EUCTR2021-003304-41-HU进行中（未招募）1 期
A randomised, double-blind, placebo-controlled, parallel group, dose-finding study evaluating efficacy, safety and tolerability of BI 1291583 qd over at least 24 weeks in patients with bronchiectasis - CatC inhibitor Phase II in bronchiectasis
适应症
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 240
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional clinical trial of medicinal product
入排标准
- 性别
- All
入选标准
- •- Male or female (not of childbearing potential) patients
- •- 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.
- •- 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 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
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 100
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 140
排除标准
- •- AST and / or ALT >3.0 x ULN at Visit 1
- •- Estimated glomerular filtration rate (eGFR) according to CKD-EPI formula < 30 mL/min at Visit 1.
- •- An absolute blood neutrophil count <1,000/mm3 at Visit 1.
- •- Any clinically relevant finding in the medical examination (including BP, PR, or 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.
- •- A current diagnosis of
- •-- Cystic Fibrosis
- •-- Hypogammaglobulinemia
- •-- Common variable immunodeficiency
- •-- a1-antitrypsin deficiency
- •-- Allergic bronchopulmonary aspergillosis 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 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.
- •- 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).
- •- 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 criteria apply.
研究者
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