Nerandomilast in children with fibrosing ILD: tolerability and potential benefit

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This Phase 3 trial investigates nerandomilast in participants aged 2 to 17 with fibrosing ILD. In participants aged 6 to 17, the study begins with random assignment to nerandomilast or placebo for 6 months, followed by a period where all participants receive nerandomilast for at least 2 years. The study evaluates safety, pharmacokinetics, and clinical outcomes, including lung function and imaging, to see if nerandomilast can provide clinical benefit. Enrollment requires confirmed fibrosing ILD on HRCT and adequate lung function among older children, with ongoing monitoring through central review and investigator assessments.

Why it matters

Who can join: the full rules

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.

Where it's running

• Children's Hospital Colorado
  Aurora, Colorado, United States Recruiting
• Boston Children's Hospital
  Boston, Massachusetts, United States Recruiting
• M Health Fairview Masonic Children's Hospital
  Minneapolis, Minnesota, United States Recruiting
• Fundacion Respirar
  Caba, Argentina Recruiting
• Women's and Children's Hospital
  North Adelaide, South Australia, Australia Recruiting
• Brussels - UNIV HUDERF
  Brussels, Belgium Recruiting

Study contacts

• Study coordinator: Boehringer Ingelheim
• Email: clintriage.rdg@boehringer-ingelheim.com
• Phone: 1-800-243-0127

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.