A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis
Public ClinicalTrials.gov record NCT05032066. Field values are reproduced from the official study page; the official ClinicalTrials.gov record remains the source of truth for eligibility, enrollment, and contact information.
Data is sourced from official ClinicalTrials.gov public API records. Always review the official ClinicalTrials.gov record for the latest information.
Official title
A Phase 2b Randomized, Double-blind, Placebo-controlled, Repeat-dose, Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis
Brief summary
Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.
HZNP-HZN-825-303 (HARBOR) comprises of 2 parts. Part 1 (Core Phase) is a randomized, double-blind, placebo-controlled, repeat-dose, multicenter trial to evaluate the efficacy, safety and tolerability of HZN-825 in participants with Idiopathic Pulmonary Fibrosis (IPF). Part 2 (Extension Phase) is an optional, open-label, repeat-dose, multicenter extension of the Core Phase. The trial will include up to an 8-week Screening Period and a 52-week Double-blind Treatment Period in the Core Phase and 52 weeks of open-label HZN-825 treatment in the Extension Phase. During the Core Phase, participants will be screened within 8 weeks prior to the baseline (Day 1) Visit. Approximately 135 participants who meet the trial eligibility criteria will be randomly assigned in a 1:1:1 ratio on Day 1 to receive HZN-825 300 mg QD, HZN-825 300 mg BID or matching placebo orally for 52 weeks using the following 2 stratification factors: 1. Concomitant use of approved IPF therapy (i.e., nintedanib or pirfenidone): yes or no 2. Forced vital capacity (FVC) % predicted at Baseline: ≥70% or \<70% Participants who complete the 52-week Double blind Treatment Period of the Core Phase of the trial will be invited to extend their participation in the 52-week Extension Phase of the trial.
Study identification
- NCT ID
- NCT05032066
- Recruitment status
- Terminated
- Study type
- Interventional
- Phase
- Phase 2
- Enrollment
- 153 participants
Conditions and interventions
Conditions
Eligibility (public fields only)
- Age range
- 18 Years and older
- Sex
- All
- Healthy volunteers
- Healthy volunteers not accepted
This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.
Study timeline
- Start date
- Jan 20, 2022 (Actual)
- Primary completion
- Jul 22, 2024 (Actual)
- Completion
- Jan 2, 2025 (Actual)
- Last update posted
- Dec 3, 2025
2022 – 2025
United States locations
- U.S. sites
- 22
- U.S. states
- 14
- U.S. cities
- 21
| Facility | City | State | ZIP | Site status |
|---|---|---|---|---|
| University of Alabama at Birmingham | Birmingham | Alabama | 35233 | — |
| Palmtree Clinical Research | Palm Springs | California | 92262 | — |
| St. Francis Medical Institute | Clearwater | Florida | 33765 | — |
| Central Florida Pulmonary Group PA | Orlando | Florida | 32803 | — |
| DBC Research Corp. | Tamarac | Florida | 33321 | — |
| GCP Clinical Research | Tampa | Florida | 33609 | — |
| University of Kansas Medical Center | Kansas City | Kansas | 66160 | — |
| Nebraska Pulmonary Specialties LLC | Lincoln | Nebraska | 68510 | — |
| Dartmouth Hitchcock Medical Center | Lebanon | New Hampshire | 03756-1000 | — |
| Stony Brook Medicine Advanced Specialty Care | Commack | New York | 11725 | — |
| Clinical Research of Gastonia | Gastonia | North Carolina | 28054 | — |
| Shelby Clinical Research | Shelby | North Carolina | 28150 | — |
| Southeastern Research Center | Winston-Salem | North Carolina | 27103 | — |
| The Cleveland Clinic Foundation | Cleveland | Ohio | 44195 | — |
| Thomas Jefferson University | Philadelphia | Pennsylvania | 19107 | — |
| Temple University Hospital | Philadelphia | Pennsylvania | 19140-5103 | — |
| Clinical Research of Rock Hill | Rock Hill | South Carolina | 29732 | — |
| Clinical Trials Center of Middle Tennessee | Franklin | Tennessee | 37067 | — |
| Vanderbilt University Medical Center | Nashville | Tennessee | 37204 | — |
| El Paso Pulmonary Association - Elligo | El Paso | Texas | 79902-1124 | — |
| Metroplex Pulmonary and Sleep Medicine Center | McKinney | Texas | 75069 | — |
| Northwestern Memorial Hospital | Milwaukee | Wisconsin | 53226-3522 | — |
Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.
Non-U.S. locations
This page focuses on the U.S. directory. The official record also lists 60 non-U.S. sites.
About this trial record page
- What this page shows
- Public field values for ClinicalTrials.gov record NCT05032066, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
- What this page does not do
- No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
- Where the data comes from
- Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
- Last refresh
- Last update posted Dec 3, 2025 · Synced Oct 21, 2026
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Open the official record
The complete public registry record, listed eligibility criteria, and available contact information for NCT05032066 live on ClinicalTrials.gov.