What is nerandomilast studying for pulmonary fibrosis?

Nerandomilast is being studied to see how well people with idiopathic or progressive pulmonary fibrosis tolerate long-term treatment. Researchers want to find out if it helps improve lung function and delays worsening symptoms, hospital visits, or death. The study is sponsored by Boehringer Ingelheim and focuses on people who previously took nerandomilast.

Who may be eligible for this pulmonary fibrosis clinical trial?

Adults aged 18 or older who have completed treatment with nerandomilast in previous studies may be eligible. All genders can participate. Important factors include no planned lung transplantation, acceptable body weight, and willingness to use birth control if applicable. Please review eligibility criteria for more details.

Is there any cost to participate in this pulmonary fibrosis clinical trial?

Study-related care, including the study drug and all trial visits, is provided at no cost. Personal travel expenses may vary and are not guaranteed to be covered. Participants can expect to attend regular visits as part of the study.

Actively Recruiting

Phase 3

Age: 18Years +

All Genders

ID06238622

An Open-label Extension Trial of the Long-term Safety and Efficacy of BI 1015550 Taken Orally in Patients With Idiopathic Pulmonary Fibrosis IPF and Progressive Pulmonary Fibrosis PPF FIBRONEER-ON

Led by Boehringer Ingelheim · Updated on 2026-05-13

1700

Participants Needed

373

Research Sites

1 weeks

Total Duration

AI-Summary

What this Trial Is About

Researchers are studying people with idiopathic pulmonary fibrosis IPF or progressive pulmonary fibrosis PPF who have previously completed treatment with the drug nerandomilast. The study aims to understand how well participants tolerate long-term treatment with nerandomilast and whether it helps improve lung function or delays worsening symptoms, hospitalizations, or death. This is a phase 3 open-label extension trial sponsored by Boehringer Ingelheim. Participants will take nerandomilast tablets daily for up to 1 year and 10 months. They may continue their usual treatments for pulmonary fibrosis alongside the study treatment. There is no placebo group, and all participants receive nerandomilast during this extension period. Throughout the study, participants will visit their doctors regularly for health check-ups and lung function tests. Researchers will closely monitor any side effects and changes in lung function, particularly forced vital capacity FVC, over nearly two years. The study will track time until symptom worsening, hospital visits, or death to assess the treatments long-term safety and effects.

CONDITIONS

Brief Title

A Follow-up Study to Test Long-term Treatment With Nerandomilast in People With Pulmonary Fibrosis Who Took Part in a Previous Study With Nerandomilast

Who Can Participate

Age: 18Years +

All Genders

Eligibility Criteria

You may qualify if you...

Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) according to protocol
Signed and dated written informed consent before joining the trial
Women of childbearing potential must use highly effective birth control methods with low failure rates
Women taking oral contraceptives must also use a barrier method during intercourse
In France, fertile males must use acceptable birth control methods

You will not qualify if you...

Any disease that may increase risk during trial participation, as judged by the investigator
Suicidality or suicidal behavior at Visit 1, including active suicidal thoughts with intent
Severe depression or high anxiety scores at Visit 1
Recent malignant neoplasm except treated skin or cervical cancers
Planned lung transplantation with a scheduled surgery date
Body mass index below 18.5 kg/m² with significant unexplained weight loss during the parent trial
Ongoing serious adverse events except latent tuberculosis from the parent trial
Need or desire to take restricted medications that could interfere with the trial
Additional exclusion criteria as determined by the investigators

Research Team

Boehringer Ingelheim

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