day 1 to Week 56
Primary Change from HZN-825 baseline in vital signs as reported as TEAEs Day 1 to Week 56
Primary Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements. Clinically significant changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT interval corrected using Fridericia's formula (QTcF). Baseline to Week 52
Primary Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements. Clinically significant changes in ECGs is defined as any clinical significant difference in heart rate, RR interval, PR interval, QRS, and QT interval corrected using Fridericia's formula (QTcF). Baseline to Week 52
Primary Change from trial baseline in abnormal laboratory test results Clinically significant lab values in serum chemistry, hematology, lipids, coagulation tests and urinalyses will be assessed (including Grade 3 or higher per common terminology criteria for adverse events) Day 1 to Week 56
Primary Change from HZN-825 baseline in abnormal laboratory test results Clinically significant lab values in serum chemistry, hematology, lipids, coagulation tests and urinalyses will be assessed (including Grade 3 or higher per common terminology criteria for adverse events) Day 1 to Week 56
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