Graves DiseasePhase 1NCT06980649
Study of BHV-1300 in Graves' Disease
A Phase 1 study testing BHV-1300 in people with Graves Disease, run by Biohaven Therapeutics Ltd. at 18 sites in 2 countries.
Trial summary
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Graves Disease
- What is being tested?
- BHV-1300
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 18 sitesin 2 countries
- Study dates
- 21 Aug 2025to Sep 2027
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. Participants must have serologically confirmed Graves' Disease.
Who cannot join
- 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.
- History of treatment with radioactive iodine or thyroid surgery.
Trial locations and contacts
18 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
18 sites in 2 countries
United States10 sites, 10 recruiting
- Recruiting
Site-110
Canton, Ohio, 44718
- Recruiting
Site-104
Columbus, Georgia, 31904
- Recruiting
Site-109
Dallas, Texas, 75246
- Recruiting
Site-108
Greenville, North Carolina, 27834
- Recruiting
Site-106
Houston, Texas, 77054
- Recruiting
Site-101
Houston, Texas, 77095
- Recruiting
Site-107
Memphis, Tennessee, 38119
- Recruiting
Site-100
Miami, Florida, 33126
- Recruiting
Site-105
Shavano Park, Texas, 78231
- Recruiting
Site-103
South Gate, California, 90280
Australia8 sites, 8 recruiting
- Recruiting
Site-004
Fitzroy, 3065
- Recruiting
Site-011
Herston, 4029
- Recruiting
Site-001
Kotara, 2289
- Recruiting
Site-003
Melbourne, 3128
- Recruiting
Site-010
Oaklands Park, 5046
- Recruiting
Site-008
Parkville, 3050
- Recruiting
Site-006
St Leonards, 2065
- Recruiting
Site-002
Torquay, 3228
About this study
Official title: An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.
- Conditions
- Graves Disease
- Being tested
- BHV-1300
- Keywords
- Autoimmune thyroid disease, hyperthyroidism, anti thyroid drug, thyroid disease, autoimmune diseases, endocrine system diseases
- Medical subject headings
- Graves Disease, Hyperthyroidism, Thyroid Diseases, Autoimmune Diseases, Endocrine System Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-1300Drug
BHV-1300 is delivered subcutaneously (SC)
| Study group | Role | What they receive |
|---|---|---|
| BHV-1300 | Experimental | Not described Receives: Drug: BHV-1300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks).
Measured: Baseline to Week 52
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
Measured: Baseline to Week 52
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2025
- Study start21 Aug 2025
- Primary completionSep 2027 (estimated)
- Study completionSep 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves DiseaseStudies of the same condition, open and under way.
- More trials run by Biohaven Therapeutics Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 15 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Biohaven Therapeutics Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06980649
- Sponsor's protocol ID
- BHV1300-202
- Status last verified
- Jul 2026
- First submitted
- 12 May 2025
- Last updated
- 31 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
- ClinicalTrials.gov ID
- NCT06980649
- Acronym / sponsor ID
- BHV1300-202
- Conditions
- Graves Disease
- Keywords
- Autoimmune thyroid disease, hyperthyroidism, anti thyroid drug, thyroid disease, autoimmune diseases, endocrine system diseases
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Aug 2025 (actual)
- Primary completion
- Sep 2027 (estimated)
- Study completion
- Sep 2027 (estimated)
- First posted
- 20 May 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| BHV-1300 | Experimental | Drug: BHV-1300 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 1. Participants must have serologically confirmed Graves' Disease.
Key exclusion criteria (2 listed)
- 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.
- History of treatment with radioactive iodine or thyroid surgery.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| BHV-1300BHV-1300 is delivered subcutaneously (SC) | Drug | BHV-1300 |
Primary outcome
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
Time frame: Baseline to Week 52
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks).
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities
Time frame: Baseline to Week 52
To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Jul 2026.
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Graves' Disease
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
18 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing BHV-1300 in people with Graves Disease, run by Biohaven Therapeutics Ltd. at 18 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 31 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 18 sites in United States, Australia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Chief Medical Officer (203-404-0410, clinicaltrials@biohavenpharma.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths (time frame: Baseline to Week 52). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Jul 2026.