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New treatment option for Graves Disease
Official title Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease
ClinicalTrials.gov ID: NCT07661056
What this study is testing
What is BHV-1300?
BHV-1300 is an investigational medicine, given as an injection under the skin, being studied as a potential treatment for graves disease.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 70
You may be able to join if
- Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- Participants must have active hyperthyroidism due to Graves' disease Key
You likely can't join if
- History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
- History of treatment with radioactive iodine or thyroid surgery.
- Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit.
- Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid...
- Have autoimmune disease other than Graves' disease requiring treatment
- Have moderate to severe thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective...
See the full eligibility criteria
- Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- Participants must have active hyperthyroidism due to Graves' disease Key
- History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
- History of treatment with radioactive iodine or thyroid surgery.
- Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit.
- 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...
- Have autoimmune disease other than Graves' disease requiring treatment
- Have moderate to severe thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
The study team makes the final eligibility decision.
Where it's taking place
- Burbank, California, United States
- San Diego, California, United States
- Walnut Creek, California, United States
- Doral, Florida, United States
- Hialeah, Florida, United States
- Lenexa, Kansas, United States
- Las Vegas, Nevada, United States
- Asheville, North Carolina, United States
- Morehead City, North Carolina, United States
- Statesville, North Carolina, United States
- Wilmington, North Carolina, United States
- Canton, Ohio, United States
- Dallas, Texas, United States
- Denton, Texas, United States
- El Paso, Texas, United States
- Houston, Texas, United States
- McKinney, Texas, United States
- Layton, Utah, United States
- Midlothian, Virginia, United States
- Seattle, Washington, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 70 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Burbank, California, United States; San Diego, California, United States; Walnut Creek, California, United States; Doral, Florida, United States; Hialeah, Florida, United States; Lenexa, Kansas, United States and 14 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.