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)

Conditions

• Fibrosing Interstitial Lung Disease

Eligibility Criteria

Sex

ALL

Age

2 Years - 17 Years

Healthy Volunteers

Not accepted

Interventions

• Nerandomilast — DRUG
  Nerandomilast
• Placebo — DRUG
  Placebo

Study Details

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. The purpose of this study is to understand how nerandomilast is tolerated and handled by the body and whether nerandomilast also helps children and adolescents with ILD. For participants aged 6 to 17 years when joining, the study has 2 parts. In the first part, participants are put into 1 of 2 groups randomly, which means by chance. One group gets nerandomilast and the other group placebo. Placebo looks like nerandomilast but does not contain any medicine. Participants are twice as likely to be in the nerandomilast group. They take tablets twice a day for 6 months. After these 6 months, in the second part of this study, they get nerandomilast for at least 2 years regardless of what they got in the first part. Young participants aged 2 to 5 years when joining get nerandomilast from the start. They receive tablets twice a day for at least 2 and a half years. Depending on when a person joins, the study lasts between 2 and a half years and up to 5 years. During this time, participants may visit the study site about 18 to 30 times. Study doctors collect blood samples to check participants' health and to find out how their body handles the study medicine. Doctors also check the function of the lungs, body growth, and how participants feel. The study doctors also regularly check participants' health and take note of any changes. For participants aged 6 to 17 years, the results are compared between the groups to see whether nerandomilast treatment helps children and adolescents.

Key Dates

Start date

Jul 27, 2026

Status verified

May 2026

Primary completion

Apr 27, 2029

Completion

Apr 14, 2031

Study Design

Enrollment

35 participants (estimated)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Experimental: Participants aged 2 to <6 years
  Part A and Part B: Nerandomilast (open-label)
• Experimental: Participants aged 6 to <18 years, group 1
  Part A: Nerandomilast (blinded), Part B: Nerandomilast (open-label)
• Experimental: Participants aged 6 to <18 years, group 2
  Part A: Placebo (blinded), Part B: Nerandomilast (open-label)

Primary Outcome Measure

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 [ Time Frame: At week 2 in Part A and Week 28 in Part B ]

Central Contacts

• Boehringer Ingelheim
  1-800-243-0127
  [email protected]

Locations (7)

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