A Study To Find Out Whether BI 1015550 Improves Lung Function In People With Progressive Fibrosing Interstitial Lung Disease (PF-ILDs)

Overview

About this study

The purpose of this study is to demonstrate a reduction in lung function decline as measured by the change from baseline in Forced Vital Capacity (FVC) for BI 1015550 when compared to placebo in patients with progressive fibrosing interstitial lung diseases (PF-ILDs). 

Participation eligibility

Participant eligibility includes age, gender, type and stage of disease, and previous treatments or health concerns. Guidelines differ from study to study, and identify who can or cannot participate. There is no guarantee that every individual who qualifies and wants to participate in a trial will be enrolled. Contact the study team to discuss study eligibility and potential participation.

Inclusion Criteria:

1. Written Informed Consent consistent with ICH-GCP and local laws signed prior to entry
into the study (and prior to any study procedure including shipment of high-resolution
computed tomography (HRCT) to reviewer).

2. Patients (male/female), aged ≥ 18 years when signing the informed consent, with a
physician diagnosed progressive fibrosing Interstitial Lung Disease (PF-ILD) other
than Idiopathic Pulmonary Fibrosis (IPF) (presence of reticular abnormality with
traction bronchiectasis with or without honeycombing on HRCT, performed within 12
months of Visit 1) AND who fulfil at least one of the following criteria for PF-ILD
within 24 months of Visit 1 despite management according to current clinical practice
to treat ILD, as assessed by the investigator (refer to Exclusion Criteria):

1. Clinically significant decline in Forced Vital Capacity (FVC) % predicted (pred)
based on a relative decline of ≥ 10%;

2. Marginal decline in FVC % pred based on a relative decline of ≥5-<10% combined
with worsening of respiratory symptoms;

3. Marginal decline in FVC % pred based on a relative decline of ≥5-<10% combined
with increasing extent of fibrotic changes on chest imaging;

4. Worsening of respiratory symptoms as well as increasing extent of fibrotic
changes on chest imaging.

3. Patients need to be either:

-- on a stable therapy* with nintedanib or pirfenidone for at least 12 weeks prior to
Visit 1 and during screening and planning to stay on this background treatment after
randomization. Combination of nintedanib plus pirfenidone is not allowed;

[*stable therapy is defined as the individually and general tolerated regimen of
either nintedanib or pirfenidone (no dose changes) for at least 12 weeks]; OR

-- not on a therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit
1 or during the screening period. (e.g., either antifibrotic (AF)-treatment naïve or
previously discontinued) and start or re-start of an antifibrotic is not planned.

4. Patients treated with permitted immunosuppressive agents for the underlying disease
(e.g. Mycophenolat-Mofetil (MMF), methotrexat (MTX), azathioprine (AZA) ?) need to be
on a stable treatment for at least 12 weeks prior to visit 1 and during screening
period:

For oral corticosteroids, the dose should not have been > 20 mg prednisolone/day (or
equivalent) within 4 weeks prior to visit 1 For patients with underlying Connective
Tissue Disease (CTD), the CTD should be stable, defined as no initiation of new
therapy or withdrawal of therapy for CTD within 12 weeks prior to Visit 1 and during
the screening period.

5. Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1.

6. Diffusing capacity for carbon monoxide (DLCO) corrected for Haemoglobin (Hb) [visit 1]
≥ 25% and <90% predicted of normal at Visit 1.

7. Female and male patients: Women of childbearing potential (WOCBP) and men able to
father a child 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. A list of contraception methods meeting these criteria and
instructions on the duration of their use is provided in the patient information.

Exclusion Criteria:

1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume (FEV)1/FVC <
0.7) at Visit 1.

2. In the opinion of the Investigator, other clinically significant pulmonary
abnormalities.

3. Acute IPF or Interstitial Lung Disease (ILD) exacerbation within 3 months prior to
screening and/or during the screening period (investigator-determined).

4. Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit
1 and/or during the screening period.

5. Relevant chronic or acute infections including human immunodeficiency virus (HIV) and
viral hepatitis and a confirmed infection with severe acute respiratory syndrome
coronavirus 2 (SARS-CoV-2) within the 4 weeks prior to Visit 1 or during the screening
period.

A patient can be re-screened if the patient was treated and/or cured from the acute
infection.

6. Any documented active or suspected malignancy or history of malignancy within 5 years
prior to Visit 1, except appropriately treated basal cell carcinoma of the skin,
"under surveillance" prostate cancer or in situ carcinoma of uterine cervix.

7. Major surgery (major according to the investigator's assessment) performed within 3
months prior to Visit 1 or planned during the course of the trial. Being on a
transplant list is allowed.

8. Aspartate amino transferase (AST) or Alanine amino transferase (ALT) > 2.5 x upper
limit of normal (ULN) or total Bilirubin > 1.5 x ULN at Visit 1.

Additional Exclusion Criteria may apply.

Eligibility last updated 7/7/22. Questions regarding updates should be directed to the study team contact.

 

Participating Mayo Clinic locations

Study statuses change often. Please contact the study team for the most up-to-date information regarding possible participation.

Mayo Clinic Location Status Contact

Rochester, Minn.

Mayo Clinic principal investigator

Cassandra Braun, M.D.

Closed for enrollment

Contact information:

Shannon Daley

5072930637

daley.shannon@mayo.edu

More information

Publications

Publications are currently not available