What side effects are associated with this type of intervention?

Common treatments for Systemic Sclerosis, such as mycophenolate mofetil, methotrexate, and rituximab, are associated with side effects including gastrointestinal disturbances, increased risk of infections, liver toxicity, and bone marrow suppression. Rituximab can also cause infusion reactions, serum-sickness-like reactions, and rarely, progressive multifocal leukoencephalopathy.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of systemic sclerosis, particularly focusing on managing symptoms and complications. For instance, immunosuppressive agents like mycophenolate mofetil and cyclophosphamide are commonly used to treat skin and lung involvement. Additionally, drugs like nintedanib have been approved to slow the decline in lung function in patients with systemic sclerosis-associated interstitial lung disease. While the specific mechanism of HZN-825 is not detailed, these treatments generally aim to modulate the immune response and manage fibrosis, which are key aspects of systemic sclerosis therapy.

What other types of research exist?

Promising novel alternatives to HZN-825 for Systemic Sclerosis patients include nintedanib and tocilizumab. Nintedanib, an antifibrotic agent, has been approved for slowing the rate of decline in pulmonary function in SSc-associated interstitial lung disease. Tocilizumab, an IL-6 receptor antagonist, has shown efficacy in reducing skin thickening and improving lung function in SSc patients. Both drugs have demonstrated safety and efficacy in clinical trials and represent viable options for SSc treatment in 2024.

← Back to Search

Unknown

HZN-825 for Scleroderma

Phase 2

Waitlist Available

Research Sponsored by Amgen

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be older than 18 years old

Must not have

Women of childbearing potential (WOCBP) or male participants not agreeing to use highly effective method(s) of birth control throughout the trial and for 4 weeks after last dose of trial drug as defined in the protocol

New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-301 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)

Timeline

Screening 3 weeks

Treatment Varies

Follow Up day 1 to week 56

Awards & highlights

No Placebo-Only Group

Summary

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.

Who is the study for?

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.

What is being tested?

The study tests HZN-825 over 52 weeks in patients with diffuse cutaneous systemic sclerosis. The focus is on lung function improvement (FVC %) and safety by monitoring adverse events up to four weeks after the last dose.

What are the potential side effects?

While specific side effects aren't listed here, participants will be closely monitored for any adverse reactions including serious ones and special interest events related to HZN-825 throughout the treatment period.

Eligibility Criteria

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I agree to use effective birth control during and for 4 weeks after the trial.

Select...

I was diagnosed with a new cancer after joining Trial HZNP-HZN-825-301, except for skin or early cervical cancer which were treated successfully.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ day 1 to week 56

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~day 1 to week 56

This trial's timeline: 3 weeks for screening, Varies for treatment, and day 1 to week 56 for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Change from HZN-825 Baseline, defined as the latest measurement prior to the first dose of HZN-825 in either trial HZNP-HZN-825-301 or this extension trial in FVC % predicted

Change from HZN-825 baseline in abnormal laboratory test results

Change from HZN-825 trial baseline in abnormal and clinically significant 12-lead ECG measurements.

+3 more

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: HZN-825Experimental Treatment1 Intervention

HZN-825 will be administered by mouth (PO) twice daily (BID) for 52 weeks

0 / 2Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for Systemic Sclerosis (SSc) include immunosuppressive agents, antifibrotic drugs, and vasodilators. Immunosuppressive agents, such as methotrexate and mycophenolate mofetil, work by reducing the immune system's activity, thereby decreasing inflammation and preventing further tissue damage. Antifibrotic drugs, like nintedanib, inhibit pathways that lead to fibrosis, helping to reduce the thickening and hardening of the skin and internal organs. Vasodilators, such as calcium channel blockers, improve blood flow by relaxing blood vessels, which is particularly important for managing Raynaud's phenomenon and preventing digital ulcers. These treatments are vital for SSc patients as they target the disease's core mechanisms, potentially slowing its progression and improving quality of life.

Ketanserin in the treatment of Raynaud's phenomenon associated with generalized scleroderma.A randomized double-blind controlled trial of sulphasalazine combined with pulses of methylprednisolone or placebo in the treatment of rheumatoid arthritis.Systemic Lupus Erythematosus Presenting as Myopericarditis with Acute Heart Failure: A Case Report and Literature Review.