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)

May 11, 2026 updated by: Boehringer Ingelheim

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)

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 Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

35

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Argentina
      • CABA, Argentina, C1245AAM
        • Hospital de Pediatria Prof. Dr. Juan P. Garrahan
        • Contact:
      • CABA, Argentina, 1426
  • Belgium
      • Brussels, Belgium, 1020
  • Brazil
      • Barra Mansa, Brazil, 27323240
        • Serviços Medicos Respirar Sul Fluminense
        • Contact:
      • Porto Alegre, Brazil, 90160-093
        • Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles
        • Contact:
      • Recife, Brazil, 50070-550
      • São Paulo, Brazil, 5403-900
        • Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP
        • Contact:
  • Canada
    • Alberta
      • Calgary, Alberta, Canada, T3B 6A8
    • Ontario
      • Toronto, Ontario, Canada, M5G 1X8
  • China
      • Beijing, China, 100045
        • Beijing Children's Hospital, Capital Medical University
        • Contact:
      • Changsha, China, 410005
        • Hunan Provincial People's Hospital
        • Contact:
      • Shanghai, China, 201102
        • The Children's Hospital of Fudan University
        • Contact:
  • Czechia
      • Prague, Czechia, 150 00
  • Denmark
      • Aarhus N, Denmark, 8200
  • Finland
      • Helsinki, Finland, PL 281, 00029
        • HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö
        • Contact:
      • Tampere, Finland, 33520
  • France
      • Bron, France, 69677
      • Créteil, France, 94000
      • Marseille, France, 13387
      • Paris, France, 75012
      • Paris, France, 75015
  • Germany
      • Berlin, Germany, 13353
      • Hamburg, Germany, 22081
        • Hamburger Zentrum für Kinder- und Jugendrheumatologie
        • Contact:
      • Hanover, Germany, 30625
  • Greece
      • Thessaloniki, Greece, 54642
        • Aristotle University, Thessaloniki
        • Contact:
  • Italy
      • Genova, Italy, 16147
      • Roma, Italy, 00165
  • Japan
      • Fukuoka, Fukuoka, Japan, 813-0017
      • Osaka, Izumi, Japan, 594-1101
        • Osaka Women's and Children's Hospital
        • Contact:
      • Tokyo, Setagaya-ku, Japan, 157-8535
        • National Center for Child Health and Development
        • Contact:
  • Mexico
      • Guadalajara, Mexico, 44340
        • Centro de Investigación Clínica y Medicina Traslacional (CIMeT)
        • Contact:
  • Netherlands
      • Amsterdam, Netherlands, 1105 AZ
  • Poland
      • Warsaw, Poland, 02 091
        • University Clinical Center of the Medical University of Warsaw
        • Contact:
  • Portugal
      • Lisbon, Portugal, 1649-035
  • South Korea
      • Seoul, South Korea, 03080
  • Spain
      • Barcelona, Spain, 08035
      • Seville, Spain, 41013
  • United Kingdom
  • United States
    • California
      • Los Angeles, California, United States, 90027
    • Colorado
      • Aurora, Colorado, United States, 80045
    • Maryland
      • Baltimore, Maryland, United States, 21287
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
    • Minnesota
      • Minneapolis, Minnesota, United States, 55454
    • Ohio
      • Columbus, Ohio, United States, 43205
    • Pennsylvania
      • Philadelphia, Pennsylvania, United States, 19104

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Participants aged 2 to <6 years
Part A and Part B: Nerandomilast (open-label)
Drug: Nerandomilast
Nerandomilast
Other Names:
  • JASCAYD®
Experimental: Participants aged 6 to <18 years, group 1
Part A: Nerandomilast (blinded), Part B: Nerandomilast (open-label)
Drug: Nerandomilast
Nerandomilast
Other Names:
  • JASCAYD®
Experimental: Participants aged 6 to <18 years, group 2
Part A: Placebo (blinded), Part B: Nerandomilast (open-label)
Drug: Placebo
Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Area under the concentration curve (AUC) T,SS based on sampling at steady state using rich sampling in participants from 6 years to less than 18 years and sparse sampling in participants younger than 6 years
Time Frame: At week 2 in Part A and Week 28 in Part B
At week 2 in Part A and Week 28 in Part B
Occurrence of a treatment-emergent adverse event
Time Frame: up to Week 26
up to Week 26

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest
Time Frame: at Week 26 and Week 52
at Week 26 and Week 52
Absolute change from baseline in height [cm]
Time Frame: at Week 26 and Week 52
at Week 26 and Week 52
Absolute change from baseline in pediatric quality of life inventory (PedsQL™)
Time Frame: at Week 26 and Week 52
Health-related quality of life will be assessed in children using the PedsQL™ questionnaire. For younger children who are unable to perform self-assessment, a parent proxy may be required. The score ranges from 0-100, a higher score indicates a better health related quality of life.
at Week 26 and Week 52
Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial
Time Frame: up to 5 years
up to 5 years
Time to first respiratory-related hospitalisation [days] over the whole trial
Time Frame: up to 5 years
up to 5 years
Time to first acute interstitial lung disease (ILD) exacerbation or death [days] over the whole trial
Time Frame: up to 5 years
up to 5 years
Time to death [days] over the whole trial
Time Frame: up to 5 years
up to 5 years
Absolute change from baseline in FVC [% predicted] (applicable to participants ≥6 years)
Time Frame: at Week 26 and Week 52
at Week 26 and Week 52
Absolute change from baseline in 6-min walk distance [m] (applicable to participants ≥6 years)
Time Frame: at Week 26 and Week 52
at Week 26 and Week 52
Acceptability based on number/size of tablets
Time Frame: at Week 2 and Week 26

Acceptability is defined as the overall ability and willingness of the participant to use the medicinal product as intended.

Assessment of acceptability will be performed by the participant using the acceptability questionnaire.
at Week 2 and Week 26
Acceptability based on the use of the dispenser
Time Frame: at Week 2 and Week 26
at Week 2 and Week 26

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Boehringer Ingelheim

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

July 27, 2026

Primary Completion (Estimated)

April 27, 2029

Study Completion (Estimated)

April 14, 2031

Study Registration Dates

First Submitted

January 23, 2026

First Submitted That Met QC Criteria

January 23, 2026

First Posted (Actual)

January 26, 2026

Study Record Updates

Last Update Posted (Actual)

May 12, 2026

Last Update Submitted That Met QC Criteria

May 11, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Other Study ID Numbers

  • 1305-0022
  • 2025-523369-32-00 (Registry Identifier: CTIS)
  • 1111-1326-6351 (Registry Identifier: WHO - International Clinical Trials Registry Platform (ICTRP))

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement".

Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.

IPD Sharing Time Frame

One year after the approval has been granted by major Regulatory Authorities and after the primary manuscript has been accepted for publication, or after termination of the development program.

IPD Sharing Access Criteria

For study documents - upon signing of a 'Document Sharing Agreement'.

For study data - 1. after the submission and approval of the research proposal (checks will be performed by the sponsor and/or the independent review panel, including checking that the planned analysis does not compete with sponsor's publication plan); 2. and upon signing of a legal agreement.

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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