Recruiting
Phase 3

Nerandomilast

Sponsor:

Boehringer Ingelheim

Code:

NCT07366034

Conditions

Fibrosing Interstitial Lung Disease

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

Interventions

Nerandomilast

Placebo

Study Details

Brief 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.

Conditions

Fibrosing Interstitial Lung Disease

Study ID

NCT07366034

Start date

Jul 21, 2026

Status verified date

Oct, 2026

Completion date

Apr 14, 2031

Anticipated

Primary completion date

Apr 27, 2029

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 2 - 17

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

35 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

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)

Interventions

Nerandomilast

Nerandomilast

Placebo

Placebo

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 ]
  • Occurrence of a treatment-emergent adverse event [ Time Frame: up to Week 26 ]

Central Contacts and Locations

Central contacts

Boehringer Ingelheim

1-800-243-0127clintriage.rdg@boehringer-ingelheim.com

Locations

Boston Children's Hospital

Recruiting

Boston, Massachusetts, United States, 02115

Contacts

Boehringer Ingelheim

833-602-2368unitedstates@bitrialsupport.com

More Information

Sponsor

Boehringer Ingelheim

Last update posted

Oct 13, 2026

Last verified

Oct, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-14. This information was provided to ClinicalTrials.gov by Boehringer Ingelheim on 2026-10-13. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.