This is a 2-cohort (observational and treatment cohort) extension study for participants completing feeder studies (IMVT-1401-3201 or IMVT-1401-3202). The observational cohort will assess the durability of proptosis response of feeder studies off treatment. The treatment cohort will evaluate the efficacy of batoclimab as assessed by proptosis responder rate.
Study Type
INTERVENTIONAL
Allocation
NON_RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
180
Observational cohort study
Batoclimab is a fully human anti-neonatal fragment crystallizable receptor (FcRn) monoclonal antibody
Duration of proptosis response off treatment in study eye in batoclimab responder participants in the feeder studies
Time frame: Up to Week 24
Percentage of proptosis responders in study eye in placebo non-responder participants in the feeder studies
Time frame: At Week 24
Percentage of proptosis responders in study eye in batoclimab non-responder participants in the feeder studies
Time frame: At Week 24
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Site Number - 1520
Glendora, California, United States
Site Number - 1501
Aurora, Colorado, United States
Site Number - 1526
Livonia, Michigan, United States
Site Number - 1513
Rochester, Minnesota, United States
Site Number - 1540
Las Vegas, Nevada, United States
Site Number - 1508
Houston, Texas, United States
Site Number - 1558
Mesquite, Texas, United States
Site Number - 1511
Morgantown, West Virginia, United States
Site Number - 1518
Milwaukee, Wisconsin, United States
Site Number - 7565
Sydney, Australia
...and 45 more locations