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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 (IMMUNO-BOS)

2026년 8월 14일 업데이트: Hopital Foch

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.

연구 개요

상태

모병

정황

개입 / 치료

연구 유형

중재적

등록 (추정된)

36

단계

  • 2 단계

연락처 및 위치

이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.

연구 연락처

연구 연락처 백업

연구 장소

  • 프랑스
      • Besançon, 프랑스
        • 아직 모집하지 않음
        • CHU de Besançon
        • 연락하다:
        • 수석 연구원:
          • Cindy BARNIG, Professor
      • Bordeaux, 프랑스
        • 아직 모집하지 않음
        • Hopital Haut-Leveque - CHU Bordeaux
        • 연락하다:
        • 수석 연구원:
          • Elodie BLANCHARD, Doctor
      • Caen, 프랑스
        • 아직 모집하지 않음
        • CHU Caen Normandie
        • 연락하다:
        • 수석 연구원:
          • Frederic RIVIERE, Doctor
      • Lille, 프랑스
        • 아직 모집하지 않음
        • CHRU de Lille
        • 연락하다:
        • 수석 연구원:
          • Frederic WALLYN, Doctor
      • Paris, 프랑스
        • 아직 모집하지 않음
        • Hôpital Saint-Louis APHP
        • 연락하다:
        • 수석 연구원:
          • Amira BENATTIA, Doctor
      • Suresnes, 프랑스, 92150
        • 모병
        • Foch Hospital
        • 연락하다:
        • 수석 연구원:
          • Hélène SALVATOR, Professor

참여기준

연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.

자격 기준

공부할 수 있는 나이

  • 성인
  • 고령자

건강한 자원 봉사자를 받아들입니다

아니

설명

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

공부 계획

이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.

연구는 어떻게 설계됩니까?

디자인 세부사항

  • 주 목적: 치료
  • 할당: 해당 없음
  • 중재 모델: 단일 그룹 할당
  • 마스킹: 없음(오픈 라벨)

무기와 개입

참가자 그룹 / 팔
개입 / 치료
실험적: 팔 1
의약품: Tezepelumab
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.

연구는 무엇을 측정합니까?

주요 결과 측정

결과 측정
측정값 설명
기간
Change in the annualized number of bronchial exacerbations
기간: 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
13 months

2차 결과 측정

결과 측정
측정값 설명
기간
Number of days alive and without bronchial exacerbation
기간: 13 months
Number of days during the study period during which the participant is alive and without bronchial exacerbation. Unit of measure: days.
13 months
Number of days alive and without hospitalization
기간: 13 months
Number of days during the study period during which the participant is alive and without hospitalization.
13 months
Change in corticosteroid regimen
기간: 13 months
Change in corticosteroid regimen, including inhaled and/or systemic corticosteroid therapy.
13 months
Change in Asthma Control Questionnaire 6 (ACQ-6) score
기간: 13 months
Change in the Asthma Control Questionnaire 6 (ACQ-6) score during the study period. Unit of measure: score, ranging from 0 to 6.
13 months
Change in Breathlessness, Cough and Sputum Scale (BCSS) score
기간: 13 months
Change in the Breathlessness, Cough and Sputum Scale (BCSS) total score during the study period. Unit of measure: score, ranging from 0 to 4.
13 months
Change in St George's Respiratory Questionnaire (SGRQ) score
기간: 13 months
Change in the St George's Respiratory Questionnaire (SGRQ) total score during the study period. Unit of measure: score, ranging from 0 to 100.
13 months
Change in forced expiratory volume in 1 second (FEV1)
기간: 13 months
Change in forced expiratory volume in 1 second (FEV1), measured by spirometry before and after bronchodilator administration. Unit of measure: liters (L).
13 months
Change in forced expiratory volume in 1 second (FEV1) percent predicted
기간: 13 months
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 (%).
13 months
Change in forced vital capacity (FVC)
기간: 13 months
Change in forced vital capacity (FVC), measured by spirometry before and after bronchodilator administration. Unit of measure: liters (L).
13 months
Change in forced vital capacity (FVC) percent predicted
기간: 13 months
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 (%).
13 months
Change in FEV1/FVC ratio
기간: 13 months
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).
13 months
Change in FEV1/FVC ratio expressed as a percentage
기간: 13 months
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 (%).
13 months
Change in total lung capacity (TLC)
기간: 13 months
Change in total lung capacity (TLC), measured by plethysmography before bronchodilator administration. Unit of measure: liters (L).
13 months
Change in total lung capacity (TLC) percent predicted
기간: 13 months
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 (%).
13 months
Change in residual volume (RV)
기간: 13 months
Change in residual volume (RV), measured by plethysmography before bronchodilator administration. Unit of measure: liters (L).
13 months
Change in residual volume (RV) percent predicted
기간: 13 months
Change in residual volume (RV), expressed as a percentage of the predicted value and measured by plethysmography before bronchodilator administration. Unit of measure: percent (%).
13 months
Change in TLC/RV ratio
기간: 13 months
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).
13 months
Change in respiratory resistance at 5 Hz (R5)
기간: 13 months
Change in respiratory resistance at 5 Hz (R5), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
13 months
Change in respiratory resistance at 20 Hz (R20)
기간: 13 months
Change in respiratory resistance at 20 Hz (R20), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
13 months
Change in respiratory resistance difference between 20 Hz and 5 Hz (R20-R5)
기간: 13 months
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.
13 months
Change in respiratory reactance at 5 Hz (X5)
기간: 13 months
Change in respiratory reactance at 5 Hz (X5), measured by inspiratory and expiratory oscillometry. Unit of measure: not specified in the protocol.
13 months
Change in frequency of resonance (Fr)
기간: 13 months
Change in frequency of resonance (Fr), measured by inspiratory and expiratory oscillometry. Unit of measure: hertz (Hz).
13 months
Change in blood eosinophil count
기간: 13 months
Change in blood eosinophil count during the study period. Unit of measure: G/L.
13 months
Change in eosinophil count in induced sputum
기간: 13 months
Change in eosinophil count in induced sputum during the study period. Unit of measure: percent (%).
13 months
Change in blood total IgE level
기간: 13 months
Change in blood total IgE level during the study period. Unit of measure: kUI/L.
13 months
Annualized hospitalization rate per patient-year
기간: 13 months
Number of hospitalization events occurring during the study period, standardized per patient-year. Unit of measure: hospitalizations per patient-year.
13 months

공동 작업자 및 조사자

여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.

스폰서

Hopital Foch

연구 기록 날짜

이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.

연구 주요 날짜

연구 시작 (실제)

2026년 6월 24일

기본 완료 (추정된)

2029년 1월 1일

연구 완료 (추정된)

2029년 1월 1일

연구 등록 날짜

최초 제출

2026년 7월 27일

QC 기준을 충족하는 최초 제출

2026년 8월 14일

처음 게시됨 (실제)

2026년 8월 18일

연구 기록 업데이트

마지막 업데이트 게시됨 (실제)

2026년 8월 18일

QC 기준을 충족하는 마지막 업데이트 제출

2026년 8월 14일

마지막으로 확인됨

2026년 8월 1일

추가 정보

이 연구와 관련된 용어

키워드

추가 관련 MeSH 약관

기타 연구 ID 번호

  • 2023_0186
  • 2024-516796-33-00 (씨티스)

개별 참가자 데이터(IPD) 계획

개별 참가자 데이터(IPD)를 공유할 계획입니까?

아니요

약물 및 장치 정보, 연구 문서

미국 FDA 규제 의약품 연구

아니

미국 FDA 규제 기기 제품 연구

아니

이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .

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