A PHASE 3, MULTICENTER, OPEN-LABEL EXTENSION STUDY TO EVALUATE LONG-TERM SAFETY, TOLERABILITY, AND EFFICACY OF TILREKIMIG IN ADULT PARTICIPANTS WITH MODERATE-TO-SEVERE CHRONIC OBSTRUCTIVE PULMONARY DISEASE (COPD)
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- Pfizer
- 入组人数
- 1,360
- 主要终点
- Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1)
研究概览
简要总结
A Continuation Study of Tilrekimig in Adults with Moderate-to-Severe Long-Term Breathing Difficulty, Known by the Medical Term of Chronic Obstructive Pulmonary Disease (COPD) to Learn About this Medicine when Used for a Long Period of Time.
详细描述
C4531015 is a multicenter, open-label extension study designed to evaluate the longer-term safety and tolerability of tilrekimig in eligible participants with chronic obstructive pulmonary disease (COPD) who have participated in and completed the applicable requirements of the parent study, C4531031.
Participants who complete the protocol-defined parent-study period may be considered for enrollment in C4531015. Before entering the extension study, participants must provide informed consent, satisfy all C4531015 eligibility criteria, and be considered appropriate for continued study treatment by the investigator. Participation in C4531031 does not automatically establish eligibility for the extension study.
All enrolled participants will receive open-label tilrekimig according to the dose, route of administration, and treatment schedule specified in the C4531015 protocol. Participants may continue protocol-permitted background COPD maintenance therapy. Use of concomitant and rescue medications will be managed according to the protocol.
The study will primarily characterize the safety and tolerability of longer-term exposure to tilrekimig. Safety monitoring will include the collection of adverse events (AEs), serious adverse events (SAEs), adverse events leading to treatment interruption or discontinuation, and other protocol-defined safety events. Participants will also undergo clinical laboratory testing, vital-sign assessments, physical examinations, and other safety evaluations at scheduled study visits.
Additional protocol-defined assessments may be conducted to characterize COPD-related clinical outcomes and the effects of continued treatment. These may include evaluation of COPD exacerbations, respiratory symptoms, lung function, health status, participant-reported outcomes (PROs), healthcare resource utilization, pharmacokinetics (PK), immunogenicity, biomarkers, or other exploratory measures, as applicable. These assessments are intended to provide supportive information and should not be interpreted as demonstrating that tilrekimig is safe or effective.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 35 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants who completed parent study C
- •Individuals of childbearing potential must be willing to use a highly effective method of contraception.
排除标准
- •Ongoing safety-significant AE.
- •Parent-study SAE incompatible with continued participation.
- •Medical, laboratory, psychiatric, or behavioral condition that increases risk or interferes with study participation.
- •Pregnancy or breastfeeding.
研究组 & 干预措施
Tilrekimig (PF-07275315)
Tilrekimig (PF-07275315) subcutaneous injection (sc)
干预措施: Tilrekimig (Drug)
结局指标
主要结局
Number of Participants With Treatment-Emergent Adverse Events During Treatment Period 1 (TP1)
时间窗: Up to 60 weeks
Number and percentage of participants with treatment-emergent adverse events. An adverse event is considered treatment-emergent if it begins or increases in severity following initiation of study intervention. Events will be summarized by severity and other protocol-defined characteristics
Number of Participants With Treatment-Emergent Serious Adverse Events During Treatment Period 1
时间窗: Up to 60 weeks
Number and percentage of participants with treatment-emergent serious adverse events. Serious adverse events are events that meet one or more of the protocol-defined seriousness criteria.
Number of Participants With Treatment-Emergent Adverse Events Leading to Permanent Discontinuation of Study Intervention During Treatment Period 1
时间窗: Up to 60 weeks
Number and percentage of participants with treatment-emergent adverse events that lead to permanent discontinuation of tilrekimig.
Number of Participants With Clinically Significant Laboratory Abnormalities During Treatment Period 1
时间窗: Up to 60 weeks
Number and percentage of participants with protocol-defined clinical abnormalities in laboratory values and vitals signs. Laboratory assessments include protocol-required hematology and blood chemistry evaluations. Abnormal laboratory findings will be evaluated according to protocol-defined criteria and investigator assessment of clinical significance. Vital-sign assessments include blood pressure, pulse rate, respiratory rate, temperature, and oxygen saturation measured by pulse oximetry.
次要结局
- Annualized Rate of Moderate or Severe COPD Exacerbations During Treatment Period 1(52 Weeks)
- Annualized Rate of Severe COPD Exacerbations During Treatment Period 1(52 Weeks)
- Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization During Treatment Period 1(52 Weeks)
- Cumulative Number of Moderate or Severe COPD Exacerbations During Treatment Period 1(52 Weeks)
- Cumulative Number of Severe COPD Exacerbations During Treatment Period 1(52 Weeks)
- Time to First Moderate or Severe COPD Exacerbation During Treatment Period 1(52 Weeks)
- Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function During Treatment Period 1(52 Weeks)
- Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire (SGRQ) Total Score During Treatment Period 1(52 Weeks)
- Change From Parent-Study Baseline in COPD Assessment Test (CAT) Total Score During Treatment Period 1(52 Weeks)
- Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication During Treatment Period 1(52 Weeks)
- Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score During Treatment Period 1(52 Weeks)
- Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score During Treatment Period 1(52 Weeks)
- COPD Exacerbations in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL(52 Weeks)
- Lung Function in Participants With Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL(52 Weeks)
- Annualized Rate of Moderate or Severe COPD Exacerbations Through End of Study(Up to 36 months)
- Annualized Rate of Severe COPD Exacerbations Through End of Study(Up to 36 months)
- Annualized Rate of COPD Exacerbations Requiring an Emergency Department Visit and/or Hospitalization Through End of Study(Up to 36 months)
- Cumulative Number of Moderate or Severe COPD Exacerbations Through End of Study(Up to 36 months)
- Cumulative Number of Severe COPD Exacerbations Through End of Study(Up to 36 months)
- Change From Parent-Study Baseline in COPD Assessment Test total score During Treatment Period 1 in participants with Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL(52 Weeks)
- Change From Parent-Study Baseline in Pre- and Post-Bronchodilator Lung Function Through End of Study(Up to 36 months)
- Change From Parent-Study Baseline in SGRQ Total Score After Week 52(Up to 36 months)
- Change from the parent-study baseline in CAT total score at each scheduled assessment after Week 52 of TP1(Up to 36 months)
- Change From Parent-Study Baseline in Saint George's Respiratory Questionnaire total score Total Score During Treatment Period 1 in participants with Parent-Study Baseline Blood Eosinophil Count ≥300 Cells/µL(52 Weeks)
- Change From Parent-Study Baseline in Weekly Use of Short-Acting Bronchodilator Medication After Week 52(Up to 36 months)
- Percentage of Participants Achieving at Least a 4-Point Improvement From Parent-Study Baseline in SGRQ Total Score After Week 52(Up to 36 months)
- Percentage of Participants Achieving at Least a 2-Point Improvement From Parent-Study Baseline in CAT Total Score After Week 52(Up to 36 months)
- Time to First Moderate or Severe COPD Exacerbation Through End of Study(Up to 36 months)