A Study to Test Whether Nerandomilast Can Help Slow Down Changes in the Lung in People With a Family History of Pulmonary Fibrosis

Condition(s) studied

Investigational drug(s) / intervention(s)

Nerandomilast: Nerandomilast

Placebo: Placebo

Study summary

This study is open to people aged 40 years or older who have at least 1 family member with pulmonary fibrosis. Pulmonary fibrosis is a condition where lung tissue becomes scarred, making it harder to breathe. People can join if a lung scan shows early changes in the lung, called interstitial lung abnormalities, which may lead to lung scarring. People with family members who have pulmonary fibrosis are more likely to develop it themselves. That is why it is important to check early for lung changes and find ways to prevent the condition from getting worse. The purpose of this study is to find out whether a medicine called nerandomilast can help slow down changes in the lung in people with a family history of pulmonary fibrosis.

Participants are put into one of 2 groups randomly, which means the group is chosen 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 twice a day for about 2 to 3 years. There is a 3 out of 5 chance that participants will receive nerandomilast instead of the placebo.

Participants are in the study for about 2 to 3 years. Participants visit the study site multiple times: more frequently during the first 2 years (about every 3 months), and then every 6 months thereafter. In the 3rd year, participants also have phone calls with the site staff every 3 months.

Doctors regularly test lung function and take chest scans to see if the treatment works. The results are compared between the 2 groups to see if nerandomilast helps. The doctors also check participants' health and take note of any unwanted effects.

Eligibility

Primary outcome measure(s)

• Time to physiologic or radiologic worsening of ILA/ILD over the whole trial — up to 164 weeks
  Defined as relative decline in forced vital capacity (FVC) % predicted of \>10% from baseline; or absolute decline in diffusing capacity of the lungs for carbon monoxide (DLCO) % predicted \>10% from baseline; or absolute increase in weighted reticulovascular score (wRVS) \>2% and total disease extent (TDE) \>2.5% on chest high resolution CT scan (HRCT), as measured by e-Lung Quantitative HRCT scoring, from baseline

Trial sites (55)

+ 15 more sites — see the full list on the official registry below.

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