First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis (AURA-AD)

Regeneron Pharmaceuticals

Status and phase: Enrolling; Phase 1

Conditions: Atopic Dermatitis; Healthy Volunteer

Treatments: Other: Placebo; Drug: REGN20423

Study type: Interventional

Funder types: Industry

Identifiers

NCT07527923

R20423-HV-2555

2025

2025-524205-32-00 (EU Trial (CTIS) Number)

Details and patient eligibility

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.

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

Enrollment: 144 estimated patients

Sex: All

Ages: 18 to 65 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Sequential Assignment

Masking: Quadruple Blind

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144 participants in 2 patient groups

Part A

Experimental group

Treatment:

Drug: REGN20423

Other: Placebo

Part B

Experimental group

Treatment:

Drug: REGN20423

Other: Placebo