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Hope for kids with scarred lungs: new drug trial launches

NCT ID NCT07366034

Disease control Sponsor: Boehringer Ingelheim Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 27, 2026 · Last updated Sep 16, 2026 · Updated 11 times

Summary

This study tests a medicine called nerandomilast in children aged 2 to 17 with fibrosing interstitial lung disease, a condition where lung tissue becomes scarred and stiff. The goal is to see if the drug is safe and how the body processes it, and to get early signs of whether it helps lung function. Some children will receive the drug, others a placebo for 6 months, then all get the drug for at least 2 more years.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 35 people

The number the study aims to enrol. It can still change while the study runs.

Started

Jul 2026

Expected to finish

Apr 2031

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

2 to 17 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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.

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Conditions

The condition(s) this trial relates to.

interstitial lung disease pulmonary fibrosis

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Fibrosing interstitial lung disease

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    47 sites in 22 countries. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. A doctor treating you

    A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.

Contacts and locations

Locations

  • Aarhus University Hospital

    NOT_YET_RECRUITING

    Aarhus N, 8200, Denmark

  • Alberta Children's Hospital

    NOT_YET_RECRUITING

    Calgary, Alberta, T3B 6A8, Canada

  • Amsterdam University Medical Center

    NOT_YET_RECRUITING

    Amsterdam, 1105 AZ, Netherlands

  • Aristotle University, Thessaloniki

    NOT_YET_RECRUITING

    Thessaloniki, 54642, Greece

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

    NOT_YET_RECRUITING

    Porto Alegre, 90160-093, Brazil

  • Beijing Children's Hospital, Capital Medical University

    RECRUITING

    Beijing, 100045, China

  • Birmingham Children's Hospital

    NOT_YET_RECRUITING

    Birmingham, B4 6NH, United Kingdom

  • Boston Children's Hospital

    NOT_YET_RECRUITING

    Boston, Massachusetts, 02115, United States

  • Brussels - UNIV HUDERF

    NOT_YET_RECRUITING

    Brussels, 1020, Belgium

  • Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)

    NOT_YET_RECRUITING

    Guadalajara, 44340, Mexico

  • Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP

    RECRUITING

    São Paulo, 5403-900, Brazil

  • Charité - Universitätsmedizin Berlin

    NOT_YET_RECRUITING

    Berlin, 13353, Germany

  • Children's Hospital Colorado

    NOT_YET_RECRUITING

    Aurora, Colorado, 80045, United States

  • Children's Hospital Los Angeles

    NOT_YET_RECRUITING

    Los Angeles, California, 90027, United States

  • Children's Hospital of Philadelphia

    NOT_YET_RECRUITING

    Philadelphia, Pennsylvania, 19104, United States

  • Clinical Research Institute S.C.

    NOT_YET_RECRUITING

    Tlalnepantla, 54055, Mexico

  • Fukuoka Children's Hospital

    NOT_YET_RECRUITING

    Fukuoka, Fukuoka, 813-0017, Japan

  • Fundacion Respirar

    RECRUITING

    CABA, 1426, Argentina

  • HOP Armand-Trousseau

    NOT_YET_RECRUITING

    Paris, 75012, France

  • HOP Femme Mère Enfant

    NOT_YET_RECRUITING

    Bron, 69677, France

  • HOP Intercommunal

    NOT_YET_RECRUITING

    Créteil, 94000, France

  • HOP Necker - Enfants Malades

    RECRUITING

    Paris, 75015, France

  • HOP Timone

    NOT_YET_RECRUITING

    Marseille, 13387, France

  • HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö

    NOT_YET_RECRUITING

    Helsinki, PL 281, 00029, Finland

  • Hamburger Zentrum für Kinder- und Jugendrheumatologie

    NOT_YET_RECRUITING

    Hamburg, 22081, Germany

  • Hospital Universitari Vall d'Hebron

    RECRUITING

    Barcelona, 08035, Spain

  • Hospital Virgen del Rocio

    NOT_YET_RECRUITING

    Seville, 41013, Spain

  • Hunan Provincial People's Hospital

    RECRUITING

    Changsha, 410005, China

  • IMIP Pernambuco

    NOT_YET_RECRUITING

    Recife, 50070-550, Brazil

  • Istituto G. Gaslini

    RECRUITING

    Genova, 16147, Italy

  • Johns Hopkins Hospital

    NOT_YET_RECRUITING

    Baltimore, Maryland, 21287, United States

  • King's College Hospital

    NOT_YET_RECRUITING

    London, SE5 9RS, United Kingdom

  • M Health Fairview Masonic Children's Hospital

    NOT_YET_RECRUITING

    Minneapolis, Minnesota, 55454, United States

  • Medizinische Hochschule Hannover

    RECRUITING

    Hanover, 30625, Germany

  • National Center for Child Health and Development

    NOT_YET_RECRUITING

    Tokyo, Setagaya-ku, 157-8535, Japan

  • Nationwide Children's Hospital

    NOT_YET_RECRUITING

    Columbus, Ohio, 43205, United States

  • Osaka Women's and Children's Hospital

    NOT_YET_RECRUITING

    Osaka, Izumi, 594-1101, Japan

  • Ospedale Pediatrico Bambino Gesù

    NOT_YET_RECRUITING

    Roma, 00165, Italy

  • Seoul National University Hospital

    RECRUITING

    Seoul, 03080, South Korea

  • Serviços Medicos Respirar Sul Fluminense

    RECRUITING

    Barra Mansa, 27323240, Brazil

  • Tampere University Hospital

    RECRUITING

    Tampere, 33520, Finland

  • The Children's Hospital of Fudan University

    RECRUITING

    Shanghai, 201102, China

  • The Hospital for Sick Children

    NOT_YET_RECRUITING

    Toronto, Ontario, M5G 1X8, Canada

  • ULS de Santa Maria, E.P.E

    NOT_YET_RECRUITING

    Lisbon, 1649-035, Portugal

  • University Clinical Center of the Medical University of Warsaw

    NOT_YET_RECRUITING

    Warsaw, 02 091, Poland

  • University Hospital Motol

    NOT_YET_RECRUITING

    Prague, 150 00, Czechia

  • Women's and Children's Hospital

    NOT_YET_RECRUITING

    North Adelaide, South Australia, 5006, Australia

More trials for these conditions

Other studies related to the condition(s) this trial covers.