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)
A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (Part A: Double-blind, Placebo-controlled in Children From 6 to Less Than 18 Years of Age and Open-label Active Treatment in Children From 2 to Less Than 6 Years of Age), Followed by an Open-label Phase With Active Treatment (Part B)
- Fibrosing Interstitial Lung Disease
At a glance
- Phase
- Phase 3
- Study type
- Interventional
- Sponsor
- Boehringer Ingelheim
- Enrolment target
- 35
- Started
- 21 July 2026
- Main results due
- 27 April 2029
- Study sites
- 47
- Registry updated
- 29 September 2026
Can you take part?
- Ages 2 years to 17 years.
- Open to any sex.
- You need the condition being studied — healthy volunteers are not accepted.
These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.
Read the full eligibility criteria
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.What this study is about
In the sponsor’s own words, from the registry.
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.
Study sites(47)
Children's Hospital Los Angeles
Los Angeles, California, United States
Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, United States
Not yet recruiting
Johns Hopkins Hospital
Baltimore, Maryland, United States
Not yet recruiting
Boston Children's Hospital
Boston, Massachusetts, United States
Not yet recruiting
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, United States
Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, United States
Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, United States
Not yet recruiting
Fundacion Respirar
CABA, Argentina
Recruiting
Women's and Children's Hospital
North Adelaide, South Australia, Australia
Not yet recruiting
Brussels - UNIV HUDERF
Brussels, Belgium
Not yet recruiting
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, Brazil
Recruiting
Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles
Porto Alegre, Brazil
Recruiting
IMIP Pernambuco
Recife, Brazil
Recruiting
Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP
São Paulo, Brazil
Recruiting
Alberta Children's Hospital
Calgary, Alberta, Canada
Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario, Canada
Not yet recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, China
Recruiting
Hunan Provincial People's Hospital
Changsha, China
Recruiting
The Children's Hospital of Fudan University
Shanghai, China
Recruiting
University Hospital Motol
Prague, Czechia
Not yet recruiting
Aarhus University Hospital
Aarhus N, Denmark
Not yet recruiting
HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö
Helsinki, Finland
Not yet recruiting
Tampere University Hospital
Tampere, Finland
Recruiting
HOP Femme Mère Enfant
Bron, France
Not yet recruiting
HOP Intercommunal
Créteil, France
Not yet recruiting
HOP Timone
Marseille, France
Not yet recruiting
HOP Armand-Trousseau
Paris, France
Not yet recruiting
HOP Necker - Enfants Malades
Paris, France
Recruiting
Charité - Universitätsmedizin Berlin
Berlin, Germany
Recruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Hamburg, Germany
Not yet recruiting
Medizinische Hochschule Hannover
Hanover, Germany
Recruiting
Aristotle University, Thessaloniki
Thessaloniki, Greece
Not yet recruiting
Istituto G. Gaslini
Genova, Italy
Recruiting
Ospedale Pediatrico Bambino Gesù
Roma, Italy
Not yet recruiting
Fukuoka Children's Hospital
Fukuoka, Fukuoka, Japan
Not yet recruiting
Osaka Women's and Children's Hospital
Osaka, Izumi, Japan
Not yet recruiting
National Center for Child Health and Development
Tokyo, Setagaya-ku, Japan
Not yet recruiting
Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
Guadalajara, Mexico
Not yet recruiting
Clinical Research Institute S.C.
Tlalnepantla, Mexico
Not yet recruiting
Amsterdam University Medical Center
Amsterdam, Netherlands
Not yet recruiting
University Clinical Center of the Medical University of Warsaw
Warsaw, Poland
Not yet recruiting
ULS de Santa Maria, E.P.E
Lisbon, Portugal
Not yet recruiting
Seoul National University Hospital
Seoul, South Korea
Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, Spain
Recruiting
Hospital Virgen del Rocio
Seville, Spain
Recruiting
Birmingham Children's Hospital
Birmingham, United Kingdom
Not yet recruiting
King's College Hospital
London, United Kingdom
Not yet recruiting
Showing 47 of 47 sites. 16 of the 47 sites on this study are recruiting right now — a site can stop enrolling while the study as a whole is still open.
Source: ClinicalTrials.gov record NCT07366034. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.
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