Idiopathic Pulmonary Fibrosis MedDRA version: 21.1 Level: PT Classification code 10021240 Term: Idiopathic pulmonary fibrosis System Organ Class: 10038738 - Respiratory, thoracic and mediastinal disorders
Conditions
Interventions
Product Code: BI 1015550
Pharmaceutical Form: Film-coated tablet
INN or Proposed INN: BI 1015550
Current Sponsor code: BI 1015550
Other descriptive name: BI 1015550
Concentration unit: mg milligram(s)
Sponsors
Boehringer Ingelheim Finland Ky
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: - Patients aged =40 years when signing the informed consent. - Diagnosis: -- a. 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 -- b. UIP or probable UIP HRCT pattern consistent with the clinical diagnosis of IPF - 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. - Forced Vital Capacity (FVC) =45% of predicted normal at Visit 1 - DLCO (corrected for haemoglobin [Hb] [Visit 1]) = 25% to =65 years) yes F.1.3.1 Number of subjects for this age range 50
Exclusion criteria
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 (see table 5.2.3 :1) 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). - Confirmed infection with SARS-CoV-2 within 4 weeks prior to visit 1 or during screening period. - Further criteria apply.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: - To investigate the efficacy of BI 1015550 compared to placebo based on the change from baseline in Forced Vital Capacity (FVC). - To investigate safety and tolerability of BI 1015550 in the overall trial population.;Secondary Objective: Not applicable;Primary end point(s): 1) The primary endpoint is the change from baseline in FVC;Timepoint(s) of evaluation of this end point: 1) 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): 1) The percentage N (%) of patients with Treatment Emergent Adverse Events (TEAE).;Timepoint(s) of evaluation of this end point: 1) 13 weeks | — |
Countries
Argentina, Australia, Austria, Canada, Chile, China, Czechia, Czech Republic, Denmark, Finland, Germany, Greece, Hungary, Italy, Japan, Korea, Republic of, Mexico, Netherlands, Poland, Russian Federation, Slovakia, Spain, Ukraine, United Kingdom, United States
Contacts
Public ContactQRPE PSC CT Information Disclosure
Boehringer Ingelheim Pharma GmbH & Co. KG
Outcome results
None listed