An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
NCT ID: NCT05626751
Last Updated: 2026-01-05
Study Results
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View full resultsBasic Information
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TERMINATED
PHASE2
174 participants
INTERVENTIONAL
2022-11-04
2025-02-24
Brief Summary
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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.
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Detailed Description
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Acquired from Horizon in 2024.
Conditions
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Study Design
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NA
SINGLE_GROUP
TREATMENT
NONE
Study Groups
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HZN-825
HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks
HZN-825
HZN-825 will be administered BID for 52 weeks
Interventions
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HZN-825
HZN-825 will be administered BID for 52 weeks
Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Amgen
INDUSTRY
Responsible Party
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Principal Investigators
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MD
Role: STUDY_DIRECTOR
Amgen
Locations
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Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd
Phoenix, Arizona, United States
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
Rambam Health Care Campus - PPDS
Haifa, , Israel
Rabin Medical Center - PPDS
Petah Tikva, , Israel
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, Italy
Hokkaido University Hospital
Sapporo, Hokkaidô, Japan
Sapporo Medical University Hospital
Sapporo, Hokkaidô, Japan
Nagasaki University Hospital
Nagasaki, Nagasaki, Japan
Saitama Medical University Hospital
Iruma-Gun, Saitama, Japan
Juntendo University Hospital
Bunkyo-Ku, Tokyo, Japan
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, Japan
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-Shi, Ôsaka, Japan
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, Mexico
Centro Integral Reumatologia SA de CV
Guadalajara, Jalisco, Mexico
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, Mexico
Centro de Investigación y Tratamiento Reumatológico S.C
San Miguel Chapultepec, Mexico City, Mexico
Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
Burócratas Del Estado, San Luis Potosí, Mexico
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, , Mexico
Unidad de Atencion Medica e Investigacion en Salud
Mérida, , Mexico
CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV
México, , Mexico
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, Poland
Twoja Przychodnia NCM
Nowa Sól, Lubusz Voivodeship, Poland
Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS
Warsaw, Masovian Voivodeship, Poland
Centrum Medyczne Reuma Park NZOZ
Warsaw, Masovian Voivodeship, Poland
Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS
Lisbon, , Portugal
Sf.Maria Clinical Hospital
Bucharest, București, Romania
Dr I Cantacuzino Clinical Hospital
Bucharest, București, Romania
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, , Romania
Institute of Rheumatology - PPDS
Belgrade, , Serbia
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, , Serbia
Chonnam National University Hospital
Gwangju, Gwangju Gwang'yeogsi, South Korea
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, South Korea
Hanyang University Seoul Hospital
Seongdong-gu, Seoul Teugbyeolsi, South Korea
Gangnam Severance Hospital, Yonsei University Health System
Seoul, , South Korea
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, Spain
Hospital Universitario A Coruña
A Coruña, , Spain
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, , Spain
Hospital de La Santa Creu i Sant Pau
Barcelona, , Spain
Hospital General Universitario Gregorio Marañon
Madrid, , Spain
Hospital Quironsalud Infanta Luisa
Seville, , Spain
Hospital Universitario Doctor Peset
Valencia, , Spain
Royal Free Hospital
London, London, City of, United Kingdom
Countries
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Provided Documents
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Document Type: Study Protocol
Document Type: Statistical Analysis Plan
Related Links
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AmgenTrials clinical trials website
Other Identifiers
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2023-509783-23-00
Identifier Type: CTIS
Identifier Source: secondary_id
HZNP-HZN-825-302
Identifier Type: -
Identifier Source: org_study_id
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