2025-523690-41-00招募中3 期
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)
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 82
- 试验地点
- 13
- 主要终点
- Adverse events, laboratory assessments. Assessments related to adverse events include: • Occurrence/frequency • Relationship to IMP as assessed by Investigator • Intensity • Seriousness • Death • Adverse events leading to discontinuation of IMP • Other significant AEs
研究概览
简要总结
To describe the long-term safety and tolerability of tozorakimab as an add on to standard of care.
研究设计
- 分配方式
- Not Applicable
- 主要目的
- End Of Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 years 至 65+ years（65+ Years, 18-64 Years）
- 接受健康志愿者
- 是
入选标准
- •Participants previously randomized in TITANIA, MIRANDA or PROSPERO predecessor studies: • Participants who have completed the treatment period and the follow-up and who have not been prematurely discontinued from IMP in the predecessor studies (either TITANIA or MIRANDA) • Participants who have completed the treatment period and the follow-up, or participants who have continued to receive the IMP up to the primary reporting and attended the E/D visit 12 weeks after the last dose of IMP, and who have not been prematurely discontinued from IMP in PROSPERO predecessor study.
- •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 PROSPERO, TITANIA or MIRANDA.
- •Capable of giving signed informed consent.
排除标准
- •Any clinically significant disorder or abnormal findings (clinical, laboratory, instrumental, etc) or major physical and/or cognitive impairment, which, in the opinion of the Investigator, may put the participant at risk because of his/her participation in the study or impact the interpretation of the study results, or otherwise makes the participation of the participant inappropriate.
- •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 AstraZeneca staff and/or staff at the study site).
- •Participants who are not able to comply with the study requirements, procedures, and restrictions, as judged by the Investigator or the Sponsor.
- •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: (a) Severe allergic reaction to any monoclonal and polyclonal antibody. (b) Allergy or reaction to any component of the IMP formulation.
- •Treatment with any marketed or investigational biologic product other than tozorakimab within PROSPERO, TITANIA, or MIRANDA studies, for any reason, within 4 months or 5 half-lives prior to Visit 1 of ROMEO (first IMP administration), whichever is longer. Exceptions include: Participants on stable therapy for at least 3 months before visit 1 of ROMEO, who intend to stay on treatment throughout the study with marketed biologics* that are not likely to interfere with the safety assessment and/or efficacy of tozorakimab for the treatment of osteoporosis, migraine pain, T2DM, obesity, ocular, cardiovascular, or metabolic diseases are allowed to participate in the study. *Examples of approved marketed biologics include: denosumab, romosozumab, CGRP-antagonists, GLP-1 agonists, GIP/GLP-1 agonists, PCSK9 inhibitors, recombinant botulinum neurotoxin, mAbs targeting SARS-COV-2 viral components (marketed or authorised), recombinant erythropoietin, VEGF inhibitors for ocular diseases. Medications not listed here should be discussed with the study team.
- •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 of immunosuppressive medication at visit 1 of ROMEO (including but not limited to: methotrexate, troleandomycin, cyclosporine, azathioprine, rectal corticosteroids, and systemic corticosteroids), or expected need for chronic use during the study.
结局指标
主要结局
Adverse events, laboratory assessments. Assessments related to adverse events include: • Occurrence/frequency • Relationship to IMP as assessed by Investigator • Intensity • Seriousness • Death • Adverse events leading to discontinuation of IMP • Other significant AEs
Adverse events, laboratory assessments. Assessments related to adverse events include: • Occurrence/frequency • Relationship to IMP as assessed by Investigator • Intensity • Seriousness • Death • Adverse events leading to discontinuation of IMP • Other significant AEs
次要结局
未报告次要终点
研究者
Delphine LEYNAUD
Scientific
AstraZeneca AB
研究点 (13)
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