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Long-term treatment with nerandomilast for pulmonary fibrosis patients

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)

Phase 3 Interventional Boehringer Ingelheim · NCT06238622

This study is testing if taking nerandomilast for up to 1 year and 10 months can help people with pulmonary fibrosis breathe better and slow down their symptoms.

Quick facts

PhasePhase 3
Study typeInterventional
Enrollment1700 (estimated)
Ages18 Years and up
SexAll
SponsorBoehringer Ingelheim Industry-sponsored
Locations373 sites (Birmingham, Alabama and 372 other locations)
Trial IDNCT06238622 on ClinicalTrials.gov

What this trial studies

This study focuses on individuals with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously participated in trials involving nerandomilast. The primary aim is to evaluate the long-term tolerance of nerandomilast and its effectiveness in improving lung function and delaying the progression of symptoms. Participants will take nerandomilast tablets for up to 1 year and 10 months while continuing their regular pulmonary fibrosis treatments. Regular doctor visits will be conducted to monitor health and perform lung function tests.

Who should consider this trial

Good fit: Ideal candidates are individuals who have completed prior treatment with nerandomilast in specified parent trials without premature discontinuation.

Not a fit: Patients who have not participated in the previous studies or those with other significant health issues may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could improve lung function and extend the time before symptoms worsen for patients with pulmonary fibrosis.

How similar studies have performed: Previous studies involving nerandomilast have shown promise, indicating potential for success in this follow-up study.

Eligibility criteria

Show full inclusion / exclusion criteria 
Inclusion Criteria:

1. Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocol (i.e. completed treatment with or without temporary treatment interruption)
2. Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial
3. Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth control per ICH M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly. WOCBP taking oral contraceptives (OCs) also have to ensure the use of one barrier method during sexual intercourse with their partner, e.g., condom to account for the risk of potentially reduced efficacy of the OCs in the event of severe vomiting and diarrhoea. For France, fertile males must be ready and able to use acceptable methods of birth control

Exclusion Criteria:

1. Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
2. Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at Visit 1:

   * any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
   * any suicidal ideation of type 4 or 5 in the Columbia-Suicide Severity Rating Scale (C-SSRS) (i.e. active suicidal thought with intent but without specific plan, or active suicidal thought with plan and intent)
3. Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1.
4. An occurrence of malignant neoplasm other than appropriately treated basal cell carcinoma or in situ squamous cell carcinoma of the skin or in situ carcinoma of uterine cervix at Visit 1.
5. Patient will undergo lung transplantation, with an assigned date of surgery.
6. Patients with a Body Mass index (BMI) \<18.5 kg/m² that experienced an additional, unexplained and clinically significant (\>10%) weight loss during the parent trial
7. At Visit 1, patients with ongoing Adverse Event of Special Interest (AESI), except for latent tuberculosis (suspected vasculitis, Drug Induced Liver Injury (DILI), severe infections) that led to temporary treatment interruption in the parent trial
8. Patients who must or wish to take restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

Further exclusion criteria apply.

Where this trial is running

Birmingham, Alabama and 372 other locations

+323 more sites — see ClinicalTrials.gov for the full list.

Study contacts

How to participate

  1. Review the eligibility criteria above with your treating physician.
  2. Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
  3. Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
View on ClinicalTrials.gov → Find more trials like this →
Conditions Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis
Last reviewed 2026-06-13 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.