Long-term Safety and Tolerability of Tozorakimab in Patients With COPD and History of Exacerbations

Официальное название

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)

Обзор

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.

Вмешательства

• Препарат Tozorakimab Dose Regimen 1
  Participants previously randomised in the MIRANDA predecessor study will receive Tozorakimab in ROMEO according to this dose regimen
• Препарат Tozorakimab Dose Regimen 2
  Participants previously randomised in the TITANIA or PROSPERO predecessor studies will receive Tozorakimab in ROMEO according to this dose regimen

Первичные конечные точки

• Adverse events [Срок оценки: 2-3 years]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Франция · 13 центров

• Research Site — Aix-en-Provence
• Research Site — Brest
• Research Site — Colmar
• Research Site — Gleizé
• Research Site — Grenoble
• Research Site — Lyon
• Research Site — Marseille
• Research Site — Montpellier
• … и ещё 5 центров

Идентификаторы

NCT: NCT07566195 · D9180C00015 · 2025-523690-41-00

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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