Status:
RECRUITING
A Study to Test Whether Nerandomilast Helps People With Lungfibrosis Related to Rheumatic Diseases
Lead Sponsor:
Boehringer Ingelheim
Conditions:
Interstitial Lung Diseases
Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improve...
Eligibility 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
Key Trial Info
Start Date :
September 13 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
July 30 2027
Estimated Enrollment :
400 Patients enrolled
Trial Details
Trial ID
NCT06806592
Start Date
September 13 2025
End Date
July 30 2027
Last Update
April 14 2026
Active Locations (158)
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1
University of Alabama at Birmingham
Birmingham, Alabama, United States, 35233
2
Mayo Clinic-Arizona
Scottsdale, Arizona, United States, 85259
3
University of California Los Angeles
Los Angeles, California, United States, 90095
4
Paradigm Clinical Research - San Diego
San Diego, California, United States, 92108