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

Официальное название

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

Обзор

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

Вмешательства

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

Первичные конечные точки

• 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. [Срок оценки: Week 26]

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

Критерии участия

Критерии включения

• Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies
• Participants must have active hyperthyroidism due to Graves' disease

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Четверное слепое

Основная цель

Лечение

Центры проведения

США · 30 центров

• 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
• … и ещё 22 центра

Идентификаторы

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

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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