Testing Nerandomilast for idiopathic pulmonary fibrosis
Official 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
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
- 1 group
- Sites in Québec, Edmonton and 9 more cities
- Recruiting
Interventions
- Medication
Nerandomilast
Nerandomilast
Canadian Sites (13)
13 of 13 recruiting
- Recruiting
University of Alberta Hospital (University of Alberta)
Edmonton, Alberta
- Recruiting
Kelowna Respirology & Allergy Research
Kelowna, British Columbia
- Recruiting
St. Paul's Hospital (Vancouver)
Vancouver, British Columbia
- Recruiting
Vancouver General Hospital
Vancouver, British Columbia
- Recruiting
Dr. Georges-L.-Dumont University Hospital Centre
Moncton, New Brunswick
- Recruiting
QEII Health Sciences Centre
Halifax, Nova Scotia
- Recruiting
St. Joseph's Healthcare Hamilton
Hamilton, Ontario
- Recruiting
Dr. Syed Anees Medicine Professional Corporation
Windsor, Ontario
- Recruiting
Institut Universitaire de Cardiologie et de Pneumologie de Quebec (IUCPQ)
Québec
- Recruiting
Centre Hospitalier de l'Universite de Montreal (CHUM)
Montreal, Quebec
- Recruiting
McGill University Health Centre (MUHC)
Montreal, Quebec
- Recruiting
CIC Mauricie (Trois Rivieres)
Trois-Rivières, Quebec
- Recruiting
Royal University Hospital (Saskatoon)
Saskatoon, Saskatchewan
Eligibility Criteria
See who this study is looking for14 criteria
The trial’s own eligibility text, word for word from the registry. Only the trial site can say who takes part.
Inclusion
- +Patients who completed treatment in the parent trials (1305-0014, 1305-0023, or 1305-0035) without prematurely discontinuing treatment permanently according to protocolProtocolThe detailed plan a study must follow.Read more → (i.e. completed treatment with or without temporary treatment interruption)
- +Signed and dated written informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more → in accordance with ICH-GCP and local legislation prior to admission to the trial
- +Women of childbearing potential (WOCBP) must be ready and able to use highly effective methods of birth controlControl groupThe group a new treatment is measured against.Read more → 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
- −Any disease that may put the patient at risk when participating in this trial at investigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more →'s discretion.
- −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)
- −Patients with clinically relevant severe depression at investigator's discretion or a Hospital Anxiety and Depression Scale (HADS) subscore \>14 at Visit 1.
- −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.
- −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
- −At Visit 1, patients with ongoing Adverse EventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → 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
- −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 criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → apply.
- −Patient will undergo lung transplantation, with an assigned date of surgery.
In plain language
Assembled directly from this trial’s registry record. Every sentence traces to a field below — nothing here is generated or interpreted.
What this study is
This study is testing a treatment for a condition.
Phase 3Phase 3A large study comparing a treatment against the current standard.Read more → — a large study comparing this against the current standard, usually across many hospitals.
From the trial registry
Built from these fields:
- designModule.designInfo.primaryPurpose
- designModule.phases
Who receives what
Everyone in this study is in one group and receives Nerandomilast.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].label
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
How the study is run
There is only one group in this study, so there is no assignment to different treatments.
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
From the trial registry
Built from these fields:
- designModule.designInfo.allocation
- designModule.designInfo.maskingInfo.masking
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
Built from these fields:
- armsInterventionsModule.armGroups[].type
- armsInterventionsModule.armGroups[].interventionNames
Who the study is looking for
The study lists a minimum age of 18 years, with no upper limit given.
The study is open to people of any sex.
The study does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
These are the criteria the study lists. Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part.
From the trial registry
Built from these fields:
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How big and how long
The study aims to enrol about 1,700 people.
The study is currently expected to finish around May 2027.
The main measurement is taken over: Up to 99 weeks and 3 days.
From the trial registry
Built from these fields:
- designModule.enrollmentInfo.count
- statusModule.completionDateStruct.date
- outcomesModule.primaryOutcomes[].timeFrame
What the study measures
Occurrence of any adverse eventAdverse eventAny medical problem that happens during a study, whether or not the treatment caused it.Read more → over the course of the extension trial (yes/no) i.e. up until the follow-upFollow-upContinued check-ins after the treatment part is finished.Read more →/end of study visit planned at the latest at week 99 — measured over Up to 99 weeks and 3 days.
From the trial registry
Built from these fields:
- outcomesModule.primaryOutcomes[].measure
- outcomesModule.primaryOutcomes[].timeFrame
Source: NCT06238622 on ClinicalTrials.gov. The full registry text is further down this page — this summary never replaces it.
Not medical advice. What do these terms mean?
What is being tested — in plain terms
About NerandomilastDrug
Nerandomilast
From the trial registry — its own words, unedited.
What a drug is here: A medicine — a chemical or small-molecule treatment — given as the thing being studied.
Read the full explanation → · in clinical review
Common questions
Answered from this trial’s registry record. Where the record doesn’t say, these answers say so rather than filling the gap.
Am I eligible for this trial?
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can decide whether someone can take part. Concord cannot make that determination, and neither can any tool that has not examined you.
What the study lists: a minimum age of 18 years.
The full inclusionInclusion criteriaThe things you must have or be for a study to consider you.Read more → and exclusion criteriaExclusion criteriaThe things that would prevent someone from taking part.Read more → are published on this page, exactly as the study team wrote them.
The useful next step is to bring this trial to your doctor. Answering a few questions first gives them something concrete to review.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.eligibilityCriteria
Is there a placebo?
This study does not list a placeboPlaceboA dummy treatment with no active medicine, used for comparison.Read more → group.
From the trial registry
- armsInterventionsModule.armGroups[].type
Would I know which treatment I am getting?
This study is open-labelOpen-labelEveryone knows which treatment is being given — nothing is hidden.Read more →: everyone knows which treatment is being given, including you and the study team.
There is only one group in this study, so there is no assignment to different treatments.
From the trial registry
- designModule.designInfo.maskingInfo.masking
- designModule.designInfo.allocation
Who can join?
The study lists a minimum age of 18 years, with no upper limit given.
It is open to people of any sex.
It does not accept healthy volunteersHealthy volunteerSomeone without the condition being studied who takes part anyway.Read more →.
Only the trial siteTrial siteA hospital or clinic where a study is actually run.Read more → can confirm whether a particular person can take part.
From the trial registry
- eligibilityModule.minimumAge
- eligibilityModule.sex
- eligibilityModule.healthyVolunteers
How long would this take?
The study's main measurement is taken over: Up to 99 weeks and 3 days.
The study as a whole is currently expected to finish around 2027-05-05.
How long any one person takes part can differ from the study length. The study team can tell you what the schedule looks like in practice.
From the trial registry
- outcomesModule.primaryOutcomes[].timeFrame
- statusModule.completionDateStruct.date
How many people are taking part?
The study aims to enrol about 1,700 people.
From the trial registry
- designModule.enrollmentInfo.count
Where is this happening?
This study lists 18 locations, including: Québec, Canada; Edmonton, Alberta, Canada; Kelowna, British Columbia, Canada; Vancouver, British Columbia, Canada; Moncton, New Brunswick, Canada; Halifax, Nova Scotia, Canada, and 12 more.
Sites can open and close during a study, so confirm with the team before travelling.
From the trial registry
- trial_locations
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.
Other Sites (8)
University of Michigan
Ann Arbor, Michigan, United States
Corewell Health William Beaumont University Hospital
Royal Oak, Michigan, United States
University of Minnesota
Minneapolis, Minnesota, United States
Mayo Clinic, Rochester
Rochester, Minnesota, United States
Northern Westchester Hospital
Mount Kisco, New York, United States
Columbia University Medical Center-New York Presbyterian Hospital
New York, New York, United States
NewYork-Presbyterian/Weill Cornell Medical Center
New York, New York, United States
Virginia Mason Medical Center
Seattle, Washington, United States
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See if this trial could fit youThis page is for informational purposes only and does not constitute medical advice. Clinical trial eligibility can only be determined by the trial site after proper screening. Trial information is sourced from ClinicalTrials.gov and may not reflect the most current status. Always consult your healthcare provider before making decisions about clinical trial participation.