Clinical Trials

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) with a diagnosis of Idiopathic Pulmonary Fibrosis (IPF), aged ≥
40 years when signing the informed consent. IPF diagnosis based on 2018
ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator based on chest HRCT scan
taken within 12 months of Visit 1 and if available surgical lung biopsy; AND Usual
interstitial pneumonia (UIP) or probable UIP HRCT pattern consistent with the clinical
diagnosis of IPF, as confirmed by central review prior to Visit 2.

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

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

6. 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.