Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-26 @ 3:19 PM
NCT ID:
NCT07366034
Eligibility Criteria:
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.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
2 Years
Maximum Age:
17 Years
Study:
NCT07366034
Study Brief:
Protocol Section:
NCT07366034