Graves Disease study: BHV-1300
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?
An investigational once‑daily subcutaneous injectable medicine being studied 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 study aims to evaluate how well BHV-1300 works and how safe it is for adults with Graves' disease.
- Who it's for
- Adults with Graves' disease who are currently 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) or 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) or 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 is enrolling
- Tucson, Arizona, United States
- Burbank, California, United States
- Huntington Beach, California, United States
- La Jolla, California, United States
- Oakland, California, United States
- San Diego, California, United States
- South Gate, California, United States
- Walnut Creek, California, United States
- Washington D.C., District of Columbia, United States
- Doral, Florida, United States
- Fort Myers, Florida, United States
- Hialeah, Florida, United States
- Hollywood, Florida, United States
- Miami, Florida, United States
- Palm Beach Gardens, Florida, United States
- Tampa, Florida, United States
- Atlanta, Georgia, United States
- Fayetteville, Georgia, United States
- Champaign, Illinois, United States
- Oak Brook, Illinois, United States
+ 38 more site(s).
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
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, but 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?
This study is enrolling now at Tucson, Arizona, United States; Burbank, California, United States; Huntington Beach, California, United States; La Jolla, California, United States; Oakland, California, United States; San Diego, California, United States and 52 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.