HZN-825 for Idiopathic Pulmonary Fibrosis

No longer recruiting at 99 trial locations

Overseen By Horizon Therapeutics

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Amgen

Must be taking: IPF therapy

Must not be taking: Prednisone, Cyclosporine, Rifampin

Disqualifiers: Cardiovascular diseases, ILD, Infections, others

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 3

Duration: 52 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new treatment called HZN-825, a potential drug for Idiopathic Pulmonary Fibrosis (IPF), a lung condition that causes scarring and makes breathing difficult. The study has two parts: the first part compares different doses of HZN-825 and a placebo to assess effectiveness and safety, while the second part offers extended treatment for those who wish to continue. The trial seeks individuals diagnosed with IPF within the last seven years who either use IPF treatments like nintedanib or pirfenidone or are not on any such treatment. Participants must undergo a lung scan and meet certain health criteria to join. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group, offering participants a chance to contribute to important advancements in IPF treatment.

Do I have to stop taking my current medications for the trial?

If you are on a stable dose of approved IPF therapy like nintedanib or pirfenidone, you can continue taking it during the trial. However, any changes to your medication regimen are not allowed during the trial. If you are not currently on IPF therapy, you should not start any new treatments during the trial.

Is there any evidence suggesting that HZN-825 is likely to be safe for humans?

Research shows that HZN-825 is undergoing testing for safety in treating idiopathic pulmonary fibrosis (IPF). Earlier studies have examined its safety and tolerability. Although detailed information on side effects is not yet available, the current trial phase suggests early evidence of safety for humans. Treatments reaching this stage have generally been well-tolerated in past studies. However, it is important to remember that this treatment remains under study, and complete safety information will only be available after collecting more data from ongoing and future trials. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IPF?

HZN-825 is unique because it targets idiopathic pulmonary fibrosis (IPF) in a novel way. Most treatments for IPF, like pirfenidone and nintedanib, aim to slow disease progression by reducing lung scarring, but HZN-825 works differently by tackling the fibrotic process itself. This oral medication is taken with meals and offers flexibility with once or twice daily dosing. Researchers are excited about HZN-825 because it has the potential to provide a more targeted and efficient approach to managing IPF, possibly offering patients improved outcomes and quality of life.

What evidence suggests that HZN-825 might be an effective treatment for Idiopathic Pulmonary Fibrosis?

This trial will evaluate HZN-825 for idiopathic pulmonary fibrosis (IPF). Research has shown that HZN-825 blocks a protein called LPAR1, which is linked to the worsening of lung function in IPF. Early studies suggested that HZN-825 could slow this decline. However, a later study did not meet its main goals, resulting in mixed outcomes. Despite this, because HZN-825 targets LPAR1, it might still help manage IPF symptoms. More research is needed to confirm its effectiveness. Participants in this trial will receive either HZN-825 or a placebo to further assess its impact. ^{1 3 4 6 7}

Who Is on the Research Team?

MD

Principal Investigator

Amgen

Are You a Good Fit for This Trial?

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.

Inclusion Criteria

Willing and able to comply with the prescribed treatment protocol and evaluations for the duration of the trial

I cannot take approved treatments for my lung condition.

I had a detailed lung scan within the last 6 months or will have one to check for IPF.

Exclusion Criteria

Anticipated use of another investigational agent for any condition during the course of the trial for Extension Phase

Your total bilirubin levels are higher than 1.5 times the upper limit of normal.

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

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

8 weeks

1 visit (in-person)

Treatment

Participants receive HZN-825 or placebo for 52 weeks in a double-blind manner

52 weeks

Regular visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

2 visits (in-person)

Extension

Participants may opt into a 52-week open-label extension to continue receiving HZN-825

52 weeks

Regular visits (in-person)

What Are the Treatments Tested in This Trial?

Interventions

• HZN-825
• Placebo

Trial Overview 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.

How Is the Trial Designed?

Group I: HZN-825-300 mg twice daily (BID) Experimental Treatment 1 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 Treatment 1 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 BID Placebo Group 1 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.

Who Is Running the Clinical Trial?

Amgen

Lead Sponsor

Trials

1,508

Recruited

1,433,000+

Founded

1980

Headquarters

Thousand Oaks, USA

Known For

Human Therapeutics

Top Products

Enbrel, Prolia, Neulasta, Otezla

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 Therapeutics Ireland DAC

Lead Sponsor

Trials

21

Recruited

2,500+

Citations

1. clinicaltrials.gov clinicaltrials.gov/ct2/show/NCT05032066

NCT05032066 | A Multicenter Trial to Evaluate the Efficacy ... The trial was terminated due to not meeting primary or key secondary endpoints. A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 ...

2. trial.medpath.com trial.medpath.com/clinical-trial/d08283c46db65a56/euctr2021-001253-32-es-phase-2b-trial-hzn-825-pulmonary-fibrosis

A Study to Evaluate the Efficacy, Safety and Tolerability of ... Clinical Trials Trial Details. A Study to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects with Idiopathic Pulmonary Fibrosis. Phase 1.

3. sciencedirect.com sciencedirect.com/science/article/pii/S002235652539823X

Can a novel lysophosphatidic acid receptor 1 antagonist ... It remains an open question whether using an irreversible antagonist of LPA1 is sufficient to halt IPF-mediated decline in FVC.

4. onderzoekmetmensen.nl onderzoekmetmensen.nl/en/node/53568/pdf

A Phase 2b Randomized, Double-blind HZN-825 is under investigation as a novel therapy for IPF because it selectively antagonizes LPAR1, which has been shown to be associated with ...

5. firstwordpharma.com firstwordpharma.com/story/5485551

Horizon Therapeutics plc Announces First Patient Enrolled ... "This trial will help determine the safety, efficacy and tolerability of Horizon's LPAR1 antagonist in slowing the decline of lung function due ...

6. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/38757472/

Pharmacokinetics of Fipaxalparant, a Small-Molecule ... Fipaxalparant (HZN-825) is a small molecule acting as a negative allosteric modulator of LPAR1 and is in phase 2 clinical evaluations for treating diffuse ...

7. clinicaltrialsregister.eu clinicaltrialsregister.eu/ctr-search/trial/2021-001253-32/IT

Clinical Trials Register The primary objective is to demonstrate the efficacy of 2 dose regimens of HZN-825 versus placebo in subjects with IPF, as determined by a ...