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NCT07366034PHASE3Recruiting

A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease (FIBRONEER-chILD)

Boehringer Ingelheim

Start Date

7/22/2026

Completion Date

4/14/2031

Summary

This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD). Nerandomilast has just been approved in some countries to help adults with a lung condition called idiopathic pulmonary fibrosis. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD. For participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine. Participants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part. Young participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years. Depending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents.

Eligibility Criteria

Age Range: 2 years to 17 years

Inclusion Criteria: * Children and adolescents 2 to \<18 years old at Visit 2. * Participants with evidence of fibrosing ILD on high-resolution computed tomography (HRCT) within 12 months of Visit 1 as assessed by the investigator and confirmed by central review. * For children ≥6 years: Participants with forced vital capacity (FVC) % predicted ≥25% at Visit 2. * Participants with clinically significant fibrosing ILD at Visit 2, as assessed by the investigator based on any of the following: * Fan score ≥3, or * Documented evidence of clinical progression over time based on either * a 5-10% relative decline in FVC % predicted accompanied by worsening symptoms, or * a ≥10% relative decline in FVC % predicted, or * increased fibrosis on HRCT, or * other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity). Further inclusion criteria apply. Exclusion Criteria: * Previous treatment with nerandomilast. * Participants treated with other oral/systemic PDE4 and non-selective PDE inhibitors within 30 days before Visit 1. * Participants treated with pirfenidone in the 8 weeks prior to Visit 1. * Unstable pulmonary arterial hypertension (PAH). * Active vasculitis, unstable or uncontrolled within 8 weeks prior to Visit 1 or during the screening period. * Any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour) in the past (lifetime). * Any suicidal ideation of type 4 or 5 on the columbia suicidal severity rating scale (C-SSRS) in the past 3 months at Visit 1 or at Visit 2 (i.e. active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent, and plan). * Participants with clinically significant depression symptoms defined as the short version of mood and feeling questionnaire (SMFQ) score ≥8. Further exclusion criteria apply.

Interventions

DRUG

Nerandomilast

DRUG

Placebo

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Conditions

Fibrosing Interstitial Lung Disease

Locations

Children's Hospital Los Angeles

Los Angeles, California 90027

United States

Children's Hospital Colorado

Aurora, Colorado 80045

United States

Johns Hopkins Hospital

Baltimore, Maryland 21287

United States

Boston Children's Hospital

Boston, Massachusetts 02115

United States

University of Minnesota

Minneapolis, Minnesota 55454

United States

Nationwide Children's Hospital

Columbus, Ohio 43205

United States

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania 19104

United States

Fundacion Respirar

CABA, 1426

Argentina

Hospital de Pediatria Prof. Dr. Juan P. Garrahan

CABA, C1245AAM

Argentina

Women's and Children's Hospital

North Adelaide, South Australia 5006

Australia

Brussels - UNIV HUDERF

Brussels, 1020

Belgium

Serviços Medicos Respirar Sul Fluminense

Barra Mansa, 27323240

Brazil

Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles

Porto Alegre, 90160-093

Brazil

IMIP Pernambuco

Recife, 50070-550

Brazil

Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP

São Paulo, 5403-900

Brazil

Alberta Children's Hospital

Calgary, Alberta T3B 6A8

Canada

The Hospital for Sick Children

Toronto, Ontario M5G 1X8

Canada

Beijing Children's Hospital, Capital Medical University

Beijing, 100045

China

Hunan Provincial People's Hospital (The First Affiliated Hospital of Hunan Normal University)

Changsha, 410005

China

The Children's Hospital of Fudan University

Shanghai, 201102

China

University Hospital Motol

Prague, 150 00

Czechia

Aarhus University Hospital

Aarhus N, 8200

Denmark

HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö

Helsinki, PL 281, 00029

Finland

Tampere University Hospital

Tampere, 33520

Finland

HOP Femme Mère Enfant

Bron, 69677

France

HOP Intercommunal

Créteil, 94000

France

HOP Timone

Marseille, 13387

France

HOP Armand-Trousseau

Paris, 75012

France

HOP Necker - Enfants Malades

Paris, 75015

France

Charité - Universitätsmedizin Berlin

Berlin, 13353

Germany

Hamburger Zentrum für Kinder- und Jugendrheumatologie

Hamburg, 22081

Germany

Medizinische Hochschule Hannover

Hanover, 30625

Germany

Aristotle University, Thessaloniki

Thessaloniki, 54642

Greece

Istituto G. Gaslini

Genova, 16147

Italy

Ospedale Pediatrico Bambino Gesù

Roma, 00165

Italy

Fukuoka Children's Hospital

Fukuoka, Fukuoka, 813-0017

Japan

Osaka Women's and Children's Hospital

Osaka, Izumi, 594-1101

Japan

National Center for Child Health and Development

Tokyo, Setagaya-ku, 157-8535

Japan

Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)

Guadalajara, 44340

Mexico

Clinical Research Institute S.C.

Tlalnepantla, 54055

Mexico

Amsterdam University Medical Center

Amsterdam, 1105 AZ

Netherlands

University Clinical Center of the Medical University of Warsaw

Warsaw, 02 091

Poland

ULS de Santa Maria, E.P.E

Lisbon, 1649-035

Portugal

Seoul National University Hospital

Seoul, 03080

South Korea

Hospital Universitari Vall d'Hebron

Barcelona, 08035

Spain

Hospital Virgen del Rocío

Seville, 41013

Spain

Birmingham Children's Hospital

Birmingham, B4 6NH

United Kingdom

King's College Hospital

London, SE5 9RS

United Kingdom