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Long-term Nerandomilast Treatment for Pulmonary Fibrosis

This study is for people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF) who have previously participated in a study involving the medication nerandomilast (also known as BI 1015550). The main goal is to understand how well people tolerate long-term treatment with nerandomilast. Researchers also want to see if nerandomilast can improve lung function and delay the worsening of symptoms, hospitalizations, or death. You would take nerandomilast tablets for up to 1 year and 10 months and can continue your usual pulmonary fibrosis treatments. You will have regular doctor visits during this time. The study is currently recruiting a large number of participants, with a planned enrollment of 1700 people.

Study design
This is an interventional study, meaning participants will receive a specific treatment. It is open to a large number of participants, with a planned enrollment of 1700.
What's involved
You would take nerandomilast tablets for up to 1 year and 10 months. You will also have regular doctor visits during the study period.
Compensation
Not stated in the trial record.
Follow-up
The study will track adverse events for up to 99 weeks and 3 days, which is the planned follow-up/end of study visit.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06238622

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

Recruiting
PHASE3Ages 18+InterventionalTreatment
Boehringer Ingelheim
~1,700 participants
Updated 2026-08-20 on ClinicalTrials.gov
What's tested:Nerandomilast

At a glance

Recruiting sites
95 of 373 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99
Measured over Up to 99 weeks and 3 days

Conditions

Idiopathic Pulmonary Fibrosis
Progressive Pulmonary Fibrosis

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NCT06238622

Where you'd take part

This study runs at 373 sites. They're the same protocol — you choose where, and that choice sets who your contact draft is addressed to.

  • A. O. Universitaria Careggi

    Florence, Italystudy coordinator listed

    Recruiting

  • A.O. San Gerardo di Monza

    Monza, Italystudy coordinator listed

    Recruiting

  • A.O.U. Policlinico Vittorio Emanuele

    Catania, Italystudy coordinator listed

    Recruiting

  • A.O.U. Senese

    Siena, Italystudy coordinator listed

    Recruiting

  • Akdeniz Universitesi Tip Fakultesi -ANTALYA-33606

    Antalya, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Ankara Universitesi Tip Fakultesi

    Ankara, Turkey (Türkiye)study coordinator listed

    Recruiting

  • Aso Co.,Ltd Iizuka Hospital

    Fukuoka, Iizuka, Japanstudy coordinator listed

    Recruiting

  • ASST degli Spedali Civili di Brescia

    Brescia, Italystudy coordinator listed

    Recruiting

Sites open and close at different times, so the status above is per site — it can differ from the study's overall status.

Who to contact

Boehringer Ingelheim
[email protected]
1-800-243-0127
Email the study team

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Eligibility criteria

Exclusion

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.

What this trial measures

  • Occurrence of any adverse event over the course of the extension trial (yes/no) i.e. up until the follow-up/end of study visit planned at the latest at week 99Up to 99 weeks and 3 days