Study of BHV-1300 in Graves' Disease
ConditionGraves Disease
Trial statusRecruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBiohaven Therapeutics Ltd.
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
None
Disqualifiers
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.
Trial design
Design model
Single group
Treatments tested in this trial
BHV-1300
DrugBHV-1300 is delivered subcutaneously (SC)
Treatment groups
15 Participants
are divided into 1 treatment groupGroup A: BHV-1300Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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 522
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 52Sponsors and contacts
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Source ClinicalTrials.gov