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Recruiting NCT07527923

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

Phase I Interventional Healthy Volunteer Atopic Dermatitis

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: REGN20423, Placebo.
Who it may be relevant to
Registry conditions: Healthy Volunteer, Atopic Dermatitis. Basic parameters: 18 years — 65 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Belgium
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

  • 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]
Secondary outcome measures (12)
  • Concentrations of REGN20423 in serum [Time frame: Up to 57 weeks]
  • Absolute values from baseline of total Interleukin 13 (IL-13) [Time frame: Up to 52 weeks]
  • Absolute values from baseline of total Immunoglobulin E (IgE) [Time frame: Up to 52 weeks]
  • Absolute values from baseline of total eosinophil counts in blood [Time frame: Up to 52 weeks]
  • Absolute values from baseline of total periostin [Time frame: Up to 52 weeks]
  • Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC) [Time frame: Up to 52 weeks]
  • Percent change from baseline of total IL-13 [Time frame: Up to 52 weeks]
  • Percent change from baseline of total IgE [Time frame: Up to 52 weeks]
  • Percent change from baseline of total eosinophil counts in blood [Time frame: Up to 52 weeks]
  • Percent change from baseline of total periostin [Time frame: Up to 52 weeks]
  • Percent change from baseline of total TARC [Time frame: Up to 52 weeks]
  • Occurrence of Anti-Drug Antibodies (ADA) to REGN20423 [Time frame: Up to 57 weeks]

Eligibility criteria

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

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

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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Sequential
Masking
Quadruple blind
Primary purpose
Treatment

Study locations

Belgium · 1 center
  • Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) — Leuven

Identifiers

NCT: NCT07527923 · R20423-HV-2555 · 2025-524205-32-00

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗