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| ID | Type | Description | Link |
|---|---|---|---|
| 2026-526455-53-00 | EU Trial (CTIS) Number |
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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
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| BHV-1300 | Experimental | BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. |
|
| Placebo | Placebo Comparator | Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| BHV-1300 | Drug | delivered subcutaneously via autoinjector |
| |
| Placebo |
| Measure | Description | 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 |
| Measure | Description | 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 |
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Key Inclusion Criteria:
Key Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Chief Medical Officer | Contact | 203-404-0410 | clinicaltrials@biohavenpharma.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Site-032 | Recruiting | Burbank | California | 91501 | United States | |
| Site-006 |
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| Drug |
delivered subcutaneously via autoinjector |
|
| 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 or 4 lab abnormalities | Up to 26 weeks |
| Recruiting |
| San Diego |
| California |
| 92108 |
| United States |
| Site-067 | Recruiting | Walnut Creek | California | 94598 | United States |
| Site-019 | Recruiting | Hialeah | Florida | 33016 | United States |
| Site-025 | Recruiting | Lenexa | Kansas | 66234 | United States |
| Site-064 | Recruiting | Morehead City | North Carolina | 28557 | United States |
| Site-008 | Recruiting | Canton | Ohio | 44718 | United States |
| Site-055 | Recruiting | Dallas | Texas | 75231 | United States |
| Site-043 | Recruiting | Denton | Texas | 76210 | United States |
| Site-071 | Recruiting | Houston | Texas | 77058 | United States |
| Site-054 | Recruiting | McKinney | Texas | 75069 | United States |
| Site-013 | Recruiting | Layton | Utah | 84041 | United States |
| ID | Term |
|---|---|
| D006111 | Graves Disease |
| D006980 | Hyperthyroidism |
| ID | Term |
|---|---|
| D005094 | Exophthalmos |
| D009916 | Orbital Diseases |
| D005128 | Eye Diseases |
| D006042 | Goiter |
| D013959 | Thyroid Diseases |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
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