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

30. september 2026 opdateret af: 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

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

45

Fase

  • Fase 1

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

18 år og ældre (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

Alle

Beskrivelse

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

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Sekventiel tildeling
  • Maskning: Firedobbelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Eksperimentel: Dosiseskalering
Medicin: REGN24493

Administered per the protocol.
Placebo komparator: Placebo komparator
Medicin: Placebo

Administered per the protocol.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of Treatment-Emergent Adverse Events (TEAEs)
Tidsramme: Up to approximately 68 weeks
Up to approximately 68 weeks

Sekundære resultatmål

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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

Regeneron Pharmaceuticals

Efterforskere

  • Studieleder: Clinical Trial Management, Regeneron Pharmaceuticals

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

2. november 2026

Primær færdiggørelse (Anslået)

28. januar 2030

Studieafslutning (Anslået)

28. januar 2030

Datoer for studieregistrering

Først indsendt

30. september 2026

Først indsendt, der opfyldte QC-kriterier

30. september 2026

Først opslået (Faktiske)

6. oktober 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. oktober 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

30. september 2026

Sidst verificeret

1. september 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

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

Plan for individuelle deltagerdata (IPD)

Planlægger du at dele individuelle deltagerdata (IPD)?

JA

IPD-planbeskrivelse

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

IPD-delingstidsramme

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-delingsadgangskriterier

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-deling Understøttende informationstype

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE
  • CSR

Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter

Studerer et amerikansk FDA-reguleret lægemiddelprodukt

Ja

Studerer et amerikansk FDA-reguleret enhedsprodukt

Ingen

Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .

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