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.
調査の概要
研究の種類
入学 (推定)
段階
- フェーズ 3
連絡先と場所
研究連絡先
- 名前：AstraZeneca Clinical Study Information Center
- 電話番号：1-877-240-9479
- メール：information.center@astrazeneca.com
研究場所
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Aix-en-Provence、フランス、13616
- 積極的、募集していない
- Research Site
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Brest、フランス、29609
- 積極的、募集していない
- Research Site
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Colmar、フランス、68024
- 引きこもった
- Research Site
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Gleizé、フランス、69400
- 積極的、募集していない
- Research Site
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Grenoble、フランス、38043
- 募集
- Research Site
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Lyon、フランス、69317
- 募集
- Research Site
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Marseille、フランス、13015
- 募集
- Research Site
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Montpellier、フランス、34295
- 募集
- Research Site
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Pessac、フランス、33600
- 募集
- Research Site
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Pringy、フランス、74374
- 積極的、募集していない
- Research Site
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Quimper、フランス、29000
- 積極的、募集していない
- Research Site
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Saint-Herblain、フランス、44800
- 積極的、募集していない
- Research Site
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Toulouse、フランス、31000
- 積極的、募集していない
- Research Site
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
説明
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.
研究計画
研究はどのように設計されていますか？
デザインの詳細
- 主な目的：処理
- 割り当て：なし
- 介入モデル：並列代入
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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実験的：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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実験的：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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この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
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Adverse events
時間枠：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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協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
本研究に関する用語
追加の関連 MeSH 用語
その他の研究ID番号
- D9180C00015
- 2025 (米国 NIH グラント/契約：Faculty of Social Sciences Scientific Grant at the University of Gdańsk)
- 2025-523690-41-00 (Ctis)
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
IPD プランの説明
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 共有時間枠
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 共有アクセス基準
IPD 共有サポート情報タイプ
- STUDY_PROTOCOL
- SAP
医薬品およびデバイス情報、研究文書
米国FDA規制医薬品の研究
米国FDA規制機器製品の研究
米国で製造され、米国から輸出された製品。
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。