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New treatment option for Healthy Volunteer
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 healthy volunteer.
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
- 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.
- 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
- Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis Key Part A:
- Is judged by the investigator to be in good health based on medical history, physical examination, vital signs, Electrocardiograms (ECGs), and...
- 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
You likely can't join if
- 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...
- History of alcohol or drug abuse as determined by the investigator Part B:
See the full eligibility criteria
- Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis Key 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...
- 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 Key
- 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
The study team makes the final eligibility decision.
Where it's taking place
- 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 - 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?
Study sites include Leuven, Vlaams-Brabant, Belgium. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.