Bronchiolitis Obliterans Syndrome (BOS)Phase 2IMMUNO-BOSNCT07771855
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
A Phase 2 study testing Tezepelumab in people with Bronchiolitis Obliterans Syndrome (BOS) and HSCT, run by Hopital Foch at 6 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Bronchiolitis Obliterans Syndrome (BOS), HSCT, Bronchial Disease
- What is being tested?
- Tezepelumab
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 6 sitesFrance
- Study dates
- 24 Jun 2026to Jan 2029
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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 for at least three months.
Show all 9Show fewer
- Stable dose of systemic immunosuppressive regimen for the last 4 weeks
- Being covered by a national health insurance
- Signed consent form
Who cannot join
- Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH
- FEV1< 20% theorical value
- Being deprived of liberty or under guardianship
- Absence of signed consent
- Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE
- 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
Show all 10Show fewer
- Respiratory infection in the course of treatement (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
- Severe GVHD scleroderma-like manifestations of skin making subcutaneous injections of the investigational treatment impossible or overly difficult
- Pregnant, breastfeeding or lactating women
Trial locations and contacts
6 sites in 1 country. Contact the study team or a site near you to ask about taking part.
DRCI Promotion contact
6 sites in 1 country
France6 sites, 6 recruiting
- Not yet recruiting
CHU de Besançon
Besançon
Cindy BARNIG, Professor, cbarnig@chu-besancon.fr
Cindy BARNIG, Professor
- Not yet recruiting
Hôpital Haut-Lévêque - CHU Bordeaux
Bordeaux
Elodie BLANCHARD, Doctor, elodie.blanchard@chu-bordeaux.fr
Elodie BLANCHARD, Doctor
- Not yet recruiting
CHU Caen Normandie
Caen
Frederic RIVIERE, Doctor, riviere-f@chu-caen.fr
Frederic RIVIERE, Doctor
- Not yet recruiting
CHRU de Lille
Lille
Frederic WALLYN, Doctor, frederic.wallyn@chu-lille.fr
Frederic WALLYN, Doctor
- Not yet recruiting
Hôpital Saint-Louis APHP
Paris
Amira BENATTIA, Doctor, amira.benattia@aphp.fr
Amira BENATTIA, Doctor
- Recruiting
Foch Hospital
Suresnes, 92150
Hélène SALVATOR, Professor, +33 1 46 25 24 95, h.salvator@hopital-foch.com
Hélène SALVATOR, Professor
About this study
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.
Since 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.
The 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.
- Being tested
- Tezepelumab
- Keywords
- Efficacy anti-TSLP monoclonal antibody (tezepelumab) in chronic bronchial disease induced Bronchiolitis obliterans syndrome (BOS) in HSCT recipient., BOS, HSCT, tezepzlumab
- Medical subject headings
- Bronchiolitis Obliterans Syndrome, Bronchial Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TezepelumabDrug
Participants will receive tezepelumab (TEZSPIRE®) 210 mg by subcutaneous injection once every 4 weeks for 12 months, starting with one injection on the day of enrollment. The investigational product is supplied as a pre-filled syringe containing 210 mg of tezepelumab in 1.91 mL (110 mg/mL). A total of 13 subcutaneous injections are planned during the study. The first injection at enrollment and injections at Visits 4, 7, 10 and 13 will be administered at the investigation center. Injections at Visits 2, 3, 5, 6, 8, 9, 11 and 12 will be administered at the participant's home by a nurse from the Libhéros network.
| Study group | Role | What they receive |
|---|---|---|
| Arm 1 | Experimental | Not described Receives: Drug: Tezepelumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in the annualized number of bronchial exacerbations
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
Measured: 13 months
Secondary outcomes (26)
Number of days alive and without bronchial exacerbation
Number of days during the study period during which the participant is alive and without bronchial exacerbation. Unit of measure: days.
Measured: 13 months
Number of days alive and without hospitalization
Number of days during the study period during which the participant is alive and without hospitalization.
Measured: 13 months
Change in corticosteroid regimen
Change in corticosteroid regimen, including inhaled and/or systemic corticosteroid therapy.
Measured: 13 months
Change in Asthma Control Questionnaire 6 (ACQ-6) score
Change in the Asthma Control Questionnaire 6 (ACQ-6) score during the study period. Unit of measure: score, ranging from 0 to 6.
Measured: 13 months
Change in Breathlessness, Cough and Sputum Scale (BCSS) score
Change in the Breathlessness, Cough and Sputum Scale (BCSS) total score during the study period. Unit of measure: score, ranging from 0 to 4.
Measured: 13 months
Change in St George's Respiratory Questionnaire (SGRQ) score
Change in the St George's Respiratory Questionnaire (SGRQ) total score during the study period. Unit of measure: score, ranging from 0 to 100.
Measured: 13 months
Change in forced expiratory volume in 1 second (FEV1)
Change in forced expiratory volume in 1 second (FEV1), measured by spirometry before and after bronchodilator administration. Unit of measure: liters (L).
Measured: 13 months
Change in forced expiratory volume in 1 second (FEV1) percent predicted
Change in forced expiratory volume in 1 second (FEV1), expressed as a percentage of the predicted value and measured by spirometry before and after bronchodilator administration. Unit of measure: percent (%).
Measured: 13 months
Change in forced vital capacity (FVC)
Change in forced vital capacity (FVC), measured by spirometry before and after bronchodilator administration. Unit of measure: liters (L).
Measured: 13 months
Change in forced vital capacity (FVC) percent predicted
Change in forced vital capacity (FVC), expressed as a percentage of the predicted value and measured by spirometry before and after bronchodilator administration. Unit of measure: percent (%).
Measured: 13 months
Change in FEV1/FVC ratio
Change in the ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC), measured by spirometry before and after bronchodilator administration. Unit of measure: ratio (L/L).
Measured: 13 months
Change in FEV1/FVC ratio expressed as a percentage
Change in the ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC), measured by spirometry before and after bronchodilator administration. Unit of measure: percent (%).
Measured: 13 months
Change in total lung capacity (TLC)
Change in total lung capacity (TLC), measured by plethysmography before bronchodilator administration. Unit of measure: liters (L).
Measured: 13 months
Change in total lung capacity (TLC) percent predicted
Change in total lung capacity (TLC), expressed as a percentage of the predicted value and measured by plethysmography before bronchodilator administration. Unit of measure: percent (%).
Measured: 13 months
Change in residual volume (RV)
Change in residual volume (RV), measured by plethysmography before bronchodilator administration. Unit of measure: liters (L).
Measured: 13 months
Change in residual volume (RV) percent predicted
Change in residual volume (RV), expressed as a percentage of the predicted value and measured by plethysmography before bronchodilator administration. Unit of measure: percent (%).
Measured: 13 months
Change in TLC/RV ratio
Change in the ratio of total lung capacity (TLC) to residual volume (RV), measured by plethysmography before bronchodilator administration. Unit of measure: ratio (L/L).
Measured: 13 months
Change in respiratory resistance at 5 Hz (R5)
Change in respiratory resistance at 5 Hz (R5), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
Measured: 13 months
Change in respiratory resistance at 20 Hz (R20)
Change in respiratory resistance at 20 Hz (R20), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
Measured: 13 months
Change in respiratory resistance difference between 20 Hz and 5 Hz (R20-R5)
Change in the difference between respiratory resistance at 20 Hz and 5 Hz (R20-R5), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
Measured: 13 months
Change in respiratory reactance at 5 Hz (X5)
Change in respiratory reactance at 5 Hz (X5), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
Measured: 13 months
Change in frequency of resonance (Fr)
Change in frequency of resonance (Fr), measured by inspiratory and expiratory oscillometry. Unit of measure: hertz (Hz).
Measured: 13 months
Change in blood eosinophil count
Change in blood eosinophil count during the study period. Unit of measure: G/L.
Measured: 13 months
Change in eosinophil count in induced sputum
Change in eosinophil count in induced sputum during the study period. Unit of measure: percent (%).
Measured: 13 months
Change in blood total IgE level
Change in blood total IgE level during the study period. Unit of measure: kUI/L.
Measured: 13 months
Annualized hospitalization rate per patient-year
Number of hospitalization events occurring during the study period, standardized per patient-year. Unit of measure: hospitalizations per patient-year.
Measured: 13 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Aug 2026
- Study start24 Jun 2026
- Primary completionJan 2029 (estimated)
- Study completionJan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Bronchiolitis Obliterans Syndrome (BOS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 36 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hopital Foch
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07771855
- Sponsor's protocol ID
- 2023_0186
- Other IDs
- 2024-516796-33-00
- Acronym
- IMMUNO-BOS
- Status last verified
- Aug 2026
- First submitted
- 27 Jul 2026
- Last updated
- 18 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07771855
- Acronym / sponsor ID
- IMMUNO-BOS / 2023_0186
- Keywords
- Efficacy anti-TSLP monoclonal antibody (tezepelumab) in chronic bronchial disease induced Bronchiolitis obliterans syndrome (BOS) in HSCT recipient., BOS, HSCT, tezepzlumab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 36 participants (estimated)
- Lead sponsor
- Hopital FochUniversity, hospital or other
- Study start
- 24 Jun 2026 (actual)
- Primary completion
- Jan 2029 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 18 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Since 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.
The 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Arm 1 | Experimental | Drug: Tezepelumab |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (9 listed)
- 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
Key exclusion criteria (10 listed)
- Patients with an indication to increase their immunosuppressive treatment, in particular due to active GVH
- FEV1< 20% theorical value
- Being deprived of liberty or under guardianship
- Absence of signed consent
- Hypersensitivity (allergy) to tezelumab or to any of the excipients of TEZPIRE
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| TezepelumabParticipants will receive tezepelumab (TEZSPIRE®) 210 mg by subcutaneous injection once every 4 weeks for 12 months, starting with one injection on the day of enrollment. The investigational product is supplied as a pre-filled syringe containing 210 mg of tezepelumab in 1.91 mL (110 mg/mL). A total of 13 subcutaneous injections are planned during the study. The first injection at enrollment and injections at Visits 4, 7, 10 and 13 will be administered at the investigation center. Injections at Visits 2, 3, 5, 6, 8, 9, 11 and 12 will be administered at the participant's home by a nurse from the Libhéros network. | Drug | Arm 1 |
Primary outcome
Change in the annualized number of bronchial exacerbations
Time frame: 13 months
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
26 secondary outcomes
Number of days alive and without bronchial exacerbation
Time frame: 13 months
Number of days alive and without hospitalization
Time frame: 13 months
Change in corticosteroid regimen
Time frame: 13 months
Change in Asthma Control Questionnaire 6 (ACQ-6) score
Time frame: 13 months
Change in Breathlessness, Cough and Sputum Scale (BCSS) score
Time frame: 13 months
Change in St George's Respiratory Questionnaire (SGRQ) score
Time frame: 13 months
Change in forced expiratory volume in 1 second (FEV1)
Time frame: 13 months
Change in forced expiratory volume in 1 second (FEV1) percent predicted
Time frame: 13 months
Change in forced vital capacity (FVC)
Time frame: 13 months
Change in forced vital capacity (FVC) percent predicted
Time frame: 13 months
Change in FEV1/FVC ratio
Time frame: 13 months
Change in FEV1/FVC ratio expressed as a percentage
Time frame: 13 months
Change in total lung capacity (TLC)
Time frame: 13 months
Change in total lung capacity (TLC) percent predicted
Time frame: 13 months
Change in residual volume (RV)
Time frame: 13 months
Change in residual volume (RV) percent predicted
Time frame: 13 months
Change in TLC/RV ratio
Time frame: 13 months
Change in respiratory resistance at 5 Hz (R5)
Time frame: 13 months
Change in respiratory resistance at 20 Hz (R20)
Time frame: 13 months
Change in respiratory resistance difference between 20 Hz and 5 Hz (R20-R5)
Time frame: 13 months
Change in respiratory reactance at 5 Hz (X5)
Time frame: 13 months
Change in frequency of resonance (Fr)
Time frame: 13 months
Change in blood eosinophil count
Time frame: 13 months
Change in eosinophil count in induced sputum
Time frame: 13 months
Change in blood total IgE level
Time frame: 13 months
Annualized hospitalization rate per patient-year
Time frame: 13 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
DRCI Promotion contact
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Tezepelumab in people with Bronchiolitis Obliterans Syndrome (BOS) and HSCT, run by Hopital Foch at 6 sites in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 10 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 18 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yahya DEBZA (+33 1 46 25 36 42, y.debza@hopital-foch.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in the annualized number of bronchial exacerbations (time frame: 13 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Aug 2026.