RecruitingPhase 1interventionalRules rewrite

Phase 1: testing REGN20423 for Healthy Volunteer

This study will test an experimental 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.

Official registry: https://clinicaltrials.gov/study/NCT07527923 · Regeneron Pharmaceuticals · enrollment listed as 160

What this phase means

Phase 1: the first tests in people. The main question is safety and dose, not whether it cures the condition. Groups are small. Side effects are watched closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are REGN20423, or Placebo. The registry lists allocation as randomized. This study will test an experimental 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).

They plan to enroll about 160 people at 9 sites. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: REGN20423, Placebo

Primary outcome (registry wording): Occurrence of Treatment Emergent Adverse Events (TEAEs)

Who it is for (from inclusion criteria)

Ages 18 Years to 65 Years
Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis
Maximum age of 65 years of age (Part A Only)
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 body-mass index (BMI) within 18 to 31 kg/m² (inclusive) at the screening visit
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

Who the registry excludes

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
Known or suspected history of immunosuppression
Presence of skin comorbidities at screening that may interfere with study assessments

Public study contact (from the registry)

Clinical Trials Administrator

844-734-6643

clinicaltrials@regeneron.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

9 listed

Cahaba Dermatology & Skin Health Center, LLC — Birmingham, Alabama (recruiting)
Arkansas Research Trials — North Little Rock, Arkansas (recruiting)
Alliance Clinical, Focus Clinical Research — West Hills, California (recruiting)
Florida International Research Center — Miami, Florida (recruiting)
Encore Medical Research of Weston LLC — Weston, Florida (recruiting)
Rophe Adult and Pediatric Medicine — Union City, Georgia (recruiting)
National Allergy and Asthma Research, LLC — North Charleston, South Carolina (recruiting)
Texas Dermatology and Laser Specialists — San Antonio, Texas (recruiting)

+ 1 sites outside the US on the same record

Related recruiting trials in this snapshot

RecruitingNot a traditional drug phasePittsburgh, Pennsylvania

Not a traditional drug phase: Blood draw, skin biopsy or urine collection for Cutaneous T-cell Lymphoma

This is a tissue, urine, and blood banking protocol for cutaneous t-cell lymphoma (CTCL), eczema, and atopic dermatitis patients for current and future research.

NCT00177268 · Official ClinicalTrials.gov record · University of Pittsburgh

RecruitingNot a traditional drug phaseBethesda, Maryland

Studies of Skin Microbes in Healthy People and in People With Skin Conditions

This study will examine microbes (e.g., bacteria, fungi, viruses) that live on human skin and how microbes contribute to health and disease. It will analyze healthy human skin and how the these microorganisms might change in patients with atopic dermatitis (AD), a skin condition also known as eczema.

NCT00605878 · Official ClinicalTrials.gov record · National Human Genome Research Institute (NHGRI)

RecruitingPhase 2Bethesda, Maryland

Phase 2: testing Trimethoprim/sulfamethoxazole (TMP/SMZ) for Eczema

Background: \- Atopic dermatitis, or eczema, is a chronic skin disorder. Patients sometimes have infections with S.

NCT01631617 · Official ClinicalTrials.gov record · National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS)

FAQ about this NCT record

Is NCT07527923 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07527923?

Phase 1. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07527923?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary