An Open-label Extension Trial of HZNP-HZN-825-301 in Adult Participants With Diffuse Cutaneous Systemic Sclerosis (Diffuse Cutaneous SSc)
← catalyst calendarSponsored by Amgen (industry) · AMGN — their whole pipeline →.
Phase
Phase 2
Status
Terminated
Study type
Interventional
Design
Na · None · Treatment
Enrollment
174actual
Sites
65
Countries
Argentina, Chile, Greece +12
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 not stopped due to safety reasons
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 | 2022-11-04 | 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 | 2022-11-25 | actual | When this record first appeared on the registry |
| Results posted | 2026-01-05 | actual | When the sponsor posted results to the registry |
| Record updated | 2026-01-05 | 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
Intervention
- Drug: HZN-825
Primary outcomes
what the primary-completion date above is the date OFChange From Baseline in Forced Vital Capacity Percentage (FVC%) Predicted at Week 52
measured Baseline and Week 52
Number of Participants Who Experienced Treatment-emergent Adverse Events (TEAEs) and Serious 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)
measured Day 1 and at Weeks 4, 28 and 52
Number of Participants Using Any Concomitant Medication
measured From 1st dose to last dose + 28 days; median (min, max) time on trial was 8.5 (1.0, 14.0) months
Posted documents
hosted by the registry — we link, never re-serveStudy Protocolposted 2024-10-14 · 3.8 MB · Prot_000.pdf
Statistical Analysis Planposted 2024-01-11 · 796 KB · SAP_001.pdf
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