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ACTIVE NOT RECRUITINGPhase3

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

Sponsor: Boehringer Ingelheim

NCT ID: NCT06238622

View on ClinicalTrials.gov ↗

At a glance

What the study gets you
Access to the study treatment being tested
Type of study
Interventional (receives a drug or procedure)
Time in hospital
In-person visits at study sites — visit count not specified by the sponsor
Drug or intervention
Nerandomilast (drug)
How long the study runs
Study runs about 36 months (dates as stated)
About the drug or intervention
Nerandomilast — drug: Nerandomilast
Patient visit burden
Not specified by the sponsor
Type of study
Testing a treatment
Ages
18 Years and over
Who
All
Number of participants
1,666
Started
2024-05-06
Last checked
2026-09

Plain English Summary

What is this study?

  • • Testing a new treatment for idiopathic pulmonary fibrosis
  • • Phase3 - 1,666 participants
  • • This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF)

Who can take part?

  • • Ages 18 Years and over
  • • Diagnosed with idiopathic pulmonary fibrosis

Where?

  • • Aberdeen - Aberdeen Royal Infirmary
  • • Birmingham - Queen Elizabeth Hospital Birmingham
  • • Bristol - Southmead Hospital
  • • Edinburgh - Royal Infirmary of Edinburgh
  • • +9 more UK sites

This is a simplified summary. Always discuss with your doctor before making any decisions.

About This Trial

This study is open to people with idiopathic pulmonary fibrosis (IPF) or progressive pulmonary fibrosis (PPF). They can only take part if they have completed treatment in a previous study with a medicine called nerandomilast or BI 1015550. The goal of this study is to find out how well people with pulmonary fibrosis tolerate long- term treatment with nerandomilast. The study also tests whether nerandomilast improves lung function and prolongs the time until symptoms get worse, participants need to go to the hospital, or die. Every participant takes nerandomilast as tablets for up to 1 year and 10 months. The participants may also continue their regular treatment for pulmonary fibrosis during the study. Participants visit their doctors regularly. During these visits, the doctors collect information on any health problems of the participants. Participants also regularly do lung function tests.

Idiopathic Pulmonary FibrosisProgressive Pulmonary Fibrosis

How this trial compares with your answers

Answer 2 more questions to improve match

What we know so far

Condition· Matched your search
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Still need:

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Preliminary match based on your answers. Full eligibility requires on-site assessment including medical history, physical exam, and lab tests. This does not guarantee enrolment.

Eligibility at a Glance

Key info

  • Age: 18 Years and over
  • Who can join: All genders

What the study is looking for

  • ✓Signed and dated written agreement to take part in accordance with ICH-GCP and local legislation prior to admission to the...

Who cannot take part

  • ✗Any disease that may put the patient at risk when participating in this trial at investigator's discretion.
  • ✗Patient exhibits suicidality, in the clinical judgment of the investigator or according to the following criteria at...
  • ✗any suicidal behaviour (i.e. actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behaviour)
  • ✗Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and...
  • ✗An occurrence of malignant tumour other than appropriately treated basal cell carcinoma or in situ squamous cell...
See the full 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 Is This Study? (13 UK sites)

Aberdeen Royal Infirmary

Aberdeen AB25 2ZN, United Kingdom

Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Queen Elizabeth Hospital Birmingham

Birmingham B15 2GW, United Kingdom

Hospital R&D contact (matched)

Sarah Pountain Head of Research Governance

R&D@uhb.nhs.uk0121 371 4185

Southmead Hospital

Bristol BS10 5NB, United Kingdom

Hospital R&D contact (matched)

Helen Lewis-White

Research@nbt.nhs.uk0117 41 49330

Royal Infirmary of Edinburgh

Edinburgh EH16 4SA, United Kingdom

Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

Royal Devon and Exeter Hospital, Wonford

Exeter EX2 5DW, United Kingdom

Hospital R&D contact (matched)

Samantha Smart

rduh.research-eastern@nhs.net01392 406075

Royal Lancaster Infirmary

Lancaster LA1 4RP, United Kingdom

Hospital R&D contact (matched)

Colleen Bowthorpe

colleen.bowthorpe@nhs.scot01387 241815

St James's University Hospital

Leeds LS9 7TF, United Kingdom

Hospital R&D contact (matched)

R&I Team

leedsth-tr.researchfacilitation@nhs.net0113 2060469

Guy's Hospital

London SE1 9RT, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Royal Brompton Hospital

London SW3 6NP, United Kingdom

Hospital R&D contact (matched)

Main Email: gstt.research.rbhh@nhs.net

gstt.research.rbhh@nhs.netn/a

Altnagelvin Area Hospital

Londonderry BT47 6SB, United Kingdom

Hospital R&D contact (matched)

Mary Mc Gonigle

research.office@westerntrust.hscni.net028 71611362

Wythenshawe Hospital

Manchester M23 9QZ, United Kingdom

Churchill Hospital

Oxford OX3 7LE, United Kingdom

Southampton General Hospital

Southampton SO16 6YD, United Kingdom

Hospital R&D contact (matched)

Dr Mikayala King

researchmanagement@uhs.nhs.uk023 81208215
Data sourced from ClinicalTrials.gov · Last verified: 2026-09