A study to test whether nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH

Participant type

Healthy volunteers

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

23 Mar 2026 → ongoing

Decision date (initial)

2026-03-04

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2025-522383-33-00

WHO UTN

U1111-1322-6453

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Therapy, Efficacy, Safety

The primary objective is to investigate the effect of nerandomilast in reducing the overall risk of worsening of lung abnormalities/fibrosis in participants with a family history of pulmonary fibrosis.

Secondary objectives 1

1. As secondary objectives, the study will further explore the effect of nerandomilast in reducing the risk of worsening of fibrosis in participants with a family history of pulmonary fibrosis based on individual metrics of Quantitative HRCT scoring and changes in lung function assessed via FVC and DLCO.

Conditions and MedDRA coding

Interstitial lung diseases

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 6

1. 1. Individuals ≥40 years of age at the time of first signed informed consent at Visit 1a
2. 2. Participants must have at least 1 first-degree relative (biological parent, sibling, or child) with confirmed pulmonary fibrosis (idiopathic pulmonary fibrosis [IPF], idiopathic nonspecific interstitial pneumonia [NSIP], and/or pulmonary fibrosis due to known genetic cause [e.g. short telomere syndrome, MUC5B mutation, surfactant protein mutations])
3. 3. HRCT scan with evidence of interstitial lung abnormalities involving at least 5% of a single lung zone, or ILD, based on central evaluation.
4. 4. FVC ≥80% of predicted normal at Visit 1b
5. 5. Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin ≥70% of predicted normal at Visit 1b
6. Further inclusion criteria apply.

Exclusion criteria 6

1. 1. Prior known pulmonary fibrosis that, in the opinion of the Investigator, requires treatment with approved therapies
2. 2. Prebronchodilator FEV1/FVC <0.7 at Visit 1b
3. 3. HRCT findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
4. 4. Any medical condition that is known to predispose to the development of pulmonary fibrosis (e.g. known connective tissue disease)
5. 5. Prior or current use of nerandomilast, nintedanib, or pirfenidone
6. Further exclusion criteria apply.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Time to physiologic or radiologic worsening of ILA/ILD (defined as: relative decline in FVC % predicted of >10% from baseline; or absolute decline in DLCO % predicted >10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) >2% and total disease extent (TDE) >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring, from baseline) over the whole trial

Secondary endpoints 9

1. Absolute change from baseline in wRVS on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104
2. Absolute change from baseline in TDE on e-Lung Quantitative HRCT scoring at weeks 26, 52, and 104
3. Absolute change from baseline in FVC (% predicted) at weeks 26, 52, and 104
4. Absolute change from baseline in DLCO (% predicted) at weeks 26, 52, and 104
5. Time to relative decline from baseline in FVC (% predicted) of >10% over 52 weeks and over the whole trial
6. Time to absolute decline from baseline in FVC (% predicted) of >5% over 52 weeks and over the whole trial
7. Time to absolute decline from baseline in DLCO (% predicted) of >10% over 52 weeks and over the whole trial
8. Time to absolute increase in wRVS >2% and TDE >2.5% on chest HRCT, as measured by e-Lung Quantitative HRCT scoring over 52 weeks and over the whole trial
9. Time to physiologic or radiologic worsening of ILA/ILD over 52 weeks

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 2

Placebo 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Boehringer Ingelheim International GmbH

Sponsor organisation

Boehringer Ingelheim International GmbH

Address

Binger Strasse 173

City

Ingelheim Am Rhein

Postcode

55216

Country

Germany

Scientific contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim International GmbH

Contact name

CT Disclosure & Data Transparency

Locations

6 EU/EEA countries · 20 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 141 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

2 submissions — initial application plus substantial / non-substantial modifications