Refer a Patient

Do You Have a Patient with Idiopathic Pulmonary Fibrosis (IPF)?

Study Purpose

The HARBOR Study is evaluating the safety, efficacy and tolerability of a potential medicine (HZN-825) that may slow disease progression in participants with IPF.

Study Design

The HARBOR Study is a phase 2b, randomized, double-blind, placebo-controlled study. Approximately 360 participants will be enrolled in this study and randomized 1:1:1 to one of two HZN-825 dosing groups or the placebo group.

The total duration of participation is approximately 64 weeks and includes screening (up to eight weeks), double-blind treatment (52 weeks) and a safety follow-up period (four weeks after the last dose of the potential medicine). Participants who complete the 52-week double-blind treatment period may be eligible to enter a 52-week open-label extension study.

Primary Objective

The primary objective of this study is to demonstrate the efficacy of two dose regimens of HZN-825 versus placebo in participants with IPF, as determined by a comparison of change in forced vital capacity after 52 weeks of treatment.

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About the Potential Medicine

HZN-825 is an oral lysophosphatidic acid receptor 1 (LPAR1) antagonist that prevents gene activation. In previous studies, LPAR1 antagonists significantly slowed the rate of decline in forced vital capacity tests, thus suggesting the potential for LPAR1 antagonists to be used as treatments for various fibrotic conditions.

To learn more about the HZN-825 compound and the mechanism of action, please watch the following video:

Key Inclusion Criteria

  • Between 18 and 80 years of age (inclusive) at screening
  • Current diagnosis of IPF, as defined by ATS/ERS/JRS/ALAT guidelines and determined by central review (the date of initial diagnosis of IPF should be greater than or equal to one year but less than or equal to seven years prior to screening)
  • Not currently being treated with specific IPF medicines due to:
    • Intolerance or not responding to approved IPF medicines
    • Ineligibility to receive approved IPF medicines
    • Declining approved IPF medicines
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Key Exclusion Criteria

  • Any of the following cardiovascular diseases:
    • Uncontrolled, severe hypertension (≥ 160/100 mmHg), within six months of screening
    • Myocardial infarction within six months of screening
    • Unstable cardiac angina within six months of screening
  • Interstitial lung disease (ILD) associated with known primary diseases (e.g., sarcoidosis, amyloidosis and COVID-19), connective tissue disorders (e.g., rheumatoid arthritis, systemic lupus erythematosus, Sjogren’s, dermatomyositis, scleroderma), exposures (e.g., radiation, silica, asbestos and coal dust) or drugs (e.g., amiodarone)
  • Clinically significant pulmonary hypertension requiring chronic medical care
  • Malignant condition in the past five years (except successfully treated basal/squamous cell carcinoma of the skin or cervical cancer in situ)
  • Pregnant or lactating women and women who plan to become pregnant or breastfeed during the study and within one month after the last dose of the potential medicine

HARBOR Study Research Sites

If you have a patient who may be interested in participating and may qualify, refer your patient to this study website to take the prescreening questionnaire to determine eligibility or fill out a contact request form to request contact directly from an active research site.

Find the Site Nearest You

Enter your zip code below or click on the map to find the participating research site(s) nearest you.

View full list of locations.

Active site locations

Future site locations