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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)

RecruitingPhase 3Ages 2 Years - 17 YearsAllBoehringer Ingelheim
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In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

๐Ÿ“‹ Eligibility rules (as published)
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 โ‰ฅ6 years: Participants with forced vital capacity (FVC) % predicted โ‰ฅ25% 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 โ‰ฅ3, 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 โ‰ฅ10% 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 โ‰ฅ8. Further exclusion criteria apply.
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What it tests

  • Nerandomilast
  • Placebo
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Where

47 sites
Children's Hospital Los Angeles
Los Angeles, United States
Children's Hospital Colorado
Aurora, United States
Johns Hopkins Hospital
Baltimore, United States
Boston Children's Hospital
Boston, United States
M Health Fairview Masonic Children's Hospital
Minneapolis, United States
Nationwide Children's Hospital
Columbus, United States
Children's Hospital of Philadelphia
Philadelphia, United States
Fundacion Respirar
CABA, Argentina

โ€ฆand 39 more on ClinicalTrials.gov.

๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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