Last updated 8 days ago
A Study to Find Out How Nerandomilast is Tolerated, Handled by the Body, and if it Helps Children and Adolescents With Interstitial Lung Disease
35 patients around the world
Available in Argentina, United States, Mexico, Brazil
Boehringer Ingelheim
4Research sites
35Patients around the world
This study is for people with
Interstitial Lung Disease
Requirements for the patient
To 17 Years
All Gender
Medical requirements
- 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.Documented evidence of clinical progression over time based on either.A 5-10% relative decline in FVC % predicted accompanied by worsening symptoms.A ≥10% relative decline in FVC % predicted.Increased fibrosis on HRCT.Other measures of clinical worsening attributed to progressive lung disease (e.g. increased oxygen requirement, decreased diffusion capacity).
- 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.
Sites
Fundación Respirar
Hospital de Pediatría Dr. Juan P. Garrahan
Serviços Médicos Respirar Sul Fluminense
Instituto da Criança e do Adolescente - ICr HCFMUSP
SponsorBoehringer Ingelheim
Study typeInterventional
Conditions
Interstitial Lung Disease
Requirements
To 17 YearsAll Gender
Unique study IDclinicaltrials.gov
NCT07366034
