The study consists of 3 phases:
Screening phase
Up to 2 months before starting the study treatment. The study team will assess if you meet the eligibility criteria.
Treatment phase
The study will be conducted in two parts, Part A and Part B, with a maximum of 30 months of investigational study drug administration.
PART A:
In Part A, enrolled participants will be assigned to 1 of the 2 treatment groups to receive either investigational study drug or placebo. Participants have a 67% chance to receive the investigational study drug.
Participants will either receive the investigational study drug or the placebo given through an infusion into a vein in your arm (intravenously).
PART B:
All participants entering part B will receive the investigational study drug for up to 24 months to evaluate safety and efficacy. Participants will not receive placebo during part B.
Follow up phase:
For up to 15 months, after participants complete Part B, the study team will continue to monitor for safety.