Extension of the CBYM338B2203 phase IIb/III study to evaluate the long-term efficacy, safety and tolerability of intravenous BYM338 in patients with sporadic inclusion body myositis

ovartis Pharma Services AG0 个研究点目标入组 240 人开始时间: 2015年8月5日最近更新: 2018年2月19日

适应症

试验速览

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•- Patients who completed the core study
•- Written informed consent must be obtained before any extension study assessment is performed
•- Able to communicate well with the investigator
•- Willing to participate for the entire duration of the extension study with commitment to follow study requirements and procedures.
•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 72
•F.1.3 Elderly (>=65 years) yes
•F.1.3.1 Number of subjects for this age range 168

•- Women who are pregnant
•- Women of child-bearing potential unless they are using highly effective methods of contraception during dosing and for 6 months after the last BYM338 dose
•- Current use of prohibited treatments
•- History of severe hypersensitivity reaction in the core study
•- History of adverse event(s) (including those from the core study) prior to the start of study drug in the extension study that, in the judgment of the investigator, taking into account the subject’s overall status, prevent the subject from entering the extension study
•- Clinically significant abnormal liver function tests
•- Any medical condition or laboratory finding which, in the opinion of the investigator may interfere with participation in the study, might confound the results of the study, or pose an additional safety risk in administering BYM338
•Other protocol-defined exclusion criteria may apply.

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