Ensayos clínicos

Inclusion Criteria:

• Patients aged ≥ 40 years when signing the informed consent.
• Diagnosis: 
  • IPF based on 2018 ATS/ERS/JRS/ALAT Guideline [R18-2794] as confirmed by the investigator based on chest HRCT scan taken within 12 months of Visit 1 and if available surgical lung biopsy; and
  • UIP or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF, as confirmed by central review prior to Visit 2*

*if indeterminate HRCT finding IPF may be confirmed locally by (historical) biopsy

• Stable for at least 8 weeks prior to Visit 1. Patients have to be either:
  • not on therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 (combination of nintedanib plus pirfenidone not allowed); or
  • on stable* therapy with nintedanib or pirfenidone for at least 8 weeks prior to Visit 1 and planning to stay stable on this background therapy after randomisation.

[*stable therapy is defined as the individually and general tolerated regimen of either pirfenidone or nintedanib]

• Forced Vital Capacity (FVC) ≥ 45% of predicted normal at Visit 1.
• DLCO (corrected for haemoglobin [Hb] [Visit 1]) ≥ 25% to < 80% of predicted normal at Visit 1.
• Signed and dated written informed consent in accordance with ICH-GCP and local legislation prior to admission to the trial.

Exclusion Criteria:

• Relevant airways obstruction (pre-bronchodilator FEV1/FVC < 0.7) at Visit 1.
• In the opinion of the Investigator, other clinically significant pulmonary abnormalities.
• Acute IPF exacerbation within 4 months prior to screening and/or during the screening period (investigator-determined).
• Lower respiratory tract infection requiring antibiotics within 4 weeks prior to Visit 1 and/or during the screening period.
• 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).
• 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.
• Evidence of active infection (chronic or acute) based on clinical exam or laboratory findings at Visit 1 or at Visit 2.
• Any suicidal behaviour in the past 2 years (i.e., actual attempt, interrupted attempt, aborted attempt, or preparatory acts or behavior).
• Any suicidal ideation of type 4 or 5 on the C-SSRS in the past 3 months or at Visit 1; i.e., active suicidal thought with method and intent but without specific plan; or active suicidal thought with method, intent and plan.
• Baseline condition or medical history of vasculitis.
• AST orALT > 1.5 x ULN or total Bilirubin > 1.5 x ULN at Visit 1.
• eGFR (Chronic Kidney Disease Epidemiology Collaboration [CKD-EPI] formula or Japanese version of CKD-EPI for Japanese patients) ≤ 45 ml/min/1.73 m^2 at Visit 1.
  • Note: Laboratory parameters from Visit 1 have to satisfy the laboratory threshold values as shown above. Visit 2 laboratory results will be available only after randomisation. In case at Visit 2 the results do no longer satisfy the entry criteria, the Investigator has to decide whether it is justified that the patient remains on study drug. The justification for decision needs to be documented. Laboratory parameters that are found to be abnormal at Visit 1 are allowed to be re-tested (once) if it is thought to be a measurement error; i.e., there was no abnormal result of this test in the recent history of the patient and there is no related clinical sign, or the result of a temporary and reversible medical condition, once that condition is resolved.
• Patients with underlying chronic liver disease (Child Pugh A, B or C hepatic impairment).
• Cardiovascular diseases, any of the following:
  • Severe hypertension (uncontrolled under treatment ≥ 160/100 mmHg at multiple occasions) within 3 months of Visit 1;
  • Myocardial infarction within 6 months of Visit 1;
  • Unstable cardiac angina within 6 months of Visit 1.
• History of thrombotic event (including stroke and transient ischemic attack) within 6 months of Visit 1.
• Surgery of the GI tract that could interfere with PK of the trial medication (except appendectomy or simple hernia repair). day or any drug considered likely to interfere with the safe conduct of the trial.
• Patients not expected to comply with the protocol requirements or not expected to complete the trial as scheduled.
• Previous randomisation in this trial.
• Currently enrolled in another investigational device or drug trial, or less than 30 days since ending another investigational device or drug trial(s), or receiving other investigational treatment(s).
• In the opinion of the Investigator, active alcohol or drug abuse.
• Inability to refrain from smoking on trial days.
• Male patients who do not agree to minimize the risk of female partners becoming pregnant from first dosing day until 3 months after the study completion. Acceptable methods of contraception comprises barrier contraception and a medically accepted contraceptive method for the female partner (intra-uterine device with spermicide, hormonal contraceptive used for at least two months prior), true sexual abstinence (when
• this is in line with the preferred and usual lifestyle of the patient), or surgically sterilized, including vasectomy.
• Women who are not surgically sterilised or who are not postmenopausal, defined as at least 1 year of spontaneous amenorrhea (in questionable cases a blood sample with simultaneous levels of Follicle-stimulating hormone (FSH) above 40 U/L and estradiol below 30 ng/L is confirmatory).
• History of allergy or hypersensitivity or contraindications to the class of drugs under study including known hypersensitivity to the drug or its excipients.
• Patients with a significant disease or condition other than IPF which in the opinion of the investigator, may put the patient at risk because of participation, interfere with study procedures, or cause concern regarding the patient’s ability to participate in the study or any medical condition which could lead to a life expectancy < 12 months.
• The patient has a confirmed infection with SARS-CoV-2 within the 4 weeks prior to Visit 1 and/or during the screening period.