An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)

Phase 2

• Conditions: Diffuse Cutaneous Systemic Sclerosis; Sclerosis, Systemic
• Interventions: Drug: HZN-825

• Registration Number: NCT05626751
• Lead Sponsor: Amgen

Brief 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.

Detailed 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.

Study Timeline

• Study First Submitted: 2022-11-01
• Study Start: 2022-11-04
• Study First Submitted QC: 2022-11-15
• Study First Posted: 2022-11-25
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-04
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-09-25
• Study Completion: 2026-09-25

Recruitment & Eligibility

• Status: ENROLLING_BY_INVITATION
• Sex: All
• Target Recruitment: 240

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

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
HZN-825	HZN-825	HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks

Primary Outcome Measures

Name	Time	Method
Change from trial baseline in abnormal laboratory test results	Day 1 to Week 56	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)
Change from HZN-825 baseline in abnormal laboratory test results	Day 1 to Week 56	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)
Change from HZN-825 baseline in vital signs as reported as TEAEs	Day 1 to Week 56
Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements.	Baseline to Week 52	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).
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	Baseline to Week 52	As measured by a pulmonary function test called a spirometry.
Incidence of adverse events of special interest (AESI) orthostatic hypotension	Day 1 to Week 52
Incidence and frequency of use of concomitant medication	Day 1 to Week 56
Change from trial baseline in vital signs as reported as TEAEs	Day 1 to Week 56
Change from trial baseline in abnormal and clinically significant 12-lead electrocardiogram (ECG) measurements.	Baseline to Week 52	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).
Incidence of treatment emergent adverse events (TEAEs)	Day 1 to Week 56
Change from trial baseline, defined as the latest measurement prior to the first dose of HZN-825 in FVC % predicted	Baseline to Week 52	As measured by a pulmonary function test called a spirometry.

Trial Locations

Locations (73)

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, Argentina

Aprillus Asistencia e Investigacion de Arcis Salud SRL; 🇦🇷 Ciudad Autónoma de Buenos Aires, Argentina

Clínica Adventista Belgrano; 🇦🇷 Cuiudad Autónoma De Buenos Aires, Argentina

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

Medizinische Universität Graz-Auenbruggerplatz 52; 🇦🇹 Graz, Steiermark, Austria

CHU de Bordeaux - Hôpital Pellegrin; 🇫🇷 Bordeaux, Gironde, France

AP-HP - Hôpital Cochin - Port-Royal, site Cochin; 🇫🇷 Paris, France

Universitätsklinikum Freiburg; 🇩🇪 Freiburg, Baden-Württemberg, Germany

Universitatsklinikum Erlangen-Universitätsstr. 21-23; 🇩🇪 Erlangen, Bayern, Germany

Universitätsklinikum Würzburg; 🇩🇪 Würzburg, Bayern, Germany

Universitätsklinikum Carl Gustav Carus an der TU Dresden; 🇩🇪 Dresden, Sachsen, Germany

Charité - Universitätsmedizin Berlin; 🇩🇪 Berlin, Germany

Laiko General Hospital of Athens; 🇬🇷 Athens, Attiki, 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-Yafo, Tel-Aviv, Israel

Rambam Health Care Campus - PPDS; 🇮🇱 Haifa, Israel

Rabin Medical Center - PPDS; 🇮🇱 Petah Tiqva, Israel

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia; 🇮🇹 Udine, Friuli-Venezia Giulia, Italy

Hokkaido University Hospital; 🇯🇵 Sapporo-Shi, Hokkaidô, Japan

Sapporo Medical University Hospital; 🇯🇵 Sapporo, Hokkaidô, Japan

Nagasaki University Hospital; 🇯🇵 Nagasaki-Shi, 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

Dr I Cantacuzino Clinical Hospital; 🇷🇴 Bucharest, Bucuresti, Romania

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL; 🇷🇴 Brasov, Romania

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; 🇪🇸 Sevilla, Spain

Hospital Universitario Doctor Peset; 🇪🇸 Valencia, Spain

Inselspital Bern; 🇨🇭 Bern, Switzerland

Royal Free Hospital; 🇬🇧 London, London, City Of, United Kingdom

Institute of Rheumatology - PPDS; 🇷🇸 Belgrade, Serbia

Institute for Treatment and Rehabilitation Niska Banja; 🇷🇸 Niška Banja, Serbia

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; 🇦🇷 Ciudad Autónoma de Buenos Aires, Ciudad Autónoma De BuenosAires, Argentina

Centro de Investigaciones Médicas Tucumán - PPDS; 🇦🇷 San Miguel De Tucumán, Tucumán, Argentina

Osaka Medical and Pharmaceutical University Hospital; 🇯🇵 Takatsuki-Shi, Ôsaka, Japan

Chonnam National University Hospital; 🇰🇷 Gwangju, Gwangju Gwang'yeogsi, Korea, Republic of

Seoul National University Bundang Hospital; 🇰🇷 Seongnam, Gyeonggido, Korea, Republic of

Hanyang University Seoul Hospital; 🇰🇷 Seongdong-gu, Seoul Teugbyeolsi, Korea, Republic of

Gangnam Severance Hospital, Yonsei University Health System; 🇰🇷 Seoul, Korea, Republic of

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran; 🇲🇽 Mexico City, Distrito Federal, Mexico

Centro de Investigación y Tratamiento Reumatológico S.C; 🇲🇽 San Miguel Chapultepec, Distrito Federal, Mexico

Centro de Estudios de Investigacion Basica Y Clinica SC; 🇲🇽 Guadalajara, Jalisco, Mexico

Centro Integral Reumatologia SA de CV; 🇲🇽 Guadalajara, Jalisco, 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; 🇲🇽 Merida, Mexico

CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV; 🇲🇽 Mexico, Mexico

Twoja Przychodnia NCM; 🇵🇱 Nowa Sól, Lubuskie, Poland

Malopolskie Centrum Kliniczne; 🇵🇱 Kraków, Malopolskie, Poland

Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS; 🇵🇱 Warszawa, Mazowieckie, Poland

Centrum Medyczne Reuma Park NZOZ; 🇵🇱 Warszawa, Mazowieckie, Poland

Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS; 🇵🇹 Lisboa, Portugal

Sf.Maria Clinical Hospital; 🇷🇴 Bucharest, Bucuresti, Romania