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New treatment option for Fibrosing Interstitial Lung Disease
Official title 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)
ClinicalTrials.gov ID: NCT07366034
What this study is testing
What is Nerandomilast?
Nerandomilast is an investigational medicine, given as a twice-daily pill taken by mouth, being studied as a potential treatment for fibrosing interstitial lung disease.
Also referred to as JASCAYD®.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 2 to 17
You may be able to join if
- 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...
- 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
You likely can't join if
- 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).
See the full eligibility 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 apply.
- 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...
- Participants with clinically significant depression symptoms defined as the short version of mood and feeling questionnaire (SMFQ) score ≥8. Further exclusion criteria apply.
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Aurora, Colorado, United States
- Baltimore, Maryland, United States
- Boston, Massachusetts, United States
- Minneapolis, Minnesota, United States
- Columbus, Ohio, United States
- Philadelphia, Pennsylvania, United States
- CABA, Argentina
- North Adelaide, South Australia, Australia
- Brussels, Belgium
- Barra Mansa, Brazil
- Porto Alegre, Brazil
- Recife, Brazil
- São Paulo, Brazil
- Calgary, Alberta, Canada
- Toronto, Ontario, Canada
- Beijing, China
- Changsha, China
- Shanghai, China
- Prague, Czechia
+ 26 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 2 years to 17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Aurora, Colorado, United States; Baltimore, Maryland, United States; Boston, Massachusetts, United States; Minneapolis, Minnesota, United States; Columbus, Ohio, United States and 40 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.