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

NCT07540988 | Not Yet Recruiting Phase 3 FDA Drug

• 3 other identifiers: 1305-0152U1111-1337-10802026-526028-38
• Study Type: interventional
• Target: 466
• Locations: 6 countries
• Sites: 35

Brief Summary

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.

Conditions

Interstitial Lung Diseases

Outcome Measures

Primary Outcomes (1)

• Absolute change from baseline in forced vital capacity (FVC) (mL) at Week 52

  at baseline, at week 52

Secondary Outcomes (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

  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

  at baseline, at week 52

• Absolute change from baseline in FVC (% predicted) at Week 52

  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

  up to 28 months

• Time to absolute decline from baseline in FVC (% predicted) of >5% or death over the duration of the trial

  up to 28 months

Study Arms (2)

Nerandomilast arm

EXPERIMENTAL

Drug: Nerandomilast

Placebo arm

PLACEBO COMPARATOR

Drug: Placebo matching nerandomilast

Interventions

Nerandomilast DRUG

Nerandomilast

Nerandomilast arm

Placebo matching nerandomilast DRUG

Placebo matching nerandomilast

Placebo arm

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (35)

Beijing Chao-Yang Hospital

Beijing, 100020, China

Location

The Second Xiangya Hospital Of Central South University

Changsha, 410011, China

Location

West China Hospital, Sichuan University

Chengdu, 610041, China

Location

People's Hospital of Sichuan Province

Chengdu, 610072, China

Location

First Affiliated Hospital of Guangzhou Medical University

Guangzhou, 510000, China

Location

Zhejiang Hospital

Hangzhou, 310013, China

Location

Sir Run Run Shaw Hospital, Zhejiang University, School of Medicine

Hangzhou, 310016, China

Location

Nanjing Drum Tower Hospital

Nanjing, 210008, China

Location

Shanghai Chest Hospital

Shanghai, 200030, China

Location

Shanghai Pulmonary Hospital

Shanghai, 200433, China

Location

The First Affiliated Hospital of Soochow University

Suzhou, 215006, China

Location

Tianjin Medical University General Hospital

Tianjin, 300052, China

Location

Wuhan Union Hospital

Wuhan, 430022, China

Location

Tongji Hospital Affiliated Tongji Medical College Huazhong University of S & T

Wuhan, 430030, China

Location

Wuxi People's Hospital

Wuxi, 214043, China

Location

Second Affiliated Hospital of Xi'an JiaoTong University

Xi'an, 710004, China

Location

General Hospital of Ningxia Medical University

Yinchuan, 750004, China

Location

Henan Provincial People's Hospital

Zhengzhou, 450003, China

Location

HYKS Keuhkosairauksien tutkimusyksikkö

Helsinki, 000290, Finland

Location

Turku University Hospital / TYKS

Turku, 20521, Finland

Location

Azienda Ospedaliera Universitaria di Padova

Padova, 35128, Italy

Location

Tosei General Hospital

Aichi, Seto, 489-8642, Japan

Location

National Hospital Organization Kyushu Medical Center

Fukuoka, Fukuoka, 810-8563, Japan

Location

Hiroshima University Hospital

Hiroshima, Hiroshima, 734-8551, Japan

Location

Kanagawa Cardiovascular and Respiratory Center

Kanagawa, Yokohama, 236-0051, Japan

Location

Hamamatsu University Hospital

Shizuoka, Hamamatsu, 431-3192, Japan

Location

Tokushima University Hospital

Tokushima, Tokushima, 770-8503, Japan

Location

Keio University Hospital

Tokyo, Shinjuku-ku, 160-8582, Japan

Location

St. Antonius Ziekenhuis

Nieuwegein, 3435 CM, Netherlands

Location

Erasmus Medisch Centrum

Rotterdam, 3015 GD, Netherlands

Location

Kaohsiung Chang Gung Memorial Hospital

Kaohsiung City, 83301, Taiwan

Location

China Medical University Hospital

Taichung, 404, Taiwan

Location

Taichung Veterans General Hospital

Taichung, 40705, Taiwan

Location

National Taiwan University Hospital

Taipei, 10002, Taiwan

Location

Taipei Veterans General Hospital

Taipei, 112, Taiwan

Location

Related Links

• Related Info

MeSH Terms

Conditions

Lung Diseases, Interstitial

Condition Hierarchy (Ancestors)

Lung Diseases; Respiratory Tract Diseases

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 15, 2026
• First Posted: April 21, 2026
• Study Start (Estimated): August 28, 2026
• Primary Completion (Estimated): December 5, 2028
• Study Completion (Estimated): December 12, 2028
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.
• Access Criteria: For study documents -upon signing of a 'Document Sharing Agreement'. For study data -1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

Locations

CN (18); TW (5); IT (1); JP (7); FI (2); NL (2)