A study to test whether nerandomilast helps people with lung fibrosis related to rheumatic diseases

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Boehringer Ingelheim International GmbH, Boehringer Ingelheim Espana S.A.

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Respiratory Tract Diseases [C08]

Trial duration

14 Nov 2025 → ongoing

Decision date (initial)

2025-03-31

Transition trial

No

Low-intervention

No

Rare-disease indication

No

Vulnerable population

No

External identifiers

EU CT number

2024-512849-17-00

WHO UTN

U1111-1305-5857

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 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.

Secondary objectives 1

1. As secondary objectives, the study will explore the efficacy of nerandomilast based on additional qHRCT parameters, changes in lung function assessed via forced vital capacity (FVC), and effect on patient reported supplemental oxygen use. The secondary safety objective will focus on the risk of infections by evaluating the occurrence of infection-related adverse events (AEs).

Conditions and MedDRA coding

Systemic Autoimmune Rheumatic Diseases associated Interstitial Lung Diseases (SARD-ILD)

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 8

1. "Participant has SARD-ILD, defined as - Diagnosis by a rheumatologist with at least 1 of the following SARDs: RA, SSc (participants must be anticentromere auto-antibody negative), IIM, Sjögren’s disease, or MCTD - 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 "
2. "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: 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) "
3. FVC ≥45% of predicted normal at Visit 1
4. 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
5. "Participants must be on stable treatment with any IS agent for ≥6 months (or ≥3 months for participants with IIM-ILD) 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"
6. If using nintedanib, participants must be on a stable dose for ≥12 weeks prior to Visit 2
7. In the opinion of the Investigator, no change in background SoC treatment with IS, IM, or nintedanib is planned
8. Further inclusion criteria apply

Exclusion criteria 8

1. Organising pneumonia as predominant pattern in the HRCT
2. Prebronchodilator FEV1/FVC <0.7 at Visit 1
3. Acute ILD exacerbation within 3 months prior to Visit 1 and/or during the screening period, based on Investigator judgement
4. Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period
5. Any suicidal behaviour in the past 2 years
6. 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
7. Use of any of the following medications: cyclophosphamide within 6 months of Visit 1, pirfenidone within 8 weeks of Visit 1
8. Further exclusion criteria apply

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Absolute change from baseline in QILD score [%] on HRCT at Week 26

Secondary endpoints 7

1. Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26
2. Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26
3. Absolute change from baseline in vascular volume [%] on HRCT at Week 26
4. Absolute change from baseline in FVC [mL] at Week 26
5. Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at Week 26 at baseline
6. "Time to first supplemental oxygen use during the trial for oxygen non-users at baseline"
7. Occurrence of infection-related AEs from baseline over the duration of the trial

Investigational products

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

Test 1

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

Boehringer Ingelheim Espana S.A.

Sponsor organisation

Boehringer Ingelheim Espana S.A.

Address

Carrer Prat De La Riba 50, Sant Cugat Del Valles Sant Cugat Del Valles

City

Barcelona

Postcode

08174

Country

Spain

Scientific contact point

Organisation

Boehringer Ingelheim Espana S.A.

Contact name

CT Disclosure & Data Transparency

Public contact point

Organisation

Boehringer Ingelheim Espana S.A.

Contact name

CT Disclosure & Data Transparency

Sponsor responsibilities

Article 77 compliance

Boehringer Ingelheim International GmbH

Contact point sponsor

Boehringer Ingelheim International GmbH

Article 77 implementation

Boehringer Ingelheim International GmbH

Locations

7 EU/EEA countries · 58 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 209 files

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

Application history

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