Fibrosing Interstitial Lung DiseasePhase 3NCT07366034
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 testing Nerandomilast in people with Fibrosing Interstitial Lung Disease, run by Boehringer Ingelheim at 47 sites in 22 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 2 to 17 years
- Conditions the study is for
- Fibrosing Interstitial Lung Disease
- What is being tested?
- Nerandomilast
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 35 participants
- Where
- 47 sitesin 22 countries
- Study dates
- 21 Jul 2026to 14 Apr 2031
- Phase
- Phase 3
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 2 to 17 years
- All sexes
- No healthy volunteers
- Child
Who may be able to join
- 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
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- 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.
Who cannot join
- 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).
Show all 9Show fewer
- 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.
Trial locations and contacts
47 sites in 22 countries. Contact the study team or a site near you to ask about taking part.
47 sites in 22 countries
United States7 sites, 7 recruiting
- Not yet recruiting
Children's Hospital Colorado
Aurora, Colorado, 80045
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Johns Hopkins Hospital
Baltimore, Maryland, 21287
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Recruiting
Boston Children's Hospital
Boston, Massachusetts, 02115
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Nationwide Children's Hospital
Columbus, Ohio, 43205
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Children's Hospital Los Angeles
Los Angeles, California, 90027
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
M Health Fairview Masonic Children's Hospital
Minneapolis, Minnesota, 55454
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
- Not yet recruiting
Children's Hospital of Philadelphia
Philadelphia, Pennsylvania, 19104
Boehringer Ingelheim, 833-602-2368, unitedstates@bitrialsupport.com
France5 sites, 5 recruiting
- Recruiting
HOP Femme Mère Enfant
Bron, 69677
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Intercommunal
Créteil, 94000
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Timone
Marseille, 13387
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Not yet recruiting
HOP Armand-Trousseau
Paris, 75012
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
- Recruiting
HOP Necker - Enfants Malades
Paris, 75015
Boehringer Ingelheim, 0805102354, france@bitrialsupport.com
Brazil4 sites, 4 recruiting
- Recruiting
Serviços Medicos Respirar Sul Fluminense
Barra Mansa, 27323240
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Associação dos Funcionários Públicos do Estado do Rio Grande do Sul - Hospital Ernesto Dorneles
Porto Alegre, 90160-093
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
IMIP Pernambuco
Recife, 50070-550
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
- Recruiting
Centro de Pesquisa Clinica do Instituto da Crianca - HCFMUSP
São Paulo, 5403-900
Boehringer Ingelheim, 08008919295, brasil@bitrialsupport.com
China3 sites, 3 recruiting
- Recruiting
Beijing Children's Hospital, Capital Medical University
Beijing, 100045
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
Hunan Provincial People's Hospital
Changsha, 410005
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
- Recruiting
The Children's Hospital of Fudan University
Shanghai, 201102
Boehringer Ingelheim, 4001200553, china@bitrialsupport.com
Germany3 sites, 3 recruiting
- Recruiting
Charité - Universitätsmedizin Berlin
Berlin, 13353
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Not yet recruiting
Hamburger Zentrum für Kinder- und Jugendrheumatologie
Hamburg, 22081
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
- Recruiting
Medizinische Hochschule Hannover
Hanover, 30625
Boehringer Ingelheim, 08007234742, deutschland@bitrialsupport.com
Japan3 sites, 3 recruiting
- Not yet recruiting
Fukuoka Children's Hospital
Fukuoka, Fukuoka, 813-0017
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Not yet recruiting
Osaka Women's and Children's Hospital
Osaka, Izumi, 594-1101
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
- Recruiting
National Center for Child Health and Development
Tokyo, Setagaya-ku, 157-8535
Boehringer Ingelheim, 05050508862, nippon@bitrialsupport.com
Canada2 sites, 2 recruiting
- Not yet recruiting
Alberta Children's Hospital
Calgary, Alberta, T3B 6A8
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
- Not yet recruiting
The Hospital for Sick Children
Toronto, Ontario, M5G 1X8
Boehringer Ingelheim, 18336022346, canada@bitrialsupport.com
Finland2 sites, 2 recruiting
- Not yet recruiting
HUS Lasten ja nuorten sairaudet, Kliinisen tutkimuksen yksikkö
Helsinki, PL 281, 00029
- Recruiting
Tampere University Hospital
Tampere, 33520
Boehringer Ingelheim, 0800918118, suomi@bitrialsupport.com
Italy2 sites, 2 recruiting
- Recruiting
Istituto G. Gaslini
Genova, 16147
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
- Not yet recruiting
Ospedale Pediatrico Bambino Gesù
Roma, 00165
Boehringer Ingelheim, 800977373, italia@bitrialsupport.com
Mexico2 sites, 2 recruiting
- Not yet recruiting
Centro de Investigacion Clinica y Medicina Traslacional (CIMeT)
Guadalajara, 44340
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
- Not yet recruiting
Clinical Research Institute S.C.
Tlalnepantla, 54055
Boehringer Ingelheim, 018000623749, mexico@bitrialsupport.com
Spain2 sites, 2 recruiting
- Recruiting
Hospital Universitari Vall d'Hebron
Barcelona, 08035
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
- Recruiting
Hospital Virgen del Rocio
Seville, 41013
Boehringer Ingelheim, 900876092, espana@bitrialsupport.com
United Kingdom2 sites, 2 recruiting
- Not yet recruiting
Birmingham Children's Hospital
Birmingham, B4 6NH
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
- Not yet recruiting
King's College Hospital
London, SE5 9RS
Boehringer Ingelheim, 08000514022, unitedkingdom@bitrialsupport.com
Argentina1 site, 1 recruiting
- Recruiting
Fundacion Respirar
CABA, 1426
Boehringer Ingelheim, 08002667801, argentina@bitrialsupport.com
Australia1 site, 1 recruiting
- Recruiting
Women's and Children's Hospital
North Adelaide, South Australia, 5006
Boehringer Ingelheim, 1800271035, australia@bitrialsupport.com
Belgium1 site, 1 recruiting
- Recruiting
Brussels - UNIV HUDERF
Brussels, 1020
Boehringer Ingelheim, 080049616, belgique@bitrialsupport.com
Czechia1 site, 1 recruiting
- Not yet recruiting
University Hospital Motol
Prague, 150 00
Boehringer Ingelheim, 800142046, cesko@bitrialsupport.com
Denmark1 site, 1 recruiting
- Not yet recruiting
Aarhus University Hospital
Aarhus N, 8200
Boehringer Ingelheim, 80711822, danmark@bitrialsupport.com
Greece1 site, 1 recruiting
- Not yet recruiting
Aristotle University, Thessaloniki
Thessaloniki, 54642
Boehringer Ingelheim, 008000000092, hellas@bitrialsupport.com
Netherlands1 site, 1 recruiting
- Not yet recruiting
Amsterdam University Medical Center
Amsterdam, 1105 AZ
Boehringer Ingelheim, 08000204613, nederland@bitrialsupport.com
Poland1 site, 1 recruiting
- Not yet recruiting
University Clinical Center of the Medical University of Warsaw
Warsaw, 02 091
Boehringer Ingelheim, 008001218830, polska@bitrialsupport.com
Portugal1 site, 1 recruiting
- Not yet recruiting
ULS de Santa Maria, E.P.E
Lisbon, 1649-035
Boehringer Ingelheim, 800856070, portugal@bitrialsupport.com
South Korea1 site, 1 recruiting
- Recruiting
Seoul National University Hospital
Seoul, 03080
Boehringer Ingelheim, 0808802084, namhan@bitrialsupport.com
About this study
Official title: 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)
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.
Read more
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.
- Conditions
- Fibrosing Interstitial Lung Disease
- Being tested
- Nerandomilast, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NerandomilastDrug
Also called JASCAYD®
Nerandomilast
PlaceboDrug
Placebo
| Study group | Role | What they receive |
|---|---|---|
| Participants aged 2 to <6 years | Experimental | Part A and Part B: Nerandomilast (open-label) Receives: Drug: Nerandomilast |
| Participants aged 6 to <18 years, group 1 | Experimental | Part A: Nerandomilast (blinded), Part B: Nerandomilast (open-label) Receives: Drug: Nerandomilast |
| Participants aged 6 to <18 years, group 2 | Experimental | Part A: Placebo (blinded), Part B: Nerandomilast (open-label) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: At week 2 in Part A and Week 28 in Part B
Occurrence of a treatment-emergent adverse event
Measured: up to Week 26
Secondary outcomes (11)
Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest
Measured: at Week 26 and Week 52
Absolute change from baseline in height [cm]
Measured: at Week 26 and Week 52
Absolute change from baseline in pediatric quality of life inventory (PedsQL™)
Health-related quality of life will be assessed in children using the PedsQL™ questionnaire. For younger children who are unable to perform self-assessment, a parent proxy may be required. The score ranges from 0-100, a higher score indicates a better health related quality of life.
Measured: at Week 26 and Week 52
Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial
Measured: up to 5 years
Time to first respiratory-related hospitalisation [days] over the whole trial
Measured: up to 5 years
Time to first acute interstitial lung disease (ILD) exacerbation or death [days] over the whole trial
Measured: up to 5 years
Time to death [days] over the whole trial
Measured: up to 5 years
Acceptability based on number/size of tablets
Acceptability is defined as the overall ability and willingness of the participant to use the medicinal product as intended.
Assessment of acceptability will be performed by the participant using the acceptability questionnaire.
Measured: at Week 2 and Week 26
Acceptability based on the use of the dispenser
Measured: at Week 2 and Week 26
Absolute change from baseline in FVC [% predicted] (applicable to participants ≥6 years)
Measured: at Week 26 and Week 52
Absolute change from baseline in 6-min walk distance [m] (applicable to participants ≥6 years)
Measured: at Week 26 and Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jan 2026
- Study start21 Jul 2026
- Primary completion27 Apr 2029 (estimated)
- Study completion14 Apr 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fibrosing Interstitial Lung DiseaseStudies of the same condition, open and under way.
- More trials run by Boehringer IngelheimThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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 Part B: \- open-label phase with active treatment
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Boehringer Ingelheim
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07366034
- Sponsor's protocol ID
- 1305-0022
- Other IDs
- 2025-523369-32-00, 1111-1326-6351, 2025
- Status last verified
- Oct 2026
- First submitted
- 23 Jan 2026
- Last updated
- 13 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
Study at a glance
From the registry record, last updated by the sponsor on 13 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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)
- ClinicalTrials.gov ID
- NCT07366034
- Acronym / sponsor ID
- 1305-0022
- Conditions
- Fibrosing Interstitial Lung Disease
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- Boehringer IngelheimIndustry (pharma, biotech, devices)
- Study start
- 21 Jul 2026 (actual)
- Primary completion
- 27 Apr 2029 (estimated)
- Study completion
- 14 Apr 2031 (estimated)
- First posted
- 26 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
- Model description
- 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 Part B: - open-label phase with active treatment
| Arm | Type | Receives |
|---|---|---|
| Participants aged 2 to <6 years | Experimental | Drug: NerandomilastPart A and Part B: Nerandomilast (open-label) |
| Participants aged 6 to <18 years, group 1 | Experimental | Drug: NerandomilastPart A: Nerandomilast (blinded), Part B: Nerandomilast (open-label) |
| Participants aged 6 to <18 years, group 2 | Experimental | Drug: PlaceboPart A: Placebo (blinded), Part B: Nerandomilast (open-label) |
Who may qualify
- Ages
- 2 to 17 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (11 listed)
- 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:
- Further inclusion criteria apply.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| NerandomilastAlso: JASCAYD®Nerandomilast | Drug | Participants aged 2 to <6 years, Participants aged 6 to <18 years, group 1 |
| PlaceboPlacebo | Drug | Participants aged 6 to <18 years, group 2 |
Primary outcome
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
Occurrence of a treatment-emergent adverse event
Time frame: up to Week 26
11 secondary outcomes
Absolute change from baseline in oxygen saturation (SpO2) [%] on room air at rest
Time frame: at Week 26 and Week 52
Absolute change from baseline in height [cm]
Time frame: at Week 26 and Week 52
Absolute change from baseline in pediatric quality of life inventory (PedsQL™)
Time frame: at Week 26 and Week 52
Occurrence of a treatment-emergent adverse event (Yes/No) over the whole trial
Time frame: up to 5 years
Time to first respiratory-related hospitalisation [days] over the whole trial
Time frame: up to 5 years
Time to first acute interstitial lung disease (ILD) exacerbation or death [days] over the whole trial
Time frame: up to 5 years
Time to death [days] over the whole trial
Time frame: up to 5 years
Acceptability based on number/size of tablets
Time frame: at Week 2 and Week 26
Acceptability based on the use of the dispenser
Time frame: at Week 2 and Week 26
Absolute change from baseline in FVC [% predicted] (applicable to participants ≥6 years)
Time frame: at Week 26 and Week 52
Absolute change from baseline in 6-min walk distance [m] (applicable to participants ≥6 years)
Time frame: at Week 26 and Week 52
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Oct 2026.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Once the criteria in section "Time Frame" are fulfilled, researchers can use the following link https://www.clinicalstudies.boehringer-ingelheim.com/msw/datasharing to request access to the clinical study documents regarding this study, and upon a signed "Document Sharing Agreement". Furthermore, researchers can request access to the clinical study data, for this and other listed studies, after the submission of a research proposal and according to the terms outlined in the website.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
47 sites in 22 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Nerandomilast in people with Fibrosing Interstitial Lung Disease, run by Boehringer Ingelheim at 47 sites in 22 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 11 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 13 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 47 sites in United States, France, Brazil, China, Germany and 17 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Boehringer Ingelheim (1-800-243-0127, clintriage.rdg@boehringer-ingelheim.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 13 Oct 2026; AzTrials last refreshed its copy on 26 Oct 2026.