HZN-825 for Scleroderma
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests HZN-825, a medication, in people with diffuse cutaneous systemic sclerosis. It aims to see if the drug can improve lung function and overall health by affecting the disease process.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications. However, you cannot use another investigational agent during the trial.
How does the drug HZN-825 differ from other treatments for scleroderma?
HZN-825 is unique because it is being studied specifically for its potential to treat scleroderma, a condition with no current cure, by targeting the underlying disease process rather than just alleviating symptoms. Unlike some existing treatments that focus on symptom management, HZN-825 may offer a novel approach by addressing the disease's progression.12345
What data supports the effectiveness of the drug HZN-825 for treating scleroderma?
The systematic review of biological drugs for scleroderma suggests that these types of treatments, which include drugs like tocilizumab and belimumab, show trends of improvement in skin and lung function, indicating that similar drugs like HZN-825 might also be effective in treating scleroderma.12346
Who Is on the Research Team?
MD
Principal Investigator
Amgen
Are You a Good Fit for This Trial?
This trial is for adults who've completed a previous HZNP-HZN-825-301 trial for diffuse cutaneous systemic sclerosis, even if they stopped early for non-safety reasons. It's not open to pregnant women, those at reproductive age not using birth control, or anyone with new risks that could make the trial unsafe.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive open-label treatment with HZN-825 for 52 weeks
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- HZN-825
Find a Clinic Near You
Who Is Running the Clinical Trial?
Amgen
Lead Sponsor
Robert A. Bradway
Amgen
Chief Executive Officer since 2012
MBA from Harvard Business School
Paul Burton
Amgen
Chief Medical Officer since 2023
MD from University of London, PhD in Molecular and Cellular Biology from Imperial College London
Horizon Pharma Ireland, Ltd., Dublin Ireland
Lead Sponsor