Study of BHV-1300 in Graves' Disease

Phase 1

Recruiting

• Conditions: Graves Disease
• Interventions: Drug: BHV-1300

• Registration Number: NCT06980649
• Lead Sponsor: Biohaven Therapeutics Ltd.

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-20
• Study Start: 2025-08-21
• Status Verified: 2025-09
• Last Update Submitted: 2025-09-23
• Last Update Posted: 2025-09-24
• Primary Completion: 2025-11
• Study Completion: 2026-03-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 15

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
BHV-1300	BHV-1300	-

Primary Outcome Measures

Name	Time	Method
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths	Baseline to Week 12	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 12 weeks).
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities	Baseline to Week 12	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 Locations

Locations (12)

Site-106; 🇺🇸 Houston, Texas, United States

Site-004; 🇦🇺 Fitzroy, Australia

Site-008; 🇦🇺 Parkville, Australia

Site-006; 🇦🇺 St Leonards, Australia

Site-002; 🇦🇺 Torquay, Australia

Site-103; 🇺🇸 South Gate, California, United States

Site-100; 🇺🇸 Miami, Florida, United States

Site-104; 🇺🇸 Columbus, Georgia, United States

Site-101; 🇺🇸 Houston, Texas, United States

Site-105; 🇺🇸 Shavano Park, Texas, United States

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