A Multicenter, Open-label Extension Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Patients with Diffuse Cutaneous Systemic Sclerosis

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2023-509783-23-00

Acronym

HZNP-HZN-825-302

Enrollment

167

Registered

2024-09-30

Start date

2023-02-24

Completion date

2024-12-18

Last updated

2025-02-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diffuse Cutaneous Systemic Sclerosis

Brief summary

Change from both Baselines in FVC % predicted at Week 52

Detailed description

"1. Change from both Baselines in HAQ-DI at Week 52. 2. Change from both Baselines in MDGA at Week 52. 3. Change from both Baselines in PTGA at Week 52. 4. Change from both Baselines in the Physical Effects subscale of the SSPRO-18 at Week 52. "

Interventions

DRUGFipaxalparant

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Change from both Baselines in FVC % predicted at Week 52	—

Secondary

Measure	Time frame
"1. Change from both Baselines in HAQ-DI at Week 52. 2. Change from both Baselines in MDGA at Week 52. 3. Change from both Baselines in PTGA at Week 52. 4. Change from both Baselines in the Physical Effects subscale of the SSPRO-18 at Week 52. "	—

Countries

Austria, France, Germany, Greece, Italy, Poland, Portugal, Romania, Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026