Thyroid-Stimulating Hormone Receptor (TSHR) Blockade With REGN24493 in Adult Participants With Graves' Disease (GD)

Trial statusNot yet recruiting
Trial phasePhase 1
Trial typeInterventional
Biological sexAll
Age18+
SponsorRegeneron Pharmaceuticals

About this trial

This study will test an experimental Regeneron drug called REGN24493 hereby referred to as "study drug" to see if it can help treat Graves' disease. Graves' disease is a condition where the immune system causes the thyroid gland to make too much thyroid hormone.

The main purpose of this study is to learn about the safety of REGN24493 and what side effects it might cause.

The study is looking at:

* What side effects REGN24493 might cause * How much REGN24493 is in the blood at different times * How REGN24493 affects thyroid hormone levels * If the body reacts to REGN24493 in a way that could affect participant's health * What is the best dose of REGN24493 for treating Graves' disease

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Has a diagnosis of Graves' Disease for at least 4 months prior to the screening visit

Has thyroid-stimulating hormone receptor antibody (TRAb) level above the upper limit of normal at the screening visit

Euthyroid at the screening visit and at least 4 weeks prior to the screening visit as defined in the protocol

Body mass index (BMI) between 18.5 and 35.0 kg/m² (inclusive) at the screen visit

Disqualifiers

Has history of hyperthyroidism not caused by Graves' disease (eg, toxic thyroid adenoma, multinodular goiter, amiodarone-induced)

Has active thyroid storm or is at current risk of thyroid storm, as assessed by the investigator at the screening visit

Has clinically significant cardiac abnormalities attributable to uncontrolled Graves' disease (eg, arrhythmias precipitated by thyrotoxicosis, thyrotoxic cardiomyopathy)

Has any infection requiring systemic therapy within the 4 weeks prior to the screening visit

Trial design

Design model

Sequential

Treatments tested in this trial

  • REGN24493

    Drug

    Administered per the protocol.

  • Placebo

    Drug

    Administered per the protocol.

Treatment groups

45 Participants
are divided into 2 treatment groups
Group A: Dose EscalationExperimental treatment 1 intervention
Group B: Placebo ComparatorPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

Occurrence of Treatment-Emergent Adverse Events (TEAEs)

Time frame
Up to approximately 68 weeks

Secondary outcomes

1

Concentrations of REGN24493 in serum

Time frame
Day 1 through Week 68
2

Serum Thyroid-Stimulating Hormone (TSH) levels

Time frame
Day 1 through Week 68
3

Serum free T4 (fT4) levels

Time frame
Day 1 through Week 68
4

Serum free T3 (fT3) levels

Time frame
Day 1 through Week 68

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

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This trial is not recruiting at the moment. You can still explore other options: