What is the mechanism of action of this treatment?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone, both of which are antifibrotic agents that aim to slow disease progression. Nintedanib is a tyrosine kinase inhibitor that blocks pathways mediated by VEGF, FGF, and PDGF, which are involved in fibrosis. Pirfenidone has anti-inflammatory and antifibrotic properties, inhibiting the synthesis of TGF-β and TNF-α, key mediators in the fibrotic process. These mechanisms are crucial for IPF patients as they help slow the decline in lung function, potentially improving quality of life and extending survival.

What side effects are associated with this type of intervention?

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include the antifibrotic medications nintedanib and pirfenidone. Nintedanib is frequently associated with gastrointestinal side effects, particularly diarrhea, as well as liver enzyme elevations. Pirfenidone commonly causes gastrointestinal issues such as nausea and dyspepsia, along with skin-related side effects like rash and photosensitivity. Both medications have been shown to slow disease progression and reduce the frequency of acute exacerbations, but they also come with these notable side effects.

What prior FDA approvals exist?

The FDA has approved two primary antifibrotic medications for the treatment of Idiopathic Pulmonary Fibrosis (IPF): nintedanib and pirfenidone. Nintedanib is a tyrosine kinase inhibitor that targets multiple pathways involved in fibrosis, and it has been shown to slow the decline in forced vital capacity (FVC) in patients with IPF. Pirfenidone is an antifibrotic and anti-inflammatory agent that also slows the progression of IPF by reducing the decline in FVC and improving progression-free survival. Both drugs aim to manage the disease by targeting fibrotic pathways, similar to the investigational drug HZN-825 being studied for its efficacy, safety, and tolerability in IPF patients.

What other types of research exist?

Promising alternatives to HZN-825 for IPF patients include nintedanib and pirfenidone, which are established treatments known to slow disease progression and reduce acute exacerbations. Additionally, pamrevlumab, an anti-connective tissue growth factor therapy, has shown potential in clinical trials and may be a novel option for IPF treatment in 2024.

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HZN-825 for Idiopathic Pulmonary Fibrosis

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

ineligible to receive approved IPF therapies

Current diagnosis of IPF, as defined by specific guidelines and determined by central review

Must not have

New diagnosis of malignant condition after enrolling in Trial HZNP-HZN-825-303 (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)

Known active bacterial, viral, fungal, mycobacterial or other infection, including tuberculosis or atypical mycobacterial disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up baseline to week 52

Summary

This trial tests HZN-825, a new oral medicine, in people with Idiopathic Pulmonary Fibrosis (IPF). The goal is to see if it can help by blocking a receptor that causes lung scarring. The study will check its safety and effectiveness over several months.

Who is the study for?

Adults aged 18-80 with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF) for at least 1 year but not more than 7 years, who have an FEV1/FVC ratio ≥0.7 and HRCT showing significant fibrosis are eligible. They must be able to follow the trial protocol without planned changes in IPF therapy, not have severe other diseases or conditions, and agree to use effective birth control.

What is being tested?

The HARBOR trial is testing the effectiveness of HZN-825 compared to a placebo in treating IPF. Participants will either take HZN-825 once or twice daily or a placebo for one year. The study includes those on approved IPF therapies and measures lung function based on Forced Vital Capacity percentage.

What are the potential side effects?

While specific side effects of HZN-825 aren't listed here, common side effects from drugs like it may include gastrointestinal issues, skin reactions, fatigue, liver enzyme elevations, and potential risks during pregnancy.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I cannot take approved treatments for my lung condition.

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I have been diagnosed with IPF by a specialist.

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I am 18 years old or older.

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My latest lung scan shows more scarring than air pocket damage.

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My treatment for lung scarring hasn't changed recently and won't soon.

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I cannot tolerate or did not respond to approved treatments for IPF.

Exclusion Criteria

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

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I was diagnosed with a new cancer after joining Trial HZNP-HZN-825-303, but it's not skin or early cervical cancer.

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I do not have any active infections, including TB.

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I have not had a heart attack in the last 6 months.

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I have had an organ transplant.

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My kidney function is severely reduced.

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My liver function is moderately to severely impaired.

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I have a severe lab test result.

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I am on long-term medication for severe pulmonary hypertension.

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I have a liver condition related to alcohol, primary biliary cirrhosis, or primary sclerosing cholangitis.

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I have lung disease linked to a specific cause like an illness, exposure, or medication.

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I have active hepatitis B or C.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ baseline to week 52

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~baseline to week 52

This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline to week 52 for reporting.

Treatment Details

Study Objectives

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

Secondary study objectives

Core Phase: Change from baseline in K-BILD (King's Brief Interstitial Lung Disease) scores to Week 52

Core Phase: Change from baseline in L-IPF (Living with IPF[Idiopathic Pulmonary Fibrosis]) scores to Week 52

Core Phase: Change from baseline in LCQ (Leicester Cough Questionnaire) scores to Week 52

+1 more

Trial Design

3Treatment groups

Experimental Treatment

Placebo Group

Group I: HZN-825-300 mg twice daily (BID)Experimental Treatment1 Intervention

Two 150 mg oral tablets given in the morning with a meal and two 150 mg oral tablets given in the evening with a meal; total daily dose 600 mg HZN-825.

Group II: HZN-825 300 mg once daily (QD)Experimental Treatment1 Intervention

Two 150 mg oral tablets given in the morning with a meal and two matching placebo tablets given in the evening with a meal; total daily dose 300 mg HZN-825.

Group III: Placebo BIDPlacebo Group1 Intervention

Matching placebo tablets (2) given in the morning with a meal and matching placebo tablets (2) given in the evening with a meal; total dose 4 placebo tablets.

0 / 17Eligibility 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

The most common treatments for Idiopathic Pulmonary Fibrosis (IPF) include nintedanib and pirfenidone, both of which are antifibrotic agents that aim to slow disease progression. Nintedanib is a tyrosine kinase inhibitor that blocks pathways mediated by VEGF, FGF, and PDGF, which are involved in fibrosis. Pirfenidone has anti-inflammatory and antifibrotic properties, inhibiting the synthesis of TGF-β and TNF-α, key mediators in the fibrotic process. These mechanisms are crucial for IPF patients as they help slow the decline in lung function, potentially improving quality of life and extending survival.

Interstitial lung disease.