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Nerandomilast for lung fibrosis linked to autoimmune rheumatic diseases

A Double Blind, Randomised, Placebo-controlled Trial Evaluating the Efficacy and Safety of Nerandomilast Over at Least 26 Weeks in Patients With Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases (SARD-ILD)

Phase 3 Interventional Boehringer Ingelheim · NCT06806592

This trial tests whether taking nerandomilast twice daily can help adults with lung fibrosis caused by systemic autoimmune rheumatic diseases who have not improved after standard immunosuppressant treatment.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment400 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Drugs / interventionsrituximab, cyclophosphamide, prednisone
Locations158 sites (Birmingham, Alabama and 157 other locations)
Trial IDNCT06806592 on ClinicalTrials.gov

What this trial studies

Adults with systemic autoimmune rheumatic disease–associated interstitial lung disease (SARD-ILD) and persistent fibrotic changes on HRCT are randomly assigned to receive nerandomilast or matching placebo tablets twice daily for at least 26 weeks and up to 1 year while continuing their background immunosuppressant therapy. Fibrosis extent on HRCT must be greater than 10% and be confirmed by central review, and participants must show no improvement after standard immunosuppressant treatment to qualify. The study includes about 9–10 site visits over roughly 7.5 to 13 months and uses centralized imaging review and regular lung function monitoring to track effects. Safety and tolerability are monitored throughout the treatment period.

Who should consider this trial

Good fit: Adults (18+) with a rheumatologist-confirmed systemic autoimmune rheumatic disease and fibrotic interstitial lung disease involving >10% on HRCT, who show no lung-function improvement after standard immunosuppressant therapy, are the ideal candidates.

Not a fit: Patients whose lung function is improving on current immunosuppressants, those with minimal fibrosis (<10% extent on HRCT), or people with non‑SARD causes of ILD are unlikely to benefit or are ineligible.

Why it matters

Potential benefit: If successful, nerandomilast could slow progression or improve lung function in people with SARD-ILD who have not responded to standard immunosuppression.

How similar studies have performed: Other antifibrotic treatments have shown the ability to slow lung-function decline in fibrotic ILDs including some connective tissue disease–related ILDs, but nerandomilast as tested here is a novel agent in this population.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

* 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
* Further inclusion criteria apply

Exclusion Criteria:

* 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
* Further exclusion criteria apply

Where this trial is running

Birmingham, Alabama and 157 other locations

+108 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Interstitial Lung DiseasesSystemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.