Diffuse Cutaneous Systemic SclerosisPhase 2NCT05626751
An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
A Phase 2 study testing HZN-825 in people with Diffuse Cutaneous Systemic Sclerosis and Sclerosis, Systemic, run by Amgen at 65 sites in 15 countries.
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Diffuse Cutaneous Systemic Sclerosis, Sclerosis, Systemic
- What is being tested?
- HZN-825
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 174 participants
- Where
- 65 sitesin 15 countries
- Study dates
- 4 Nov 2022to 24 Feb 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
65 sites in 15 countries.
65 sites in 15 countries
United States11 sites
Michigan Medicine University of Michigan
Ann Arbor, Michigan, 48109-5000
Boston University School Of Medicine
Boston, Massachusetts, 02118-2642
Medical University of South Carolina (MUSC) - PPDS
Charleston, South Carolina, 29425-8900
Duke University Medical Center
Durham, North Carolina, 27710-3037
UT Physicians Rheumatology
Houston, Texas, 77030-5400
UCLA Medical Center
Los Angeles, California, 90095-8344
University of Miami Miller School of Medicine
Miami, Florida, 33136-1005
DelRicht Clinical Research, LLC - Internal - Covington - PPDS
New Orleans, Louisiana, 70115-3584
Arizona Arthritis and Rheumatology Associates -4550 E Bell Rd
Phoenix, Arizona, 85032-9306
IRIS Research and Development LLC
Plantation, Florida, 33324-2736
Mayo Clinic - Cancer Center - Rochester - PPDS
Rochester, Minnesota, 55905
Argentina8 sites
Consultorio Médico Dra. Rivera
Buenos Aires, Ciudad Autónoma de BuenosAires, C1426
Aprillus Asistencia e Investigacion de Arcis Salud SRL
Buenos Aires, C1406AGA
Clínica Adventista Belgrano
Cuiudad Autónoma de Buenos Aires, C1430EGF
Framingham Centro Médico
La Plata, Buenos Aires, B1900
I.R. Medical Center - Hospital de Dia
Mendoza, M5500CPH
Centro de Investigaciones Médicas Tucumán - PPDS
San Miguel de Tucumán, Tucumán Province, T4000AXL
Centro de Investigaciones Reumatológicas
San Miguel de Tucumán, Tucumán Province, T4000AXL
Clínica Mayo de U.M.C.B. S.R.L
San Miguel de Tucumán, Tucumán Province, T4000IHE
Mexico8 sites
Centro de Alta Especialidad En Reumatologia E Investigacion Del Potosi SC
Burócratas Del Estado, San Luis Potosí, 78213
Centro de Estudios de Investigacion Basica Y Clinica SC
Guadalajara, Jalisco, 44690
Centro Integral Reumatologia SA de CV
Guadalajara, Jalisco, ZC 44160
Clinica de Investigacion en Reumatologia y Obesidad
Guadalajara, 44600
Unidad de Atencion Medica e Investigacion en Salud
Mérida, 97000
CITER, Centro de Investigacion y Tratamiento de las Enfermedades Reumaticas SA de CV
México, 6700
Instituto Nacional de Ciencias Medicas y Nutricion Salvador Zubiran
Mexico City, Mexico City, 14000
Centro de Investigación y Tratamiento Reumatológico S.C
San Miguel Chapultepec, Mexico City, 11850
Japan7 sites
Juntendo University Hospital
Bunkyo-Ku, Tokyo, 113-8431
Nippon Medical School Hospital
Bunkyo-Ku, Tokyo, 113-8603
Saitama Medical University Hospital
Iruma-Gun, Saitama, 350-0495
Nagasaki University Hospital
Nagasaki, Nagasaki, 852-8102
Hokkaido University Hospital
Sapporo, Hokkaidô, 060-848
Sapporo Medical University Hospital
Sapporo, Hokkaidô, 060-8543
Osaka Medical and Pharmaceutical University Hospital
Takatsuki-Shi, Ôsaka, 569-8686
Spain7 sites
Hospital Universitario A Coruña
A Coruña, 15006
Hospital Universitario Vall d'Hebron - PPDS
Barcelona, 08035
Hospital de La Santa Creu i Sant Pau
Barcelona, 08041
Hospital General Universitario Gregorio Marañon
Madrid, 28009
Hospital Universitario Marques de Valdecilla
Santander, Cantabria, 39008
Hospital Quironsalud Infanta Luisa
Seville, 41010
Hospital Universitario Doctor Peset
Valencia, 46017
Israel4 sites
Rambam Health Care Campus - PPDS
Haifa, 31096
Rabin Medical Center - PPDS
Petah Tikva, 4910000
The Chaim Sheba Medical Center - PPDS
Ramat Gan, Tel Aviv, 52621
Tel Aviv Sourasky Medical Center Ichilov - PPDS
Tel Aviv, Tel Aviv, 64239
Poland4 sites
Malopolskie Centrum Kliniczne
Krakow, Lesser Poland Voivodeship, 30-149
Twoja Przychodnia NCM
Nowa Sól, Lubusz Voivodeship, 67-100
Medicover Integrated Clinical Services sp. z o.o - MICS - PPDS
Warsaw, Masovian Voivodeship, 00-874
Centrum Medyczne Reuma Park NZOZ
Warsaw, Masovian Voivodeship, 02-665
South Korea4 sites
Chonnam National University Hospital
Gwangju, Gwangju Gwang'yeogsi, 61469
Hanyang University Seoul Hospital
Seongdong-gu, Seoul Teugbyeolsi, 04763
Seoul National University Bundang Hospital
Seongnam, Gyeonggido, 13620
Gangnam Severance Hospital, Yonsei University Health System
Seoul, 06273
Greece3 sites
Laiko General Hospital of Athens
Athens, Attica, 115 27
Euromedica Kianous Stavros
Thessaloniki, 546 36
General Hospital of Thessaloniki ''Hippokratio''
Thessaloniki, 546 42
Romania3 sites
Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL
Brasov, 500283
Sf.Maria Clinical Hospital
Bucharest, Bucharest, 011172
Dr I Cantacuzino Clinical Hospital
Bucharest, Bucharest, 20475
Serbia2 sites
Institute of Rheumatology - PPDS
Belgrade, 11000
Institute for Treatment and Rehabilitation Niska Banja
Niška Banja, 708120
Chile1 site
Prosalud y Cia Ltda.
Santiago, Región-MetropolitanadeSantiago, 7510047
Italy1 site
Azienda Sanitaria Universitaria Friuli Centrale - PO Universitario Santa Maria della Misericordia
Udine, Friuli Venezia Giulia, 33100
Portugal1 site
Hospital de Santa Maria-Avenida Prof. Egas Moniz - PPDS
Lisbon, 1649-035
United Kingdom1 site
Royal Free Hospital
London, London, City of, NW3 2QG
About this study
Official title: A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis
Primary Objectives:
- 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.
- 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.
Read the 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.
- Being tested
- HZN-825
- Keywords
- Scleroderma, Forced vital capacity
- Medical subject headings
- Scleroderma, Diffuse, Scleroderma, Systemic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
HZN-825Drug
HZN-825 will be administered BID for 52 weeks
| Study group | Role | What they receive |
|---|---|---|
| HZN-825 | Experimental | HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks Receives: Drug: HZN-825 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Nov 2022
- Study start4 Nov 2022
- Primary completion24 Feb 2025
- Study completion24 Feb 2025
Why it stopped: The study was not stopped due to safety reasons
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Diffuse Cutaneous Systemic SclerosisStudies of the same condition, open and under way.
- More trials run by AmgenThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 174 participants (actual)
Sponsor and investigators
- Lead sponsor
- Amgen
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- MD, Study director, Amgen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05626751
- Sponsor's protocol ID
- HZNP-HZN-825-302
- Other IDs
- 2023-509783-23-00, 2023
- Status last verified
- Nov 2025
- First submitted
- 1 Nov 2022
- Last updated
- 5 Jan 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
Study at a glance
From the registry record, last updated by the sponsor on 5 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis
- ClinicalTrials.gov ID
- NCT05626751
- Acronym / sponsor ID
- HZNP-HZN-825-302
- Keywords
- Scleroderma, Forced vital capacity
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: The study was not stopped due to safety reasons
- Enrolment
- 174 participants (actual)
- Lead sponsor
- AmgenIndustry (pharma, biotech, devices)
- Study start
- 4 Nov 2022 (actual)
- Primary completion
- 24 Feb 2025 (actual)
- Study completion
- 24 Feb 2025 (actual)
- First posted
- 25 Nov 2022 (actual)
- Results
- Posted 5 Jan 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Primary Objectives:
- 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.
- 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 design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HZN-825 | Experimental | Drug: HZN-825HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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 (6 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| HZN-825HZN-825 will be administered BID for 52 weeks | Drug | HZN-825 |
Primary outcome
Change From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52
Time frame: Baseline and 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.
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious TEAEs
Time frame: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months
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.
Number of Participants Who Experienced AEs of Special Interest (AESI)
Time frame: Day 1 and at Weeks 4, 28 and 52
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.
Number of Participants Using Any Concomitant Medication
Time frame: From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months
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.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Jan 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- AmgenTrials clinical trials websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. De-identified individual patient data for variables necessary to address the specific research question in an approved data sharing request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
MD study director
Amgen
65 sites in 15 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing HZN-825 in people with Diffuse Cutaneous Systemic Sclerosis and Sclerosis, Systemic, run by Amgen at 65 sites in 15 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 5 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 65 sites in United States, Argentina, Mexico, Japan, Spain and 10 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 5 Jan 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52 (time frame: Baseline and Week 52). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Jan 2026.