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NCT05032066 · ClinicalTrials.gov registry record · Phase 2
A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis
A Phase 2 study, sponsored by Amgen.
- Terminated
- Registry status
- Phase 2
- Development phase
- 153
- Enrollment target
NCT05032066 is a Phase 2 study that was terminated before completion, run by Amgen. The registered enrollment target is 153 participants.
The verdict
NCT05032066, a Phase 2 study, was terminated before completion, sponsored by Amgen.
- TERMINATED
- Registry status
- Phase 2
- Development phase
- 153 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG HZN-825
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 153 participants |
| Start Date | 2022-01-20 |
| Est. Completion | 2025-01-02 |
| Phase | Phase 2 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05032066
The ClinicalTrials.gov registry entry for NCT05032066 describes a study currently listed as terminated, categorized as Phase 2. The registered enrollment target is 153 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Amgen, which has 558 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT05032066 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT05032066 about?
NCT05032066 is a clinical study titled "A Multicenter Trial to Evaluate the Efficacy, Safety and Tolerability of HZN-825 in Subjects With Idiopathic Pulmonary Fibrosis". 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...
What is the current status of trial NCT05032066?
This trial is currently terminated. It is a Phase 2 study. The enrollment target is 153 participants. The study started on 2022-01-20. Estimated completion is 2025-01-02.
What interventions are being tested in trial NCT05032066?
The interventions under investigation include: Placebo (DRUG), HZN-825 (DRUG).
Who is sponsoring clinical trial NCT05032066?
This trial is sponsored by Amgen, which has 558 total clinical trials registered on ClinicalTrials.gov.
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