2024-516796-33-00招募中2 期
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.
Hospital Foch6 个研究点 分布在 1 个国家目标入组 36 人开始时间: 2026年7月1日最近更新:
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 36
- 试验地点
- 6
- 主要终点
- The primary endpoint is the within-patient change in the annualized number of bronchial exacerbations between the 12-month period prior to treatment initiation and the 12-month treatment period. Bronchial exacerbations will be defined as acute bronchial symptoms lasting more than 48h and requiring hospitalization and/or anti infectious or corticosteroids.
研究概览
简要总结
The primary objective of this study is to evaluate the efficacy of Tezepelumab in reducing the number of bronchial exacerbations after 12 months of treatment, taking into account the T2 immune respiratory profile.
入排标准
- 年龄范围
- 18 years 至 65+ years（18-64 Years, 65+ Years）
- 接受健康志愿者
- 否
入选标准
- •Adult recipients, minimum age ≥18
- •Recipient of an allogeneic bone marrow or haematopoietic stem cell transplant
- •At more than 3 years after the date of the transplantation
- •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%)
- •Presenting an exacerbation profile: 2 or more moderate to severe bronchial exacerbations in the previous 12 months
- •On optimal inhaled therapy comprising at least one long-acting bronchodilator and one inhaled corticosteroid.
- •Stable dose of systemic immunosuppressive regimen for the last 4 weeks
- •Being covered by a national health insurance
- •Signed consent form
排除标准
- •Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVHd.
- •Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult
- •FEV1< 20% theorical value
- •Being deprived of liberty or under guardianship.
- •Absence of signed consent
- •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
- •Respiratory infection in the course of treatment (including acute bacterial and viral infection, long term treatment for fungal or non-tuberculosis mycobacteria)
- •History of documented immune complex disease (Type III hypersensitivity reactions) following any biologic therapy
- •Pregnant, breastfeeding or lactating women
- •Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE
研究组 & 干预措施
Tezspire 210 mg solution for injection in pre-filled syringe
Test
干预措施: Tezspire 210 mg solution for injection in pre-filled syringe (Drug)
结局指标
主要结局
The primary endpoint is the within-patient change in the annualized number of bronchial exacerbations between the 12-month period prior to treatment initiation and the 12-month treatment period. Bronchial exacerbations will be defined as acute bronchial symptoms lasting more than 48h and requiring hospitalization and/or anti infectious or corticosteroids.
The primary endpoint is the within-patient change in the annualized number of bronchial exacerbations between the 12-month period prior to treatment initiation and the 12-month treatment period. Bronchial exacerbations will be defined as acute bronchial symptoms lasting more than 48h and requiring hospitalization and/or anti infectious or corticosteroids.
次要结局
- Endpoints evaluating the improvement of respiratory symptoms and corticosteroids sparing (secondary objective n°1): Clinical outcomes: • Number of days alive and not exacerbating • Number of days alive and not hospitalized • Reduction in corticosteroids regimen (inhaled and/or systemic route) Outcomes from validated questionnaires: • ACQ6 score (Asthma Control Questionnaire 6) • Breathlessness, Cough and Sputum Scale (BCSS) • St George Respiratory Questionnaire (SGRQ)
- 2 Functionnal outcomes: • Pre-bronchodilator spirometry [forced expiratory volume in 1 second, forced vital capacity and the FEV1/FVC ratio. • Pre- bronchodilator plethysmography [total lung capacity, residual volume and the TLC/RV ratio] • Inspiratory and expiratory oscillometry parameters: resistance at 5 Hz, reactance at 5 Hz, Frequence of resonnance
- Immunological outcomes: • Blood eosinophilia (absolute count, G/L) • Eosinophilia in induced sputum (relative count, %) • Blood total IgE count (kUI/L)
- Exhalomic outcomes Unsupervised analysis of VOCs in exhaled air of patients blowing in a quadrupole-time-of-flight mass spectrometer (PTR-Qi-TOF MS; Ionicon, Innsbruck, Austria). Identification of VOCs (peaks corresponding to m/z) significantly changing over the year of treatment and correlation with clinical and biological readouts.
研究者
Helene Salvator
Scientific
Hospital Foch
研究点 (6)
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