Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations (ROMEO)
A Phase III, Multicentre, Open-Label, Chronic Dosing, Extension Study to Evaluate the Long-term Safety of Tozorakimab in Participants With Chronic Obstructive Pulmonary Disease (COPD) With a History of COPD Exacerbations (ROMEO)
ROMEO is a Phase III, multicentre, open-label, chronic-dosing extension study evaluating the long-term safety of two dose regimens of tozorakimab in participants with COPD and a history of exacerbations.
Eligible participants must have completed one of the predecessor studies.
연구 개요
연구 유형
등록 (추정된)
단계
- 3단계
연락처 및 위치
연구 연락처
- 이름: AstraZeneca Clinical Study Information Center
- 전화번호: 1-877-240-9479
- 이메일: information.center@astrazeneca.com
연구 장소
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Aix-en-Provence, 프랑스, 13616
- 모집하지 않고 적극적으로
- Research Site
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Brest, 프랑스, 29609
- 모집하지 않고 적극적으로
- Research Site
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Colmar, 프랑스, 68024
- 빼는
- Research Site
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Gleizé, 프랑스, 69400
- 모집하지 않고 적극적으로
- Research Site
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Grenoble, 프랑스, 38043
- 모병
- Research Site
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Lyon, 프랑스, 69317
- 모병
- Research Site
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Marseille, 프랑스, 13015
- 모병
- Research Site
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Montpellier, 프랑스, 34295
- 모병
- Research Site
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Pessac, 프랑스, 33600
- 모병
- Research Site
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Pringy, 프랑스, 74374
- 모집하지 않고 적극적으로
- Research Site
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Quimper, 프랑스, 29000
- 모집하지 않고 적극적으로
- Research Site
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Saint-Herblain, 프랑스, 44800
- 모집하지 않고 적극적으로
- Research Site
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Toulouse, 프랑스, 31000
- 모집하지 않고 적극적으로
- Research Site
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참여기준
자격 기준
공부할 수 있는 나이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
설명
Inclusion Criteria:
- Participants previously randomized in predecessor studies.
- Participants should be affiliated with the French Social Security system.
- Participants who are willing to continue using contraceptive methods as agreed to for the predecessor studies.
- Capable of giving signed informed consent.
Exclusion Criteria:
- Clinically important pulmonary disease other than COPD.
- Participant meeting criteria for IP discontinuation as judged by the Investigator or the Sponsor.
- Current alcohol, drug or chemical abuse.
- Treatment with systemic corticosteroids or other immunosuppressive medication within 2 weeks prior to Visit 1 of ROMEO.
Known history of:
- Severe allergic reaction to any monoclonal and polyclonal antibody.
- Allergy or reaction to any component of the IMP formulation.
- Receipt of blood products or immunoglobulins within 30 days prior to visit 1 of ROMEO.
- Receipt of live attenuated vaccines within 30 days prior to visit 1 of ROMEO.
- Chronic use (or expected need for chronic use during the study) of immunosuppressive medications (including, but not limited to, systemic corticosteroids), marketed or investigational biologic, or another prohibited medication.
- Chronic use of antibiotics if the duration of treatment is < 3 months prior to Visit 1 of ROMEO (first IMP administration). Chronic macrolide or other antibiotic therapy is allowed provided the participant has been on a stable dose/regimen for ≥ 3 months prior to Visit 1 of ROMEO (first IMP administration) and has had at least one COPD exacerbation while on stable therapy.
- Use of allergen immunotherapy within 3 months of Visit 1 of ROMEO (first IMP administration), except for stable maintenance dose allergen-specific immunotherapy started 4 weeks prior to V1.
- Use of interferon gamma within 3 months of visit 1 of ROMEO (first IMP administration).
- Participation in any interventional clinical trial or receipt of any investigational non-biologic product within 30 days or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer.
- Involvement in the planning and/or conduct of the study (applies to both staff employed by the Sponsor and/or staff at the study site).
- Participants who are not able to comply with the study requirements, procedures, and restrictions.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Tozorakimab Dose Regimen 1
Subcutaneous injection of Tozorakimab via a pre-filled syringe.
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Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
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실험적: Tozorakimab Dose Regimen 2
Subcutaneous injection of Tozorakimab via a pre-filled syringe.
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Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse events
기간: 2-3 years
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Assessments related to AEs include: Occurrence/frequency, Relationship to IMP as assessed by Investigator, Intensity, Seriousness, Death, AEs leading to discontinuation of IMP, Other significant AEs. Medically significant abnormal laboratory results will be reported as AEs. |
2-3 years
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공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (추정된)
연구 완료 (추정된)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- D9180C00015
- 2025 (미국 NIH 보조금/계약: Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523690-41-00 (씨티스)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
IPD 계획 설명
Qualified researchers can request access to anonymized individual patient-level data from AstraZeneca group of companies sponsored clinical trials via the request portal. All request will be evaluated as per the AZ disclosure commitment:
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
Yes, indicates that AZ are accepting requests for IPD, but this does not mean all requests will be shared.
IPD 공유 기간
AstraZeneca will meet or exceed data availability as per the commitments made to the EFPIA/PhRMA Data-Sharing Principles. For details of our timelines, please refer to our disclosure commitment at :
https://astrazenecagrouptrials.pharmacm.com/ST/Submission/Disclosure.
IPD 공유 액세스 기준
IPD 공유 지원 정보 유형
- 연구_프로토콜
- 수액
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
미국에서 제조되어 미국에서 수출되는 제품
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