[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchiectasis-with-pseudomonas-aeruginosa-colonization\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchiectasis-with-pseudomonas-aeruginosa-colonization":27},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,3,0,[8,41,64],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":14,"acronym":15,"eligibilityCriteria":16,"healthyVolunteers":11,"sex":17,"minAge":18,"maxAge":4,"enrollmentInfo":19,"targetDuration":4,"studyType":22,"phases":23,"briefSummary":25,"conditions":26,"keywords":4,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":29,"lastUpdatePostDateStruct":30,"startDateStruct":33,"completionDateStruct":35,"leadSponsor":37,"locationsCount":40},"100652431","phase-2-a-study-of-azd0292-in-chinese-participants-with-bronchiectasis-and-chronic-pseudomonas-aeruginosa-colonization-100652431",false,"NCT07774403","A Study of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase II Randomized, Double-blind, Placebo-controlled, Parallel Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Chinese Participants With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","BREEZE","Inclusion Criteria:\n\n* Participant must be ≥ 18 years of age at the time of signing the informed consent\u002Fassent.\n* Weight ≥ 35 kg.\n* Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n* Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n* Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n* Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n* Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n* Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n* Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n* Primary lung diagnosis other than bronchiectasis\n* Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n* Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n* Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n* Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n* AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n* History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n* Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n* Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n* Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n* Participation with a study intervention used within the last 30 days or 5 half-lives of the investigational product from the other clinical study, whichever is longer, prior to screening.\n* Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration","ALL","18 Years",{"count":20,"type":21},84,"ESTIMATED","INTERVENTIONAL",[24],"PHASE2","AZD0292 is a bispecific IgG1k mAb being evaluated for the prevention of exacerbations in bronchiectasis patients chronically colonized with PsA.",[27],"Bronchiectasis With Pseudomonas Aeruginosa Colonization","RECRUITING","2026-08-18",{"date":31,"type":32},"2026-08-19","ACTUAL",{"date":34,"type":32},"2026-06-24",{"date":36,"type":21},"2028-06-06",{"name":38,"class":39},"AstraZeneca","INDUSTRY",40,{"id":42,"slug":43,"hasResults":11,"nctId":44,"briefTitle":45,"officialTitle":46,"acronym":47,"eligibilityCriteria":48,"healthyVolunteers":11,"sex":17,"minAge":49,"maxAge":4,"enrollmentInfo":50,"targetDuration":4,"studyType":22,"phases":52,"briefSummary":25,"conditions":53,"keywords":54,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":56,"lastUpdatePostDateStruct":57,"startDateStruct":58,"completionDateStruct":60,"leadSponsor":62,"locationsCount":63},"100599779","phase-2-a-study-to-evaluate-the-efficacy-safety-and-pk-of-azd0292-administered-iv-in-participants-12-years-of-age-and-older-with-bronchiectasis-and-chronic-pseudomonas-aeruginosa-colonization-100599779","NCT07088926","A Study to Evaluate the Efficacy, Safety, and PK of AZD0292 Administered IV in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","A Phase IIb Randomized, Double-blind, Placebo-controlled, Parallel, Multidose Study to Evaluate the Efficacy, Safety, and PK of AZD0292 in Participants 12 Years of Age and Older With Bronchiectasis and Chronic Pseudomonas Aeruginosa Colonization","CLEAR","Inclusion Criteria:\n\n1. Participant must be ≥ 12 years of age at the time of signing the informed consent\u002Fassent\n2. Weight ≥ 35 kg\n3. Bronchiectasis diagnosed by a physician and confirmed by CT demonstrating abnormal bronchial dilation in ≥ 1 lobe. Note: A historical CT scan within the past 5 years is acceptable. If not available, a CT scan should be conducted at screening to confirm eligibility.\n4. Participants who are receiving appropriate standard of care therapy per local guidelines and have a documented history of ≥ 2 moderate exacerbations or ≥ 1 severe exacerbation in the preceding 12 months requiring antibiotics\n5. Participants who are clinically stable and free from an exacerbation of bronchiectasis for 4 weeks prior to randomization\n6. Participants with pre- or post-bronchodilator FEV1 ≥ 25% predicted value at screening.\n7. Presence of positive (PCR or culture) PsA in an airway sample at least once in the last 24 months prior to screening\n8. Presence of culture positive PsA in sputum at least within 5 weeks of randomization. Participants who have previously received PsA eradication therapy, as determined appropriate by their treating provider, but remain colonized with PsA are eligible for the study.\n9. Capable of giving signed informed consent\u002Fassent which includes compliance with the requirements and restrictions listed in the ICF and in this protocol\n\nExclusion Criteria:\n\n1. Primary lung diagnosis other than bronchiectasis\n2. Evidence of active tuberculosis or active nontuberculous mycobacteria being treated or requiring treatment. Participants currently receiving treatment for active TB or nontuberculous mycobacteria may be considered after completion of an appropriate course of therapy\n3. Evidence of an active allergic bronchopulmonary aspergillosis being treated or requiring treatment\n4. Need for long term supplemental oxygen. Oxygen use for ambulation and relief of breathlessness after exercise is allowed\n5. Malignancy, current or within the previous 5 years, except for stable prostate cancer, adequately treated non-invasive basal cell and squamous cell carcinoma of the skin and cervical carcinoma in situ treated with apparent success more than one year prior to enrolment\n6. AIDS or Advanced human immunodeficiency virus disease (CD4 count of \\\u003C 200 cells\u002Fmm3)\n7. History of severe adverse reaction associated with a mAb, and\u002For history of severe allergic reaction (eg, anaphylaxis that required the use of epinephrine\u002Fadrenaline or hospitalization), and\u002For history of immune complex disease (Type III hypersensitivity reactions) to monoclonal antibody administration\n8. Treatment with long term anti-PsA antibiotics, macrolides, or DPP-1 inhibitors, which are newly initiated within the 3 months prior to screening\n9. Chronic immunosuppressive therapy (including prednisolone \\> 5 mg or equivalent) newly initiated within the last 3 months\n10. Receipt of investigational products indicated for the treatment or prevention of bronchiectasis exacerbations or expected receipt during the study\n11. Participants with CF on CFTR modulator therapies which are newly initiated within the previous 3 months prior to screening\n12. Female participants who are pregnant, lactating, or WOCBP and not using a highly effective method of contraception or abstinence from at least 4 weeks prior to study intervention administration and until at least 6 months after study intervention administration","12 Years",{"count":51,"type":21},435,[24],[27],[55],"Bronchiectasis Chronic Pseudomonas Aeruginosa Colonization","2026-08-17",{"date":29,"type":32},{"date":59,"type":32},"2025-11-06",{"date":61,"type":21},"2028-06-14",{"name":38,"class":39},187,{"id":65,"slug":66,"hasResults":11,"nctId":67,"briefTitle":68,"officialTitle":69,"acronym":4,"eligibilityCriteria":70,"healthyVolunteers":71,"sex":17,"minAge":18,"maxAge":72,"enrollmentInfo":73,"targetDuration":4,"studyType":22,"phases":75,"briefSummary":77,"conditions":78,"keywords":81,"overallStatus":28,"whyStopped":4,"lastUpdateSubmitDate":85,"lastUpdatePostDateStruct":86,"startDateStruct":88,"completionDateStruct":90,"leadSponsor":92,"locationsCount":94},"100647357","phase-1-first-in-human-trial-of-ctx-187-in-healthy-volunteers-and-chronically-infected-patients-100647357","NCT07708116","First in Human Trial of CTX-187 in Healthy Volunteers and Chronically Infected Patients","A Phase 1 First-In-Human, Double-Blind, Single and Multiple Ascending Dose Trial to Evaluate Safety, Tolerability, Pharmacokinetics, and Immunogenicity of Intravenous Doses of CTX-187 in Healthy Volunteers Followed by Multiple Doses in Patients With a Bacterial Infection","Inclusion Criteria\n\n1. Parts A and B: Healthy adult males and\u002For females, 18 to 65 years of age.\n2. Parts A and B: Body mass index (BMI): ≥18.0 and ≤32.0 kg\u002Fm\\^2 and weight \\>50 kg.\n3. Parts A and B: Good physical and mental health without clinically significant abnormalities.\n4. Part C: Adult males and\u002For females, 18 to 75 years of age.\n5. Part C: Prior clinical and computerized tomography diagnosis of bronchiectasis.\n6. Part C: P. aeruginosa in sputum, bronchoalveolar lavage or another airway sample at least once in the 12 months prior to screening and P. aeruginosa in sputum during screening, both of which should be at least 21 days apart.\n7. Part C: Otherwise in good physical and mental health without clinically significant abnormalities.\n\nExclusion Criteria\n\n1. Parts A and B: Previous participation in the current trial.\n2. Parts A and B: History or presence of significant cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant.\n3. Parts A and B: Participation in a drug trial within the previous 30 days before the first dose of trial drug or 5x elimination half-life, if known, whichever is longer.\n4. Part C: Known hypersensitivity to any reagents contained in CTX-187 or documented hypersensitivity reaction or anaphylaxis to any medication.\n5. Parts A, B and C: Known clinical diagnosis of cystic fibrosis, active allergic bronchopulmonary aspergillosis or active tuberculosis or nontuberculous mycobacterial infection; primary diagnosis of asthma or chronic obstructive pulmonary disease.\n6. Part C: Treatment with long term inhaled, systemic or nebulized anti-pseudomonal antibiotics which are newly initiated within the previous 3 months prior to screening.\n7. Part C: Receipt of anti-pseudomonal antibiotics for an exacerbation during the screening period.\n8. Part C: History or presence of unstable co-morbidities: cardiovascular, pulmonary, hepatic, renal, haematological, gastrointestinal, endocrine, immunologic, dermatologic, or neurological disease, including any acute illness or surgery within the past 3 months determined by the Investigator to be clinically relevant. Participants on stable doses of anti-hypertensive medications or statins may be included following discussion between the Investigator and the medical monitor.\n9. Part C: History of known or suspected Clostridioides difficile infection or diarrhoea within one week of recruitment, not resolved during the past 5 days.\n10. Part C: Participants with an acute exacerbation of bronchiectasis.",true,"65 Years",{"count":74,"type":21},104,[76],"PHASE1","The primary objective of this trial is to assess the safety and tolerability of single and multiple ascending intravenously (IV) infused doses of CTX-187 when administered to healthy adult male and female participants and participants with a bacterial infection (bronchiectasis participants chronically infected with P. aeruginosa).",[79,27,80],"Bronchiectasis Adult","Bacterial Infections",[82,83,84,80],"CTX-187","Bronchiectasis","Pseudomonas Aeruginosa","2026-07-13",{"date":87,"type":32},"2026-07-16",{"date":89,"type":32},"2026-06-16",{"date":91,"type":21},"2027-12-31",{"name":93,"class":39},"Centauri Therapeutics Limited",1]