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

Phase
Recruitment status
Participants
Lead sponsor
Boehringer Ingelheim
Start date
Number of sites

Summary
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.
Acronym
FIBRONEER™-ON
Short 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
Official title
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)

Control arm
Registry reports results
Listing at source
Recruitment status
Phase
Study type
Interventional

Completion date
First posted
Registry last updated
Primary completion date
Start date

Participants
Participant count basis
Planned participants
Protocol amendments
Number of sites

Data monitoring committee
Registry sponsor category
Lead sponsor
Boehringer Ingelheim
Source registry
ClinicalTrials.gov

Registry ID
ClinicalTrials.gov ID
Registry record
Open registry record

Allocation
Not applicable
Model
Single group
Purpose
Treatment
Masking
No masking
Sources for study design

  1. 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

    Timeframe: Up to 99 weeks and 3 days

  1. Absolute change from baseline in Forced vital capacity (FVC) (mL) over time

    Timeframe: Up to 98 weeks

  2. Absolute change from baseline in % predicted in Forced vital capacity (FVC) over time

    Timeframe: Up to 98 weeks

  3. Time to absolute decline in FVC % predicted of >10% from baseline over the duration of the trial

    Timeframe: Up to 98 weeks

  4. Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation, first hospitalisation for respiratory cause, or death (whichever occurs first) over the duration of the trial

    Timeframe: Up to 98 weeks

  5. Time to first acute Idiopathic Pulmonary Fibrosis/Progressive Pulmonary Fibrosis (IPF/PPF) exacerbation or death over the duration of the trial

    Timeframe: Up to 98 weeks

  6. Time to hospitalisation for respiratory cause or death over the duration of the trial

    Timeframe: Up to 98 weeks

  7. Time to absolute decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial

    Timeframe: Up to 98 weeks

  8. Time to relative decline in Forced vital capacity (FVC) % predicted of >10% from baseline or death over the duration of the trial

    Timeframe: Up to 98 weeks

Sources for outcomes

Sex
All
Age groups
Adults, Older adults
Minimum age
18 Years
Healthy volunteers
No

  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

  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.

Sources for eligibility

  • University of Alabama at BirminghamBirmingham, United StatesActive, not recruiting
  • University of ArizonaTucson, United StatesActive, not recruiting
  • University of Southern CaliforniaLos Angeles, United StatesActive, not recruiting
  • Cedars-Sinai Medical CenterLos Angeles, United StatesActive, not recruiting
  • University of California Los AngelesLos Angeles, United StatesActive, not recruiting
  • University of California DavisSacramento, United StatesRecruiting
  • National Jewish HealthDenver, United StatesActive, not recruiting
  • Yale University School of MedicineNew Haven, United StatesActive, not recruiting
  • Christiana HospitalNewark, United StatesCompleted
  • Georgetown UniversityWashington D.C., United StatesActive, not recruiting
  • St. Francis Medical InstituteClearwater, United StatesCompleted
  • University of FloridaGainesville, United StatesActive, not recruiting
  • Clinical Research Specialists LLC - KissimmeeKissimmee, United StatesActive, not recruiting
  • Advanced Pulmonary Research InstituteLoxahatchee Groves, United StatesActive, not recruiting
  • Piedmont Physicians Pulmonary & Sleep Medicine of BuckheadAtlanta, United StatesActive, not recruiting
  • The Emory ClinicAtlanta, United StatesActive, not recruiting
  • Northshore University Health SystemEvanston, United StatesActive, not recruiting
  • University of Kansas Medical CenterKansas City, United StatesActive, not recruiting
  • Tulane Medical CenterNew Orleans, United StatesActive, not recruiting
  • Johns Hopkins HospitalBaltimore, United StatesActive, not recruiting
  • Massachusetts General HospitalBoston, United StatesActive, not recruiting
  • Brigham and Women's HospitalBoston, United StatesActive, not recruiting
  • St. Elizabeth's Medical CenterBoston, United StatesActive, not recruiting
  • Beth Israel Deaconess Medical CenterBoston, United StatesActive, not recruiting
  • University of MichiganAnn Arbor, United StatesActive, not recruiting

And 348 more, listed on the interactive page.

Sources for sites

  • 2023
  • 2023-507353-15-00
Sources for references

Related records

Drugs (1)

Lead sponsors (1)

Conditions (2)