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

NCT07366034 | Not Yet Recruiting Phase 3 DMC FDA Drug

• 3 other identifiers: 1305-00222025-523369-32-001111-1326-6351
• Study Type: interventional
• Target: 35
• Locations: 20 countries
• Sites: 44

Brief 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.

Conditions

Fibrosing Interstitial Lung Disease

Outcome Measures

Primary Outcomes (2)

• 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

  At week 2 in Part A and Week 28 in Part B

• Occurrence of a treatment-emergent adverse event

  up to Week 26

Secondary Outcomes (11)

• Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest

  at Week 26 and Week 52

• Absolute change from baseline in height [cm]

  at Week 26 and Week 52

• Absolute change from baseline in pediatric quality of life inventory (PedsQL™)

  at Week 26 and Week 52

• Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial

  up to 5 years

• Time to first respiratory-related hospitalisation [days] over the whole trial

  up to 5 years

Study Arms (3)

Participants aged 2 to <6 years

EXPERIMENTAL

Part A and Part B: Nerandomilast (open-label)

Drug: Nerandomilast

Participants aged 6 to <18 years, group 1

EXPERIMENTAL

Part A: Nerandomilast (blinded), Part B: Nerandomilast (open-label)

Drug: Nerandomilast

Participants aged 6 to <18 years, group 2

EXPERIMENTAL

Part A: Placebo (blinded), Part B: Nerandomilast (open-label)

Drug: Placebo

Interventions

Nerandomilast DRUG

Nerandomilast

Also known as: JASCAYD®

Participants aged 2 to <6 years; Participants aged 6 to <18 years, group 1

Placebo DRUG

Placebo

Participants aged 6 to <18 years, group 2

Eligibility Criteria

• Age: 2 Years - 17 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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).

You may not qualify if:

• 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.

Sponsors & Collaborators

• Boehringer Ingelheim: lead

Study Sites (44)

Children's Hospital Los Angeles

Los Angeles, California, 90027, United States

Location

Children's Hospital Colorado

Aurora, Colorado, 80045, United States

Location

Johns Hopkins Hospital

Baltimore, Maryland, 21287, United States

Location

Boston Children's Hospital

Boston, Massachusetts, 02115, United States

Location

University of Minnesota

Minneapolis, Minnesota, 55454, United States

Location

Nationwide Children's Hospital

Columbus, Ohio, 43205, United States

Location

Children's Hospital of Philadelphia

Philadelphia, Pennsylvania, 19104, United States

Location

Fundacion Respirar

CABA, 1426, Argentina

Location

Hospital de Pediatria Prof. Dr. Juan P. Garrahan

CABA, C1245AAM, Argentina

Location

Brussels - UNIV HUDERF

Brussels, 1020, Belgium

Location

Serviços Medicos Respirar Sul Fluminense

Barra Mansa, 27323240, Brazil

Location

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

Porto Alegre, 90160-093, Brazil

Location

IMIP Pernambuco

Recife, 50070-550, Brazil

Location

Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP

São Paulo, 5403-900, Brazil

Location

Alberta Children's Hospital

Calgary, Alberta, T3B 6A8, Canada

Location

The Hospital for Sick Children

Toronto, Ontario, M5G 1X8, Canada

Location

Beijing Children's Hospital, Capital Medical University

Beijing, 100045, China

Location

Hunan Provincial People's Hospital

Changsha, 410005, China

Location

The Children's Hospital of Fudan University

Shanghai, 201102, China

Location

University Hospital Motol

Prague, 150 00, Czechia

Location

Aarhus University Hospital

Aarhus N, 8200, Denmark

Location

HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö

Helsinki, PL 281, 00029, Finland

Location

Tampere University Hospital

Tampere, 33520, Finland

Location

HOP Femme Mère Enfant

Bron, 69677, France

Location

HOP Intercommunal

Créteil, 94000, France

Location

HOP Timone

Marseille, 13387, France

Location

HOP Armand-Trousseau

Paris, 75012, France

Location

HOP Necker - Enfants Malades

Paris, 75015, France

Location

Charité - Universitätsmedizin Berlin

Berlin, 13353, Germany

Location

Hamburger Zentrum für Kinder- und Jugendrheumatologie

Hamburg, 22081, Germany

Location

Medizinische Hochschule Hannover

Hanover, 30625, Germany

Location

Aristotle University, Thessaloniki

Thessaloniki, 54642, Greece

Location

Istituto G. Gaslini

Genova, 16147, Italy

Location

Osp. Pediatrico Bambin Gesù

Roma, 00165, Italy

Location

Fukuoka Children's Hospital

Fukuoka, Fukuoka, 813-0017, Japan

Location

Osaka Women's and Children's Hospital

Osaka, Izumi, 594-1101, Japan

Location

National Center for Child Health and Development

Tokyo, Setagaya-ku, 157-8535, Japan

Location

Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)

Guadalajara, 44340, Mexico

Location

Amsterdam University Medical Center

Amsterdam, 1105 AZ, Netherlands

Location

University Clinical Center of the Medical University of Warsaw

Warsaw, 02 091, Poland

Location

ULS de Santa Maria, E.P.E

Lisbon, 1649-035, Portugal

Location

Seoul National University Hospital

Seoul, 03080, South Korea

Location

Hospital Universitari Vall d'Hebron

Barcelona, 08035, Spain

Location

Hospital Virgen del Rocío

Seville, 41013, Spain

Location

Related Links

• Related Info

Central Study Contacts

Boehringer Ingelheim

CONTACT

1-800-243-0127; clintriage.rdg@boehringer-ingelheim.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Masking applies to double-blind part of the trial.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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 Part B: \- open-label phase with active treatment

Study Record Dates

• First Submitted: January 23, 2026
• First Posted: January 26, 2026
• Study Start (Estimated): July 27, 2026
• Primary Completion (Estimated): April 27, 2029
• Study Completion (Estimated): April 14, 2031
• Last Updated: April 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• 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.
• 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.

Locations

CZ (1); AR (2); IT (2); ME (1); CA (2); PT (1); NL (1); FR (5); DK (1); DE (3); ES (2); GR (1); FI (2); PL (1); JP (3); BE (1); BR (4); US (7); CN (3); KR (1)