Testing BHV-1300 for treating Graves' Disease
Official title: An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
Run by Biohaven Pharmaceuticals, Inc. · NCT06980649 · Data updated 2026-11-12
This study is testing a new treatment called BHV-1300 to see if it can help people with Graves' Disease manage their symptoms and improve their condition.
Quick facts
| Phase | Phase 1 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Enrollment | 15 (estimated) |
| Sponsor | Biohaven Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 18 sites (South Gate, California and 17 other locations) |
| Status | Recruiting |
| Started | August 21, 2025 |
| Main results expected | September 2027 |
| Study ends | September 2027 |
| Registry record updated | July 31, 2026 |
| Trial ID | NCT06980649 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are individuals with serologically confirmed Graves' Disease and active hyperthyroidism.
✕Probably not a fit
Patients with hyperthyroidism caused by conditions other than Graves' Disease or those who have undergone radioactive iodine treatment or thyroid surgery may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This study evaluates the safety and effectiveness of BHV-1300 in individuals diagnosed with Graves' Disease, an autoimmune condition that leads to hyperthyroidism. Participants will receive the intervention to assess its impact on their condition. The study aims to gather data on how well BHV-1300 works in managing the symptoms and underlying causes of Graves' Disease. It is a Phase 1 interventional trial, focusing on a specific patient population with active hyperthyroidism.
Why it matters
Potential benefit: If successful, this treatment could provide a new therapeutic option for patients suffering from Graves' Disease.
How similar studies have gone: While this approach is novel for BHV-1300, similar studies targeting autoimmune thyroid diseases have shown promise in the past.
Who can join: the full rules
Show full inclusion / exclusion criteria
Key Inclusion Criteria: 1\. Participants must have serologically confirmed Graves' Disease. Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit. 2. History of treatment with radioactive iodine or thyroid surgery.
Where it's running
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Site-103
South Gate, California, United States Recruiting -
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Miami, Florida, United States Recruiting -
Site-104
Columbus, Georgia, United States Recruiting -
Site-108
Greenville, North Carolina, United States Recruiting -
Site-110
Canton, Ohio, United States Recruiting -
Site-107
Memphis, Tennessee, United States Recruiting
Show 12 more locations
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Site-109
Dallas, Texas, United States Recruiting -
Site-106
Houston, Texas, United States Recruiting -
Site-101
Houston, Texas, United States Recruiting -
Site-105
Shavano Park, Texas, United States Recruiting -
Site-004
Fitzroy, Australia Recruiting -
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Herston, Australia Recruiting -
Site-001
Kotara, Australia Recruiting -
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Melbourne, Australia Recruiting -
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Oaklands Park, Australia Recruiting -
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Parkville, Australia Recruiting -
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St Leonards, Australia Recruiting -
Site-002
Torquay, Australia Recruiting
Study contacts
- Study coordinator: Chief Medical Officer
- Email: clinicaltrials@biohavenpharma.com
- Phone: 203-404-0410
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Efgartigimod for Graves' Disease in adults
We are testing if efgartigimod given under the skin can help adults with Graves' disease by improving thyroid function and whether it is safe and tolerable.
-
ETHY-001 safety and activity in Thyroid Eye Disease (TED)
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Early risk stratification of thyroid eye disease in newly diagnosed Graves' disease
This study tests whether early eye-related signs, blood and tear biomarkers, or eye surface features can predict who with Graves’ disease will develop thyroid eye disease within a year.
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Felzartamab for Graves’ Disease: See if it helps control thyroids and reduce need for ATDs
This study tests felzartamab vs placebo in adults with Graves’ disease to see if it can normalize thyroid hormones and let people stop anti-thyroid drugs.
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AI-based MRI and ultrasound for thyroid-related eye disease
This study tests an AI model using orbital MRI and eye ultrasound to help diagnose activity and severity of thyroid-associated ophthalmopathy and predict its course in adults.
-
YB-101 for Graves' Disease: safety, dosing, and how it works
This study tests YB-101 versus placebo in adults with Graves' disease to see if it is safe, tolerated, and whether it can help thyroid symptoms over about 40 weeks.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.