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

NCT05626751 | Terminated Phase 2 Results FDA Drug

• 2 other identifiers: HZNP-HZN-825-3022023-509783-23-00
• Study Type: interventional
• Target: 174
• Locations: 15 countries
• Sites: 65

Brief Summary

Primary Objectives:

1. 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. 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.

Conditions

Diffuse Cutaneous Systemic Sclerosis; Sclerosis, Systemic

Keywords

Scleroderma; Forced vital capacity

Outcome Measures

Primary Outcomes (4)

• Change From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52

  FVC is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible, as measured by spirometry. FVC is a measure of respiratory function. FVC% predicted was calculated by taking the observed FVC measurement and dividing it by a predicted value multiplied by 100 (% FVC predicted = (FVC observed/FVC predicted) x 100). The predicted value is an average of the normal FVC volume for a person of the same sex, ethnicity, age and height.

  Baseline and Week 52

• Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs

  An adverse event (AE) was defined as any untoward medical occurrence in a trial participant who received an investigational product (IP), regardless of a causal relationship with treatment. An AE could be any unfavorable and unintended sign (including abnormal laboratory findings), symptom, or disease temporally associated with the use of an IP. TEAEs were defined as events that began or worsened in severity on or after the first dose of treatment through 28 days after the last dose or the cutoff date for ongoing participants. Serious TEAEs were those that resulted in death, were life-threatening, required or prolonged hospitalization, caused significant disability/incapacity, led to a congenital anomaly/birth defect, or were considered other important medical events. Clinically significant changes in vital signs, electrocardiograms (ECGs), and laboratory tests were included as TEAEs.

  From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

• Number of Participants Who Experienced AEs of Special Interest (AESI)

  The following AESI was identified for this trial: Orthostatic hypotension defined as a reduction of systolic blood pressure by ≥20 mmHg or reduction of diastolic blood pressure by ≥10 mmHg and associated with symptoms such as lightheadedness, blurred vision, weakness, fatigue, cognitive impairment, nausea, palpitations, tremulousness, headache, presyncope or syncope.

  Day 1 and at Weeks 4, 28 and 52

• Number of Participants Using Any Concomitant Medication

  Concomitant medications were defined as any medication that was ongoing, had a start date on or after the first dose of the trial drug, or had a stop date on or after the first dose date.

  From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months

Study Arms (1)

HZN-825

EXPERIMENTAL

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

Drug: HZN-825

Interventions

HZN-825 DRUG

HZN-825 will be administered BID for 52 weeks

HZN-825

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• \. 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Amgen: lead

Study Sites (65)

Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd

Phoenix, Arizona, 85032-9306, United States

Location

UCLA Medical Center

Los Angeles, California, 90095-8344, United States

Location

University of Miami Miller School of Medicine

Miami, Florida, 33136-1005, United States

Location

IRIS Research and Development LLC

Plantation, Florida, 33324-2736, United States

Location

DelRicht Clinical Research, LLC - Internal - Covington - PPDS

New Orleans, Louisiana, 70115-3584, United States

Location

Boston University School Of Medicine

Boston, Massachusetts, 02118-2642, United States

Location

Michigan Medicine University of Michigan

Ann Arbor, Michigan, 48109-5000, United States

Location

Mayo Clinic - Cancer Center - Rochester - PPDS

Rochester, Minnesota, 55905, United States

Location

Duke University Medical Center

Durham, North Carolina, 27710-3037, United States

Location

Medical University of South Carolina (MUSC) - PPDS

Charleston, South Carolina, 29425-8900, United States

Location

UT Physicians Rheumatology

Houston, Texas, 77030-5400, United States

Location

Framingham Centro Médico

La Plata, Buenos Aires, B1900, Argentina

Location

Consultorio Médico Dra. Rivera

Buenos Aires, Ciudad Autónoma de BuenosAires, C1426, Argentina

Location

Centro de Investigaciones Médicas Tucumán - PPDS

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Centro de Investigaciones Reumatológicas

San Miguel de Tucumán, Tucumán Province, T4000AXL, Argentina

Location

Clínica Mayo de U.M.C.B. S.R.L

San Miguel de Tucumán, Tucumán Province, T4000IHE, Argentina

Location

Aprillus Asistencia e Investigacion de Arcis Salud SRL

Buenos Aires, C1406AGA, Argentina

Location

Clínica Adventista Belgrano

Cuiudad Autónoma de Buenos Aires, C1430EGF, Argentina

Location

I.R. Medical Center - Hospital de Dia

Mendoza, M5500CPH, Argentina

Location

Prosalud y Cia Ltda.

Santiago, Región-MetropolitanadeSantiago, 7510047, Chile

Location

Laiko General Hospital of Athens

Athens, Attica, 115 27, Greece

Location

Euromedica Kianous Stavros

Thessaloniki, 546 36, Greece

Location

General Hospital of Thessaloniki ''Hippokratio''

Thessaloniki, 546 42, Greece

Location

The Chaim Sheba Medical Center - PPDS

Ramat Gan, Tel Aviv, 52621, Israel

Location

Tel Aviv Sourasky Medical Center Ichilov - PPDS

Tel Aviv, Tel Aviv, 64239, Israel

Location

Rambam Health Care Campus - PPDS

Haifa, 31096, Israel

Location

Rabin Medical Center - PPDS

Petah Tikva, 4910000, Israel

Location

Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia

Udine, Friuli Venezia Giulia, 33100, Italy

Location

Hokkaido University Hospital

Sapporo, Hokkaidô, 060-848, Japan

Location

Sapporo Medical University Hospital

Sapporo, Hokkaidô, 060-8543, Japan

Location

Nagasaki University Hospital

Nagasaki, Nagasaki, 852-8102, Japan

Location

Saitama Medical University Hospital

Iruma-Gun, Saitama, 350-0495, Japan

Location

Juntendo University Hospital

Bunkyo-Ku, Tokyo, 113-8431, Japan

Location

Nippon Medical School Hospital

Bunkyo-Ku, Tokyo, 113-8603, Japan

Location

Osaka Medical and Pharmaceutical University Hospital

Takatsuki-Shi, Ôsaka, 569-8686, Japan

Location

Centro de Estudios de Investigacion Basica Y Clinica SC

Guadalajara, Jalisco, 44690, Mexico

Location

Centro Integral Reumatologia SA de CV

Guadalajara, Jalisco, ZC 44160, Mexico

Location

Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran

Mexico City, Mexico City, 14000, Mexico

Location

Centro de Investigación y Tratamiento Reumatológico S.C

San Miguel Chapultepec, Mexico City, 11850, Mexico

Location

Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC

Burócratas Del Estado, San Luis Potosí, 78213, Mexico

Location

Clinica de Investigacion en Reumatologia y Obesidad

Guadalajara, 44600, Mexico

Location

Unidad de Atencion Medica e Investigacion en Salud

Mérida, 97000, Mexico

Location

CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV

México, 6700, Mexico

Location

Malopolskie Centrum Kliniczne

Krakow, Lesser Poland Voivodeship, 30-149, Poland

Location

Twoja Przychodnia NCM

Nowa Sól, Lubusz Voivodeship, 67-100, Poland

Location

Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS

Warsaw, Masovian Voivodeship, 00-874, Poland

Location

Centrum Medyczne Reuma Park NZOZ

Warsaw, Masovian Voivodeship, 02-665, Poland

Location

Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS

Lisbon, 1649-035, Portugal

Location

Sf.Maria Clinical Hospital

Bucharest, București, 011172, Romania

Location

Dr I Cantacuzino Clinical Hospital

Bucharest, București, 20475, Romania

Location

Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL

Brasov, 500283, Romania

Location

Institute of Rheumatology - PPDS

Belgrade, 11000, Serbia

Location

Institute for Treatment and Rehabilitation Niska Banja

Niška Banja, 708120, Serbia

Location

Chonnam National University Hospital

Gwangju, Gwangju Gwang'yeogsi, 61469, South Korea

Location

Seoul National University Bundang Hospital

Seongnam, Gyeonggido, 13620, South Korea

Location

Hanyang University Seoul Hospital

Seongdong-gu, Seoul Teugbyeolsi, 04763, South Korea

Location

Gangnam Severance Hospital, Yonsei University Health System

Seoul, 06273, South Korea

Location

Hospital Universitario Marques de Valdecilla

Santander, Cantabria, 39008, Spain

Location

Hospital Universitario A Coruña

A Coruña, 15006, Spain

Location

Hospital Universitario Vall d'Hebron - PPDS

Barcelona, 08035, Spain

Location

Hospital de La Santa Creu i Sant Pau

Barcelona, 08041, Spain

Location

Hospital General Universitario Gregorio Marañon

Madrid, 28009, Spain

Location

Hospital Quironsalud Infanta Luisa

Seville, 41010, Spain

Location

Hospital Universitario Doctor Peset

Valencia, 46017, Spain

Location

Royal Free Hospital

London, London, City of, NW3 2QG, United Kingdom

Location

Related Links

• AmgenTrials clinical trials website

MeSH Terms

Conditions

Scleroderma, Diffuse; Scleroderma, Systemic

Condition Hierarchy (Ancestors)

Connective Tissue Diseases; Skin and Connective Tissue Diseases; Skin Diseases

Limitations and Caveats

The trial was terminated early as the parent trial (HZNP-HZN-325-301) was terminated due to meeting pre-defined criteria for futility.

Results Point of Contact

• Title: Study Director
• Organization: Amgen Inc.

medinfo@amgen.com

866-572-6436

Study Officials

• MD

  Amgen

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 2022
• First Posted: November 25, 2022
• Study Start: November 4, 2022
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: January 5, 2026
• Results First Posted: January 5, 2026

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Data sharing requests relating to this study will be considered beginning 18 months after the study has ended and either 1) the product and indication have been granted marketing authorization in both the US and Europe or 2) clinical development for the product and/or indication discontinues and the data will not be submitted to regulatory authorities. There is no end date for eligibility to submit a data sharing request for this study.
• Access Criteria: Qualified researchers may submit a request containing the research objectives, the Amgen product(s) and Amgen study/studies in scope, endpoints/outcomes of interest, statistical analysis plan, data requirements, publication plan, and qualifications of the researcher(s). In general, Amgen does not grant external requests for individual patient data for the purpose of re-evaluating safety and efficacy issues already addressed in the product labelling. Requests are reviewed by a committee of internal advisors. If not approved, a Data Sharing Independent Review Panel will arbitrate and make the final decision. Upon approval, information necessary to address the research question will be provided under the terms of a data sharing agreement. This may include anonymized individual patient data and/or available supporting documents, containing fragments of analysis code where provided in analysis specifications. Further details are available at the URL below.

Locations

SE (2); IL (4); IT (1); ES (7); AR (8); GB (1); JP (7); PT (1); US (11); RO (3); PL (4); CL (1); GR (3); KR (4); ME (8)