Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

September 15, 2026 updated by: Biohaven Therapeutics Ltd.

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

300

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Puerto Rico
      • San Juan, Puerto Rico, 00909
        • Recruiting
        • Site-060
  • United States
    • Arizona
      • Tucson, Arizona, United States, 85741
        • Recruiting
        • Site-044
    • California
      • Burbank, California, United States, 91501
        • Recruiting
        • Site-032
      • Huntington Beach, California, United States, 92647
        • Recruiting
        • Site-062
      • Oakland, California, United States, 94611
        • Recruiting
        • Site-048
      • San Diego, California, United States, 92108
        • Recruiting
        • Site-006
      • Walnut Creek, California, United States, 94598
        • Recruiting
        • Site-067
    • Florida
      • Doral, Florida, United States, 33172
        • Recruiting
        • Site-052
      • Fort Myers, Florida, United States, 33919
        • Recruiting
        • Site-066
      • Hialeah, Florida, United States, 33016
        • Recruiting
        • Site-019
      • Hollywood, Florida, United States, 33024
        • Recruiting
        • Site-027
      • Miami, Florida, United States, 33010
        • Recruiting
        • Site-061
      • Palm Beach Gardens, Florida, United States, 33410
        • Recruiting
        • Site-059
      • Tampa, Florida, United States, 33634
        • Recruiting
        • Site-074
    • Georgia
      • Atlanta, Georgia, United States, 30303
        • Recruiting
        • Site-029
      • Fayetteville, Georgia, United States, 30214
        • Recruiting
        • Site-053
    • Illinois
      • Champaign, Illinois, United States, 61822
        • Recruiting
        • Site-031
      • Springfield, Illinois, United States, 62702
        • Recruiting
        • Site-080
    • Kansas
      • Lenexa, Kansas, United States, 66234
        • Recruiting
        • Site-025
    • Louisiana
      • Baton Rouge, Louisiana, United States, 70808
        • Recruiting
        • Site-070
    • Michigan
      • Farmington Hills, Michigan, United States, 48334
        • Recruiting
        • Site-046
    • Missouri
      • Kansas City, Missouri, United States, 64108
        • Recruiting
        • Site-004
      • St Louis, Missouri, United States, 63110
        • Recruiting
        • Site-015
    • Nevada
      • Las Vegas, Nevada, United States, 89148
        • Recruiting
        • Site-072
    • North Carolina
      • Asheville, North Carolina, United States, 28803
        • Recruiting
        • Site-038
      • Greenville, North Carolina, United States, 27834
        • Recruiting
        • Site-011
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Site-064
      • Morehead City, North Carolina, United States, 28557
        • Recruiting
        • Site-063
      • Raleigh, North Carolina, United States, 27612
        • Recruiting
        • Site-039
      • Statesville, North Carolina, United States, 28625
        • Recruiting
        • Site-033
      • Wilmington, North Carolina, United States, 28405
        • Recruiting
        • Site-045
    • Ohio
      • Canton, Ohio, United States, 44718
        • Recruiting
        • Site-008
    • Oklahoma
      • Norman, Oklahoma, United States, 73072
        • Recruiting
        • Site-037
    • South Carolina
      • North Charleston, South Carolina, United States, 29406
        • Recruiting
        • Site-010
    • Tennessee
      • Chattanooga, Tennessee, United States, 37411
        • Recruiting
        • Site-016
      • Memphis, Tennessee, United States, 38119
        • Recruiting
        • Site-017
    • Texas
      • Amarillo, Texas, United States, 79124
        • Recruiting
        • Site-081
      • Dallas, Texas, United States, 75231
        • Recruiting
        • Site-055
      • Dallas, Texas, United States, 75246
        • Recruiting
        • Site-020
      • Denton, Texas, United States, 76210
        • Recruiting
        • Site-043
      • El Paso, Texas, United States, 79935
        • Recruiting
        • Site-042
      • Houston, Texas, United States, 77058
        • Recruiting
        • Site-071
      • Houston, Texas, United States, 77040
        • Recruiting
        • Site-034
      • McKinney, Texas, United States, 75069
        • Recruiting
        • Site-054
      • San Antonio, Texas, United States, 78251
        • Recruiting
        • Site-057
      • Shavano Park, Texas, United States, 78231
        • Recruiting
        • Site-036
      • Weslaco, Texas, United States, 78596
        • Recruiting
        • Site-009
    • Utah
      • Layton, Utah, United States, 84041
        • Recruiting
        • Site-013
    • Virginia
      • Midlothian, Virginia, United States, 23112
        • Recruiting
        • Site-073
    • Washington
      • Seattle, Washington, United States, 98104
        • Recruiting
        • Site-076

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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) or 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: BHV-1300
BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Drug: BHV-1300
delivered subcutaneously via autoinjector
Placebo Comparator: Placebo
Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Drug: Placebo
delivered subcutaneously via autoinjector

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
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
Week 26

Secondary Outcome Measures

Outcome Measure
Time Frame
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
Week 26
Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6
Time Frame: Baseline to Week 6
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
Baseline to Week 26
Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26
Time Frame: Week 26
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
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
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
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
Baseline to Week 26
Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26
Time Frame: Week 26
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
Week 26
Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths
Time Frame: Up to 26 weeks
Up to 26 weeks
Number of unique participants with Grade 3 to 4 lab abnormalities
Time Frame: Up to 26 weeks
Up to 26 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Biohaven Therapeutics Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 26, 2026

Primary Completion (Estimated)

January 1, 2028

Study Completion (Estimated)

February 1, 2028

Study Registration Dates

First Submitted

June 16, 2026

First Submitted That Met QC Criteria

June 16, 2026

First Posted (Actual)

June 22, 2026

Study Record Updates

Last Update Posted (Actual)

September 17, 2026

Last Update Submitted That Met QC Criteria

September 15, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BHV1300-302
  • 2026-526455-53-00 (Ctis)

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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