Study of BHV-1300 in Graves' Disease

NCT ID: NCT06980649

Last Updated: 2025-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

RECRUITING

Clinical Phase

PHASE1

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-08-21

Study Completion Date

2026-03-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Graves Disease

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

BHV-1300

Group Type EXPERIMENTAL

BHV-1300

Intervention Type DRUG

BHV-1300 is delivered subcutaneously (SC)

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

BHV-1300

BHV-1300 is delivered subcutaneously (SC)

Intervention Type DRUG

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

Inclusion Criteria

1\. Participants must have serologically confirmed Graves' Disease.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Biohaven Therapeutics Ltd.

INDUSTRY

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Site-103

South Gate, California, United States

Site Status RECRUITING

Site-100

Miami, Florida, United States

Site Status RECRUITING

Site-104

Columbus, Georgia, United States

Site Status RECRUITING

Site-106

Houston, Texas, United States

Site Status RECRUITING

Site-101

Houston, Texas, United States

Site Status RECRUITING

Site-105

Shavano Park, Texas, United States

Site Status RECRUITING

Site-004

Fitzroy, , Australia

Site Status RECRUITING

Site-001

Kotara, , Australia

Site Status RECRUITING

Site-003

Melbourne, , Australia

Site Status RECRUITING

Site-008

Parkville, , Australia

Site Status RECRUITING

Site-006

St Leonards, , Australia

Site Status RECRUITING

Site-002

Torquay, , Australia

Site Status RECRUITING

Countries

Review the countries where the study has at least one active or historical site.

United States Australia

Central Contacts

Reach out to these primary contacts for questions about participation or study logistics.

Chief Medical Officer

Role: CONTACT

203-404-0410

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

BHV1300-202

Identifier Type: -

Identifier Source: org_study_id

More Related Trials

Additional clinical trials that may be relevant based on similarity analysis.

In Vivo CAR-T for Refractory Graves' Disease
NCT07333677 RECRUITING EARLY_PHASE1
A Study of GensSci098 in Subjects With Graves' Disease
NCT07286656 NOT_YET_RECRUITING PHASE1
Early Levothyroxine Post Radioactive Iodine
NCT01950260 COMPLETED PHASE2/PHASE3