BridgeMD
A study to test whether nerandomilast helps people with lung fibrosis related to rheumatic diseases
EU CTIS ID: 2024-512849-17-00
What this study is testing
The primary objective is to investigate the effect of nerandomilast on the extent of pulmonary involvement from baseline to Week 26 as assessed with quantitative interstitial lung disease (QILD) score in quantitative high-resolution computed tomography (qHRCT). The primary treatment comparison is as randomised, including all data collected until Week 26 regardless of treatment discontinuation, start of restricted medication, changes in background IS therapies, or initiation of nintedanib.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- "Participant has SARD-ILD, defined as - Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: RA, SSc (participants must be anticentromere auto-antibody negative), IIM, Sjögren’s disease, or MCTD (participants must be anti-U1-RNP auto-antibody positive) - Presence of fibrotic ILD on 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 IS therapy according to both criteria: - No improvement in absolute 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
You likely can't join if
- Organising pneumonia as predominant pattern in the HRCT
- Prebronchodilator FEV1/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
See the full eligibility criteria
- "Participant has SARD-ILD, defined as - Diagnosis by a rheumatologist (or equally qualified medical physician) with at least 1 of the following SARDs: RA, SSc (participants must be anticentromere auto-antibody negative), IIM, Sjögren’s disease, or MCTD (participants must be anti-U1-RNP auto-antibody positive) - Presence of fibrotic ILD on 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 IS therapy according to both criteria: - No improvement in absolute 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 SoC treatment with IS, IM, or nintedanib is planned
- Further inclusion criteria apply
- Organising pneumonia as predominant pattern in the HRCT
- Prebronchodilator FEV1/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
The study team makes the final eligibility decision.
Where it's taking place
- Australia
- United Kingdom
- Mexico
- Japan
- United States
- China
- Korea, Republic of
- Switzerland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Australia; United Kingdom; Mexico; Japan; United States; China and 2 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.