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

September 30, 2026 updated by: Regeneron Pharmaceuticals

A Phase 1, Single-Ascending Dose Study of REGN24493, an Anti-TSHR Monoclonal Antibody, in Participants With Graves' Disease

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

45

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Key Inclusion Criteria:

  1. Has a diagnosis of Graves' Disease for at least 4 months prior to the screening visit
  2. Has thyroid-stimulating hormone receptor antibody (TRAb) level above the upper limit of normal at the screening visit
  3. Euthyroid at the screening visit and at least 4 weeks prior to the screening visit as defined in the protocol
  4. Body mass index (BMI) between 18.5 and 35.0 kg/m^2 (inclusive) at the screen visit

Key Exclusion Criteria:

  1. Has history of hyperthyroidism not caused by Graves' disease (eg, toxic thyroid adenoma, multinodular goiter, amiodarone-induced)
  2. Has active thyroid storm or is at current risk of thyroid storm, as assessed by the investigator at the screening visit
  3. Has clinically significant cardiac abnormalities attributable to uncontrolled Graves' disease (eg, arrhythmias precipitated by thyrotoxicosis, thyrotoxic cardiomyopathy)
  4. Has any infection requiring systemic therapy within the 4 weeks prior to the screening visit
  5. Was hospitalized (ie, >24 hours) for a reason within 30 days of the screening visit that presents any concern to the trial investigator
  6. Has used or is using Levothyroxine (LT4) therapy at any dose within 6 weeks of the screening visit
  7. Has history of Radioactive iodine (RAI) thyroid ablation or thyroidectomy

Note: Other protocol defined Inclusion/Exclusion criteria apply

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Sequential Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Dose Escalation
Drug: REGN24493

Administered per the protocol.
Placebo Comparator: Placebo Comparator
Drug: Placebo

Administered per the protocol.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Up to approximately 68 weeks
Up to approximately 68 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Concentrations of REGN24493 in serum
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Serum Thyroid-Stimulating Hormone (TSH) levels
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Serum free T4 (fT4) levels
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Serum free T3 (fT3) levels
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Serum total T3 (TT3) levels
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Occurrence of anti-drug antibody (ADA) to REGN24493 in serum
Time Frame: Day 1 through Week 68
Day 1 through Week 68
Magnitude of anti-drug antibody (ADA) to REGN24493 in serum
Time Frame: Day 1 through Week 68
Day 1 through Week 68

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Regeneron Pharmaceuticals

Investigators

  • Study Director: Clinical Trial Management, Regeneron Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

November 2, 2026

Primary Completion (Estimated)

January 28, 2030

Study Completion (Estimated)

January 28, 2030

Study Registration Dates

First Submitted

September 30, 2026

First Submitted That Met QC Criteria

September 30, 2026

First Posted (Actual)

October 6, 2026

Study Record Updates

Last Update Posted (Actual)

October 6, 2026

Last Update Submitted That Met QC Criteria

September 30, 2026

Last Verified

September 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • R24493-GRD-25112
  • 2026-525624-15-00 (Ctis)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing

IPD Sharing Time Frame

When Regeneron has:

  • received marketing authorization from major health authorities (e.g., FDA, European Medicines Agency (EMA), Pharmaceuticals and Medical Devices Agency (PMDA), etc.) for the product and indication or has globally discontinued development of the product for all indications on or after April 2020 and has no plans for future development
  • made the study results publicly available (e.g., scientific publication, scientific conference, clinical trial registry)
  • the legal authority to share the data, and
  • ensured the ability to protect participant privacy

IPD Sharing Access Criteria

Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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