A Study to Test How Taking BI 1015550 for 12 Weeks Affects Lung Function in People With Idiopathic Pulmonary Fibrosis (IPF)
Condition: Idiopathic Pulmonary Fibrosis
MeSH terms: Pulmonary Fibrosis; Idiopathic Pulmonary Fibrosis; Fibrosis
Intervention: BI 1015550; Placebo
Intervention description: 18 milligram (mg) BI 1015550 taken orally as film-coated tablets (1x 6mg tablet, 1x 12 mg tablet) twice daily (36 mg daily), in the morning and in the evening for 12 weeks.; placebo matching BI 1015550 taken orally as film-coated tablets (matching the respective BI 1015550 tablets) twice daily, in the morning and in the evening for 12 weeks.
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 147.0
Sex: All
Minimum age: 40 Years
Healthy volunteers: No

Summary:

      This study is open to adults with idiopathic pulmonary fibrosis (IPF) who are at least 40
      years old. People taking standard medicines for IPF, including antifibrotic medicines, can
      continue taking them throughout the study.

      The purpose of the study is to find out whether a medicine called BI 1015550 can slow down
      the worsening of lung function. Participants are in the study for about 4 months. During this
      time, they visit the study site about 7 times. At the beginning, they visit the study site
      every 2 weeks.

      After 1 month of treatment, they visit the study site every 4 weeks.

      The participants are put into 2 groups by chance. 1 group gets BI 1015550. The other group
      gets placebo. Placebo tablets look like BI 1015550 tablets but contain no medicine. The
      participants take BI 1015550 or placebo tablets twice a day.

      The participants have lung function tests at study visits. The results of the lung function
      tests are compared between the BI 1015550 group and the placebo group. The doctors also
      regularly check the general health of the participants.
    

Eligibility criteria:

        Inclusion Criteria:

          1. Patients aged ≥40 years when signing the informed consent.

          2. Diagnosis:

               1. IPF based on 2018 ATS/ERS/JRS/ALAT Guideline as confirmed by the investigator
                  based on chest High Resolution Computed Tomography Scan (HRCT) scan taken within
                  12 months of Visit 1 and if available surgical lung biopsy.

                  and

               2. 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*

                    -  if indeterminate HRCT finding IPF may be confirmed locally by (historical)
                       biopsy

          3. 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]

          4. Forced Vital Capacity (FVC) ≥45% of predicted normal at Visit 1

          5. Diffusion capacity of the lung for carbon monoxide (DLCO) (corrected for haemoglobin
             [Hb] [Visit 1]) ≥ 25% to < 80% of predicted normal at Visit 1.

          6. Signed and dated written informed consent in accordance with ICH-GCP and local
             legislation prior to admission to the trial.

        Exclusion Criteria:

          1. Relevant airways obstruction (pre-bronchodilator Forced Expiratory Volume in one
             second (FEV1)/Forced Vital Capacity (FVC) < 0.7) at Visit 1.

          2. In the opinion of the Investigator, other clinically significant pulmonary
             abnormalities.

          3. Acute IPF exacerbation within 4 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. 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).

          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. Evidence of active infection (chronic or acute) based on clinical exam or laboratory
             findings at Visit 1 or at Visit 2.

          8. Any suicidal behaviour in the past 2 years (i.e. actual attempt, interrupted attempt,
             aborted attempt, or preparatory acts or behavior).

          9. The patient has a confirmed infection with SARS-CoV-2 within the 4 weeks prior to
             Visit 1 and/or during the screening period.

        Further exclusion criteria apply.