Study of BHV-1300 in Graves' Disease

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.

Recruiting

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Key information

Conditions

Graves Disease Autoimmune Diseases Endocrine System Diseases Exophthalmos Eye Diseases Goiter Hyperthyroidism Immune System Diseases Orbital Diseases Thyroid Diseases

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Site-004, Fitzroy, Australia

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Key Inclusion Criteria:

Participants must have serologically confirmed Graves' Disease.

Key Exclusion Criteria:

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.
History of treatment with radioactive iodine or thyroid surgery.

Treatment and study plan

BHV-1300

Drug

BHV-1300 is delivered subcutaneously (SC)

Primary outcomes

Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths

Time frame: 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

Time frame: 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Chief Medical Officer

CONTACT

[email protected]

203-404-0410

Sponsors and collaborators

Lead sponsor

Biohaven Therapeutics Ltd.

Industry

Registry information

Official study title

An Open-Label Biomarker Study of BHV-1300 in Graves' Disease

Important dates

Study start: 2025
Primary completion: 2027
Study completion: 2027
First posted: May 20, 2025
Registry last updated: May 22, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed