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NCT Number: NCT07527923

First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

This study will test a 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

Recruiting

Interested in participating?

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)

Leuven, Vlaams-Brabant, 3000, Belgium

Location status: Recruiting

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Key Inclusion Criteria:

Part A:

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

Part B:

  • Has a history of AD for at least 6 months at screening
  • Has EASI score ≥5 at both the screening and baseline visits
  • Has IGA score ≥2 at both the screening and baseline visits

Key Exclusion Criteria

Part A:

  • Hospitalized (>24 hours) for any reason within 30 days prior to the screening visit
  • Hypersensitivity to the study treatment or any of its excipients
  • History of clinical parasite infection, except treated trichomoniasis
  • 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
  • History of alcohol or drug abuse as determined by the investigator

Part B:

  • Known or suspected history of immunosuppression
  • Presence of skin comorbidities at screening that may interfere with study assessments
  • Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list
  • Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study

Note: Other protocol defined Inclusion/ Exclusion criteria apply

Treatment and study plan

REGN20423

Drug

Administered per the protocol

Placebo

Other

Administered per the protocol

Primary outcomes

  1. Occurrence of Treatment Emergent Adverse Events (TEAEs)

    Time frame: Up to 69 weeks

  2. Severity of TEAEs

    Time frame: Up to 69 weeks

Secondary outcomes

  1. Concentrations of REGN20423 in serum

    Time frame: Up to 57 weeks

  2. Absolute values from baseline of total Interleukin 13 (IL-13)

    Time frame: Up to 52 weeks

  3. Absolute values from baseline of total Immunoglobulin E (IgE)

    Time frame: Up to 52 weeks

  4. Absolute values from baseline of total eosinophil counts in blood

    Time frame: Up to 52 weeks

  5. Absolute values from baseline of total periostin

    Time frame: Up to 52 weeks

  6. Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC)

    Time frame: Up to 52 weeks

  7. Percent change from baseline of total IL-13

    Time frame: Up to 52 weeks

  8. Percent change from baseline of total IgE

    Time frame: Up to 52 weeks

  9. Percent change from baseline of total eosinophil counts in blood

    Time frame: Up to 52 weeks

  10. Percent change from baseline of total periostin

    Time frame: Up to 52 weeks

  11. Percent change from baseline of total TARC

    Time frame: Up to 52 weeks

  12. Occurrence of Anti-Drug Antibodies (ADA) to REGN20423

    Time frame: Up to 57 weeks

  13. Magnitude of ADA to REGN20423

    Time frame: Up to 57 weeks

  14. Absolute change from baseline in Eczema Area and Severity Index (EASI) score

    Time frame: 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)

  15. Percent change from baseline in EASI score

    Time frame: Up to 52 weeks

    Part B

  16. Achievement of EASI-50

    Time frame: Up to 52 weeks

    Part B

  17. Achievement of EASI-75

    Time frame: Up to 52 weeks

    Part B

  18. Achievement of EASI-90

    Time frame: Up to 52 weeks

    Part B

  19. Achievement of Investigator's Global Assessment (IGA) 0-1

    Time frame: 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

  20. Achievement of IGA 0-1 with reduction in IGA score by ≥2

    Time frame: Up to 52 weeks

    Part B

  21. Achievement of a reduction in IGA score by ≥2

    Time frame: Up to 52 weeks

    Part B

  22. Absolute change from baseline in % Body Surface Area (BSA)

    Time frame: Up to 52 weeks

    Part B

  23. Absolute change from baseline in EASI

    Time frame: Up to 52 weeks

    Part B

  24. Percent change from baseline in % BSA

    Time frame: Up to 52 weeks

    Part B

  25. Percent change from baseline in EASI

    Time frame: Up to 52 weeks

    Part B

Study contacts

Contact information is provided by the study sponsor or research team.

Clinical Trials Administrator

CONTACT

[email protected]

844-734-6643

Sponsors and collaborators

Lead sponsor

Regeneron Pharmaceuticals

Industry

Registry information

Official study title

A Two-Part Phase 1, Randomized, Double-Blind, Placebo-Controlled First-in-Human Study to Assess the Safety, Tolerability, Pharmacokinetics, and Immunogenicity of REGN20423 in Adult Healthy Participants and Adult Participants With Atopic Dermatitis

Acronym: AURA-AD

Important dates

Study start
2026
Primary completion
2028
Study completion
2028
First posted
Apr 14, 2026
Registry last updated
Jun 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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