Graves Disease
Conditions
Keywords
Hyperthyroidism
Brief summary
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
Interventions
DRUGBHV-1300
delivered subcutaneously via autoinjector
DRUGPlacebo
delivered subcutaneously via autoinjector
Sponsors
Biohaven Therapeutics Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Key Inclusion Criteria: 1. Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies 2. Participants must have active hyperthyroidism due to Graves' disease Key
Exclusion criteria
1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) 2. History of treatment with radioactive iodine or thyroid surgery. 3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit. 4. Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening. 5. Have autoimmune disease other than Graves' disease requiring treatment 6. Have moderate to severe thyroid eye disease (TED) or are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation. 7. Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 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. | Week 26 |
Secondary
| Measure | Time frame |
|---|---|
| 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. | Week 26 |
| Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6 | Baseline to Week 6 |
| Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26 | Baseline to Week 26 |
| Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26 | 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 | 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 | Up to 26 weeks |
| Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6 | Baseline to Week 6 |
| Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26 | Baseline to Week 26 |
| Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26 | 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 | Week 26 |
| Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths | Up to 26 weeks |
| Number of unique participants with Grade 3 to 4 lab abnormalities | Up to 26 weeks |
Countries
Puerto Rico, United States
Contacts
CONTACTChief Medical Officer
Outcome results
None listed