RECRUITING Phase 1 ClinicalTrials.gov

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

Sponsor: Regeneron Pharmaceuticals • ClinicalTrials.gov ID: NCT07527923

Registry updated: 2026-10-07

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Description

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

Interventions

REGN20423 (Drug)
Administered per the protocol
Placebo (Other)
Administered per the protocol

Eligibility criteria

Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis Key Inclusion Criteria: Part A: 1. 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 2. Has a BMI within 18 to 31 kg/m² (inclusive) at the screening visit Part B: 3. Has a history of AD for at least 6 months at screening 4. Has EASI score ≥5 at both the screening and baseline visits 5. 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

Conditions

Healthy Volunteer Atopic Dermatitis

Locations

Cahaba Dermatology & Skin Health Center, LLC — Birmingham, Alabama, United States
Arkansas Research Trials — North Little Rock, Arkansas, United States
Alliance Clinical West Hills (Focus Clinical Research) — West Hills, California, United States
Florida International Research Center — Miami, Florida, United States
National Allergy and Asthma Research, LLC — North Charleston, South Carolina, United States
Texas Dermatology and Laser Specialists — San Antonio, Texas, United States
Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) — Leuven, Vlaams-Brabant, Belgium

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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

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