An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
Novartis Pharmaceuticals
Age
36–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
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.
You may not be if
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
Clareo Health | An Extension Study of the Efficacy, Safety and Tolerability of BYM338 (Bimagrumab) in Patients With Sporadic Inclusion Body Myositis Who Previously Participated in the Core Study CBYM338B2203
