A Phase III Open-Label Extension Study To Evaluate The Long-Term Safety Of Astegolimab In Patients With Chronic Obstructive Pulmonary Disease
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 入组人数
- 2,000
- 试验地点
- 16
- 主要终点
- To evaluate the long-term safety of Astegolimab
研究概览
简要总结
This is a Phase III multicenter, open-label extension (OLE) study to evaluate the long-term safety and explore the efficacy of astegolimab in combination with standard of care (SOC). Patients with COPD who have completed the 52-week treatment period in either Study GB43311 or Study GB44332 and fulfill the eligibility criteria for the OLE will be enrolled. Patients who have discontinued treatment in either parent study will not be eligible to enroll into the OLE.
Several key aspects of the study design and study population are summarized below.
Astegolimab 476 mg will be administered Q2W by subcutaneous injection. All participants must continue to be on optimized, stable COPD maintenance therapy, with no anticipated changes in therapy throughout the study
The total duration of study participation for each individual is expected is expected to range from 1 day to more than 51 months
The purpose of this study is to assess the long-term safety and to explore the efficacy of astegolimab, a human IgG2 mAb that selectively inhibits the interleukin-33 (IL-33) receptor ST2, in participants with chronic obstructive pulmonary disease (COPD) who have completed the 52-week placebo-controlled treatment period in either the Phase IIb (GB43311) or Phase III (GB44332) astegolimab study. The open-label design will allow assessment of the impact of longer treatment duration of astegolimab on safety, lung function, COPD exacerbations, and patient-reported outcomes (PROs).
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 40.00 Year(s) 至 90.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients must meet the following criteria for study entry: 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 Participants with missing Week 52 visit assessments will not meet this eligibility criteria and cannot be enrolled in the GB43374 open-label extension study until Week 52 assessments are completed.
- •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, as defined below: 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 (>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., Müllerian 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
- •Patients who meet any of the following criteria will be excluded from study entry: 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 investigators 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 (e.g., pulmonary fibrosis, sarcoidosis, chronic pulmonary embolism or primary pulmonary hypertension, alpha-1-antitrypsin deficiency) since enrolling in the parent study 7.Active tuberculosis or untreated latent tuberculosis If a patient is positive for latent tuberculosis at screening, they can be eligible after completing treatment per local standard of care.
- •8.Treatment with a licensed respiratory biologic agent (e.g., omalizumab, dupilumab, and or anti-IL-5 therapies) at the time of study entry 9.Initiation of treatment that is considered palliative (e.g., for life expectancy less than 12 months) since enrolling in the parent study 10.History of severe allergic reaction or anaphylactic reaction to any biologic agent or known hypersensitivity to any component of astegolimab
- •Any other new serious medical condition or abnormality in clinical laboratory tests that, in the investigators judgment, precludes the patients safe participation in and completion of the study since enrolling in the parent study
- •Any new unstable cardiac disease, myocardial infarction, or New York Heart Association Class III or IV heart failure since enrolling in the parent study 13.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 14.QT interval corrected through use of Fredericias formula (QTcF) greater than 450ms if patient is male of QTcF greater than 470ms if patient is female 15.For male or female patients with QRS greater than 120ms- QTcF greater than 480ms.
结局指标
主要结局
To evaluate the long-term safety of Astegolimab
时间窗: The assessment will be carried out while comparing to baseline visit (participant who have received at least 1 dose of study drug is eligible for the analysis) based on the Incidence and severity of all AEs, SAEs, AESIs and AEs leading to death or Discontinuation Severity determined according to the DAIDS Table for Grading the Severity of Adult and Pediatric AEs (DAIDS Toxicity Grading Scale), with slight modifications for clarity and for alignment with internal practices.
次要结局
- NA(NA)
研究者
Rashmi Chitgupi
PPD Pharmaceutical Development India Private Limited