Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
NCT Number: NCT07527923
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
Interested in participating?
Request Info18 year–65 year
All sexes
Interventional
Phase 1
Leuven, Vlaams-Brabant, 3000, Belgium
Location status: Recruiting
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis
Key Inclusion Criteria:
Part A:
Part B:
Key Exclusion Criteria
Part A:
Part B:
Note: Other protocol defined Inclusion/ Exclusion criteria apply
Administered per the protocol
Administered per the protocol
Time frame: Up to 69 weeks
Time frame: Up to 69 weeks
Time frame: Up to 57 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 52 weeks
Time frame: Up to 57 weeks
Time frame: Up to 57 weeks
Time frame: Up to 52 weeks
Part B
EASI is a validated measure used to assess the severity and extent as a percentage by body area of head, trunk, arms and legs, and converted to a score of 0 to 6. Higher scores indicate higher improvement. Also, AD disease characteristics will be assessed for severity by the investigator or designee on a scale of "0" (absent) through "3" (severe)
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
IGA is a frequently used clinician-reported instrument in clinical studies for rapid and easy assessment of disease severity of AD globally. It is based on a 5-point scale with range from "0" (clear) to "4" (severe), with higher scores indicating more severe disease
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Time frame: Up to 52 weeks
Part B
Contact information is provided by the study sponsor or research team.
Regeneron Pharmaceuticals
Industry
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
Acronym: AURA-AD
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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