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Første-i-mennesker-forsøg til vurdering af REGN20423 hos raske voksne deltagere og voksne deltagere med atopisk dermatitis (AURA-AD)

3. november 2026 opdateret af: Regeneron Pharmaceuticals

Et to-delt fase 1, randomiseret, dobbeltblindt, placebo-kontrolleret første-på-mennesker-studie til vurdering af sikkerhed, tolerabilitet, farmakokinetik og immunogenicitet af REGN20423 hos raske voksne deltagere og voksne deltagere med atopisk dermatitis

This study will test an experimental study medicine called REGN20423 to see how effective it is in healthy participants (in Part A) and participants with atopic dermatitis (eczema) (in Part B). REGN20423 is a study medicine that is only used in clinical studies. REGN20423 has not previously been studied in humans.

The study is looking at:

  • What side effects REGN20423 might cause
  • How much REGN20423 is in the blood at different times
  • How well REGN20423 works in adults with atopic dermatitis
  • Whether the body makes antibodies against REGN20423
  • How the body changes after having REGN20423, which can help researchers understand why REGN20423 works better in some people than others
  • What the best dose of REGN20423 is

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

160

Fase

  • Fase 1

Kontakter og lokationer

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

Studiekontakt

Studiesteder

  • Belgien
    • Vlaams-Brabant
      • Leuven, Vlaams-Brabant, Belgien, 3000
        • Rekruttering
        • Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)
  • Forenede Stater
    • Alabama
      • Birmingham, Alabama, Forenede Stater, 35244
        • Rekruttering
        • Cahaba Dermatology & Skin Health Center, LLC
    • Arkansas
      • North Little Rock, Arkansas, Forenede Stater, 72117
        • Rekruttering
        • Arkansas Research Trials
    • California
      • West Hills, California, Forenede Stater, 91307
        • Rekruttering
        • Alliance Clinical, Focus Clinical Research
    • Florida
      • Miami, Florida, Forenede Stater, 33173
        • Rekruttering
        • Florida International Research Center
      • Weston, Florida, Forenede Stater, 33331
        • Rekruttering
        • Encore Medical Research of Weston LLC
    • Georgia
      • Union City, Georgia, Forenede Stater, 30291
        • Rekruttering
        • Rophe Adult and Pediatric Medicine
    • South Carolina
      • North Charleston, South Carolina, Forenede Stater, 29420
        • Rekruttering
        • National Allergy and Asthma Research, LLC
    • Texas
      • San Antonio, Texas, Forenede Stater, 78218
        • Rekruttering
        • Texas Dermatology and Laser Specialists

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 til 65 år (Voksen, Ældre voksen)

Tager imod sunde frivillige

Ja

Køn, der er berettiget til at studere

Alle

Beskrivelse

Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis

Key Inclusion Criteria:

Part A:

  1. Maximum age of 65 years of age (Part A Only)

  2. Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and laboratory safety testing at screening and prior to initial dose of study intervention

  3. Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit

    Part B:

  4. Has a history of AD for at least 6 months at screening

  5. Has EASI score ≥5 at both the screening and baseline visits

  6. Has IGA score ≥2 at both the screening and baseline visits

Key Exclusion Criteria

Part A:

  1. Hospitalized (>24 hours) for any reason within 30 days prior to the screening visit

  2. Hypersensitivity to the study treatment or any of its excipients

  3. History of clinical parasite infection, except treated trichomoniasis

  4. Received a live attenuated vaccine within 1 month prior to the first screening visit or anticipates need for a live attenuated vaccine during the study

  5. History of alcohol or drug abuse as determined by the investigator

    Part B:

  6. Known or suspected history of immunosuppression

  7. Presence of skin comorbidities at screening that may interfere with study assessments

  8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list

  9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study

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: Del A
Andet: Placebo

Administered per the protocol

Medicin: REGN20423

Administered per the protocol
Eksperimentel: Del B
Andet: Placebo

Administered per the protocol

Medicin: REGN20423

Administered per the protocol

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Tidsramme
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Tidsramme: Up to 69 weeks
Up to 69 weeks
Severity of TEAEs
Tidsramme: Up to 69 weeks
Up to 69 weeks

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Absolutte værdier fra baseline af total Interleukin 13 (IL-13)
Tidsramme: Op til 52 uger
Op til 52 uger
Absolutte værdier fra baseline for totalt immunoglobin E (IgE)
Tidsramme: Op til 52 uger
Op til 52 uger
Absolutte værdier fra baseline for totale eosinofiltal i blod
Tidsramme: Op til 52 uger
Op til 52 uger
Absolutte værdier fra baseline for total periostin
Tidsramme: Op til 52 uger
Op til 52 uger
Absolutte værdier fra baseline for total Thymus and Activation-Regulated Chemokine (TARC)
Tidsramme: Op til 52 uger
Op til 52 uger
Procentvis ændring fra baseline for total IL-13
Tidsramme: Op til 52 uger
Op til 52 uger
Procentvis ændring fra baseline for total IgE
Tidsramme: Op til 52 uger
Op til 52 uger
Procentvis ændring fra baseline i totale eosinofiltællinger i blod
Tidsramme: Op til 52 uger
Op til 52 uger
Procentvis ændring fra baseline for total periostin
Tidsramme: Op til 52 uger
Op til 52 uger
Procentvis ændring fra baseline i total TARC
Tidsramme: Op til 52 uger
Op til 52 uger
Concentrations of REGN20423 in serum
Tidsramme: Up to 57 weeks
Up to 57 weeks
Occurrence of Anti-Drug Antibodies (ADA) to REGN20423
Tidsramme: Up to 57 weeks
Up to 57 weeks
Magnitude of ADA to REGN20423
Tidsramme: Up to 57 weeks
Up to 57 weeks
Absolute change from baseline in Eczema Area and Severity Index (EASI) score
Tidsramme: Up to 52 weeks

Part B

EASI is a validated measure used to assess the severity and extent as a percentage by body area of head, trunk, arms and legs, and converted to a score of 0 to 6. Higher scores indicate higher improvement. Also, AD disease characteristics will be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe)
Up to 52 weeks
Percent change from baseline in EASI score
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Achievement of EASI-50
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Achievement of EASI-75
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Achievement of EASI-90
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Achievement of Investigator's Global Assessment (IGA) 0-1
Tidsramme: Up to 52 weeks

Part B

IGA is a frequently used clinician-reported instrument in clinical studies for rapid and easy assessment of disease severity of AD globally. It is based on a 5-point scale with range from "0" (clear) to "4" (severe), with higher scores indicating more severe disease
Up to 52 weeks
Achievement of IGA 0-1 with reduction in IGA score by ≥2
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Achievement of a reduction in IGA score by ≥2
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Absolute change from baseline in % Body Surface Area (BSA)
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Absolute change from baseline in EASI
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Percent change from baseline in % BSA
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks
Percent change from baseline in EASI
Tidsramme: Up to 52 weeks

Part B
Up to 52 weeks

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 (Faktiske)

22. maj 2026

Primær færdiggørelse (Anslået)

14. august 2028

Studieafslutning (Anslået)

14. august 2028

Datoer for studieregistrering

Først indsendt

7. april 2026

Først indsendt, der opfyldte QC-kriterier

7. april 2026

Først opslået (Faktiske)

14. april 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

6. november 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

3. november 2026

Sidst verificeret

1. oktober 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • R20423-HV-2555
  • 2025-524205-32-00 (Ctis)
  • 2025 (U.S. NIH-bevilling/kontrakt)

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 .

Abonner