Graves' DiseasePhase 2/3NCT07901244
An Open-Label Study to Determine if BHV-1300 is Safe in Adults With Graves' Disease
A Phase 2/3 study testing BHV-1300 in people with Graves' Disease, run by Biohaven Therapeutics Ltd..
Trial summary
To study the long-term safety and tolerability of BHV-1300 Read more about this study
- Who is it for?
- Ages 18 to 70 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
- 356 participants
- Where
- No sites listed yet
- Study dates
- Oct 2026to Jan 2029
- Phase
- Phase 2/3
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Rollover participants have completed either parent study BHV1300-202 or BHV1300-302.
- De novo Participants must have:
- Serologically confirmed Graves' disease as documented by presence of elevated antibodies
- Active hyperthyroidism due to Graves' disease
Who cannot join
- Rollover participants must not have met early termination criteria in the parent study
- De novo participants Key Exclusion:
- History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
- 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 hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: A Phase 2b/3, Open-label, Multicenter, Study to Evaluate the Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
To study the long-term safety and tolerability of BHV-1300
Read the detailed description
This study evaluates the long-term safety and tolerability of BHV 1300 in participants with Graves' disease.
- Conditions
- Graves' Disease
- Being tested
- BHV-1300
- Keywords
- Hyperthyroidism
- Medical subject headings
- Graves Disease, Hyperthyroidism
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BHV-1300Drug
delivered subcutaneously via autoinjector
| Study group | Role | What they receive |
|---|---|---|
| BHV-1300 | Experimental | BHV-1300 is delivered subcutaneously via autoinjector Receives: Drug: BHV-1300 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of SAEs, severe AEs, AEs leading to discontinuation, or deaths
Measured: Baseline to Week 52
Frequency of clinically significant laboratory abnormalities
This objective will be measured by assessing the number of unique participants with grade 3 to 4 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 posted28 Oct 2026
- Study startOct 2026 (estimated)
- Primary completionDec 2028 (estimated)
- Study completionJan 2029 (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 2/3
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 356 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
- NCT07901244
- Sponsor's protocol ID
- BHV1300-203
- Status last verified
- Oct 2026
- First submitted
- 22 Oct 2026
- Last updated
- 28 Oct 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 28 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b/3, Open-label, Multicenter, Study to Evaluate the Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
- ClinicalTrials.gov ID
- NCT07901244
- Acronym / sponsor ID
- BHV1300-203
- Conditions
- Graves' Disease
- Keywords
- Hyperthyroidism
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 356 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- Oct 2026 (estimated)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Jan 2029 (estimated)
- First posted
- 28 Oct 2026 (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.
To study the long-term safety and tolerability of BHV-1300
Detailed description
This study evaluates the long-term safety and tolerability of BHV 1300 in participants with Graves' disease.
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-1300BHV-1300 is delivered subcutaneously via autoinjector |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Rollover participants have completed either parent study BHV1300-202 or BHV1300-302.
- De novo Participants must have:
Key exclusion criteria (8 listed)
- Rollover participants must not have met early termination criteria in the parent study
- De novo participants Key Exclusion:
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-1300delivered subcutaneously via autoinjector | Drug | BHV-1300 |
Primary outcome
Frequency of SAEs, severe AEs, AEs leading to discontinuation, or deaths
Time frame: Baseline to Week 52
Frequency of clinically significant laboratory abnormalities
Time frame: Baseline to Week 52
This objective will be measured by assessing the number of unique participants with grade 3 to 4 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 28 Oct 2026.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing BHV-1300 in people with Graves' Disease, run by Biohaven Therapeutics Ltd..
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 4 inclusion and 8 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: opening soon, as of the sponsor's last update on 28 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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 combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Frequency of SAEs, severe AEs, AEs leading to discontinuation, or 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 28 Oct 2026; AzTrials last refreshed its copy on 1 Nov 2026.