AI Cure is a research tool showing open data. Not medical advice. Discuss with your doctor. Terms

← Trials
🧪

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

RecruitingPhase 2Ages 18 Years - anyAllHopital Foch
💬

In plain words

What the trial is, and whether it could suit you

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

Sign in to get the eligibility rules as simple questions to take to your doctor.

📋 Eligibility rules (as published)
Inclusion Criteria: 1. Adult recipients, minimum age 18 2. Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant 3. At more than 3 years after the date of the transplantation 4. BOS defined by the occurrence of a new fixed obstructive ventilatory disorder after the allograft (accepted criteria: FEV1/FVC ≤70% and FEV1 \< 75% pred value and decline of more than 10% over less than 2 years OR FEV1/FVC \> 70% and FEV1 \< 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/or RV/TLC \> 40%) 5. Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months 6. On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid for at least three months. 7. Stable dose of systemic immunosuppressive regimen for the last 4 weeks 8. Being covered by a national health insurance 9. Signed consent form Exclusion Criteria: 1. Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH 2. FEV1\< 20% theorical value 3. Being deprived of liberty or under guardianship 4. Absence of signed consent 5. Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE 6. 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 7. Respiratory infection in the course of treatement (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria) 8. History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy 9. Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult 10. Pregnant, breastfeeding or lactating women
💊

What it tests

  • Tezepelumab
📍

Where

6 sites
CHU de Besançon
Besançon, France
Hôpital Haut-Lévêque - CHU Bordeaux
Bordeaux, France
CHU Caen Normandie
Caen, France
CHRU de Lille
Lille, France
Hôpital Saint-Louis APHP
Paris, France
Foch Hospital
Suresnes, France
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
🛡️

AI Cure shows public evidence (Open Targets, ClinicalTrials.gov, PubMed, openFDA, DepMap, AlphaFold) with its source, and AI summaries that cite it — not medical advice and not a cure. Treatment decisions belong with your doctor. Research ideas are shared only with approved researchers and labs, who can test them. In an emergency call your local emergency number (112 in India and Europe, 911 in the US). AI Cure Terms of Use · Privacy