A multiple-dose, double-blind, placebo-controlled, parallel study to assess the efficacy, safety and tolerability of ACZ885 (Canikumab) in patients with pulmonary sarcoidosis

ovartis Pharma Services AG0 个研究点目标入组 90 人开始时间: 2015年1月8日最近更新: 2015年9月14日

适应症

试验速览

暂无简介。

•Disease duration of = 1 year
•Evidence of clinically active disease defined by having all of the following criteria:
•MMRC dyspnea questionnaire score = 1
•Threshold FVC = 80%
•Evidence of parenchymal disease on HRCT
•Positive [F-18]FDG-PET/CT signal (parenchymal and/or lymph node) on first 24 patients, for the remaining patients, HRCT will be used to confirm the positive parenchymal or lymph node involvement
•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 12
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 8

•Extra-pulmonary sarcoidosis as primary treatment indication (e.g., involving brain, heart, eye and renal disease with significant hypercalcemia)
•Any conditions or significant medical problems which in the opinion of the investigator immunocompromises the patient and/ or places the patient at unacceptable risk for immunomodulatory therapy, such as:
•Absolute neutrophil count (ANC) •Platelets •Any active or recurrent bacterial, fungal (with exception of onychomycosis) or viral infection
•Presence of Human Immunodeficiency Virus (HIV) infection, Hepatitis B or Hepatitis C infections based on screening lab result
•Presence of active or latent tuberculosis (TB) established during screening
•Clinical evidence or history of multiple sclerosis or other demyelinating diseases, or Felty’s syndrome

发起方