NCT07661056RecruitingPhase 3
A Phase 3, Double-blind, Multicenter, Randomized, Placebo-Controlled Study to Evaluate the Efficacy, Safety and Tolerability of BHV-1300 in the Treatment of Adults With Graves' Disease
Biohaven Therapeutics Ltd.50 sites in 2 countries300 target enrollmentStarted: June 26, 2026Last updated:
Conditions
Interventions
Drugs
Trial Snapshot
- Phase
- Phase 3
- Status
- Recruiting
- Sponsor
- Biohaven Therapeutics Ltd.
- Enrollment
- 300
- Locations
- 50
- Primary Endpoint
- Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
Study Overview
Brief Summary
The purpose of this study is to evaluate the efficacy and safety of BHV-1300 in adult participants with Graves' disease who are actively hyperthyroid
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Eligibility Criteria
- Ages
- 18 Years to 70 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
Inclusion Criteria
- •Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
- •Participants must have active hyperthyroidism due to Graves' disease
Exclusion Criteria
- •History of hyperthyroidism not caused by Graves' Disease (e.g., toxic adenoma or toxic multinodular goiter)
- •History of treatment with radioactive iodine or thyroid surgery.
- •Have received levothyroxine, desiccated thyroid extract, or T3 at any dose within six weeks of the Baseline/Day 1 Visit.
- •Thyroid storm, i.e. severe thyrotoxicosis with evidence of systemic decompensation (e.g., Burch-Wartkofsky Point Scale of ≥ 45 or Japanese Thyroid Association category 1 or 2, with accompanying manifestations including hyperpyrexia, tachycardia, arrhythmias, congestive heart failure, agitation, delirium, psychosis, stupor, and coma, as well as nausea, vomiting, diarrhea, or hepatic failure) within 6 weeks of Screening.
- •Have autoimmune disease other than Graves' disease requiring treatment
- •Have moderate to severe thyroid eye disease (TED) or are expected to require immediate surgical intervention and/or are planning corrective surgery/irradiation or medical therapy for TED during study participation.
- •Are expected to require urgent or emergent thyroid surgery or ablation within six weeks of Baseline/Day 1 or throughout the study.
Arms & Interventions
BHV-1300
Experimental
BHV-1300 is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Intervention: BHV-1300 (Drug)
Placebo
Placebo Comparator
Matching placebo is delivered subcutaneously via autoinjector. Participants will be randomized in a 2:1 ratio to receive either BHV-1300 or placebo.
Intervention: Placebo (Drug)
Outcomes
Primary Outcomes
Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid function (total T3, free T4 (FT4), & TSH within normal limits) at Week 26.
Time Frame: Week 26
Secondary Outcomes
- Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6(Baseline to Week 6)
- Number of participants on BHV-1300 vs placebo who are not on an antithyroid drug and with normal thyroid hormone (Total T3 and FT4) at Week 26.(Week 26)
- Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6(Baseline to Week 6)
- Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26(Baseline to Week 26)
- Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26(Week 26)
- Time to normal thyroid hormones (defined as Total T3 & FT4 within normal limits) and off ATD of participants on BHV-1300 vs placebo(Up to 26 weeks)
- Time to euthyroidism (defined as Total T3, FT4, and TSH within normal limits) and off ATD of participants on BHV-1300 vs placebo(Up to 26 weeks)
- Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26(Baseline to Week 26)
- Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26(Week 26)
- Number of participants who are euthyroid (defined as Total T3, FT4, and TSH within normal limits), off ATD and TRAb seronegative at Week 26(Week 26)
- Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths(Up to 26 weeks)
- Number of unique participants with Grade 3 or 4 lab abnormalities(Up to 26 weeks)
- Number of unique participants with Grade 3 to 4 lab abnormalities(Up to 26 weeks)
Investigators
Study Sites (50)
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