Recruiting NCT06806592

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

Phase III Interventional Interstitial Lung Diseases Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied: The protocol lists: Nerandomilast, Placebo matching nerandomilast.
Who it may be relevant to: Registry conditions: Interstitial Lung Diseases, Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases. Basic parameters: from 18 years · All.
What needs checking: Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place: United States, Australia, Austria, China, France +11
Next step: Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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)

Overview

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 improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Interventions

Drug Nerandomilast
Nerandomilast
Drug Placebo matching nerandomilast
Placebo matching nerandomilast

Primary outcome measures

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

Secondary outcome measures (7)

Absolute change from baseline in quantitative lung fibrosis (QLF) score [%] on HRCT at Week 26 [Time frame: At baseline and at Week 26]
Absolute change from baseline in quantitative ground glass opacity (QGGO) score [%] on HRCT at Week 26 [Time frame: At baseline and at Week 26]
Absolute change from baseline in vascular volume [%] on HRCT at Week 26 [Time frame: At baseline and at Week 26]
Absolute change from baseline in forced vital capacity (FVC) [mL] at Week 26 [Time frame: At baseline and at Week 26]
Absolute change from baseline in supplemental oxygen use over the whole trial for oxygen users at baseline [Time frame: At baseline and at Week 52]
Time to first supplemental oxygen use during the trial for oxygen non-users at baseline [Time frame: Up to Week 52]
Occurrence of infection-related adverse events (AEs) from baseline over the duration of the trial [Time frame: Up to 1 year]

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation: Randomized
Model: Parallel assignment
Masking: Quadruple blind
Primary purpose: Treatment

Study locations

United States · 33 centers

University of Alabama at Birmingham — Birmingham
Mayo Clinic-Arizona — Scottsdale
University of California Los Angeles — Los Angeles
Paradigm Clinical Research - San Diego — San Diego
National Jewish Health — Denver
Yale University School of Medicine — New Haven
Meris Clinical Research-Brandon-69466 — Brandon
Miami VA Healthcare System — Miami
… and 25 more centers

Germany · 18 centers

Charité - Universitätsmedizin Berlin — Berlin
Immanuel-Krankenhaus GmbH — Berlin
Universitätsklinikum Bonn AöR — Bonn
Städtisches Klinikum Braunschweig gGmbH — Braunschweig
Gesundheit Nord gGmbH | Klinikverbund Bremen — Bremen
Krankenhaus Porz am Rhein gGmbH — Cologne
Universitätsklinikum Düsseldorf — Düsseldorf
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH — Essen
… and 10 more centers

China · 17 centers

Beijing Chao-Yang Hospital — Beijing
China-Japan Friendship Hospital — Beijing
Peking Union Medical College Hospital — Beijing
West China Hospital, Sichuan University — Chengdu
People's Hospital of Sichuan Province — Chengdu
Guangdong Provincial People's Hospital — Guangzhou
The First Affiliated Hospital, Zhejiang University — Hangzhou
The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
… and 9 more centers

Japan · 15 centers