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Clinical Trials in the USA / NCT06980649
Recruiting Phase 1

Study of BHV-1300 in Graves' Disease

NCT06980649 · tracked via the Priya Life Science USA tracker
Sponsor
Biohaven Therapeutics Ltd
Phase
Phase 1
Started
2025-08-21
Last updated
2026-07-31

Condition(s) studied

Graves Disease

Investigational drug(s) / intervention(s)

BHV-1300 →

BHV-1300: BHV-1300 is delivered subcutaneously (SC)

Study summary

The purpose of this study is to determine if BHV-1300 is a safe treatment in participants with Graves' Disease and to explore its effect on disease-specific biomarkers.

Eligibility

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Key Inclusion Criteria: 1\. Participants must have serologically confirmed Graves' Disease. Key Exclusion Criteria: 1. History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter) and/or history of thyroid storm within six weeks of the Baseline visit. 2. History of treatment with radioactive iodine or thyroid surgery.

Primary outcome measure(s)

  • Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths — Baseline to Week 52
    To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with SAEs, AEs leading to discontinuation or deaths that are observed during the Open-label Treatment Phase (up to 52 weeks).
  • Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities — Baseline to Week 52
    To assess the safety and tolerability of BHV-1300. This objective will be measured by assessing the number of unique subjects with Grade 3 or 4 treatment-emergent laboratory abnormalities.

Trial sites (18)

FacilityCityRegionStatus
Site-103 South Gate California Recruiting
Site-100 Miami Florida Recruiting
Site-104 Columbus Georgia Recruiting
Site-108 Greenville North Carolina Recruiting
Site-110 Canton Ohio Recruiting
Site-107 Memphis Tennessee Recruiting
Site-109 Dallas Texas Recruiting
Site-106 Houston Texas Recruiting
Site-101 Houston Texas Recruiting
Site-105 Shavano Park Texas Recruiting
Site-004 Fitzroy Australia Recruiting
Site-011 Herston Australia Recruiting
Site-001 Kotara Australia Recruiting
Site-003 Melbourne Australia Recruiting
Site-010 Oaklands Park Australia Recruiting
Site-008 Parkville Australia Recruiting
Site-006 St Leonards Australia Recruiting
Site-002 Torquay Australia Recruiting

More Biohaven Therapeutics Ltd. trials in the USA

A Study to Determine if BHV-8000 is Effective, Safe and Tolerable as a Treatment for Adults Living With Early Parkinson's Disease Recruiting
A Study to Determine if BHV-7000 is Effective and Safe in Adults With Refractory Focal Onset Epilepsy Active, not recruiting
A Phase 1 Study of BHV-1530 in Advanced Solid Tumors Recruiting
Study of BHV-1400 in IgA Nephropathy Recruiting
A Phase 1b Study of BHV-7000 in Participants With Inherited Erythromelalgia Active, not recruiting

Other trials for the same condition

NEXUS Study: A Study to Test Single and Multiple Doses of MER511 Given to Adults With Graves' Disease Recruiting
A Study to Assess Efficacy and Safety of Efgartigimod PH20 SC PFS in Adult Participants With Graves' Disease Recruiting
Evaluating an AI Tool for Detecting Thyrotoxic States Recruiting
Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06980649 on ClinicalTrials.gov ↗ ← All trials in the USA