CTIS2023-503290-38-00RecruitingPhase 1
A randomised, double-blind, parallel group, roll-over study evaluating long-term safety and efficacy of oral doses of BI 1291583 q.d. in patients with bronchiectasis (ClairleafTM) - 1397-0017
Boehringer Ingelheim International GmbH0 sites223 target enrollmentStarted: May 9, 2023Last updated:
Conditions
Trial Snapshot
- Phase
- Phase 1
- Status
- Recruiting
- Enrollment
- 223
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional
Eligibility Criteria
- Ages
- 18 to 65+ (—)
- Sex
- All
Inclusion Criteria
- •Patients who completed treatment period in Phase II trial (1397-0012) 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. Men participating in this clinical trial must use male contraception (condom or sexual abstinence) if their sexual partner is a WOCBP., Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation.
Exclusion Criteria
- •Moderate or severe liver disease (defined by Child-Pugh score B or C hepatic impairment) or AST and/or ALT >3.0x ULN at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then)., Received any live attenuated vaccine within 4 weeks prior to Visit 1., Medical conditions associated with severe periodontal disease (to be evaluated by a periodontist or dentist) at Visit 1: • Any tooth that can potentially cause pain or infection as noted in the oral exam unless they are corrected before Visit 2 (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, Patients who must or wish to continue the intake of restricted medications (Table 6) or any drug considered likely to interfere with the safe conduct of the trial., Further exclusion criteria apply., Estimated glomerular filtration rate (eGFR) according to 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/mm3 (equivalent to <1,000 cells/µL or <109 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., A new diagnosis of: • Hypogammaglobulinemia • Common variable immunodeficiency • a1-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, 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 HCV RNA), or human immunodeficiency virus (HIV) infection, or known infection status at Visit 2., Any new evidence of a concomitant disease, such as 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 t
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