NCT07661056 Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease
| NCT ID | NCT07661056 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | Biohaven Therapeutics Ltd. |
| Condition | Graves Disease |
| Study Type | INTERVENTIONAL |
| Enrollment | 300 participants |
| Start Date | 2026-06-26 |
| Primary Completion | 2028-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 300 participants in total. It began in 2026-06-26 with a primary completion date of 2028-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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
Eligibility Criteria
Key Inclusion Criteria: 1. Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies 2. Participants must have active hyperthyroidism due to Graves' disease Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) 2. History of treatment with radioactive iodine or thyroid surgery. 3. Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit. 4. 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. 5. Have autoimmune disease other than Graves' disease requiring treatment 6. Have moderate to severe thyroid eye disease (TED) and are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation. 7. Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT07661056 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, up to 70 Years, studying Graves Disease. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT07661056 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 300 participants.
Is NCT07661056 currently recruiting?
Yes, NCT07661056 is actively recruiting participants. Contact the research team at clinicaltrials@biohavenpharma.com for enrollment information.
Where is the NCT07661056 trial being conducted?
This trial is being conducted at Burbank, United States, Walnut Creek, United States, Hialeah, United States, Lenexa, United States and 4 additional locations.
Who is sponsoring the NCT07661056 clinical trial?
NCT07661056 is sponsored by Biohaven Therapeutics Ltd.. The trial plans to enroll 300 participants.