Graves DiseasePhase 3NCT07661056
Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease
A Phase 3 study testing BHV-1300 in people with Graves Disease, run by Biohaven Therapeutics Ltd. at 56 sites in 3 countries.
Trial summary
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid 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?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 56 sitesin 3 countries
- Study dates
- 26 Jun 2026to Feb 2028
- Phase
- Phase 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
- Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- Participants must have active hyperthyroidism due to Graves' disease
Who cannot join
- 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 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
56 sites in 3 countries. Contact the study team or a site near you to ask about taking part.
56 sites in 3 countries
United States53 sites, 53 recruiting
- Recruiting
Site-081
Amarillo, Texas, 79124
- Recruiting
Site-038
Asheville, North Carolina, 28803
- Recruiting
Site-029
Atlanta, Georgia, 30303
- Recruiting
Site-070
Baton Rouge, Louisiana, 70808
- Recruiting
Site-032
Burbank, California, 91501
- Recruiting
Site-008
Canton, Ohio, 44718
- Recruiting
Site-031
Champaign, Illinois, 61822
- Recruiting
Site-016
Chattanooga, Tennessee, 37411
- Recruiting
Site-055
Dallas, Texas, 75231
- Recruiting
Site-020
Dallas, Texas, 75246
- Recruiting
Site-043
Denton, Texas, 76210
- Recruiting
Site-052
Doral, Florida, 33172
- Recruiting
Site-042
El Paso, Texas, 79935
- Recruiting
Site-046
Farmington Hills, Michigan, 48334
- Recruiting
Site-053
Fayetteville, Georgia, 30214
- Recruiting
Site-066
Fort Myers, Florida, 33919
- Recruiting
Site-011
Greenville, North Carolina, 27834
- Recruiting
Site-019
Hialeah, Florida, 33016
- Recruiting
Site-027
Hollywood, Florida, 33024
- Recruiting
Site-034
Houston, Texas, 77040
- Recruiting
Site-071
Houston, Texas, 77058
- Recruiting
Site-062
Huntington Beach, California, 92647
- Recruiting
Site-004
Kansas City, Missouri, 64108
- Recruiting
Site-072
Las Vegas, Nevada, 89148
- Recruiting
Site-013
Layton, Utah, 84041
- Recruiting
Site-025
Lenexa, Kansas, 66234
- Recruiting
Site-054
McKinney, Texas, 75069
- Recruiting
Site-017
Memphis, Tennessee, 38119
- Recruiting
Site-061
Miami, Florida, 33010
- Recruiting
Site-073
Midlothian, Virginia, 23112
- Recruiting
Site-063
Morehead City, North Carolina, 28557
- Recruiting
Site-064
Morehead City, North Carolina, 28557
- Recruiting
Site-037
Norman, Oklahoma, 73072
- Recruiting
Site-010
North Charleston, South Carolina, 29406
- Recruiting
Site-048
Oakland, California, 94611
- Recruiting
Site-077
Orchard Park, New York, 14224
- Recruiting
Site-059
Palm Beach Gardens, Florida, 33410
- Recruiting
Site - 012
Philadelphia, Pennsylvania, 19107
- Recruiting
Site-039
Raleigh, North Carolina, 27612
- Recruiting
Site-057
San Antonio, Texas, 78251
- Recruiting
Site-006
San Diego, California, 92108
- Recruiting
Site-076
Seattle, Washington, 98104
- Recruiting
Site-036
Shavano Park, Texas, 78231
- Recruiting
Site-078
South Gate, California, 90280
- Recruiting
Site-080
Springfield, Illinois, 62702
- Recruiting
Site-015
St Louis, Missouri, 63110
- Recruiting
Site-033
Statesville, North Carolina, 28625
- Recruiting
Site-074
Tampa, Florida, 33634
- Recruiting
Site-044
Tucson, Arizona, 85741
- Recruiting
Site-067
Walnut Creek, California, 94598
- Recruiting
Site-035
Washington D.C., District of Columbia, 20010
- Recruiting
Site-009
Weslaco, Texas, 78596
- Recruiting
Site-045
Wilmington, North Carolina, 28405
Puerto Rico2 sites, 2 recruiting
- Recruiting
Site-060
San Juan, 00909
- Recruiting
Site-058
San Juan, 00926
About this study
Official title: A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid
- Conditions
- Graves Disease
- Being tested
- BHV-1300, Placebo
- 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
PlaceboDrug
delivered subcutaneously via autoinjector
| Study group | Role | What they receive |
|---|---|---|
| BHV-1300 | Experimental | BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. Receives: Drug: BHV-1300 |
| Placebo | Placebo comparator | Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
Measured: Week 26
Secondary outcomes (12)
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.
Measured: Week 26
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6
Measured: Baseline to Week 6
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26
Measured: Baseline to Week 26
Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26
Measured: Week 26
Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo
Measured: Up to 26 weeks
Time to euthyroidism (defined as Total T3, FT4, and TSH within normal limits) and off ATD of participants on BHV-1300 vs placebo
Measured: Up to 26 weeks
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6
Measured: Baseline to Week 6
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26
Measured: Baseline to Week 26
Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26
Measured: Week 26
Number of participants who are euthyroid (defined as Total T3, FT4, and TSH within normal limits), off ATD and TRAb seronegative at Week 26
Measured: Week 26
Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths
Measured: Up to 26 weeks
Number of unique participants with Grade 3 to 4 lab abnormalities
Measured: Up to 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2026
- Study start26 Jun 2026
- Primary completionJan 2028 (estimated)
- Study completionFeb 2028 (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.
- 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 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
- NCT07661056
- Sponsor's protocol ID
- BHV1300-302
- Other IDs
- 2026-526455-53-00
- Status last verified
- Oct 2026
- First submitted
- 16 Jun 2026
- Last updated
- 19 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 19 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
- ClinicalTrials.gov ID
- NCT07661056
- Acronym / sponsor ID
- BHV1300-302
- Conditions
- Graves Disease
- Keywords
- Hyperthyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Biohaven Therapeutics Ltd.Industry (pharma, biotech, devices)
- Study start
- 26 Jun 2026 (actual)
- Primary completion
- Jan 2028 (estimated)
- Study completion
- Feb 2028 (estimated)
- First posted
- 22 Jun 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.
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| BHV-1300 | Experimental | Drug: BHV-1300BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. |
| Placebo | Placebo comparator | Drug: PlaceboMatching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- Participants must have active hyperthyroidism due to Graves' disease
Key exclusion criteria (7 listed)
- 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 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
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 |
| Placebodelivered subcutaneously via autoinjector | Drug | Placebo |
Primary outcome
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
Time frame: Week 26
12 secondary outcomes
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.
Time frame: Week 26
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6
Time frame: Baseline to Week 6
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26
Time frame: Baseline to Week 26
Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26
Time frame: Week 26
Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo
Time frame: Up to 26 weeks
Time to euthyroidism (defined as Total T3, FT4, and TSH within normal limits) and off ATD of participants on BHV-1300 vs placebo
Time frame: Up to 26 weeks
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6
Time frame: Baseline to Week 6
Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26
Time frame: Baseline to Week 26
Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26
Time frame: Week 26
Number of participants who are euthyroid (defined as Total T3, FT4, and TSH within normal limits), off ATD and TRAb seronegative at Week 26
Time frame: Week 26
Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths
Time frame: Up to 26 weeks
Number of unique participants with Grade 3 to 4 lab abnormalities
Time frame: Up to 26 weeks
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 19 Oct 2026.
Related trials for Graves Disease
RecruitingPhase 1
Evaluation of ETHY-001 for Safety, Tolerability, and Clinical Activity in Thyroid Eye Disease
Thyroid Eye Disease (TED), Graves' Disease
Active, not recruitingPhase 2
Impact of Vitamin D Therapy on Thyroid Function and Antibody Levels in Pediatric Graves' Disease
Graves Disease, Graves' Disease
RecruitingPhase 2
A Study to Learn About The Effects of Felzartamab on Thyroid Function and Its Safety in Adults With Graves' Disease Ages 18 to 75 Years Old
Graves' Disease
Not yet recruitingPhase 2
Prophylactic Treatment of Graves Ophthalmopathy (GO) in Newly Diagnosed Graves' Disease (GD) With Atorvastatin (ATORGO)
Graves Disease, Graves Disease (Basedow's Disease)
RecruitingPhase 3
Study to Assess Linsitinib in Participants With Moderate to Severe Active Thyroid Eye Disease (TED)
Thyroid Eye Disease, TED, Graves Orbitopathy
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.
56 sites in 3 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing BHV-1300 in people with Graves Disease, run by Biohaven Therapeutics Ltd. at 56 sites in 3 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 2 inclusion and 7 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 19 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 56 sites in United States, Puerto Rico, Canada. 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. Some participants in this study may receive a placebo. 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 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?
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26. (time frame: Week 26). 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 19 Oct 2026.