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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.
EU CTIS ID: 2024-516796-33-00
What this study is testing
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.
- Therapeutic exploratory (Phase II)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join if
- 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.
You likely can't join if
- 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
See the full eligibility criteria
- 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
- 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
The study team makes the final eligibility decision.
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years. The study team makes the final eligibility decision.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.