About the Flex Study
The purpose of the Flex Study is to evaluate the effectiveness and safety of an investigational medication compared to standard of care on reducing symptoms in adults with DM.
The purpose of the Flex Study is to evaluate the effectiveness and safety of an investigational medication compared to standard of care on reducing symptoms in adults with DM.
Eligible participants must:
There are additional eligibility requirements that the study doctor can explain to you.
The investigational medication is called ravulizumab. “Investigational” means that it has not been approved by country-specific regulatory health authorities to be used for DM and its use is being allowed for research purposes only. Participants will be assigned at random to receive either the investigational medication or the placebo. Neither the participant nor the study team will know which study treatment option has been assigned, but in case of an emergency, they can quickly find out. Both the investigational medication and the placebo are administered as intravenous (IV) infusions.
The total duration of the Flex Study is between 104 and 128 weeks and consists of:
Screening
This period lasts up to four weeks. During this time, the study staff reviews a potential participant’s medical history and performs tests to see if they qualify for the study.
Study Treatment period
Participants are enrolled in either Part A or Part B and selected at random to receive either the investigational medication (ravulizumab) or a placebo, which looks just like the investigational medication but contains no active ingredients. The study doctor collects blood and urine samples and performs assessments during study site visits to check on participants’ health.
Open-label extension period
If a participant is eligible to continue taking the investigational medication, the study doctor will discuss the option of participating in the open-label extension period. This period may last up to 74 weeks (one and a half years) or until the investigational medication is approved in the US, whichever occurs first, and includes 11 visits to the study site.
Throughout the study, the study doctor may perform a number of tests and procedures, including but not limited to: