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Recruiting NCT07661056

Study to Determine if BHV-1300 is Effective and Safe in Adults With Graves' Disease

Phase III Interventional Graves Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: BHV-1300, Placebo.
Who it may be relevant to
Registry conditions: Graves Disease. Basic parameters: 18 years — 70 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United States
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official title

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

Overview

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

Interventions

  • Drug BHV-1300
    delivered subcutaneously via autoinjector
  • Drug Placebo
    delivered subcutaneously via autoinjector

Primary outcome measures

  • 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 outcome measures (12)
  • 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. [Time frame: Week 26]
  • Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6 [Time frame: Baseline to Week 6]
  • Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26 [Time frame: Baseline to Week 26]
  • Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26 [Time frame: 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 [Time frame: 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 [Time frame: Up to 26 weeks]
  • Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 6 [Time frame: Baseline to Week 6]
  • Change from baseline in Total IgG of participants on BHV-1300 vs placebo at Week 26 [Time frame: Baseline to Week 26]
  • Number of participants who are TRAb seronegative (defined as TRAb < ULN) at Week 26 [Time frame: 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 [Time frame: Week 26]
  • Number of unique participants with SAEs, moderate and severe AEs, AEs leading to discontinuation or deaths [Time frame: Up to 26 weeks]
  • Number of unique participants with Grade 3 or 4 lab abnormalities [Time frame: Up to 26 weeks]

Eligibility criteria

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) and 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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

United States · 30 centers
  • Site-032 — Burbank
  • Site-062 — Huntington Beach
  • Site-006 — San Diego
  • Site-067 — Walnut Creek
  • Site-052 — Doral
  • Site-019 — Hialeah
  • Site-031 — Champaign
  • Site-025 — Lenexa
  • … and 22 more centers

Identifiers

NCT: NCT07661056 · BHV1300-302 · 2026-526455-53-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗