NCT06376045终止2 期
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose Ranging Study to Assess the Efficacy and Safety of Rocatinlimab in Adult Subjects With Moderate-to-severe Asthma
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 发起方
- Amgen
- 入组人数
- 317
- 试验地点
- 296
- 主要终点
- Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
研究概览
简要总结
The primary objective of this study is to describe the efficacy of rocatinlimab in reducing asthma exacerbations.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be between the ages of 18 and
- •Asthma diagnosed by a physician for ≥ 12 months prior to the screening visit.
- •Existing therapy with medium-dose to high doses of inhaled corticosteroids (ICS) (defined as > 250 µg fluticasone propionate or equivalent ICS) in combination with at least 1 additional controller medication (eg, LABA, leukotriene receptor antagonist [LTRA], LAMA, methylxanthine, oral corticosteroids up to a daily dose of 10 mg prednisone equivalent) for at least 90 days prior to the screening visit with a stable dose for at least 30 days prior to the screening visit.
- •Documented history of ≥ 1 asthma exacerbation in the past year prior to the screening visit, with at least 1 exacerbation during treatment with medium-dose to high doses of ICS (> 250 μg fluticasone propionate or equivalent ICS).
- •Morning pre-BD FEV1 ≥ 35% and ≤ 90% of predicted normal at the screening visit and day 1 pre-randomization visits.
- •ACQ-6 score ≥ 1.5 at the day 1 pre randomization visit.
排除标准
- •Asthma exacerbation that results in emergency treatment or hospitalization, or treatment with systemic steroids at any time from 30 days prior to the day 1 pre randomization visit.
- •Any clinically important pulmonary disease other than asthma.
- •Current smoker, including active vaping of any products and/or marijuana, or former smoker with cessation within 6 months of screening, or history of > 10 pack-years.
- •Suspicion of, or confirmed, coronavirus disease 2019 (COVID-19) infection during the screening period including known history of COVID-19 infection within 4 weeks prior to Screening; mechanical ventilation or extracorporeal membrane oxygenation (ECMO) secondary to COVID-19 within 3 months prior to screening; participants with COVID-19 infection who have not yet sufficiently recovered to participate in the procedures of a clinical trial.
- •Active chronic or acute infection requiring treatment with systemic antibiotics, antiviral, antiparasitic, antiprotozoal, or antifungals which has not completely resolved, or for which therapy has not been completed, within 4 weeks before day 1 pre-randomization visit.
- •Positive or indeterminate QuantiFERON GOLD from central laboratory at screening.
- •Active malignancy; multiple myeloma; myeloproliferative or lymphoproliferative disorder; or a history of any of these conditions within 5 years prior to informed consent
- •History of major immunologic reaction to any other biologic product or any excipient of rocatinlimab.
- •Diagnosis of a helminth parasitic infection within 6 months prior to day 1 pre-randomization visit that had not been treated with or had failed to respond to standard of care therapy.
- •Evidence of human immunodeficiency virus (HIV) infection or positive for HIV antibodies at screening or current acquired, common variable or inherited, primary or secondary immunodeficiency.
- •Active and non-virally suppressed hepatitis B infection at initial screening,
- •Positive for hepatitis C virus (HCV) antibody at screening with confirmed positive HCV RNA.
研究组 & 干预措施
Treatment Arm B: Dose 1 Rocatinlimab
Experimental
Participants will receive dose 1 rocatinlimab by SC injection during the blinded treatment period.
干预措施: Rocatinlimab (Drug)
Treatment Arm A: Placebo
Placebo Comparator
Participants will receive placebo by subcutaneous (SC) injection during the blinded treatment period.
干预措施: Placebo (Drug)
Treatment Arm C: Dose 2 Rocatinlimab
Experimental
Participants will receive dose 2 rocatinlimab by SC injection during the blinded treatment period.
干预措施: Rocatinlimab (Drug)
Treatment Arm D: Dose 3 Rocatinlimab
Experimental
Participants will receive dose 3 rocatinlimab by SC injection during the blinded treatment period.
干预措施: Rocatinlimab (Drug)
结局指标
主要结局
Annualized Rate of Composite Endpoint for Exacerbations (CompEx) Events During the Blinded Treatment Period
时间窗: Up to Week 48
次要结局
- Number of Participant Achieving ACQ-6 Response at Week 48(Week 48)
- Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score(Baseline, Weeks 12, 24, 36 and 48)
- Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period(Up to Week 48)
- Time to First Asthma Exacerbation Event(Up to 62 weeks)
- Number of Participants with a CompEx Event During the Double Blinded Treatment Period(Up to Week 48)
- Change From Baseline in ACQ-6(Up to Week 48)
- Change From Baseline in Asthma Quality of Life Questionnaire with Standardized Activities (AQLQ [S]) Self-Administered Score(Baseline, Weeks 12, 24, 36 and 48)
- Number of Participants Achieving AQLQ (S) Response at Week 48(Up to Week 48)
- Annualized Rate of Asthma Exacerbation Leading to Hospitalization or Emergency Room Visits During the Blinded Treatment Period(Up to Week 48)
- Time to First Asthma Exacerbation Event(Up to 62 weeks)
- Time to First CompEx Event(Up to 62 weeks)
- Change From Baseline in Pre-BD FEV1(Up to 62 weeks)
- Change From Baseline in Asthma Symptom Diary (ASD) Score(Up to Week 48)
- Number of Participant Achieving ACQ-6 Response at Week 48(Week 48)
- Annualized Asthma Exacerbation Rate (AAER)(Up to Week 48)
- Change From Baseline in Pre-bronchodilator (BD) Forced Expiratory Volume in 1 Second (FEV1)(Baseline and Week 48)
- Change From Baseline in Asthma Control Questionnaire 6 (ACQ-6) Score at Week 48(Baseline and Week 48)
- Number of Participants with a CompEx Event During the Double Blinded Treatment Period(Up to Week 48)
- Annualized Rate of CompEx Events(Weeks 12, 24 and 36)
- Change From Baseline in Fractional Exhaled Nitric Oxide (FeNO) Levels(Up to 62 weeks)
- Serum Rocatinlimab Concentrations(Up to 62 weeks)
- Trough Concentration (Ctrough) of Rocatinlimab(Up to 62 weeks)
- Number of Participants with Treatment-emergent Adverse Events(Up to 62 weeks)
- Number of Participants with Serious Adverse Events(Up to 62 weeks)
- Number of Participants with Anti-rocatinlimab Antibody Formation(Up to 62 weeks)
研究者
研究点 (296)
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