Health TrialsbyHealthPanel

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

ConditionGraves Disease
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexAll
Age18-70
SponsorBiohaven Therapeutics Ltd.

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Participants must have serologically confirmed Graves' disease as documented by presence of elevated autoantibodies

Participants must have active hyperthyroidism due to Graves' disease

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • BHV-1300

    Drug

    delivered subcutaneously via autoinjector

  • Placebo

    Drug

    delivered subcutaneously via autoinjector

Treatment groups

300 Participants
are divided into 2 treatment groups
Group A: BHV-1300Experimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 6

Time frame
Baseline to Week 6
3

Change from baseline in TRAb (TBII) of participants on BHV-1300 vs placebo at Week 26

Time frame
Baseline to Week 26
4

Exposure-adjusted Cumulative ATD dose, of participants on BHV-1300 vs placebo at Week 26

Time frame
Week 26

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Biohaven Therapeutics Ltd.

Lead sponsor

Source ClinicalTrials.gov
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