The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
300
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
Time frame: Week 26
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.
Time frame: Week 26
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6
Time frame: Baseline to Week 6
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26
Time frame: Baseline to Week 26
Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26
Time frame: Week 26
Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo
Time frame: Up to 26 weeks
Time to euthyroidism (defined as Total T3, FT4, and TSH within normal limits) and off ATD of participants on BHV-1300 vs placebo
Time frame: Up to 26 weeks
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6
Time frame: Baseline to Week 6
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26
Time frame: Baseline to Week 26
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Site-044
Tucson, Arizona, United States
RECRUITINGSite-032
Burbank, California, United States
RECRUITINGSite-062
Huntington Beach, California, United States
RECRUITINGSite-048
Oakland, California, United States
RECRUITINGSite-006
San Diego, California, United States
RECRUITINGSite-067
Walnut Creek, California, United States
RECRUITINGSite-052
Doral, Florida, United States
RECRUITINGSite-066
Fort Myers, Florida, United States
RECRUITINGSite-019
Hialeah, Florida, United States
RECRUITINGSite-027
Hollywood, Florida, United States
RECRUITING...and 40 more locations
Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26
Time frame: Week 26
Number of participants who are euthyroid (defined as Total T3, FT4, and TSH within normal limits), off ATD and TRAb seronegative at Week 26
Time frame: Week 26
Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths
Time frame: Up to 26 weeks
Number of unique participants with Grade 3 to 4 lab abnormalities
Time frame: Up to 26 weeks