HZN-825 for Idiopathic Pulmonary Fibrosis

Recruiting in Palo Alto (17 mi)

+82 other locations

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Amgen

Prior Safety Data

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

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.

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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.

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Treatment Details

Interventions

HZN-825 (Other)
Placebo (Other)

Trial OverviewThe 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

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.