临床试验/NCT06132256

NCT06132256招募中2 期

A 26-Week, Randomized, Double-Blind, Placebo-Controlled, Multi-center Study to Evaluate the Efficacy, Safety, and Tolerability of Axatilimab in Subjects With Idiopathic Pulmonary Fibrosis (IPF)

Syndax Pharmaceuticals82 个研究点分布在 11 个国家目标入组 135 人开始时间: 2023年12月11日最近更新: 2025年12月22日

适应症

干预措施

试验速览

阶段: 2 期
状态: 招募中
发起方: Syndax Pharmaceuticals
入组人数: 135
试验地点: 82
主要终点: Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])

研究概览研究设计入排标准研究组 & 干预措施结局指标研究者研究点记录与标识符相似试验相关资讯

研究概览

简要总结

The study will evaluate the efficacy and safety of axatilimab in participants with IPF.

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: 40 Years 至 —（Adult, Older Adult）
性别: All
接受健康志愿者: 否

入选标准

•Documented diagnosis of IPF per the 2018 American Thoracic Society (ATS)/European Respiratory Society (ERS)/Japanese Respiratory Society (JRS)/Latin American Thoracic Society Clinical Practice Guideline (Raghu 2018).
•Chest high-resolution computed tomography (HRCT) performed within 12 months prior to first Screening Visit and according to the minimum requirements for IPF diagnosis by central review based on participant's HRCT only (if no lung biopsy is available) or based on both HRCT and lung biopsy (with application of the different criteria in either situation). If an evaluable HRCT <12 months prior to Screening is not available, an HRCT can be performed at first Screening Visit to determine eligibility, according to the same requirements as the historical HRCT. If a participant has an indeterminate usual interstitial pneumonia (UIP) pattern and their HRCT is >6 months old, if in the opinion of the Investigator their disease has progressed, an additional HRCT may be obtained and reviewed for eligibility.
•FVC ≥45% of predicted normal at Screening Visits.
•Forced expiratory volume in 1 second (FEV1)/FVC ≥0.7 at Screening Visits.
•DLco ≥30% and ≤90% of predicted, corrected for hemoglobin at first Screening Visit.

排除标准

•Abnormalities detected on electrocardiogram (ECG) of either rhythm or conduction that in the opinion of the Investigator are clinical significant. Participants with implantable cardiovascular devices (for example, pacemaker) affecting the QT interval time may be enrolled in the study based upon Investigator judgment following cardiologist consultation if deemed necessary, and only after discussion with the Medical Monitor.
•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.
•Interstitial lung disease associated with known primary diseases (for example, connective tissue disease, sarcoidosis and amyloidosis), exposures (for example, radiation, silica, asbestos, and coal dust), or drugs (for example, amiodarone).
•Participants who cannot meet protocol-specified baseline stability criteria.
•Acute IPF exacerbation within 3 months prior to screening.
•Receiving nintedanib in combination with pirfenidone
•Receiving systemic corticosteroids equivalent to prednisone >10 milligrams (mg)/day or equivalent within 2 weeks prior to Screening.
•Use of any of the following therapies within 4 weeks prior to Screening and during the Screening Period, or planned during the study: imatinib, ambrisentan, azathioprine, mycophenolate mofetil, cyclophosphamide, cyclosporine A, tacrolimus, bosentan, methotrexate, inhaled treprostinil, phosphodiesterase-5 inhibitors, including sildenafil (unless for occasional use), prednisone at steady dose >10 mg/day or equivalent, or other investigational therapy.
•History of cigarette smoking or vaping within the previous 3 months.
•Female participant who is pregnant or breastfeeding.
•Previous exposure to study intervention or known allergy/sensitivity to study drug.
•Receiving an investigational treatment within 28 days of randomization.
•Inadequate IV access.

研究组 & 干预措施

Axatilimab

Experimental

Participants will receive axatilimab every 2 weeks during the 26-week Treatment Period.

干预措施: Axatilimab (Drug)

Placebo

Placebo Comparator

Participants will receive placebo every 2 weeks during the 26-week Treatment Period.

干预措施: Placebo (Other)

结局指标

主要结局

Annualized rate of decline in morning pre-dose trough forced vital capacity (FVC) (milliliter [mL])

时间窗: Baseline through Week 26

次要结局

Annualized rate of decline in FVC percent predicted over 26 weeks(Baseline through Week 26)
Time to disease progression(Baseline through Week 26)
Change in St. George's Respiratory Questionnaire (SGRQ) score from Baseline to Week 26(Baseline, Week 26)
Change in diffusion capacity for carbon monoxide (DLco % of predicted, corrected for hemoglobin) from Baseline to Week 26(Baseline, Week 26)

研究者

发起方

Syndax Pharmaceuticals

申办方类型

Industry

责任方

Sponsor

研究点 (82)

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