NCT05626751

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

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

• Status: Terminated
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 174 (actual)
• Sponsor: Amgen · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

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. 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.

Conditions

• Diffuse Cutaneous Systemic Sclerosis
• Sclerosis, Systemic

Interventions

Type	Name	Description
DRUG	HZN-825	HZN-825 will be administered BID for 52 weeks

Timeline

• Start date: 2022-11-04
• Primary completion: 2025-02-24
• Completion: 2025-02-24
• First posted: 2022-11-25
• Last updated: 2026-01-05
• Results posted: 2026-01-05

Locations

65 sites across 15 countries: United States, Argentina, Chile, Greece, Israel, Italy, Japan, Mexico, Poland, Portugal, Romania, Serbia, South Korea, Spain, United Kingdom

Regulatory

• FDA-regulated drug study