Healthy Volunteer study: REGN20423
Official title First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
ClinicalTrials.gov ID: NCT07527923
What this study is testing
What is REGN20423?
REGN20423 is an investigational medicine being studied as a potential treatment for atopic dermatitis (eczema).
Plain-language explanation of the investigational treatment. It is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- The study aims to learn about safety, how the drug moves in the body, the best dose, and any early signs of effect in people with eczema.
- Who it's for
- Adults who are healthy or who have atopic dermatitis (eczema).
- What's involved
- Participants will receive the study drug, have blood draws and other simple tests, and may have skin examinations to check for side effects and drug activity.
- Time commitment
- The trial lasts several weeks with a few clinic visits for dosing and follow‑up testing.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 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 Key
You likely can't join if
- 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...
- Known or suspected history of immunosuppression
- Presence of skin comorbidities at screening that may interfere with study assessments
See the full eligibility criteria
- 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...
- 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 Key
- 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
- 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
The study team makes the final eligibility decision.
Where it is enrolling
- Birmingham, Alabama, United States
- North Little Rock, Arkansas, United States
- West Hills, California, United States
- Miami, Florida, United States
- Weston, Florida, United States
- Union City, Georgia, United States
- North Charleston, South Carolina, United States
- San Antonio, Texas, United States
- Leuven, Vlaams-Brabant, Belgium
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part, but confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
This study is enrolling now at Birmingham, Alabama, United States; North Little Rock, Arkansas, United States; West Hills, California, United States; Miami, Florida, United States; Weston, Florida, United States; Union City, Georgia, United States and 3 more locations. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.