Study of Efficacy and Safety of Canakinumab in Patients With Hereditary Periodic Fevers

Novartis Pharma K.K.0 个研究点目标入组 180 人开始时间: 待定

试验速览

阶段: 3 期
发起方: Novartis Pharma K.K.
入组人数: 180
主要终点: Proportion of participants with resolution of initial flare at time of the randomization and absence of new flares

暂无简介。

•Patient's written informed consent (or parent's written informed consent in case of pediatric patient) at screening
•Male and female patients at least 2 years of age at the time of the screening visit
•Confirmed diagnosis and active flare at randomization
•CRP >10mg/L at randomization

•Use of the following therapies (within varying protocol defined timeframes): Corticosteroids, anakinra, canakinumab, rilonacept, tocilizumab, TNF inhibitors, abatacept, tofacitinib, rituximab, leflunomide, thalidomide, cyclosporine, intravenous immunoglobulin, 6-Merceptopurine, azathioprine, cyclophosphamide, or chlorambucil, any other investigational biologics
•History of malignancy of any organ system (other than localized basal cell carcinoma of the skin or in - situ cervical cancer), treated or untreated
•Significant medical diseases, including but not limited to the following:
•a. History of organ transplantation
•b. Elevated liver enzymes >=2x ULN
•c. Increase in total bilirubin
•d. Serious hepatic disorder (Child-Pugh scores B or C)
•e. Chronic Kidney Disease
•f. Thyroid disease
•g. Diagnosis of active peptic ulcer disease
•h. Coagulopathy
•i. Significant CNS effects including vertigo and dizziness
•Any conditions or significant medical problems which immunecompromise the patient and/or places the patient at unacceptable risk for immunomodulatory therapy
•Live vaccinations within 3 months prior to the start of the trial, during the trial, and up to 3 months following the last dose
•Other protocol defined inclusion/exclusion may apply

Proportion of participants with resolution of initial flare at time of the randomization and absence of new flares

时间窗: 16 weeks

To demonstrate significant reduction of disease activity with canakinumab versus placebo

Percentage of participants who achieve Physician's global assessment < 2(16 weeks)
Percentage of participants with the serologic remission(16 weeks)

发起方