Not medical advice. This website is not medical advice, a diagnosis, a match to a trial, or a recommendation to join a study. Listings are plain-English rewrites of public ClinicalTrials.gov records. Whether a site is still enrolling, and whether you qualify, can only be confirmed by the study team and your clinician. Source registry: ClinicalTrials.gov. Editorial rules: methodology.
PlainTrials
RecruitingPhase 3interventionalRules rewrite

Phase 3: testing Nerandomilast for Fibrosing Interstitial Lung Disease

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.

Official registry: https://clinicaltrials.gov/study/NCT07366034 · Boehringer Ingelheim · enrollment listed as 35

What this phase means

Phase 3: this treatment already looked useful in smaller studies. Now it is tested in a large group, often against standard care or a dummy treatment, to see if it should be approved.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Nerandomilast, or Placebo. The registry lists allocation as randomized. This study is open to children and adolescents aged 2 to 17 years with interstitial lung disease (ILD).

They plan to enroll about 35 people at 47 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

A Study to Evaluate the Dose-exposure, Safety, and Exploratory Efficacy of Nerandomilast in Children and Adolescents From 2 Years to Less Than 18 Years of Age With Fibrosing Interstitial Lung Disease (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), Followed by an Open-label Phase With Active Treatment (Part B)

Interventions: Nerandomilast, Placebo

Primary outcome (registry wording): 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

Who it is for (from inclusion criteria)

  • Ages 2 Years to 17 Years
  • 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:
  • 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

Public study contact (from the registry)

Boehringer Ingelheim

1-800-243-0127

clintriage.rdg@boehringer-ingelheim.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

47 listed

+ 40 sites outside the US on the same record

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FAQ about this NCT record

Is NCT07366034 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07366034?

Phase 3. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07366034?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary