Nerandomilast for Interstitial Lung Disease

Recruiting at 160 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Boehringer Ingelheim

Must be taking: Immunosuppressants

Must not be taking: Cyclophosphamide, Pirfenidone

Disqualifiers: Organising pneumonia, Acute ILD exacerbation, Suicidal behaviour, others

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: 8

Duration: 26 weeks

400 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

Adults 18 years of age and older or above legal age with lung fibrosis related to systemic autoimmune rheumatic disease can participate in this study. People can only take part if they show no improvement in lung function after standard treatment with immunosuppressant medicine. The main purpose of this study is to find out how a medicine called nerandomilast affects the lungs in people with systemic autoimmune rheumatic disease. Participants are put into 2 groups randomly, which means by chance. One group takes nerandomilast tablets and the other group takes placebo tablets. Placebo tablets look like nerandomilast tablets but do not contain any medicine. Participants take a tablet 2 times a day for at least 26 weeks and up to 1 year. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 to 13 months depending on when they join the study. During this time, they visit the study site about 9 to 10 times. At study visits, participants have lung function tests. At select visits, chest imaging is performed. Participants fill in questionnaires about their symptoms and quality of life. The results between the 2 groups are compared to see whether the treatment works. The doctors also regularly check participants' health and take note of any unwanted effects.

Will I have to stop taking my current medications?

The trial does not require you to stop taking your current medications. In fact, participants must continue their immunosuppressant treatment for their underlying rheumatic disease and be on stable doses of certain medications for a specified period before joining the trial.

What safety data exists for Nerandomilast (also known as nintedanib) in humans?

Nerandomilast, known as nintedanib, has been shown to be generally safe in humans, with the most common side effects being manageable gastrointestinal issues like diarrhea. Long-term studies indicate it is well tolerated for up to 51 months, with no new safety concerns identified. ^{1 2 3 4 5}

Are You a Good Fit for This Trial?

Adults with lung fibrosis related to systemic autoimmune rheumatic diseases, who haven't improved after standard immunosuppressant treatment, can join this study. They must be over 18 or the legal age in their country.

Inclusion Criteria

Forced vital capacity (FVC) ≥45% of predicted normal at Visit 1

Diffusing capacity of the lungs for carbon monoxide (DLCO) ≥25% of predicted normal corrected for haemoglobin (Hb) at Visit 1

Further inclusion criteria apply

Exclusion Criteria

I have not taken certain medications recently.

Further exclusion criteria apply

Prebronchodilator forced expiratory volume in 1 second (FEV1)/ forced vital capacity (FVC) <0.7 at Visit 1

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive nerandomilast or placebo tablets twice daily for 26 weeks, with continued immunosuppressant treatment

26 weeks

8 visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Nerandomilast

Trial Overview The trial is testing nerandomilast's effect on lung function in patients with lung fibrosis from rheumatic diseases. Participants are randomly assigned to receive either nerandomilast or a placebo for 26 weeks while continuing their usual immunosuppressants.

How Is the Trial Designed?

Group I: Nerandomilast Experimental Treatment 1 Intervention

Participants with SARD-ILDs will receive nerandomilast.

Group II: Placebo Placebo Group 1 Intervention

Participants with SARD-ILDs will receive placebo.

Who Is Running the Clinical Trial?

Boehringer Ingelheim

Lead Sponsor

Trials

2,566

Recruited

16,150,000+

Published Research Related to This Trial

In the INBUILD trial involving 663 patients with chronic fibrosing interstitial lung diseases, nintedanib significantly reduced the rate of lung function decline (measured by forced vital capacity) compared to placebo, regardless of glucocorticoid use.

The safety profile of nintedanib remained consistent whether patients were using immunomodulatory therapies or not, suggesting it can be safely combined with these treatments in managing progressive fibrosing ILDs.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. Cottin, V., Richeldi, L., Rosas, I., et al.[2021]

This study analyzed data from the Japanese Adverse Drug Event Report (JADER) and the FDA Adverse Event Reporting System (FAERS) to investigate the incidence of interstitial lung disease (ILD) potentially caused by antifibrotic drugs nintedanib and pirfenidone, both of which are first-line treatments for idiopathic pulmonary fibrosis (IPF).

The findings indicated that both nintedanib and pirfenidone were associated with signals for causing ILD, emphasizing the need for careful monitoring of these drugs due to their limited effectiveness and potential to induce lung damage.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Evaluation of the potential complication of interstitial lung disease associated with antifibrotic drugs using data from databases reporting spontaneous adverse effects. Nawa, H., Hamano, H., Niimura, T., et al.[2023]

Citations

1. England pubmed.ncbi.nlm.nih.gov

Nintedanib and immunomodulatory therapies in progressive fibrosing interstitial lung diseases. [2021]

2. Germany pubmed.ncbi.nlm.nih.gov

Real world experience with nintedanib in connective tissue disease-related interstitial lung disease: a retrospective cohort study. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Safety and tolerability of nintedanib in patients with progressive fibrosing interstitial lung diseases: data from the randomized controlled INBUILD trial. [2022]

4. New Zealand pubmed.ncbi.nlm.nih.gov

Efficacy and Safety of Nintedanib for the Treatment of Idiopathic Pulmonary Fibrosis: An Update. [2020]

5. United States pubmed.ncbi.nlm.nih.gov

Evaluation of the potential complication of interstitial lung disease associated with antifibrotic drugs using data from databases reporting spontaneous adverse effects. [2023]