Recruiting
Phase 1

BHV-1300

Sponsor:

Biohaven Therapeutics Ltd.

Code:

NCT06980649

Conditions

Graves Disease

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

Interventions

BHV-1300

Study Details

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.

Conditions

Graves Disease

Study ID

NCT06980649

Start date

Aug 21, 2025

Status verified date

Jul, 2026

Completion date

Sep, 2027

Anticipated

Primary completion date

Sep, 2027

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Not accepted

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.

Study Design

Enrollment

15 participants

Anticipated

Intervention Model

Single group

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: BHV-1300

Interventions

BHV-1300

BHV-1300 is delivered subcutaneously (SC)

Primary outcome measure

  • Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths [ Time Frame: Baseline to Week 52 ]
  • Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities [ Time Frame: Baseline to Week 52 ]

Central Contacts and Locations

Central contacts

Chief Medical Officer

203-404-0410clinicaltrials@biohavenpharma.com

Locations

Site-103

Recruiting

South Gate, California, United States, 90280

Site-100

Recruiting

Miami, Florida, United States, 33126

Site-104

Recruiting

Columbus, Georgia, United States, 31904

Site-108

Recruiting

Greenville, North Carolina, United States, 27834

Site-110

Recruiting

Canton, Ohio, United States, 44718

Site-107

Recruiting

Memphis, Tennessee, United States, 38119

Site-109

Recruiting

Dallas, Texas, United States, 75246

Site-106

Recruiting

Houston, Texas, United States, 77054

Site-101

Recruiting

Houston, Texas, United States, 77095

Site-105

Recruiting

Shavano Park, Texas, United States, 78231

More Information

Sponsor

Biohaven Therapeutics Ltd.

Last update posted

Jul 31, 2026

Last verified

Jul, 2026

Keywords

  • Autoimmune thyroid disease
  • hyperthyroidism
  • anti thyroid drug
  • thyroid disease
  • autoimmune diseases
  • endocrine system diseases

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by Biohaven Therapeutics Ltd. on 2026-07-31.