A Multicenter Trial to Evaluate the Efficacy, Safety, Tolerability and Pharmacokinetics of HZN-825 in Patients With Diffuse Cutaneous Systemic Sclerosis
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Phase
Phase 2
Status
Terminated
Study type
Interventional
Design
Randomized · Triple · Treatment
Enrollment
301actual
Sites
4
Countries
Serbia, Spain
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Why the sponsor stopped it
The study was terminated due to meeting pre-defined criteria for futility.
As filed on the registry record, in the sponsor's own words.
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2021-11-05 | actual | When the study began enrolling |
| Primary completion | 2025-02-24 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-02-24 | actual | The whole study's end, after follow-up |
| First posted | 2021-03-04 | actual | When this record first appeared on the registry |
| Results posted | 2026-03-20 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-03-20 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Diffuse Cutaneous Systemic Sclerosis
- Sclerosis, Systemic
Interventions
- Drug: HZN-825 BID
- Drug: Placebo
- Drug: HZN-825 QD
Primary outcome
what the primary-completion date above is the date OFChange From Baseline in Forced Vital Capacity Percent (FVC%) Predicted at Week 52
measured Baseline and Week 52
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-08-22 · 2.9 MB · Prot_002.pdf
Statistical Analysis Planposted 2024-10-28 · 20.3 MB · SAP_001.pdf
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