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

NCT05626751 · Status: TERMINATED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 174

Last updated 2026-01-05

Study results available
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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.

Conditions

  • Diffuse Cutaneous Systemic Sclerosis
  • Sclerosis, Systemic

Interventions

DRUG

HZN-825

HZN-825 will be administered BID for 52 weeks

Sponsors & Collaborators

Principal Investigators

  • MD · Amgen

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-11-04
Primary Completion
2025-02-24
Completion
2025-02-24
FDA Drug
Yes

Countries

  • United States
  • Argentina
  • Chile
  • Greece
  • Israel
  • Italy
  • Japan
  • Mexico
  • Poland
  • Portugal
  • Romania
  • Serbia
  • South Korea
  • Spain
  • United Kingdom

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05626751 on ClinicalTrials.gov