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A Study of Nerandomilast for Lung Fibrosis Related to Rheumatic Diseases

This study is testing whether a medicine called nerandomilast can help people with lung fibrosis (scarring of the lungs) caused by systemic autoimmune rheumatic diseases (SARD-ILD). You may be able to join if you are an adult aged 18 or older with SARD-ILD and your lung function hasn't improved with standard treatments. The main goal is to see how nerandomilast affects your lungs by measuring changes in lung scarring on HRCT scans after 26 weeks. Participants will be randomly assigned to receive either nerandomilast tablets or a placebo (an inactive tablet that looks the same). The study plans to enroll 400 people, but its current status is unclear.

Study design
This is an interventional study where participants are randomly assigned to one of two groups: nerandomilast or a matching placebo. The study plans to enroll 400 participants.
What's involved
Participants will take a tablet two times a day for at least 26 weeks and up to one year. Lung scans (HRCT) will be performed at the beginning and at Week 26.
Compensation
Not stated in the trial record.
Follow-up
The primary endpoint is measured at Week 26, and participants take medication for up to 1 year.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06806592

A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~400 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:NerandomilastPlacebo matching nerandomilast

At a glance

Recruiting sites
139 of 154 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26
Measured over At baseline and at Week 26

Conditions

Interstitial Lung Diseases
Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

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Where it's being run

154 sites across 38 states
Germany18
China17
Japan15
Spain14
United Kingdom13
France8
Italy7
Mexico7

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

Participant has systemic autoimmune rheumatic diseases associated interstitial lung diseases (SARD-ILD), defined as
Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: Rheumatoid arthritis (RA), systemic sclerosis (SSc) (participants must be anticentromere auto-antibody negative), idiopathic inflammatory myopathy (IIM), Sjögren's disease, or mixed connective tissue disease (MCTD) (participants must be anti-U1-ribonucleoprotein particle (RNP) auto-antibody positive)
Presence of fibrotic interstitial lung disease (ILD) on high-resolution computed tomography (HRCT), defined as presence of reticular abnormality with traction bronchiectasis with or without honeycombing (HC), with disease extent \>10% on HRCT performed within 12 months of Visit 1 or, if historical scan is not available, on baseline HRCT taken prior to Visit 2, as confirmed by central review
No lung function improvement and no clinically significant ILD improvement as a treatment response to immunosuppressant (IS) therapy according to both criteria:
No improvement in absolute forced vital capacity (FVC) % predicted \>5% within the 15 months prior to Visit 1, as measured by 2 spirometry assessments that must be ≥3 months apart. (Note: 1: In the case of multiple PFTs over the 15 months prior to screening, exceptional values of absolute change in FVC % predicted \>5% are acceptable if the overall trend of FVC % predicted is declining or stable; note 2: Visit 1 spirometry may be used to fulfill the inclusion criterion if there is only 1 spirometry reading in the 15 months prior to Visit 1)
No clinically significant improvement in ILD based on clinician's judgement (including symptoms, imaging/HRCT, or other assessments as considered relevant and documented by the Investigator)
FVC ≥45% of predicted normal at Visit 1
Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) within 3 months prior to or at Visit 1
Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) prior to visit 2, with the following specifications:
If using prednisone, participants must be on stable dose for ≥4 weeks prior to Visit 2
If using rituximab, participants must have completed their first cycle \>6 months prior to Visit 2
If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
In the opinion of the Investigator, no change in background standard of care (SoC) treatment with immunosuppressant (IS), immunomodulator (IM), or nintedanib is planned

Exclusion

Organising pneumonia as predominant pattern in the HRCT
Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) \<0.7 at Visit 1
Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
Any suicidal behaviour in the past 2 years
Any suicidal ideation of type 4 or 5 on the Columbia-Suicide Severity Rating Scale (C-SSRS) in the past 3 months or at Visit 1, and/or at Visit 2
Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1

What this trial measures

  • Absolute change from baseline in quantitative interstitial lung disease (QILD) score [%] on high-resolution computed tomography (HRCT) at Week 26At baseline and at Week 26

    QILD will be assessed via quantitative high-resolution computed tomography (qHRCT). QILD are quantitative measures of different radiological patterns associated with lung fibrosis. QLF is a measure of reticulation with architectural distortion. QGGO is a measure of ground glass opacities (i.e. hazy or cloudy areas) within the lung. QHC is a measure of HC within the lung. QILD is the sum of QLF, QGGO, and QHC. Quantification of HRCT scans will be performed centrally via a machine learning algorithm. QILD \[%\] is the QILD volume \[mL\] as a percent of the total lung volume. A higher QILD percentage or volume indicates a higher extent of disease.