EUCTR2021-004794-31-FR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
适应症
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 and restrictions listed in the consent form.
- •3. =6-month history of documented sarcoidosis including histological confirmation in the subject’s medical records.
- •4. Have HRCT and [18F]-FDG PET/CT scans at Screening consistent with active pulmonary sarcoidosis of the lung parenchyma by central read.
- •5. ppFVC =50% to =90% and DLCO =50% at Screening.
- •6. If receiving prednisone (or equivalent), dose must have been =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, dose must have been stable for =3 months prior to Screening and subject must agree to cessation of their IST therapy at randomization.
- •8. Symptomatic as indicated by modified Medical Research Council Dyspnea scale >1 (i.e., Grade 2 or more) in the prior 6 months.
- •9. Female subjects must agree to use an approved highly effective birth control (BC) method (<1% failure rate per year) for at least 28 days prior to randomization, throughout the study and for 8 weeks (56 days) post last dose of study drug, unless documented to have a reproductive status of non-childbearing potential or is postmenopausal as defined below:
- •Non-childbearing potential defined as pre-menopausal female with medical history of total hysterectomy, bilateral oophorectomy (removal of ovaries), bilateral salpingectomy, bilateral tubal ligation, or bilateral hysteroscopic sterilization at least 3 months prior to Screening;
- •Postmenopausal defined as12 months of spontaneous amenorrhea; otherwise, a follicle stimulating hormone (FSH) confirmation will be required. For females with questionable menopausal history (e.g., irregular menstrual periods and age >40 years) a documented serum FSH level must be =30 mIU/mL;
- •Woman of childbearing potential (WCBP) who is already using an established method of highly effective contraception or agrees to use one of the allowed BC methods, for at least 28 days prior to randomization and throughout the study, and for 8 weeks (56 days) following the last dose of study drug.
- •10.Male subjects must agree to, and attest that, female partners of childbearing potential are using one of the allowed highly effective methods of contraception as described above and for consistent duration.
- •11. Body Mass Index (BMI) =40 kg/m2 at Screening.
- •12. Vaccination for COVID-19 with completion of the primary series at least 2 weeks prior to randomization.
- •Are the trial subjects under 18? no
- •Number of subjects for this age range:
- •F.1.2 Adults (18-64 years) yes
- •F.1.2.1 Number of subjects for this age range 80
- •F.1.3 Elderly (>=65 years) yes
- •F.1.3.1 Number of subjects for this age range 20
排除标准
- •1. Hospitalized for any respiratory illness =30 days prior to Screening.
- •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).
- •5. Platelet count <100,000 per mm3.
- •6. Hemoglobin =9.5 g/dL.
- •7. Absolute neutrophil count <1,000 per mm3.
- •8. Corrected serum calcium >3.5 mmol/L (14 mg/dL).
- •9. Positive for anti-GM-CSF autoantibody, or history of pulmonary alveolar proteinosis (PAP).
- •10. Use of any biologic immunomodulator agent (approved or investigational) within the 6 months prior to Screening. Allergens for hypersensitivity desensitization or vaccines are not excluded per this criterion. Treatment with immunoglobulin within 6 months prior to Screening. Treatment with any investigational immunomodulator (e.g., Neuropilin 2 (NRP2) modulator) within 6 months prior to Screening.
- •11. Treatment with any Janus kinase (JAK) inhibitor within 3 months prior to Screening.
- •12. Participation in another interventional clinical trial within 6 months prior to Screening.
- •13. History of left ventricular ejection fraction (LVEF) =30% 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.
- •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. Has documented laboratory-confirmed SARS-CoV-2 infection as determined by polymerase chain reaction (PCR) or other approved clinical testing =3 months prior to randomization.
- •18. Administration of any fully live virus or bacterial vaccinations within 3 months prior to Screening or administration of non-live or liveattenuated
- •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 42 days prior to randomization.
- •20. Three or more lower, respiratory tract infections requiring antimicrobial therapy within 12 months prior to Screening.
- •21. 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. Note: Lobectomy performed =12 months prior to randomization is allowed.
- •25. Prior use within 12 months of Screening of, or inability to refrain from throughout the study period and 8 weeks (56 days) after last dose of
- •study drug, smoking or using any form of inhaled tobacco, inhaled nicotine (including vaping) or inhaled cannabis preparations.
- •26. A diagnosis of, or presentation consistent with, Lofgren’s syndrome.
- •27. Other significant pulmonary disease likely to interfere with the primary endpoint; the Principal Investigator must discuss any such concerns with the Sponsor or designee prior to randomiza
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