Not yet recruiting NCT07540988

FIBRONEER-ACT: A Study to Test Whether Nerandomilast Helps People With Fibrosing Interstitial Lung Disease at Risk for Disease Progression

Phase III Interventional Interstitial Lung Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nerandomilast, Placebo matching nerandomilast.
Who it may be relevant to: Registry conditions: Interstitial Lung Diseases. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Argentina, Austria, Belgium, Brazil +13
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

A Double-blind, Randomized, Placebo-controlled Trial Investigating the Efficacy and Safety of Nerandomilast Over at Least 52 Weeks in Patients With Fibrosing Interstitial Lung Disease at Risk for Disease Progression (FIBRONEER-ACT)

Overview

This study is open to adults with fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF). People can join the study if they have been diagnosed with this condition within the last 3 years and are at risk of developing progressive pulmonary fibrosis (PPF). The purpose of this study is to find out whether a medicine called nerandomilast helps people with fibrosing interstitial lung disease who may be at risk for their disease getting worse. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets, and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Nerandomilast is a type of medicine that may help reduce lung function decline and slow disease progression. Participants are in the study for up to about 2 years and 4 months. During this time, they visit the study site regularly. Doctors regularly test lung function using methods like spirometry to measure forced vital capacity (FVC, maximum amount of air a participant can blow out after taking a deep breath) and DLCO (diffusing capacity of the lungs for carbon monoxide; it estimates how well oxygen moves from the lungs into the blood). Additionally, high-resolution computed tomography (HRCT) is performed to monitor how the lung condition is changing over time. The results are compared between the groups to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Interventions

Drug Nerandomilast
Nerandomilast
Drug Placebo matching nerandomilast
Placebo matching nerandomilast

Primary outcome measures

Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52 [Time frame: at baseline, at week 52]

Secondary outcome measures (8)

Absolute change from baseline in total disease extent (TDE [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52 [Time frame: at baseline, at week 52]
Absolute change from baseline in reticulovascular score (RVS [%]), as measured by e-Lung quantitative high resolution computed tomography (HRCT) scoring at Week 52 [Time frame: at baseline, at week 52]
Absolute change from baseline in FVC (% predicted) at Week 52 [Time frame: at baseline, at week 52]
Time to development of incident progressive pulmonary fibrosis (PPF) (as assessed and documented by investigator) or death over the duration of the trial [Time frame: up to 28 months]
Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial [Time frame: up to 28 months]
Time to relative decline from baseline in FVC (% predicted) of >10% or death over the duration of the trial [Time frame: up to 28 months]
Absolute change from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) at Week 52 [Time frame: at baseline, at week 52]
Time to absolute decline from baseline in diffusing capacity of the lungs for carbon monoxide (DLCO [% predicted]) of >10% or death over the duration of the trial [Time frame: up to 28 months]

Eligibility criteria

Inclusion criteria

Male and female individuals ≥18 years of age at the time of first signed informed consent at Visit 1a
Signed and dated written informed consent in accordance with International Council for Harmonisation of Technical Requirements for Pharmaceuticals for Human Use (ICH) - Good Clinical Practice (GCP) and local legislation prior to admission to the trial
Diagnosis of fibrosing interstitial lung disease (ILD) other than idiopathic pulmonary fibrosis (IPF) as established by the investigator
Presence of fibrotic lung disease on high resolution computed tomography (HRCT), defined as reticulation with traction bronchiectasis/ bronchiolectasis and/or honeycombing, and extent of fibrosis ≥10%, as assessed by central review prior to randomization
Time since ILD diagnosis ≤3 years before randomization
FVC ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for hemoglobin (Hb) at Visit 1
Patients treated with permitted immunosuppressive/immunomodulatory agents for an underlying systemic disease (e.g. methotrexate (MTX), azathioprine (AZA)) need to be on stable treatment for at least 12 weeks prior to Visit 1 and during screening period
Further inclusion criteria apply.

Exclusion criteria

Known diagnosis of idiopathic pulmonary fibrosis (IPF) based on multidisciplinary discussion (MDD) and according to the American Thoracic Society (ATS)/European Respiratory Society (ERS) 2022 guidelines
Known diagnosis of autoimmune-ILDs other than rheumatoid arthritis-associated ILD (RA-ILD)
Known diagnosis of sarcoidosis
Patients with predominant features of organizing pneumonia on HRCT, as assessed by central review
Patients who developed ILD due to Severe Acute Respiratory Syndrome Coronavirus 2 (SARS-CoV-2) infection/Coronavirus Disease 2019 (COVID-19) (based on investigators judgement)
Meeting criteria for progressive pulmonary fibrosis (PPF), as assessed by investigator
Meeting criteria for treatment with currently approved therapies for the fibrosing ILD (e.g. PPF), as assessed by investigator
Prior or current use of nerandomilast, nintedanib, or pirfenidone
Further exclusion criteria apply.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 27 centers

University of Alabama at Birmingham — Birmingham
University of Southern California — Los Angeles
Newport Native MD, Inc — Newport Beach
Clinical Research Specialists LLC - Kissimmee — Kissimmee
Lakeland Regional Medical Center - Lakeland — Lakeland
Advanced Pulmonary Research Institute — Loxahatchee Groves
Avanza Medical Research Center — Pensacola
Coastal Pulmonary & Critical Care — St. Petersburg
… and 19 more centers

China · 18 centers

Beijing Chao-Yang Hospital — Beijing
The Second Xiangya Hospital Of Central South University — Changsha
West China Hospital, Sichuan University — Chengdu
People's Hospital of Sichuan Province — Chengdu
First Affiliated Hospital of Guangzhou Medical University — Guangzhou
Zhejiang Hospital — Hangzhou
Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine — Hangzhou
Nanjing Drum Tower Hospital — Nanjing
… and 10 more centers

Japan · 15 centers