Testing BHV-1300 for treating Graves' Disease
An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
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 |
| Enrollment | 15 (estimated) |
| Ages | 18 Years to 65 Years |
| Sex | All |
| Sponsor | Biohaven Pharmaceuticals, Inc. Industry-sponsored |
| Locations | 17 sites (South Gate, California and 16 other locations) |
| Trial ID | NCT06980649 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are individuals with serologically confirmed Graves' Disease and active hyperthyroidism.
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.
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 performed: While this approach is novel for BHV-1300, similar studies targeting autoimmune thyroid diseases have shown promise in the past.
Eligibility criteria
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 this trial is running
South Gate, California and 16 other locations
- Site-103 — South Gate, California, United States (Recruiting)
- Site-100 — Miami, Florida, United States (Recruiting)
- Site-104 — Columbus, Georgia, United States (Recruiting)
- Site-108 — Greenville, North Carolina, United States (Not_yet_recruiting)
- Site-110 — Canton, Ohio, United States (Recruiting)
- Site-107 — Memphis, Tennessee, United States (Recruiting)
- Site-109 — Dallas, Texas, United States (Not_yet_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)
- Site-001 — Kotara, Australia (Recruiting)
- Site-003 — Melbourne, Australia (Recruiting)
- Site-010 — Oaklands Park, Australia (Recruiting)
- Site-008 — Parkville, Australia (Recruiting)
- Site-006 — St Leonards, Australia (Recruiting)
- Site-002 — Torquay, Australia (Recruiting)
Study contacts
- Study coordinator: Chief Medical Officer
- Email: clinicaltrials@biohavenpharma.com
- Phone: 203-404-0410
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.