144 Participants NeededMy employer runs this trial

REGN20423 for Atopic Dermatitis

(AURA-AD Trial)

Recruiting at 4 trial locations
CT
Overseen ByClinical Trials Administrator
Age: 18+
Sex: Any
Trial Phase: Phase 1
Sponsor: Regeneron Pharmaceuticals
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)

What You Need to Know Before You Apply

What is the purpose of this trial?

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

Who Is on the Research Team?

CT

Clinical Trial Management

Principal Investigator

Regeneron Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults who are either healthy or have had atopic dermatitis (eczema) for at least 6 months. Participants must be in generally good health, with a BMI between 18 and 31, and meet certain eczema severity scores if joining the eczema group.

Inclusion Criteria

4. Has EASI score ≥5 at both the screening and baseline visits
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
See 4 more

What Are the Treatments Tested in This Trial?

Interventions

  • REGN20423

Trial Overview

The study is testing REGN20423, a new medicine not previously used in humans, compared to a placebo. It will first test safety and dosing in healthy adults, then see how well it works for adults with atopic dermatitis.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Group I: Part BExperimental Treatment2 Interventions
Group II: Part AExperimental Treatment2 Interventions

Find a Clinic Near You

Who Is Running the Clinical Trial?

Regeneron Pharmaceuticals

Lead Sponsor

Trials
690
Recruited
948,000+
Founded
1988
Headquarters
Tarrytown, USA
Known For
Precision medicine
Top Products
Dupixent, EYLEA, Libtayo, Praluent
Leonard Schleifer profile image

Leonard Schleifer

Regeneron Pharmaceuticals

Chief Executive Officer since 1988

MD and PhD in Medicine

George Yancopoulos profile image

George Yancopoulos

Regeneron Pharmaceuticals

Chief Medical Officer since 1997

MD from Harvard Medical School