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

Launched by BOEHRINGER INGELHEIM · Apr 26, 2023

Keywords

ClinConnect Summary

**Clinical Trial Summary: Clairleaf™ Study on BI 1291583 for Bronchiectasis**

The Clairleaf™ study is testing a medication called BI 1291583 for adults with bronchiectasis, a lung condition that causes inflammation and can lead to breathing difficulties. If you are at least 18 years old and have previously participated in studies using this medicine (Airleaf™ or Clairafly™), you may be eligible to join this new trial. The main goal is to see if BI 1291583 can help reduce symptoms of bronchiectasis and to understand how well patients tolerate the medication over a longer period.

If you participate, you will take a daily tablet of BI 1291583 for up to one year. Depending on what you took in the earlier studies, you will either continue your previous dose or be randomly assigned to a low, medium, or high dose of the study medication. Throughout the study, you’ll have 10 visits and receive four phone calls from the study team, who will check on your health and any side effects. This is an opportunity to help researchers learn more about this treatment and potentially improve care for others with bronchiectasis.

Gender

ALL

Eligibility criteria

• 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 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, as well as one barrier method. A list of contraception methods meeting these criteria is provided in the patient information.
• • Signed and dated written informed consent prior to admission to the trial, in accordance 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 hepatic impairment) or aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) \>3.0x Upper limit of normal (ULN) at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
• • Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula \<30 mL/min at Visit 1 (or at the last safety 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, if no 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, if no more than 6 weeks passed since then), that in the opinion of the investigator may put 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 or requiring treatment according to local guidelines
• • Palmoplantar keratosis; or keratoderma climactericum
• • Hypothyroidism, myxedema, chronic lymphedema with associated hyperkeratosis of the skin, acrocyanosis. If a subject has hypothyroidism but is treated and compensated, 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 atopic dermatitis ≥10%
• • Active extensive verruca vulgaris, as per investigator's discretion
• • Active fungal infection of hand and/or feet not adequately treated and responsive to antifungal therapy, as per investigator's discretion.
• • Any clinically relevant respiratory infection within 4 weeks prior Visit 2, unless recovered in the opinion of the investigator by Visit 2.
• • Any acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks 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 be available after randomisation. In case the results no longer satisfy the entry criteria, 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 a higher risk of invasive pneumococcal disease or other invasive opportunistic infections (such as histoplasmosis, listeriosis, coccidioidomycosis, pneumocystosis), that in the opinion of the investigator, may put the patient at risk by participating in the trial.
• • Received any live attenuated vaccine within 4 weeks prior to Visit 1.
• • Further exclusion criteria apply