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 and effective treatment in participants with Graves' Disease.

Detailed Description

Not available

Study Timeline

• Status Verified: 2025-05
• Study Start: 2025-05
• Study First Submitted: 2025-05-12
• Study First Submitted QC: 2025-05-12
• Study First Posted: 2025-05-20
• Last Update Submitted: 2025-05-23
• Last Update Posted: 2025-05-28
• Primary Completion: 2025-11
• Study Completion: 2026-03

Recruitment & Eligibility

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

Inclusion Criteria

1. Participants must have serologically confirmed Graves' Disease.
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) 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
Proportion of participants with normalization of T3 and T4	Baseline to Week 12

Secondary 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 (1)

Site-001; 🇦🇺 Kotara, Australia