NCT07527923 · Regeneron Pharmaceuticals
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
(AURA-AD)
What this study is about
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.
View original scientific 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.
Interventions
DRUG
REGN20423
Administered per the protocol
OTHER
Placebo
Administered per the protocol
Primary outcome measures
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 69 weeks
Severity of TEAEs
Time frame: Up to 69 weeks
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
Inclusion criteria
- 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
- 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
Where
- Birmingham, Alabama
- North Little Rock, Arkansas
- West Hills, California
- Miami, Florida
- North Charleston, South Carolina
- San Antonio, Texas
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Oct 7, 2026 · Source of record for eligibility and locations