Recruiting

Phase 3

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

Sponsor:

Boehringer Ingelheim

Code:

NCT06806592

Conditions

Interstitial Lung Diseases

Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Nerandomilast

Placebo matching nerandomilast

Study Details

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 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.

Conditions

Interstitial Lung Diseases

Systemic Autoimmune Rheumatic Diseases Associated Interstitial Lung Diseases

Study ID

NCT06806592

Start date

Sep 13, 2025

Status verified date

Aug, 2026

Completion date

Jul 30, 2027

Anticipated

Primary completion date

Jul 17, 2027

Anticipated

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

400 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Nerandomilast

Participants with SARD-ILDs will receive nerandomilast.

placebo comparator: Placebo

Participants with SARD-ILDs will receive placebo.

Interventions

Nerandomilast

Placebo matching nerandomilast

Primary outcome measure

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 ]

Central Contacts and Locations

Central contacts

Boehringer Ingelheim

1-800-243-0127 clintriage.rdg@boehringer-ingelheim.com

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35205

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Mayo Clinic-Arizona

Recruiting

Scottsdale, Arizona, United States, 85259

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of California Los Angeles

Recruiting

Los Angeles, California, United States, 90095

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Paradigm Clinical Research - San Diego

Recruiting

San Diego, California, United States, 92108

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

National Jewish Health

Recruiting

Denver, Colorado, United States, 80206

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Yale University School of Medicine

Recruiting

New Haven, Connecticut, United States, 06510

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Meris Clinical Research-Brandon-69466

Recruiting

Brandon, Florida, United States, 33511

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Miami VA Healthcare System

Recruiting

Miami, Florida, United States, 33125

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Piedmont Physicians Pulmonary & Sleep Medicine of Buckhead

Recruiting

Atlanta, Georgia, United States, 30309

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Augusta University

Recruiting

Augusta, Georgia, United States, 30912

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

The University of Chicago Medical Center

Recruiting

Chicago, Illinois, United States, 60637

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Northshore University Health System

Recruiting

Evanston, Illinois, United States, 60201

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Kansas Medical Center

Recruiting

Kansas City, Kansas, United States, 66160

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Brigham and Women's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Minnesota

Recruiting

Minneapolis, Minnesota, United States, 55455

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Mayo Clinic, Rochester

Recruiting

Rochester, Minnesota, United States, 55902

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Nebraska Medical Center

Recruiting

Omaha, Nebraska, United States, 68198-1230

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Northwell Health

Recruiting

Great Neck, New York, United States, 11021

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

NYU Langone Health

Recruiting

New York, New York, United States, 10017

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Columbia University Medical Center-New York Presbyterian Hospital

Recruiting

New York, New York, United States, 10032

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Onsite Clinical Solutions

Recruiting

Salisbury, North Carolina, United States, 28144

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Southeastern Research Center-Winston Salem-69289

Recruiting

Winston-Salem, North Carolina, United States, 27103

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Temple Lung Center

Recruiting

Philadelphia, Pennsylvania, United States, 19140

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

The University of Texas Health Science Center at Houston

Recruiting

Houston, Texas, United States, 77030

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Texas Health Science Center at San Antonio

Recruiting

San Antonio, Texas, United States, 78229

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Utah Health Sciences Center

Recruiting

Salt Lake City, Utah, United States, 84108

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

Rheumatology and Pulmonary Clinic

Recruiting

Beckley, West Virginia, United States, 25801

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

University of Wisconsin

Recruiting

Madison, Wisconsin, United States, 53792

Contacts

Boehringer Ingelheim

833-602-2368 unitedstates@bitrialsupport.com

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Aug 20, 2026

Last verified

Aug, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-08-20.