Clairleafᵀᴹ: A Study to Test Long-term Treatment With BI 1291583 in People With Bronchiectasis Who Took Part in a Previous Study With This Medicine

Inclusion Criteria:

• Patients who completed the treatment period in Phase II trials (1397-0012 or 1397-0013) as planned per protocol.

• Male or female patients. Women of childbearing potential (WOCBP) must be ready andable to use highly effective methods of birth control per ICH M3 (R2) that result ina low failure rate of less than 1% per year when used consistently and correctly, aswell as one barrier method. A list of contraception methods meeting these criteriais provided in the patient information.

• Signed and dated written informed consent prior to admission to the trial, inaccordance with Good Clinical Practice (GCP) and local legislation.

Exclusion Criteria:

Laboratory and medical examination

• Moderate or severe liver disease (defined by Child-Pugh score B or C hepaticimpairment) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) >3.0x Upper limit of normal (ULN) at Visit 1 (or at the last safety assessmentin the parent trial, if no more than 6 weeks passed since then).

• Estimated glomerular filtration rate (eGFR) according to Chronic Kidney DiseaseEpidemiology Collaboration (CKD-EPI) formula <30 mL/min at Visit 1 (or at the lastsafety assessment in the parent trial, if no more than 6 weeks passed since then).

• An absolute blood neutrophil count <1,000/mm^3 (equivalent to <1,000 cells/μL or <10^9 cells/L) at Visit 1 (or at the last safety assessment in the parent trial, ifno more than 6 weeks passed since then).

• Any findings in the medical examination and/or laboratory value assessed at Visit 1 (or at the last safety assessment in the parent trial, concerning the lab tests, ifno more than 6 weeks passed since then), that in the opinion of the investigator mayput the patient at risk by participating in the trial.

New concomitant diagnosis and therapy

• A new diagnosis of

• Hypogammaglobulinemia

• Common variable immunodeficiency

• α1-antitrypsin deficiency being treated augmentation therapy

• Allergic bronchopulmonary aspergillosis being treated or requiring treatment

• Tuberculosis or non-tuberculous mycobacterial infection being treated orrequiring treatment according to local guidelines

• Palmoplantar keratosis; or keratoderma climactericum

• Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis ofthe skin, acrocyanosis. If a subject has hypothyroidism but is treated andcompensated, the subject is allowed into the trial

• Psoriasis affecting palms and soles; or body surface area for psoriasis ≥10%

• Reactive arthritis (Reiter's syndrome); keratoderma blennorrhagicum

• Pityriasis rubra pilaris

• Atopic dermatitis affecting palms and soles; or body surface area for atopicdermatitis ≥10%

• Active extensive verruca vulgaris, as per investigator's discretion

• Active fungal infection of hand and/or feet not adequately treated andresponsive to antifungal therapy, as per investigator's discretion.

• Any clinically relevant respiratory infection within 4 weeks prior Visit 2, unlessrecovered in the opinion of the investigator by Visit 2.

• Any acute infection requiring systemic or inhaled anti-infective therapy within 4weeks prior Visit 2.

• Positive serological tests for hepatitis B, hepatitis C (also confirmed with (Hepatitis C Virus ribonucleic acid test (HCV RNA))), or human immunodeficiency virus (HIV) infection, or known infection status at Visit 2. (The test results will beavailable after randomisation. In case the results no longer satisfy the entrycriteria, these patients will be discontinued.)

• Any new evidence of a concomitant disease, such as Papillon-Lefèvre Syndrome (PLS),relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic,immunological, hormonal disorders, or patients who are immunocompromised with ahigher risk of invasive pneumococcal disease or other invasive opportunisticinfections (such as histoplasmosis, listeriosis, coccidioidomycosis,pneumocystosis), that in the opinion of the investigator, may put the patient atrisk by participating in the trial.

• Received any live attenuated vaccine within 4 weeks prior to Visit 1.

• Further exclusion criteria apply