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Clairleaf TM: A study to test long-term treatment with BI 1291583 in people with bronchiectasis who took part in a previous study with this medicine
EU CTIS ID: 2023-503290-38-00
What this study is testing
The primary objective is to evaluate safety by assessing the absolute number and the percent of patients with treatment-emergent adverse event (TEAEs) over the course of the trial.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- Patients who completed treatment period in Phase II trial (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.
You likely can't join if
- 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).
See the full eligibility criteria
Who can join
- Patients who completed treatment period in Phase II trial (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.
What rules you out
- 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 • 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 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 the patient at risk by participating in the trial.
The study team makes the final eligibility decision.
Where it's taking place
- Korea, Republic of
- Canada
- Israel
- Mexico
- Japan
- United States
- Australia
- United Kingdom
- Turkey
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 65+ years, 18-64 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Korea, Republic of; Canada; Israel; Mexico; Japan; United States and 3 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.