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

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: Graves Disease
• Intervention / Treatment: Drug: BHV-1300; Drug: Placebo

• Study Type: Interventional
• Enrollment (Estimated): 300
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Chief Medical Officer; Phone Number: 203-404-0410; Email: clinicaltrials@biohavenpharma.com

Study Locations

• United States
  • California
    • Burbank, California, United States, 91501
      • Recruiting
      • Site-032
    • San Diego, California, United States, 92108
      • Recruiting
      • Site-006
    • Walnut Creek, California, United States, 94598
      • Recruiting
      • Site-067
  • Florida
    • Hialeah, Florida, United States, 33016
      • Recruiting
      • Site-019
  • Kansas
    • Lenexa, Kansas, United States, 66234
      • Recruiting
      • Site-025
  • North Carolina
    • Morehead City, North Carolina, United States, 28557
      • Recruiting
      • Site-064
  • Ohio
    • Canton, Ohio, United States, 44718
      • Recruiting
      • Site-008
  • Texas
    • Dallas, Texas, United States, 75231
      • Recruiting
      • Site-055
    • Denton, Texas, United States, 76210
      • Recruiting
      • Site-043
    • Houston, Texas, United States, 77058
      • Recruiting
      • Site-071
    • McKinney, Texas, United States, 75069
      • Recruiting
      • Site-054
  • Utah
    • Layton, Utah, United States, 84041
      • Recruiting
      • Site-013

Participation Criteria

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) 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.

Study Plan

How is the study designed?

Design Details

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

Number of Arms

2

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

Collaborators and Investigators

• Sponsor: Biohaven Therapeutics Ltd.

Study record dates

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): July 10, 2026
• Last Update Submitted That Met QC Criteria: July 8, 2026
• Last Verified: July 1, 2026

More Information

Terms related to this study

• Keywords: Hyperthyroidism
• Additional Relevant MeSH Terms: Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Eye Diseases; Exophthalmos; Orbital Diseases; Goiter; Thyroid Diseases; Graves Disease; Hyperthyroidism
• 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