Actively Recruiting

Phase 3
Age: 40Years +
All Genders
NCT07201922

A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Led by Boehringer Ingelheim · Updated on 2026-05-14

80

Participants Needed

56

Research Sites

171 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis. Participants are put into one of 2 groups randomly, which means the group is chosen 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 twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo. Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months. Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.

CONDITIONS

Official 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

Age: 40Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Individuals 40 years of age or older at the time of informed consent
  • Have at least one first-degree relative with confirmed pulmonary fibrosis (including IPF, NSIP, or genetic causes)
  • High resolution CT scan showing interstitial lung abnormalities involving at least 5% of a single lung zone or interstitial lung disease
  • Forced vital capacity (FVC) at least 80% of predicted normal
  • Lung diffusing capacity for carbon monoxide (DLCO), corrected for hemoglobin, at least 70% of predicted normal
  • Further inclusion criteria apply
Not Eligible

You will not qualify if you...

  • Prior known pulmonary fibrosis requiring approved treatment
  • Prebronchodilator FEV1/FVC ratio less than 0.7 at Visit 1b
  • CT scan findings consistent with probable or definite usual interstitial pneumonia (UIP) pattern
  • Any medical condition that predisposes to pulmonary fibrosis such as known 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

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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, 23298

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

Not Yet Recruiting

17

CEDIC - Centro de Investigacion Clinica

CABA, Argentina, C1060ABN

Actively Recruiting

18

Consultorios Médicos del Buen Ayre

Capital Federal, Argentina, 1425

Not Yet 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

Not Yet Recruiting

22

The Alfred Hospital

Melbourne, Victoria, Australia, 3004

Actively Recruiting

23

Cliniques Universitaires Saint-Luc

Brussels, Belgium, 1200

Not Yet 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

Not Yet 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

Not Yet 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

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Research Team

B

Boehringer Ingelheim

CONTACT

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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