Clairleaf

JRCT ID: jRCT2041230099

Registered date:31/10/2023

Basic Information

• Recruitment status: Recruiting
• Health condition(s) or Problem(s) studied: non-cystic fibrosis bronchiectasis (nCFB)
• Date of first enrollment: 25/12/2023
• Target sample size: 220
• Countries of recruitment: United States,Japan,Canada,Japan,Mexico,Japan,Belgium,Japan,Bulgaria,Japan,Czech Republic,Japan,Denmark,Japan,France,Japan,Germany,Japan,Greece,Japan,Hungary,Japan,Israel,Japan,Italy,Japan,Latvia,Japan,Netherlands,Japan,Poland,Japan,Portugal,Japan,Spain,Japan,Turkey,Japan,United Kingdom,Japan,Republic of Korea,Japan,Australia,Japan
• Study type: Interventional

Intervention(s)

Drug: BI 1291583 (1mg, 2.5mg, 5mg)
Route: oral

Outcome(s)

• Primary Outcome: Occurrence of treatment-emergent adverse events (TEAEs) over the course of this trial.

Secondary Outcome

. Time to first pulmonary exacerbation from first drug
administration in this trial to the end of the trial
. Rate of pulmonary exacerbations (number of events per person
time) over the course of this trial

Key inclusion & exclusion criteria

• Age minimum: >= 18age old
• Age maximum: Not applicable
• Gender: Both

Include criteria

1. Patients who completed the treatment period in Phase II trial (1397-0012) as planned
per protocol.
2. 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.
3. Signed and dated written informed consent prior to admission to the trial, in accordance with Good Clinical Practice (GCP) and local legislation.

Exclude criteria

1. 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).
2. 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).
3. An absolute blood neutrophil count <1,000/mm^3 at Visit 1 (or at the last safety assessment in the parent trial, if no more than 6 weeks passed since then).
4. 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.
5. 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 (Reiters 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 investigators discretion
. Active fungal infection of hand and/or feet not adequately treated and responsive to antifungal therapy, as per investigators discretion
6. Any clinically relevant respiratory infection within 4 weeks prior Visit 2
7. Any acute infection requiring systemic or inhaled anti-infective therapy within 4 weeks prior Visit 2
8. 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. (The test results will be available after randomisation. In case the results no longer satisfy the entry criteria, these patients will be discontinued.)
9. 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
10. Received any live attenuated vaccine within 4 weeks prior to Visit 1
Further exclusion criteria apply

Related Information

• Primary Sponsor: Kutsunai Mitsuru
• Secondary ID(s): NCT05846230