First-in-human test of REGN20423 in healthy adults and adults with eczema

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a Phase 1, first-in-human trial to evaluate REGN20423. Part A enrolls healthy volunteers to study safety, dosing, and pharmacokinetics. Part B enrolls adults with atopic dermatitis to assess safety and preliminary efficacy and immune response. The study will measure side effects, drug levels over time, potential antibodies against the drug, and changes in disease activity to help determine an appropriate dose for further research.

Why it matters

Who can join: the full rules

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

Where it's running

• Cahaba Dermatology & Skin Health Center, LLC
  Birmingham, Alabama, United States Recruiting
• Arkansas Research Trials
  North Little Rock, Arkansas, United States Recruiting
• Alliance Clinical, Focus Clinical Research
  West Hills, California, United States Recruiting
• Florida International Research Center
  Miami, Florida, United States Recruiting
• Encore Medical Research of Weston LLC
  Weston, Florida, United States Recruiting
• Rophe Adult and Pediatric Medicine
  Union City, Georgia, United States Recruiting

Study contacts

• Study coordinator: Clinical Trials Administrator
• Email: clinicaltrials@regeneron.com
• Phone: 844-734-6643

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Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.