EUCTR2021-004794-31-DE进行中（未招募）1 期
A Randomized, Double-blind, Placebo-controlled Phase 2 Study with Open-label Extension to Assess the Efficacy and Safety of Namilumab in Subjects with Chronic Pulmonary Sarcoidosis - Resolve-Lung
试验速览
- 阶段
- 1 期
- 状态
- 进行中（未招募）
- 入组人数
- 100
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Male or female subjects age = 18 years.
- •2. Able and willing to provide written informed consent, which includes compliance with study requirements, study procedures (including performing acceptable spirometry according to ATS criteria), and restrictions listed in the consent form.
- •3. = 6-month history of documented sarcoidosis (must include histological report, from any organ, in the subject's medical records).
- •4. Have HRCT scan at screening consistent with pulmonary sarcoidosis of the lung parenchyma by central read.
- •Note: An HRCT performed as part of clinical care may be used as the screening HRCT as long as the HRCT is performed within 4 weeks of the Screening Visit and is uploaded and deemed of acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study inclusion, it needs to be obtained again as part of the study inclusion procedures.
- •5. ppFVC = 50% and DLCO (hemoglobin corrected value) = 40% predicted at screening.
- •6. If receiving prednisone (or equivalent), dose must be = 25 mg, and dose must have been stable for at least 4 weeks prior to screening. In addition, subject must agree to taper their steroids beginning at the time of randomization.
- •7. If receiving methotrexate and/or other IST, subject must agree to cessation of their IST therapy at randomization.
- •8. Have additional evidence of active pulmonary sarcoidosis as defined by:
- •a. Medical Research Council Dyspnea scale > 1 (i.e., Grade 2 or more) at screening; AND
- •b. Currently on a treatment regimen for pulmonary sarcoidosis that includes OCS, IST, or the combination of OCS and IST. If not currently being treated with either OCS or IST, subjects can still be eligible if there is documentation in the medical records that they have taken OCS and/or IST in the past 2 years for their pulmonary sarcoidosis and have been unable to tolerate them, treatment was not effective, or they subsequently refused to continue taking these medications; AND
- •c. One or more of the following is present:
- •i. Screening FDG-PET scan showing pulmonary parenchymal uptake consistent with active pulmonary sarcoidosis AND with pulmonary parenchymal SUVmax = 3 on central read;
- •Note: A PET/CT performed as part of clinical care may be used as the screening PET/CT as long as the PET/CT is performed within 4 weeks of the Screening Visit and is uploaded and deemed of acceptable quality by the imaging vendor/central reader. If not of acceptable quality for study inclusion, it needs to be obtained again as part of the study inclusion procedures.
- •ii. Documentation in the subject's medical record of worsening sarcoidosis (i.e., a clinically meaningful worsening in pulmonary function parameters (e.g., = 5 percent decline in ppFVC) or clinically relevant worsening of radiographic findings (e.g., HRCT, chest x-ray) in the past 12 months);
- •iii. Documentation in the subject's medical record that tapering OCS (= 5 mg change) and/or tapering ISTs during the past 12 months resulted in an increase of pulmonary disease symptoms, signs, or activity necessitating maintenance or increase in dose of OCS and/or IST.
- •9. Female subjects must agree to use an approved highly effective birth control (BC) method (< 1% failure rate per year) for at least 4 weeks prior to randomization, throughout the study, and for 18 weeks following the last dose of study drug, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal as defined below:
- •a. Non-childbearing
排除标准
- •1. Hospitalized for any respiratory illness = 30 days prior to or during
- •2. = 20% fibrosis as indicated on HRCT-scan assessed by central read
- •prior to randomization.
- •3. Estimated glomerular filtration rate (eGFR) = 30 mL/min/1.73 m2
- •(Modification of Diet in Renal Disease [MDRD] equation) or requiring
- •chronic renal replacement therapy.
- •4. Aspartate aminotransferase (AST), alanine aminotransferase (ALT), or
- •alkaline phosphatase (ALP) > 2 × upper limit of normal range (ULN), or
- •serum total bilirubin > 1.5 × ULN.
- •Note: Subjects with documented history of Gilbert's syndrome may
- •remain eligible if they have a direct bilirubin = ULN).
- •5. Platelet count < 100,000 per mm3.
- •6. Hemoglobin = 9.5 g/dL.
- •7. Absolute neutrophil count < 1,500 per mm3.
- •8. Corrected serum calcium > 3.0 mmol/L (> 12 mg/dL).
- •9. History of pulmonary alveolar proteinosis (PAP).
- •10. Use of any prohibited immunomodulator agent, immunoglobulin or FcRn inhibitor (approved or investigational) within the 6 months prior to or during screening.
- •Note: Allergens for hypersensitivity desensitization or vaccines are not excluded. EVUSHELD administration for COVID-19 prophylaxis is allowed up to within 2 weeks prior to baseline (V2).
- •11. Treatment with any Janus kinase (JAK) inhibitor within 3 months prior to or during screening.
- •12. Participation in another interventional clinical trial within 6 months prior to or during screening and throughout the duration of participation in this study.
- •13. History of left ventricular ejection fraction (LVEF) = 40% or New York Heart Association (NYHA) class III or IV heart failure.
- •14. ECG abnormalities that warrant further clinical investigation or management at screening or Fridericia corrected QT interval (QTcF) > 480 msec on the 12-lead ECG at screening; if QTcF exceeds 480 msec, the ECG should be repeated 2 more times and the average of the 3 QTcF measures should be used to determine eligibility.
- •Note: If a subject has a pre-existing bundle branch block (BBB), the QTcF exclusion cutoff will be > 500 msec.
- •15. Pulmonary hypertension requiring therapy.
- •16. Systolic blood pressure (SBP) < 90 or > 180 mm Hg; Diastolic blood pressure (DBP) < 60 or > 110 mm Hg at screening.
- •17. Documented laboratory-confirmed severe acute respiratory syndrome coronavirus-2 (SARS-CoV-2) infection with pulmonary involvement or signs/symptoms of long COVID as determined by approved testing = 6 months prior to randomization.
- •18. Administration of any fully live virus or bacterial vaccinations within 3 months prior to or during screening or administration of non-live or live-attenuated vaccine within 2 weeks of randomization.
- •Note: COVID-19 booster and influenza vaccinations are allowed to be completed during the study.
- •19. Systemic (oral or parenteral)antibiotic or pulse OCS treatment for any indication within 6 weeks prior to randomization.
- •Note: A systemic (oral or parenteral) antibiotic prescribed for infection prophylaxis (i.e., not for treatment of an infection) is allowed as long as it was started at least 6 weeks prior to the Baseline Visit AND is not a prohibited medication per protocol.
- •20. Three or more lower-respiratory tract infections requiring antimicrobial therapy within 12 months prior to screening.
- •21. Any history of mycetoma or fungal respiratory infection.
- •22. Requirement for supplemental oxygen at rest.
- •23. History of or planned solid organ or hematopoietic cell transplantation.
- •24. Prior or planned pneumonectomy and/or planned lobectomy.
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