Nerandomilast for Interstitial Lung Disease

Recruiting at 144 trial locations

Overseen By Boehringer Ingelheim

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 3

Waitlist Available

Sponsor: Boehringer Ingelheim

Pivotal Trial (Near Approval)

Prior Safety Data

Trial Summary

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 26 weeks. Participants continue immunosuppressant treatment for their underlying rheumatic disease. Participants are in the study for about 7.5 months. During this time, they visit the study site 8 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.

Eligibility Criteria

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

Treatment Details

Interventions

• Nerandomilast (Phosphodiesterase-4 Inhibitor)

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.

Participant Groups

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+