Graves' DiseasePhase 1EMERGENCT07861152
Thyroid-Stimulating Hormone Receptor (TSHR) Blockade With REGN24493 in Adult Participants With Graves' Disease (GD)
A Phase 1 study testing REGN24493 in people with Graves' Disease, run by Regeneron Pharmaceuticals.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Graves' Disease
- What is being tested?
- REGN24493
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 45 participants
- Where
- No sites listed yet
- Study dates
- 2 Nov 2026to 28 Jan 2030
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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/m^2 (inclusive) at the screen visit
Who cannot join
- 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
- Was hospitalized (ie, >24 hours) for a reason within 30 days of the screening visit that presents any concern to the trial investigator
- Has used or is using Levothyroxine (LT4) therapy at any dose within 6 weeks of the screening visit
- Has history of Radioactive iodine (RAI) thyroid ablation or thyroidectomy
- Note: Other protocol defined Inclusion/Exclusion criteria apply
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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
- Conditions
- Graves' Disease
- Being tested
- REGN24493, Placebo
- Keywords
- Autoimmune hyperthyroidism, Autoimmune thyroid disease, Graves' disease, Graves' hyperthyroidism, Thyroid stimulating hormone receptor, Thyroid stimulating immunoglobulin (TSI), TRAb (TSH receptor antibody), TSHR, TSHR autoantibody
- Medical subject headings
- Graves Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN24493Drug
Administered per the protocol.
PlaceboDrug
Administered per the protocol.
| Study group | Role | What they receive |
|---|---|---|
| Dose Escalation | Experimental | Not described Receives: Drug: REGN24493 |
| Placebo Comparator | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Measured: Up to approximately 68 weeks
Secondary outcomes (7)
Concentrations of REGN24493 in serum
Measured: Day 1 through Week 68
Serum Thyroid-Stimulating Hormone (TSH) levels
Measured: Day 1 through Week 68
Serum free T4 (fT4) levels
Measured: Day 1 through Week 68
Serum free T3 (fT3) levels
Measured: Day 1 through Week 68
Serum total T3 (TT3) levels
Measured: Day 1 through Week 68
Occurrence of anti-drug antibody (ADA) to REGN24493 in serum
Measured: Day 1 through Week 68
Magnitude of anti-drug antibody (ADA) to REGN24493 in serum
Measured: Day 1 through Week 68
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Oct 2026
- Study start2 Nov 2026 (estimated)
- Primary completion28 Jan 2030 (estimated)
- Study completion28 Jan 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Graves' DiseaseStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 45 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07861152
- Sponsor's protocol ID
- R24493-GRD-25112
- Other IDs
- 2026-525624-15-00
- Acronym
- EMERGE
- Status last verified
- Sep 2026
- First submitted
- 30 Sep 2026
- Last updated
- 6 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 6 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1, Single-Ascending Dose Study of REGN24493, an Anti-TSHR Monoclonal Antibody, in Participants With Graves' Disease
- ClinicalTrials.gov ID
- NCT07861152
- Acronym / sponsor ID
- EMERGE / R24493-GRD-25112
- Conditions
- Graves' Disease
- Keywords
- Autoimmune hyperthyroidism, Autoimmune thyroid disease, Graves' disease, Graves' hyperthyroidism, Thyroid stimulating hormone receptor, Thyroid stimulating immunoglobulin (TSI), TRAb (TSH receptor antibody), TSHR
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 45 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 2 Nov 2026 (estimated)
- Primary completion
- 28 Jan 2030 (estimated)
- Study completion
- 28 Jan 2030 (estimated)
- First posted
- 6 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dose Escalation | Experimental | Drug: REGN24493 |
| Placebo Comparator | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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/m^2 (inclusive) at the screen visit
Key exclusion criteria (8 listed)
- 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
- Was hospitalized (ie, >24 hours) for a reason within 30 days of the screening visit that presents any concern to the trial investigator
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN24493Administered per the protocol. | Drug | Dose Escalation |
| PlaceboAdministered per the protocol. | Drug | Placebo Comparator |
Primary outcome
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Time frame: Up to approximately 68 weeks
7 secondary outcomes
Concentrations of REGN24493 in serum
Time frame: Day 1 through Week 68
Serum Thyroid-Stimulating Hormone (TSH) levels
Time frame: Day 1 through Week 68
Serum free T4 (fT4) levels
Time frame: Day 1 through Week 68
Serum free T3 (fT3) levels
Time frame: Day 1 through Week 68
Serum total T3 (TT3) levels
Time frame: Day 1 through Week 68
Occurrence of anti-drug antibody (ADA) to REGN24493 in serum
Time frame: Day 1 through Week 68
Magnitude of anti-drug antibody (ADA) to REGN24493 in serum
Time frame: Day 1 through Week 68
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Oct 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN24493 in people with Graves' Disease, run by Regeneron Pharmaceuticals.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 6 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment-Emergent Adverse Events (TEAEs) (time frame: Up to approximately 68 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Oct 2026.