PACTR202407572301048尚未招募3 期
A Phase III Open-Label Extension Study to Evaluate the Long-term Safety of Astegolimab in Patients with Chronic Obstructive Pulmonary Disease
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,000
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19 Year(s) 至 44 Year(s)（—）
- 性别
- All
入选标准
- •1. Signed Informed Consent Form.
- •2. Ability to comply with the requirements of the study protocol, according to the investigator’s best judgment.
- •3. Completion of the 52-week treatment period in either Study GB43311 or Study GB44332.For patients in Study GB43311 eligible for the additional treatment period: Continued participation in the additional treatment period up to local availability of the OLE is required.
- •4. For women of childbearing potential: agreement to remain abstinent (refrain from heterosexual intercourse) or use contraception. Women must remain abstinent or use contraceptive methods with a failure rate of < 1% per year during the treatment period and for 12 weeks after the final dose of astegolimab. A woman is considered to be of childbearing potential if she is postmenarchal, has not reached a postmenopausal state (at least 12 continuous months of amenorrhea with no identified cause other than menopause), and is not permanently infertile due to surgery (i.e., removal of ovaries, fallopian tubes, and/or uterus) or another cause as determined by the investigator (e.g., Mu¨llerian agenesis). The definition of childbearing potential may be adapted for alignment with local guidelines or regulations. Examples of contraceptive methods with a failure rate of < 1% per year include bilateral tubal ligation, male sterilization, hormonal contraceptives that inhibit ovulation, hormone-release intrauterine devices, and copper intrauterine devices. The reliability of sexual abstinence should be evaluated in relation to the duration of the clinical trial and the preferred and usual lifestyle of the patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal, or postovulation methods) and withdrawal are not adequate methods of contraception. If required per local guidelines or regulations, locally recognized adequate methods of contraception and information about the reliability of abstinence will be described in the local Informed Consent Form.
排除标准
- •1. Withdrawal of consent and/or premature discontinuation from parent study
- •2. Any permanent discontinuation of study drug in parent study
- •3. Significant non-compliance in the parent study, specifically defined as missing scheduled visits, per investigator’s judgment
- •4. Pregnant or breastfeeding, or intending to become pregnant during the study or within 12 weeks after the final dose of study drug
- •5. Any new diagnosis of asthma according to the Global Initiative for Asthma guidelines or other accepted guidelines since enrolling in the parent study
- •6. Any new clinically significant pulmonary disease other than COPD since enrolling in the parent study
- •7.Treatment with a licensed respiratory biologic agent at the time of study entry
- •8. Initiation of treatment that is considered palliative since enrolling in the parent study
- •9. History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab
- •10. Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigator's judgment, precludes the patient's safe participation in and completion of the study since enrolling in the parent study
- •11. Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study
- •12. Any new abnormal ECG that is deemed clinically significant by the investigator, including complete left bundle branch block or second- or third-degree atrioventricular heart block since enrolling in the parent study
- •13. QT interval corrected through use of Fredericia’s formula (QTcF) > 450ms if patient is male of QTcF > 470ms if patient is female. For male or female patients with QRS > 120ms: QTcF < 480ms
研究者
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