A Study to Test Whether Different Doses of BI 1291583 Help People With Bronchiectasis

• Status: Not yet recruiting
• Trial end date: 2023-12-29
• Target enrollment: 0
• Participant gender: All

Summary

This study is open to adults with bronchiectasis. People can join the study if they produce sputum and have a history of flare-ups (also called exacerbations).

The purpose of this study is to find out whether a medicine called BI 1291583 helps people with bronchiectasis.

Participants are put into 4 groups randomly, which means by chance. Participants in groups 1, 2, and 3 get different doses of BI 1291583. Participants in group 4 get placebo. Placebo tablets look like BI 1291583 tablets, but do not contain any medicine. Participants take the tablets once a day.

Participants are in the study for between 6 months and 1 year. During this time, they visit the study site about 10 times and get about 5 phone calls from the site staff.

The doctors document when participants experience flare-ups during the study. The time to the first flare-ups is compared between the treatment groups. Doctors also regularly check participants' health and take note of any unwanted effects.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Boehringer Ingelheim

Criteria

Inclusion Criteria:

• Male or female patients: Women of childbearing potential (WOCBP) adhering to contraception requirements may be included as soon as regulatory criteria are fulfilled. At start of the trial this is only considered possible for WOCBP in the USA, Canada, Mexico and Turkey.

WOCBP and men able to father a child must be ready and able to use highly effective methods of birth control per International Council for Harmonisation (ICH) M3 (R2) that result in a low failure rate of less than 1% per year when used consistently and correctly, preferably with low user dependency, and one barrier method in addition. A list of contraception methods meeting these criteria and instructions on the duration of their use is provided in the patient information.

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

• Age of patients when signing the informed consent ≥18 and ≤85 years.

• Clinical history consistent with bronchiectasis (cough, chronic sputum production and/or recurrent respiratory infections) and investigator confirmed diagnosis of bronchiectasis by computed tomography (CT) scan. Subjects whose past chest radiographic image records are not available will undergo a chest CT scan during Screening. Historical scans must not be older than 5 years.

• History of pulmonary exacerbations requiring antibiotic treatment. In the 12 months before Visit 1, patients must have had either:

• at least 2 exacerbations, or

• at least 1 exacerbation and a St. George´s Respiratory Questionnaire (SGRQ) Symptoms score of >40 at screening visit 1.

For patients on stable oral or inhaled antibiotics as chronic treatment for bronchiectasis, at least one exacerbation must have occurred since initiation of stable antibiotics.

• Current sputum producers with a history of chronic expectoration who are able to provide a spontaneous (not induced) sputum sample at Screening Visit 1.

Exclusion Criteria:

Laboratory and medical examination

• Aspartate Aminotransferase (AST) and / or Alanine Aminotransferase (ALT) >3.0 x upper limit of normal (ULN) at Visit 1

• Estimated glomerular filtration rate (eGFR) according to Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) formula < 30 mL/min at Visit 1.

• An absolute blood neutrophil count <1,000/mm^3 at Visit 1.

• Any clinically relevant finding in the medical examination (including blood pressure (BP), pulse rate (PR), or electrocardiogram (ECG)) and/or laboratory value assessed by the Investigator at Screening Visit 1 or during screening period.

• Positive serological tests for hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection, or known infection status.

Concomitant diagnosis and therapy

• A current diagnosis of:

• Cystic Fibrosis

• Hypogammaglobulinemia

• Common variable immunodeficiency

• α1-antitrypsin deficiency

• Allergic bronchopulmonary aspergillosis requiring treatment

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

• Acute severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infection

• 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 acute infections (including respiratory infections) defined as infections requiring systemic or inhaled antibiotic therapy within 4 weeks prior Visit 1 and throughout screening.

• Any evidence of a concomitant disease, such as Papillon-Lefevre Syndrome, relevant pulmonary, gastrointestinal, hepatic, renal, cardiovascular, metabolic, immunological, or hormonal disorders, that in the opinion of the investigator, may put the patient at risk by participating in the study.

• Received any live attenuated vaccine within 4 weeks prior to Visit 2.

• Medical conditions associated with periodontal disease (to be evaluated by a periodontist or dentist):

• Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before the study (e.g. pulp necrosis).

• Severe periodontal disease defined as with pocket depth measurements ≥ 6 mm on 2 or more teeth.

• Class-3 mobility or Class-3 furcation involvement.

• Scheduled tooth extraction during the study period.

• Patients who must or wish to continue the intake of restricted medications or any drug considered likely to interfere with the safe conduct of the trial.

Further exclusion criteria apply