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Taking people in Puerto RicoPhase 3

BHV-1300 compared with placebo for adults with overactive thyroid from Graves' disease

Tests BHV-1300 in adults with Graves' disease who have an overactive thyroid.

Key facts

Who runs it
Biohaven Therapeutics Ltd.
Where
San Juan, Puerto RicoSee the 2 sitesAlso in 2 other countries, 61 sites
Registry title
Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease
Status
Recruiting
Phase
Phase 3
People taking part
300 people, planned
Started
26 Jun 2026
Expected to end
Feb 2028
Type of study
Interventional, 2 groupsOne group gets a placebo (a dummy treatment), for comparison.
Treatments tested
  • BHV-1300
  • Placebo
Record updated
12 November 2026

Who can take part

AI summary

From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.

The trial is looking for adults with Graves' disease who currently have an overactive thyroid (hyperthyroidism).

Age
18 Years to 70 Years
Sex
All sexes can join.
Disease stage
Active hyperthyroidism caused by Graves' disease.
Earlier treatment
People who had radioactive iodine or thyroid surgery cannot join. People who took levothyroxine, desiccated thyroid extract or T3 within six weeks of the Baseline/Day 1 Visit cannot join.
Biomarker or test result
Graves' disease confirmed by a blood test showing raised autoantibodies.

Main reasons for not taking part

  • Overactive thyroid from another cause, such as toxic adenoma or toxic multinodular goiter
  • Thyroid storm (a severe, life-threatening thyroid flare) within 6 weeks of Screening
  • Another autoimmune disease that needs treatment
  • Moderate to severe thyroid eye disease (TED), or planned surgery, radiation or medical treatment for TED
  • Expected need for urgent thyroid surgery or ablation within six weeks of Baseline/Day 1 or during the study

The registry criteria, word for word

Show all 9 criteriaShow less

Who can take part

  • 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 take part

  • 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
  • Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study
  • History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
  • 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

Check if you might fit

Answer for yourself. This is not a decision: only the study team can say whether you can take part.

  • Are you between 18 and 70 years old?

Where in Puerto Rico

Also in 2 other countries, 61 sites

  • San JuanHospital not named in the registryContact: Chief Medical OfficerTaking people
  • San JuanHospital not named in the registryContact: Chief Medical OfficerTaking people

About the trial

What the trial wants to find out

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

The 2 groups in the trial

  • BHV-1300Treatment being tested

    BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.

  • PlaceboPlacebo, for comparison

    Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.

Questions to ask the study team

  1. How often do I need to come in, and for how long each time?
  2. Are travel costs paid?
  3. Can I keep my own doctor?
  4. What happens if I want to stop?

Contact the study team: see the registry record → Contacts and Locations

Print a page for my doctor

Data and sources

Registry record
Listed on ClinicalTrials.gov and on the EU's official list of trials (CTIS).
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
Plain-language title
BHV-1300 compared with placebo for adults with overactive thyroid from Graves' diseaseGenerated from the registry record. The registry title is the official one.
AI summary
From the trial's eligibility criteria. Read by machine on 14 November 2026.
Fit questions
Built from NCT07661056, who can take part
Record updated
12 November 2026