Nerandomilast for Interstitial Lung Disease

Not yet recruiting at 40 trial locations

Overseen By Boehringer Ingelheim

Age: < 18

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must not be taking: PDE4 inhibitors, Pirfenidone

Disqualifiers: Unstable PAH, Active vasculitis, Suicidal behavior, Depression, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: 18

What You Need to Know Before You Apply

What is the purpose of this trial?

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.

Are You a Good Fit for This Trial?

Children and adolescents aged 2 to 17 with interstitial lung disease can join this study. They must show signs of worsening lung disease, have a certain level of lung function, and meet other specific health criteria. Those who don't meet these health requirements or are under 2 years old cannot participate.

Inclusion Criteria

I am between 2 and 17 years old.

My child can breathe well enough, as shown by a lung test.

I meet other specific requirements for the trial.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment Part A

Participants aged 6 to 17 years receive either nerandomilast or placebo for 6 months. Participants aged 2 to 5 years receive nerandomilast from the start.

6 months

Regular visits, approximately 18 to 30 times over the study period

Treatment Part B

All participants receive nerandomilast for at least 2 years, regardless of initial group assignment.

At least 2 years

Follow-up

Participants are monitored for safety and effectiveness after treatment, including assessments of lung function, body growth, and overall health.

6 months

What Are the Treatments Tested in This Trial?

Interventions

• Nerandomilast

Trial Overview

The trial is testing Nerandomilast in young patients with ILD. Participants aged 6-17 are randomly assigned to receive either Nerandomilast or a placebo for the first part of the study, while those aged 2-5 start on Nerandomilast immediately.

How Is the Trial Designed?

Group I: Participants aged 6 to <18 years, group 2 Experimental Treatment 1 Intervention

Part A: Placebo (blinded), Part B: Nerandomilast (open-label)

Group II: Participants aged 6 to <18 years, group 1 Experimental Treatment 1 Intervention

Part A: Nerandomilast (blinded), Part B: Nerandomilast (open-label)

Group III: Participants aged 2 to <6 years Experimental Treatment 1 Intervention

Part A and Part B: Nerandomilast (open-label)

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+