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NCT07366034 · ClinicalTrials.gov registry record · Phase 3
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)
A Phase 3 study, sponsored by Boehringer Ingelheim.
- Not yet
- Registry status
- Phase 3
- Development phase
- 35
- Enrollment target
NCT07366034 is a Phase 3 study that has not yet begun recruiting, run by Boehringer Ingelheim. The registered enrollment target is 35 participants.
The verdict
NCT07366034, a Phase 3 study, has not yet begun recruiting, sponsored by Boehringer Ingelheim.
- NOT YET RECRUITING
- Registry status
- Phase 3
- Development phase
- 35 participants
- Enrollment target
Study Summary
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.
Interventions
- DRUG Placebo
- DRUG Nerandomilast
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 35 participants |
| Start Date | 2026-07-27 |
| Est. Completion | 2031-04-14 |
| Phase | Phase 3 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT07366034
The ClinicalTrials.gov registry entry for NCT07366034 describes a study currently listed as not yet recruiting, categorized as Phase 3. The registered enrollment target is 35 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Boehringer Ingelheim, which has 515 total studies on file at ClinicalTrials.gov.
The record links to 0 conditions, and to 2 interventions - of which Placebo is the first listed.
NCT07366034 reports 0 study locations.
Frequently Asked Questions
What is clinical trial NCT07366034 about?
NCT07366034 is a clinical study titled "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)". 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 to...
What is the current status of trial NCT07366034?
This trial is currently not yet recruiting. It is a Phase 3 study. The enrollment target is 35 participants. The study started on 2026-07-27. Estimated completion is 2031-04-14.
What interventions are being tested in trial NCT07366034?
The interventions under investigation include: Placebo (DRUG), Nerandomilast (DRUG).
Who is sponsoring clinical trial NCT07366034?
This trial is sponsored by Boehringer Ingelheim, which has 515 total clinical trials registered on ClinicalTrials.gov.
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