NCT05785624终止2 期
A Two-Cohort, Phase II, Multicenter, Randomized, Double-Blind, Parallel-Group, Placebo-Controlled Study Evaluating the Efficacy and Safety of Vixarelimab Compared With Placebo in Patients With Idiopathic Pulmonary Fibrosis and in Patients With Systemic Sclerosis-Associated Interstitial Lung Disease
适应症
干预措施
试验速览
- 阶段
- 2 期
- 状态
- 终止
- 入组人数
- 286
- 试验地点
- 188
- 主要终点
- Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)
研究概览
简要总结
The main purpose of the study is to evaluate the efficacy of vixarelimab compared with placebo on lung function in participants with idiopathic pulmonary fibrosis (IPF) and in participants with systemic sclerosis-associated interstitial lung disease (SSc-ILD). Participants who complete 52-weeks of treatment in the Double-blind Treatment (DBT) period can choose to enroll in the optional Open-label Extension (OLE) period to receive treatment with vixarelimab for another 52 weeks.
Cohort 1 has completed enrollment and has been closed for further enrollment. Cohort 2 is enrolling participants.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 85 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •for all Participants:
- •FVC ≥45% predicted during screening as determined by the over-reader
- •Forced expiratory volume in 1 second (FEV1)/FVC ratio >0.70 during screening as determined by the over-reader
- •DLco ≥30% and ≤90% of predicted during screening (Hgb corrected) as determined by the over-reader
- •Minimum 6-MWT distance of 150 m with maximum use of 6 liters per minute (L/min) at sea-level and up to 8 L/min at altitude (> 5000 feet [1524 m] above sea level) of supplemental oxygen while maintaining oxygen saturation of >83% during the 6MWT during screening
- •Participant and investigator consideration of all medicinal treatment options and/or possibly lung transplantation prior to consideration of participation in the study
- •Inclusion Criteria for Cohort 1:
- •Age 40-85 years
- •Documented diagnosis of IPF or IPF (likely)
- •HRCT pattern consistent with the diagnosis of IPF, confirmed by central review of chest HRCT and central review of any available lung biopsy
- •For participants receiving pirfenidone or nintedanib treatment for IPF: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with plans to continue treatment during the study period
- •Inclusion Criteria for Cohort 2:
- •Age 18-85 years
- •Diagnosis of SSc as defined using the American College of Rheumatology/European Alliance of Associations for Rheumatology (EULAR) criteria
- •HRCT demonstrating ≥10% extent of fibrosis, confirmed by central review of Chest HRCT
- •Evidence of progression of pulmonary fibrosis
- •For participants receiving tocilizumab treatment for SSc-ILD: treatment for ≥3 months with a stable dose for ≥4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
- •For participants receiving nintedanib treatment for SSc-ILD: treatment for ≥ 3 months with a stable dose for ≥ 4 weeks prior to screening and during screening, with no contraindications according to local prescribing information, and no intention to change or modify their treatment regimen for the duration of the study
- •Availability of skin for biopsy preferably on proximal forearms having Modified Rodnan Skin Score (mRSS) ≥2 at the biopsy location
- •Inclusion Criteria for OLE Period:
- •Completion of 52 weeks of treatment in the double-blinded treatment period
- •Investigator determination of a favorable benefit-risk for the individual participant, i.e., the expectation of reasonable likelihood for therapeutic benefit and tolerability of the study drug after evaluation of the preceding 52 weeks of double-blinded treatment
排除标准
- •for all Participants:
- •Percentage of predicted FVC value showing improvement in the 6-month period prior to screening and including screening value
- •Known post-bronchodilator response in FEV1 and/or FVC (defined as an increase in percent predicted values by ≥ 10)
- •Resting oxygen saturation of <89% using up to 4 L/min of supplemental oxygen at sea level and up to 6 L/min at altitude (5000 feet [1524 m] above sea level) during screening
- •History of lung transplant
- •Previous treatment with vixarelimab
- •Acute respiratory or systemic bacterial, viral, or fungal infection either during screening or prior to screening not successfully resolved by 4 weeks prior to screening visit
- •Presence of pulmonary hypertension requiring treatment
- •History of malignancy within the 5 years prior to screening
- •Positive hepatitis C virus (HCV) antibody test result accompanied by a positive HCV ribonucleic acid (RNA) test at screening
- •Known immunodeficiency
- •Known evidence of active or untreated latent tuberculosis
- •Exclusion Criteria for Cohort 1:
- •Evidence of other known causes of ILD
- •Emphysema present on ≥50% of the HRCT, or the extent of emphysema is greater than the extent of fibrosis, according to central review of the HRCT
- •Exclusion Criteria for Cohort 2:
- •Evidence of other known causes of ILD
- •Rheumatic autoimmune disease other than SSc
- •Receiving pirfenidone treatment within 4 weeks prior to screening
- •Receipt of nintedanib in combination with tocilizumab
- •Exclusion Criteria for OLE Period:
- •Significant non-compliance in the double-blinded treatment period, per investigator's judgment
- •Any new clinically significant pulmonary disease other than IPF or SSc-ILD since enrolling in the double-blinded treatment period
研究组 & 干预措施
DBT: Cohort 1: Vixarelimab
Experimental
Participants with IPF will receive vixarelimab, subcutaneously (SC), once every two weeks (Q2W) for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.
干预措施: Vixarelimab (Drug)
DBT: Cohort 1: Placebo
Placebo Comparator
Participants with IPF will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period. This cohort has completed enrollment and has been closed.
干预措施: Placebo (Drug)
DBT: Cohort 2: Vixarelimab
Experimental
Participants with SSC-ILD will receive vixarelimab, SC, Q2W for 52 weeks in the DBT period.
干预措施: Vixarelimab (Drug)
DBT: Cohort 2: Placebo
Placebo Comparator
Participants with SSC-ILD will receive vixarelimab matching placebo, SC, Q2W for 52 weeks in the DBT period.
干预措施: Placebo (Drug)
OLE Period: Cohort 1: Vixarelimab
Experimental
Participants with IPF who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.
干预措施: Vixarelimab (Drug)
OLE Period: Cohort 2: Vixarelimab
Experimental
Participants with SSC-ILD who complete 52 weeks of treatment in the DBT period can choose to enroll in the OLE period to receive vixarelimab, SC, Q2W for 52 weeks.
干预措施: Vixarelimab (Drug)
结局指标
主要结局
Cohorts 1 and 2: Absolute Change From Baseline in Forced Vital Capacity (FVC)
时间窗: Baseline up to Week 52
FVC is a pulmonary function test parameter that indicates the amount of air that can be forcibly exhaled from the lungs after taking the deepest breath possible. It's measured by spirometry, which is a common breathing test to check lung function.
次要结局
- Cohorts 1 and 2: Absolute Change From Baseline in Percentage of Predicted FVC(Baseline up to Week 52)
- Cohorts 1 and 2: Change From Baseline in Health-Related Quality of Life (HRQoL) Measured Using King's Brief Interstitial Lung Disease (K-BILD) Questionnaire(Baseline up to Week 52)
- Cohorts 1 and 2: Change From Baseline in Dyspnea Measured Using L-PF Symptoms Dyspnea Domain Score(Baseline up to Week 52)
- Cohorts 1 and 2: Time to First Acute Exacerbation of ILD, or Suspected Acute Exacerbation of ILD(From the start of study treatment until end of DBT (up to Week 52))
- Cohorts 1, 2 and OLE Period: Number of Participants With Adverse Events (AEs)(Up to Week 52)
- Cohorts 1 and 2: Absolute Change From Baseline in 6-Minute Walk Test (6MWT) Distance(Baseline up to Week 52)
- Cohorts 1 and 2: Change From Baseline in Diffusion Capacity of the Lung for Carbon Monoxide Adjusted for Hemoglobin (DLco [Hb])(Baseline up to Week 52)
- Cohorts 1 and 2: Time to Disease Progression(From the start of study treatment until disease progression or death, whichever occurs first (up to Week 52 of DBT))
- Cohorts 1 and 2: Change From Baseline in Quantitative Lung Fibrosis on High-Resolution Computed Tomography (HRCT) Scan of the Thorax(Baseline up to Week 52)
- Cohort 2: Change From Baseline in Skin Sclerosis Assessed Using Modified Rodnan Skin Score (mRSS)(Baseline up to Week 52)
- Cohorts 1 and 2: Change From Baseline in Cough Measured Using Living with Pulmonary Fibrosis (L-PF) Symptoms Cough Domain Score(Baseline up to Week 52)
- Cohorts 1 and 2: Percentage of Participants with Deaths(Up to Week 52)
- Cohort 2: Change From Baseline in Pruritus Measured Using the Five-Dimension Itch Scale (5-D Itch) Total Score(Baseline up to Week 52)
- Cohorts 1 and 2: Serum Concentration of Vixarelimab(Baseline up to Week 52)
- Cohorts 1 and 2: Number of Participants With Anti-Drug Antibodies (ADAs) to Vixarelimab(Baseline up to Week 52)
研究者
研究点 (188)
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