Study on Fipaxalparant for Patients with Idiopathic Pulmonary Fibrosis

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What is this study about?

This clinical study is focused on a disease known as idiopathic pulmonary fibrosis (IPF), which is a condition where the lungs become scarred over time, making breathing increasingly difficult. The investigation involves using a medication called Fipaxalparant, known by the code name HZN-825, to assess its effectiveness, safety, and how well it is tolerated by individuals with IPF. IPF does not have a known cause, and this study aims to understand if this medication can help manage the disease.

The goal of the study is to test the impact of two different doses of HZN-825 compared to a placebo, over a 52-week period. Participants will take the medication in tablet form by mouth. The primary focus is to see if there are changes in lung function, specifically in a measure called forced vital capacity (FVC), which relates to how much air a person can forcefully exhale from their lungs after taking a deep breath. This measure is crucial as it can indicate the progression of lung conditions like IPF.

In addition to evaluating the lung capacity, other aspects such as safety and side effects of the treatment will be observed. The trial is structured in two parts; the initial phase involves a comparison with a placebo, and the subsequent extension phase continues to assess the medication’s effectiveness over a longer period with open-label treatment, meaning that participants will know they are receiving the actual drug.

1 Core Phase Initiation

Upon joining the study, the participant begins the Core Phase, which lasts for 52 weeks.

The primary goal is to evaluate the effectiveness of two different doses of the medication HZN-825 compared to a placebo.

The participant will take the medication orally in the form of a film-coated tablet.

2 Medication Administration

The participant will receive HZN-825 or a placebo, depending on the group assignment.

The medication is administered in a repeat-dose format, meaning it is taken regularly over the course of the study.

3 Monitoring and Assessments

Throughout the Core Phase, the participant’s lung function will be monitored by measuring the forced vital capacity (FVC), which is the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible.

Additional assessments include the 6-minute walk test (6MWT) to evaluate exercise capacity, and questionnaires to assess quality of life and respiratory symptoms.

4 Completion of Core Phase

At the end of 52 weeks, the participant completes the Core Phase.

The primary measurement is the change in FVC percentage from the beginning to the end of this phase.

5 Extension Phase Initiation

Participants who complete the Core Phase may enter the Extension Phase, which also lasts for 52 weeks.

This phase is open-label, meaning all participants receive HZN-825 and no placebo is used.

6 Continuation of Treatment

During the Extension Phase, the participant continues to take HZN-825 as prescribed.

The focus remains on assessing the long-term effectiveness and safety of the medication.

7 Final Assessments

At the end of the Extension Phase, the participant undergoes final assessments to measure changes in lung function and overall health status.

The primary measurement is the change in FVC percentage from both the initial baseline and the start of the Extension Phase.

Who Can Join the Study?

You must provide written consent to participate.
You should be a male or female who is at least 18 years old.
You need to have a current diagnosis of Idiopathic Pulmonary Fibrosis (IPF), which is a lung condition, confirmed by specific guidelines.
Your initial diagnosis of IPF should have been made within the last 7 years.
If you are on IPF medication, your dose should be stable for at least 3 months before starting the trial, with no plans to change it during the trial.
If you are not currently on IPF medication, you should have stopped any previous IPF treatment at least 4 weeks before starting the trial, with no plans to restart it during the trial.
You must have a High-Resolution Computed Tomography (HRCT) scan of your lungs done within 6 months before the trial, showing specific patterns related to IPF.
Your HRCT scan should show between 10% and less than 50% lung fibrosis, which is a type of lung scarring, and more fibrosis than emphysema, a lung condition.
Your lung function tests during screening should meet these criteria:
- Forced Vital Capacity (FVC), a measure of lung function, should be at least 45% of what is predicted as normal.
- Forced Expiratory Volume in 1 second (FEV1)/FVC ratio should be at least 0.7.
- Diffusing Capacity of the Lung for Carbon Monoxide (DLCO), corrected for hemoglobin, should be between 25% and 90% of what is predicted as normal.
You should have an estimated life expectancy of at least 30 months for conditions not related to IPF.
Your vaccinations should be up to date, based on your age, other health conditions, and local availability.
You must be willing and able to follow the treatment plan and attend evaluations throughout the trial.

Who Cannot Join the Study?

Patients who have a different lung condition other than Idiopathic Pulmonary Fibrosis (IPF) cannot participate. IPF is a disease that causes scarring of the lungs for an unknown reason.
Patients who are not within the specified age range for the study cannot participate. The age range is typically defined by the study but is not specified here.
Patients who are not able to follow the study procedures or take the study medication as required cannot participate.
Patients who are pregnant or breastfeeding cannot participate.
Patients who have participated in another clinical trial recently may not be eligible to participate.
Patients with certain medical conditions that could interfere with the study results or pose a risk to the patient cannot participate.
Patients who are taking medications that could interfere with the study treatment cannot participate.
Patients who have a history of drug or alcohol abuse may not be eligible to participate.
Patients who have a known allergy to the study medication or its ingredients cannot participate.
Patients who have had a recent major surgery or are planning to have surgery during the study period may not be eligible to participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain
Centre Hospitalier Universitaire De Bordeaux	Bordeaux	France

Other Sites

Site Name	City	Country
University General Hospital Of Heraklion	Heraklion	Greece
Evangelismos S.A.	Athens	Greece
General University Hospital Of Larissa	Larissa	Greece
University General Hospital Of Ioannina	Ioannina	Greece
General University Hospital Of Patras	Patras	Greece
Aafchw Msnkhgg Ctzsvi	Athens	Greece
Pnkrea Garokoct Gvigob Mvddmhc Kqjsyros sbdm	Sosnowiec	Poland
Axwszmzfyd Ptiytztq Hkifjqdd Db Mxqftpncg	Marseille	France
Ehglfrh Ujdugqjogdlw Molyexi Ckyhgia Rzenpwkdp (mytwewu Mfe	Rotterdam	The Netherlands
Awuisjo Ojajodciiwb Useaorjjkqotg Sdeors	Siena	Italy
Cpzldj Hgairnkcvnk Rvwhktna Ueugfggfocoyk Db Tpugr	Tours	France

Trial status

Country	Status	Recruitment Start
France	Not recruiting	24.05.2022
Greece	Not recruiting	24.05.2022
Italy	Not recruiting	24.05.2022
Poland	Not recruiting	24.05.2022
Spain	Not recruiting	24.05.2022
The Netherlands	Not recruiting	24.05.2022

Trial locations

Investigated drugs:

Fipaxalparant

HZN-825 is a medication being studied for its potential to treat idiopathic pulmonary fibrosis (IPF). This condition causes scarring of the lungs, leading to breathing difficulties. The trial aims to evaluate how effective, safe, and tolerable HZN-825 is for patients with IPF. The study involves comparing the lung function of patients taking HZN-825 to those who do not, by measuring changes in their forced vital capacity (FVC) over a period of 52 weeks.

Investigated diseases:

Idiopathic pulmonary fibrosis

Idiopathic Pulmonary Fibrosis – Idiopathic Pulmonary Fibrosis (IPF) is a chronic lung disease characterized by the progressive scarring of lung tissue. This scarring, or fibrosis, leads to a gradual decline in lung function, making it increasingly difficult for individuals to breathe. The exact cause of IPF is unknown, which is why it is termed “idiopathic.” Over time, the thickened and stiff lung tissue hampers the ability of the lungs to transfer oxygen into the bloodstream. Symptoms often include a persistent dry cough and shortness of breath, especially during physical activity. As the disease progresses, individuals may experience fatigue and a decrease in exercise tolerance.

Trial ID:

2023-509784-24-00

Protocol code:

HZNP-HZN-825-303

NCT ID:

NCT05032066

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Fipaxalparant for Patients with Idiopathic Pulmonary Fibrosis

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