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Clinical Trials in China / NCT06806592
Recruiting Phase 3

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

NCT06806592 · tracked via the Priya Life Science China tracker
Sponsor
Boehringer Ingelheim
Phase
Phase 3
Started
2025-09-13
Last updated
2026-09-16

Condition(s) studied

Interstitial Lung DiseasesSystemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Investigational drug(s) / intervention(s)

Nerandomilast →Placebo matching nerandomilast

Nerandomilast: Nerandomilast

Placebo matching nerandomilast: Placebo matching nerandomilast

Study 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 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.

Eligibility

Sex
ALL
Min age
18 Years
Max age
Healthy volunteers
No
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

Primary outcome measure(s)

Trial sites (153)

FacilityCityRegionStatus
University of Alabama at Birmingham Birmingham Alabama Recruiting
Mayo Clinic-Arizona Scottsdale Arizona Recruiting
University of California Los Angeles Los Angeles California Recruiting
Paradigm Clinical Research - San Diego San Diego California Recruiting
National Jewish Health Denver Colorado Recruiting
Yale University School of Medicine New Haven Connecticut Recruiting
Meris Clinical Research-Brandon-69466 Brandon Florida Recruiting
Miami VA Healthcare System Miami Florida Recruiting
Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead Atlanta Georgia Recruiting
Augusta University Augusta Georgia Recruiting
Northwestern University Chicago Illinois Recruiting
The University of Chicago Medical Center Chicago Illinois Recruiting
Northshore University Health System Evanston Illinois Recruiting
University of Kansas Medical Center Kansas City Kansas Recruiting
Massachusetts General Hospital Boston Massachusetts Recruiting
Brigham and Women's Hospital Boston Massachusetts Recruiting
University of Minnesota Minneapolis Minnesota Recruiting
Mayo Clinic, Rochester Rochester Minnesota Recruiting
University of Nebraska Medical Center Omaha Nebraska Recruiting
Northwell Health Great Neck New York Recruiting
NYU Langone Health New York New York Recruiting
Columbia University Medical Center-New York Presbyterian Hospital New York New York Recruiting
Onsite Clinical Solutions Salisbury North Carolina Recruiting
Southeastern Research Center-Winston Salem-69289 Winston-Salem North Carolina Recruiting
Temple Lung Center Philadelphia Pennsylvania Recruiting
University of Pittsburgh Medical Center Pittsburgh Pennsylvania Recruiting
The University of Texas Health Science Center at Houston Houston Texas Recruiting
University of Texas Health Science Center at San Antonio San Antonio Texas Recruiting
University of Utah Health Sciences Center Salt Lake City Utah Recruiting
Rheumatology and Pulmonary Clinic Beckley West Virginia Recruiting
University of Wisconsin Madison Wisconsin Recruiting
Royal Prince Alfred Hospital Camperdown, Sydney New South Wales Recruiting
St Vincent's Hospital Sydney Darlinghurst New South Wales Recruiting
The Prince Charles Hospital Chermside Queensland Recruiting
Austin Hospital Heidelberg Victoria Recruiting
Fiona Stanley Hospital Murdoch Western Australia Recruiting
Krems University Hospital Krems Austria Completed
Klinikum Wels - Grieskirchen GmbH Wels Austria Recruiting
Beijing Chao-Yang Hospital Beijing China Recruiting
China-Japan Friendship Hospital Beijing China Recruiting

+ 113 more sites — see the full list on the official registry below.

More Boehringer Ingelheim trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06806592 on ClinicalTrials.gov ↗ ← All trials in China