NCT07516951招募中2 期
A Phase IIb, Multicentre, Randomised, Double Blind, Placebo Controlled, Three-arm Parallel-group Study to Evaluate the Efficacy, Safety, and Tolerability at Week 24 of 2 Doses of CHF10067 (Zampilimab),in Participants With Idiopathic Pulmonary Fibrosis
适应症
干预措施
相关药物
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 入组人数
- 240
- 试验地点
- 4
- 主要终点
- Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24.
研究概览
简要总结
The purpose of this study is to evaluate the efficacy, safety, and tolerability at Week 24 of 2 doses of CHF10067 (zampilimab) in participants with idiopathic pulmonary fibrosis (IPF).
It is a phase IIb, multicentre, randomised, double-blind, placebo-controlled, three-arm parallel-group study.
A total of 240 participants with IPF (Idiomatic Pulmonary Fibrosis) will be randomised in approximately 150 investigational sites in North and Latin America, Europe, Asia, and Oceania.
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)
盲法说明
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor) The Investigational Medicinal Product (IMP) is blinded for the participant, investigators, and the sponsor. At the study site an unblinded pharmacist (or designee) will prepare the IMP and an unblinded clinical research associate will check the IMP related documentation Unblinded Sponsor and Clinical Research organization's Study Managers and Clinical Supplies representative will be also assigned.
入排标准
- 年龄范围
- 40 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Informed consent: Participant's written informed consent obtained prior to any study-related procedure.
- •Sex and age: Male or female, of any race and ethnicity, aged ≥40 years with a life expectancy of at least 1 year at screening in the opinion of the Investigator.
- •Body weight ≥45 kg.
- •Diagnosis of IPF: Diagnosis as defined by the 2018 and 2022 American Thoracic Society/European Respiratory Society/Japanese Respiratory Society/Latin American Thoracic Society Guidelines for a maximum 8 years before screening. The most recent High-resolution computed tomography (HRCT) ≤6 months prior to screening, reviewed by central reading, should be used to confirm the diagnosis.
- •Lung function: FVC ≥45% of predicted normal value and a ratio of forced expiratory volume in the first second (FEV1)/FVC ≥0.7 at screening.
- •Diffusing capacity of the lung for carbon monoxide (DLCO) corrected for haemoglobin ≥25% of predicted normal at screening.
- •Oxygen saturation measured by pulse oximetry (peripheral capillary oxygen saturation [SpO2]) >90% at rest when the maximum oxygen flow is 4 L/min by standard nasal cannula or the equivalent oxygen delivery via reservoir nasal cannula (≤2 L/min).
排除标准
- •Participant with a documented diagnosis of coeliac disease.
- •Low respiratory tract infection: Documented low respiratory tract infection in the last 4 weeks prior to screening or documented acute exacerbation of IPF (defined as acute worsening or development of dyspnoea typically <1 month duration;
- •Lung cancer: Active diagnosis or history of lung cancer.
- •Emphysema: HRCT (refer to inclusion criterion [Diagnosis of IPF]), reviewed by central reading, shows the presence of emphysema ≥20% or that the extent of emphysema is greater than the extent of fibrosis.
- •Organ transplantation: End-stage fibrotic disease expected to require organ transplantation within 6 months from screening.
- •Other medical conditions: Clinically relevant and uncontrolled pulmonary (including any non-IPF pulmonary diagnosis), cardiac, hepatic, gastrointestinal, renal, endocrine, metabolic, neurologic, psychiatric disorders, active or untreated latent tuberculosis/tuberculosis infection that may interfere with the participant's ability to complete this study according to the Investigator's judgement.
- •Any other comorbid non-IPF pulmonary condition that may impact FVC according to the Investigator's judgement. Emphysema is allowed, unless it meets the above exclusion criterion regarding emphysema.
- •Participant currently treated, or been treated with cytotoxic and immunosuppressant/modulator drugs within 48 weeks prior to screening. Systemic (IV, intramuscular, or oral) corticosteroids prednisone- equivalent dose of >10 mg/day used for >10 days.
- •Hypersensitivity: Known intolerance and/or hypersensitivity to any of the excipients contained in the formulation or any other substance used in the study.
- •History of allergic or anaphylactic reaction to human, humanised, chimeric immunoglobulins (Igs), or murine monoclonal antibodies.
研究组 & 干预措施
Arm A
Experimental
CHF10067 (Test Dose 1)
干预措施: CHF10067 (Drug)
Arm C
Placebo Comparator
Placebo
干预措施: Placebo (Other)
Arm B
Experimental
CHF10067 (Test Dose 2)
干预措施: CHF10067 (Drug)
结局指标
主要结局
Primary Outcome Measure: Absolute change from baseline in ppFVC (percent predicted forced vital capacity) at Week 24.
时间窗: At Week 24
次要结局
- Categorical relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%)(At Weeks 6, 12, 18, 24 and 30)
- Rate of decline in ppFVC over 24 weeks(Up to 24 weeks)
- Absolute and relative change from baseline in FVC (forced vital capacity) milliliter (mL) at Week 24 and at Weeks 6, 12, 18, and 30(At Weeks 6, 12, 18, 24 and 30)
- Categorical absolute change from baseline in FVC (mL) at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -200 mL, -100 mL, 0 mL, 100 mL, and 200 mL)(At Weeks 6, 12, 18, 24 and 30)
- Rate of decline in FVC (mL) over 24 weeks(Up to 24 Weeks)
- Absolute change from baseline in ppFVC at Weeks 6, 12, 18, and 30(At Weeks 6, 12, 18, and 30)
- Relative change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30(At Weeks 6, 12, 18, 24 and 30)
- Categorical absolute change from baseline in ppFVC at Week 24 and at Weeks 6, 12, 18, and 30 (5 dichotomous thresholds: -10%, -5%, 0%, 5%, and 10%)(At Weeks 6, 12, 18, 24 and 30)
- Change from baseline in the Living with Pulmonary Fibrosis (L-PF) questionnaire at Week 12 and at Week 24(At Weeks 12 and 24)
- Change from baseline in specific modules of the L-PF questionnaire (symptoms and impact) and within the symptom modules of specific domains (shortness of breath, cough, and fatigue) at Week 12 and at Week 24(At Weeks 12 and 24)
- CHF10067 concentrations at each visit (Week 0 to Week 21)(From Week 0 up to Week 21)
研究者
研究点 (4)
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