[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-studies-list:{\"conditionNormalized\":\"bronchiolitis-obliterans-syndrome-bos\",\"overallStatus\":[\"RECRUITING\",\"AVAILABLE\",\"NOT_YET_RECRUITING\"],\"orderBy\":\"LastUpdateSubmitDate:desc\",\"size\":25,\"offset\":0}":3,"health-study-condition:bronchiolitis-obliterans-syndrome-bos":26},{"pageToken":4,"total":5,"offset":6,"count":5,"results":7},null,2,0,[8,46],{"id":9,"slug":10,"hasResults":11,"nctId":12,"briefTitle":13,"officialTitle":13,"acronym":14,"eligibilityCriteria":15,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":18,"targetDuration":4,"studyType":21,"phases":22,"briefSummary":24,"conditions":25,"keywords":29,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":34,"lastUpdatePostDateStruct":35,"startDateStruct":38,"completionDateStruct":40,"leadSponsor":42,"locationsCount":45},"100652201","phase-2-efficacy-of-an-anti-tslp-monoclonal-antibody-in-the-management-of-chronic-bronchial-disease-induced-by-bronchiolitis-obliterans-syndrome-in-allogeneic-hematopoietic-stem-cells-transplantation-recipients-100652201",false,"NCT07771855","Efficacy of an Anti-TSLP Monoclonal Antibody in the Management of Chronic Bronchial Disease Induced by Bronchiolitis Obliterans Syndrome in Allogeneic Hematopoietic Stem Cells Transplantation Recipients","IMMUNO-BOS","Inclusion Criteria:\n\n1. Adult recipients, minimum age 18\n2. Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant\n3. At more than 3 years after the date of the transplantation\n4. BOS defined by the occurrence of a new fixed obstructive ventilatory disorder after the allograft (accepted criteria: FEV1\u002FFVC ≤70% and FEV1 \\\u003C 75% pred value and decline of more than 10% over less than 2 years OR FEV1\u002FFVC \\> 70% and FEV1 \\\u003C 75% pred value and decline of FEV1 more than 10% over less than 2 years and Normal TLC \\> 80% OR decline of FEV1 more than 10% over less than 2 years and TLC \\> 120% and\u002For RV\u002FTLC \\> 40%)\n5. Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months\n6. On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid for at least three months.\n7. Stable dose of systemic immunosuppressive regimen for the last 4 weeks\n8. Being covered by a national health insurance\n9. Signed consent form\n\nExclusion Criteria:\n\n1. Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH\n2. FEV1\\\u003C 20% theorical value\n3. Being deprived of liberty or under guardianship\n4. Absence of signed consent\n5. Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE\n6. A helminth parasitic infection diagnosed within 6 months prior to Visit 1 that has not been treated with, or has failed to respond to, standard of care therapy\n7. Respiratory infection in the course of treatement (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria)\n8. History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy\n9. Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult\n10. Pregnant, breastfeeding or lactating women","ALL","18 Years",{"count":19,"type":20},36,"ESTIMATED","INTERVENTIONAL",[23],"PHASE2","Allogeneic hematopoietic stem cell transplantation (HSCT) is burdened with a high morbidity and mortality rates. Graft versus host disease (GVHD) is the clinical manifestation of an immune conflict. The expression of GVHD in the bronchioles is responsible for bronchiolitis obliterans syndrome (BOS), defined by the appearance of an obstructive ventilatory disorder. BOS may affect up to 10% of allogeneic transplant recipients. Repeated aggression-repair phenomena of the bronchial epithelium lead to an irreversible fibrous remodeling. The management of BOS remains a therapeutic challenge. A number of patients worsen their ventilatory disorder despite the available treatments and progress to obstructive respiratory failure complicated by repeated bronchial exacerbations. When the patient is far from the allograft and in the absence of any sign of active extrathoracic GVHD, the mechanisms of aggravation of the ventilatory disorder are equivocal. It seems more likely that the bronchial disease evolves on its own due to a persistent local inflammation without any immunological conflict. In this case, it would be reasonable to model the management on that of severe bronchial diseases for which the logic of cortisone sparing is now permitted by the arrival of targeted biotherapies.\n\nSince 2006, the therapeutic arsenal of bronchial inflammatory pathologies, mainly asthma, has been enriched with the class of targeted biotherapies. These therapies, targeting IgE (omalizumab), Th2 cytokines IL-5, IL-4, IL-13 (mepolizumab, benralizumab, dupilumab) and more recently the cytokine derived from the bronchial epithelium TSLP (tezepelumab), have shown effectiveness in reducing bronchial exacerbations, improving quality of life and reducing dependence on corticosteroids. TSLP is an alarmin that reflects bronchial epithelial involvement.\n\nThe objective of this study is to test the performance of an anti-TSLP biotherapy (tezepelumab) in the reduction of bronchial exacerbations in alloHSCT recipients suffering from obstructive bronchial disorders not supposed to be still related to an active GVHD.",[26,27,28],"Bronchiolitis Obliterans Syndrome (BOS)","HSCT","Bronchial Disease",[30,31,27,32],"Efficacy anti-TSLP monoclonal antibody (tezepelumab) in chronic bronchial disease induced Bronchiolitis obliterans syndrome (BOS) in HSCT recipient.","BOS","tezepzlumab","RECRUITING","2026-08-14",{"date":36,"type":37},"2026-08-18","ACTUAL",{"date":39,"type":37},"2026-06-24",{"date":41,"type":20},"2029-01",{"name":43,"class":44},"Hopital Foch","OTHER",6,{"id":47,"slug":48,"hasResults":11,"nctId":49,"briefTitle":50,"officialTitle":51,"acronym":52,"eligibilityCriteria":53,"healthyVolunteers":11,"sex":16,"minAge":17,"maxAge":4,"enrollmentInfo":54,"targetDuration":4,"studyType":21,"phases":56,"briefSummary":57,"conditions":58,"keywords":60,"overallStatus":33,"whyStopped":4,"lastUpdateSubmitDate":65,"lastUpdatePostDateStruct":66,"startDateStruct":68,"completionDateStruct":70,"leadSponsor":72,"locationsCount":74},"100347571","phase-2-nintedanib-in-patients-with-bronchiolitis-obliterans-syndrome-following-hematopoietic-stem-cell-transplantation-100347571","NCT03805477","Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation","Nintedanib in Patients With Bronchiolitis Obliterans Syndrome Following Hematopoietic Stem Cell Transplantation (HSCT)- a Multicentre Phase II Trial","NINBOST2018","Inclusion Criteria:\n\n* Time interval from transplant \\\u003C\u002F= 5 years at the time of inclusion\n* BOS as defined per the National Institute of Health (NIH) criteria:\n\n  1. FEV1\u002Fvital capacity \\\u003C 0.7 or the fifth percentile of predicted.\n  2. FEV1 \\\u003C 75% of predicted with ≥ 10% decline over less than 2 years.\n  3. Absence of infection in the respiratory tract, documented with investigations directed by clinical symptoms, such as chest radiographs, computed tomographic (CT) scans, or microbiologic cultures (sinus aspiration, upper respiratory tract viral screen, sputum culture, and broncho-alveolar lavage).\n  4. One of the 2 supporting features of BOS: 1. Evidence of air trapping by expiratory CT or small airway thickening or bronchiectasis by high-resolution chest CT, or 2. Evidence of air trapping by PFTs: residual volume \\> 120% of predicted or residual volume\u002Ftotal lung capacity elevated outside the 90% confidence interval and prior or current diagnosis of cGvHD per NIH criteria or histologically proven BO\n* Diagnosis of BOS within 6 months before enrollment or prior diagnosis of BOS with an absolute decline of the percentage of predicted forced expiratory volume in 1 second (FEV1) by \\>\u002F= 10% within the past 12 months before inclusion\n\nExclusion Criteria\n\n* Known intolerance to Nintedanib or any of its component\n* Pregnancy or nursing\n* Serum ALT \\> 5 x upper limit of normal (ULN) unless explained entirely by liver GvHD or total bilirubin \\> 3x ULN unless explained entirely by liver GvHD\n* Any acute pulmonary infection with viruses, bacteria or fungi within four weeks before study inclusion\n* Chronic oxygen therapy; non-invasive ventilation\n* Inability to give informed consent or to perform repeated pulmonary function tests (PFT)\n* Life expectancy \\\u003C 1 year at the time of enrolment as suggested by the treating physician\n* Hematologic malignancy in hematologic relapse\n* Symptomatic angina pectoris\n* Therapeutic anticoagulation (primary or secondary prophylactic platelet anti-aggregation allowed)\n* Recent abdominal surgery or untreated gastric ulcer",{"count":55,"type":20},20,[23],"This study investigates the safety and tolerability of Nintedanib in patients with bronchiolitis obliterans syndrome (BOS) following allogeneic hematopoietic cell transplantation. All study patients with BOS will be treated with the study drug Nintedanib (300 mg\u002Fday) as an add-on therapy to their basic immunosuppressive treatment over a 12-months treatment period.",[26,59],"Bronchiolitis Obliterans (BO)",[61,62,63,64],"allogeneic hematopoietic cell transplantation.","chronic graft-versus-host disease (cGvHD)","Nintedanib","fibrotic lung disease","2025-12-05",{"date":67,"type":37},"2025-12-15",{"date":69,"type":37},"2019-03-20",{"date":71,"type":20},"2026-12",{"name":73,"class":44},"University Hospital, Basel, Switzerland",3]