Study of BHV-1300 in Graves' Disease

Phase 1RecruitingNCT06980649

Biohaven Therapeutics Ltd.15 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Graves Disease

Interventions

BHV-1300DRUG

BHV-1300 is delivered subcutaneously (SC)

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

Locations (18)

Site-103

South Gate, California, United States

RECRUITING

Site-100

Miami, Florida, United States

Outcomes

Primary Outcomes

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

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).

Time frame: Baseline to Week 52

Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities

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.

Time frame: Baseline to Week 52

Central Contacts

Chief Medical Officer

CONTACT

203-404-0410 clinicaltrials@biohavenpharma.com

Data from ClinicalTrials.gov

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