HZN-825 for Idiopathic Pulmonary Fibrosis

Recruiting at 82 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

153 Participants Needed

Trial Summary

What is the purpose of this trial?

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.

Research Team

MD

Principal Investigator

Amgen

Eligibility Criteria

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

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)

Treatment Details

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.

Participant Groups

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+