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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT06980649




Registration number
Help: Registration number
NCT06980649
Ethics application status
Help: Ethics application status
Date submitted
Help: Date submitted
12/05/2025
Date registered
Help: Date registered
20/05/2025
Date last updated
Help: Date last updated
31/07/2026

Titles & IDs
Public title
Study of BHV-1300 in Graves' Disease
Scientific title
An Open-Label Biomarker Study of BHV-1300 in Graves' Disease
Additional trial identifiers [1] 0 0
BHV1300-202
Universal Trial Number (UTN)
Trial acronym
Related trial records

Health condition
Health condition(s) studied:
Graves Disease 0 0
Condition category
Condition code
Metabolic and Endocrine 0 0 0 0
Thyroid disease
Inflammatory and Immune System 0 0 0 0
Autoimmune diseases
Metabolic and Endocrine 0 0 0 0
Other endocrine disorders

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
Treatment: Drugs - BHV-1300

Experimental: BHV-1300 -


Treatment: Drugs: BHV-1300
BHV-1300 is delivered subcutaneously (SC)
Intervention code [1] 0 0
Treatment: Drugs
Description of the comparator or control
Control group

Outcomes
Primary outcome [1] 0 0
Number of participants with Serious AEs (SAEs), AEs leading to discontinuation, deaths
Timepoint [1] 0 0
Baseline to Week 52
Primary outcome [2] 0 0
Number of participants with Grade 3-4 (CTCAE/DAIDS) treatment-emergent laboratory abnormalities
Timepoint [2] 0 0
Baseline to Week 52

Eligibility
Key inclusion criteria
Key

1. Participants must have serologically confirmed Graves' Disease.

Key
Minimum age
18 Years
Maximum age
65 Years
Sex
Both males and females
Healthy volunteers
No
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
Purpose of the study
Treatment
Allocation to intervention
Not applicable
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Phase 1
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Recruiting
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
21/08/2025
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
1/09/2027
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
Recruitment hospital [1] 0 0
Site-004 - Fitzroy
Recruitment hospital [2] 0 0
Site-011 - Herston
Recruitment hospital [3] 0 0
Site-001 - Kotara
Recruitment hospital [4] 0 0
Site-003 - Melbourne
Recruitment hospital [5] 0 0
Site-010 - Oaklands Park
Recruitment hospital [6] 0 0
Site-008 - Parkville
Recruitment hospital [7] 0 0
Site-006 - St Leonards
Recruitment hospital [8] 0 0
Site-002 - Torquay
Recruitment postcode(s) [1] 0 0
3065 - Fitzroy
Recruitment postcode(s) [2] 0 0
4029 - Herston
Recruitment postcode(s) [3] 0 0
2289 - Kotara
Recruitment postcode(s) [4] 0 0
3128 - Melbourne
Recruitment postcode(s) [5] 0 0
5046 - Oaklands Park
Recruitment postcode(s) [6] 0 0
3050 - Parkville
Recruitment postcode(s) [7] 0 0
2065 - St Leonards
Recruitment postcode(s) [8] 0 0
3228 - Torquay
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
California
Country [2] 0 0
United States of America
State/province [2] 0 0
Florida
Country [3] 0 0
United States of America
State/province [3] 0 0
Georgia
Country [4] 0 0
United States of America
State/province [4] 0 0
North Carolina
Country [5] 0 0
United States of America
State/province [5] 0 0
Ohio
Country [6] 0 0
United States of America
State/province [6] 0 0
Tennessee
Country [7] 0 0
United States of America
State/province [7] 0 0
Texas

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Biohaven Therapeutics Ltd.
Address
Country

Ethics approval
Ethics application status

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 0 0
Address 0 0
Country 0 0
Phone 0 0
Fax 0 0
Email 0 0
Contact person for public queries
Name 0 0
Chief Medical Officer
Address 0 0
Country 0 0
Phone 0 0
203-404-0410
Fax 0 0
Email 0 0
[email protected]
Contact person for scientific queries

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided


Results publications and other study-related documents

No documents have been uploaded by study researchers.

Results not provided in https://clinicaltrials.gov/study/NCT06980649