Actively Recruiting
A Double Blind, Randomized, Placebo-controlled Trial of Nerandomilast in People With Interstitial Lung Abnormalities and Family History of Pulmonary Fibrosis to Reduce Risk of Worsening
Led by Boehringer Ingelheim · Updated on 2026-05-27
80
Participants Needed
56
Research Sites
1 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are studying people aged 40 years or older who have at least one family member with pulmonary fibrosis, a condition where lung tissue becomes scarred and breathing becomes difficult. The study focuses on individuals who show early lung changes called interstitial lung abnormalities, which may lead to scarring. The goal is to find out if the medicine nerandomilast can slow down these lung changes in people with a family history of pulmonary fibrosis. Participants are randomly assigned to one of two groups: one group takes nerandomilast tablets, and the other takes placebo tablets that look the same but contain no medicine. They take one tablet twice daily for about 2 to 3 years. There is a 60% chance of receiving nerandomilast. The study includes a treatment period of about 2 to 3 years with visits every 3 months for the first 2 years, then every 6 months, plus phone calls every 3 months during the third year. During the study, doctors will regularly test lung function and perform chest scans to monitor changes and evaluate treatment effects. Health and any side effects are also closely monitored. The main outcome measured is the time until lung changes worsen, based on lung function and imaging, over the entire study period of up to 164 weeks.
CONDITIONS
Brief Title
A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Individuals aged 40 years or older at the time of first signed informed consent
- At least one first-degree relative with confirmed pulmonary fibrosis
- Lung scan (HRCT) showing interstitial lung abnormalities involving at least 5% of a single lung zone or interstitial lung disease
- Forced vital capacity (FVC) of 80% or more of predicted normal at Visit 1b
- Diffusing capacity of the lungs for carbon monoxide (DLCO) corrected for hemoglobin of 70% or more of predicted normal at Visit 1b
- Further inclusion criteria apply
You will not qualify if you...
- Known pulmonary fibrosis requiring treatment with approved therapies
- Prebronchodilator forced expiratory volume in 1 second (FEV1)/FVC ratio less than 0.7 at Visit 1b
- Lung scan findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
- Any medical condition known to increase risk of pulmonary fibrosis (e.g., connective tissue disease)
- Prior or current use of nerandomilast, nintedanib, or pirfenidone
- Further exclusion criteria apply
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Up to 164 weeks
Participants receive either Nerandomilast or placebo to help slow down lung changes related to pulmonary fibrosis.
Visits at baseline, Week 26, Week 52, and Week 104
Trial Site Locations
Total: 56 locations
1
University of California Los Angeles
Los Angeles, California, United States, 90095
Not Yet Recruiting
2
University of Colorado Denver
Aurora, Colorado, United States, 80045
Not Yet Recruiting
3
Clinical Research Specialists LLC - Kissimmee
Kissimmee, Florida, United States, 34746
Not Yet Recruiting
4
University of Kansas Medical Center
Kansas City, Kansas, United States, 66160
Not Yet Recruiting
5
Brigham and Women's Hospital
Boston, Massachusetts, United States, 02115
Actively Recruiting
6
University of Michigan
Ann Arbor, Michigan, United States, 48109
Not Yet Recruiting
7
University of Minnesota
Minneapolis, Minnesota, United States, 55455
Not Yet Recruiting
8
Weill Cornell Medicine-New York-60569
New York, New York, United States, 10021
Not Yet Recruiting
9
University of Pennsylvania
Philadelphia, Pennsylvania, United States, 19104
Not Yet Recruiting
10
Medical University of South Carolina
Charleston, South Carolina, United States, 29425
Not Yet Recruiting
11
Vanderbilt University Medical Center
Nashville, Tennessee, United States, 37204
Not Yet Recruiting
12
Baylor College of Medicine
Houston, Texas, United States, 77030
Not Yet Recruiting
13
Virginia Commonwealth University
Richmond, Virginia, United States, 23219
Not Yet Recruiting
14
Centro de Investigaciones Metabolicas (CINME)-C.A.B.A-61553
C.a.b.a, Argentina, C1056ABJ
Not Yet Recruiting
15
Hospital Italiano de Buenos Aires
CABA, Argentina, 1181
Not Yet Recruiting
16
Centro de Investigación Clinica Belgrano
CABA, Argentina, 1425
Actively Recruiting
17
CEDIC - Centro de Investigacion Clinica
CABA, Argentina, C1060ABN
Actively Recruiting
18
Consultorios Médicos del Buen Ayre
Capital Federal, Argentina, 1425
Actively Recruiting
19
Royal Prince Alfred Hospital
Camperdown, New South Wales, Australia, 2050
Not Yet Recruiting
20
Lung Research Queensland
Chermside, Queensland, Australia, 4032
Actively Recruiting
21
The Prince Charles Hospital
Chermside, Queensland, Australia, 4032
Actively Recruiting
22
The Alfred Hospital
Melbourne, Victoria, Australia, 3004
Actively Recruiting
23
Cliniques Universitaires Saint-Luc
Brussels, Belgium, 1200
Actively Recruiting
24
UZ Leuven
Leuven, Belgium, 3000
Actively Recruiting
25
QEII Health Sciences Centre
Halifax, Nova Scotia, Canada, B3H 3A7
Not Yet Recruiting
26
St. Joseph's Healthcare Hamilton
Hamilton, Ontario, Canada, L8N 4A6
Not Yet Recruiting
27
McGill University Health Centre (MUHC)
Montreal, Quebec, Canada, H4A 3J1
Not Yet Recruiting
28
Hôpital Louis Pradel
Bron, France, 69677
Not Yet Recruiting
29
INS Coeur Poumon
Lille, France, 59037
Actively Recruiting
30
HOP Bichat
Paris, France, 75877
Not Yet Recruiting
31
HOP Pontchaillou
Rennes, France, 35033
Actively Recruiting
32
Hôpital Larrey - CHU de Toulouse
Toulouse, France, 31059
Not Yet Recruiting
33
Ruhrlandklinik, Westdeutsches Lungenzentrum am Universitätsklinikum Essen gGmbH
Essen, Germany, 45239
Not Yet Recruiting
34
Medizinische Hochschule Hannover
Hanover, Germany, 30625
Actively Recruiting
35
Lungenfachklinik Immenhausen
Immenhausen, Germany, 34376
Not Yet Recruiting
36
Krankenhaus Bethanien gGmbH
Solingen, Germany, 42699
Not Yet Recruiting
37
IRCCS MultiMedica
Milan, Italy, 20123
Not Yet Recruiting
38
Azienda Ospedaliera Universitaria di Padova
Padova, Italy, 35128
Not Yet Recruiting
39
Fondazione Policlinico Universitario Agostino Gemelli IRCCS
Roma, Italy, 00168
Not Yet Recruiting
40
Tosei General Hospital
Aichi, Seto, Japan, 489-8642
Not Yet Recruiting
41
Tsuboi Hospital
Fukushima, Koriyama, Japan, 963-0197
Actively Recruiting
42
Kanagawa Cardiovascular and Respiratory Center
Kanagawa, Yokohama, Japan, 236-0051
Actively Recruiting
43
National Hospital Organization Kinki-Chuo Chest Medical Center
Osaka, Sakai, Japan, 591-8555
Not Yet Recruiting
44
Hamamatsu University Hospital
Shizuoka, Hamamatsu, Japan, 431-3192
Actively Recruiting
45
National Center for Global Health and Medicine
Tokyo, Shinjuku-ku, Japan, 162-8655
Actively Recruiting
46
St. Antonius Ziekenhuis
Nieuwegein, Netherlands, 3435 CM
Not Yet Recruiting
47
Erasmus Medisch Centrum
Rotterdam, Netherlands, 3015 GD
Not Yet Recruiting
48
Severance Hospital
Seoul, South Korea, 03722
Actively Recruiting
49
Asan Medical Center
Seoul, South Korea, 05505
Not Yet Recruiting
50
Samsung Medical Center
Seoul, South Korea, 06351
Not Yet Recruiting
51
Hospital de Galdakao
Galdakao, Spain, 48960
Not Yet Recruiting
52
Hospital Universitari de Bellvitge
L'Hospitalet Del Llobregat, Spain, 08907
Not Yet Recruiting
53
Hospital Universitario De La Princesa
Madrid, Spain, 28006
Not Yet Recruiting
54
Hospital Virgen del Rocío
Seville, Spain, 41013
Not Yet Recruiting
55
Royal Devon and Exeter Hospital, Wonford
Exeter, United Kingdom, EX2 5DW
Actively Recruiting
56
Royal Brompton Hospital
London, United Kingdom, SW3 6HP
Actively Recruiting
Research Team
B
Boehringer Ingelheim
How is the study designed?
Study Type
INTERVENTIONAL
Masking
QUADRUPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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