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| ID | Type | Description | Link |
|---|---|---|---|
| 2025-524205-32-00 | EU Trial (CTIS) Number |
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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:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Part A | Experimental |
| |
| Part B | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| REGN20423 | Drug | Administered per the protocol |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to 69 weeks | |
| Severity of TEAEs | Up to 69 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Concentrations of REGN20423 in serum | Up to 57 weeks | |
| Absolute values from baseline of total Interleukin 13 (IL-13) | Up to 52 weeks | |
| Absolute values from baseline of total Immunoglobulin E (IgE) |
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Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis
Key Inclusion Criteria:
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 intervention
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 Exclusion Criteria
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
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Clinical Trials Administrator | Contact | 844-734-6643 | clinicaltrials@regeneron.com |
| Name | Affiliation | Role |
|---|---|---|
| Clinical Trial Management | Regeneron Pharmaceuticals | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven) | Recruiting | Leuven | Vlaams-Brabant | 3000 | Belgium |
All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
When Regeneron has:
Qualified researchers can submit a proposal for access to individual patient or aggregate level data from a Regeneron-sponsored clinical trial through Vivli. Regeneron's Independent Research Request Evaluation Criteria can be found at: https://www.regeneron.com/sites/default/files/Regeneron-External-Data-Sharing-Policy-and-Independent-Research-Request-Evaluation-Criteria.pdf
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| ID | Term |
|---|---|
| D003876 | Dermatitis, Atopic |
| D004485 | Eczema |
| D003872 | Dermatitis |
| ID | Term |
|---|---|
| D012873 | Skin Diseases, Genetic |
| D030342 | Genetic Diseases, Inborn |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D012871 | Skin Diseases |
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Part A is sequential Part B is parallel
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| Placebo |
| Other |
Administered per the protocol |
|
| Up to 52 weeks |
| Absolute values from baseline of total eosinophil counts in blood | Up to 52 weeks |
| Absolute values from baseline of total periostin | Up to 52 weeks |
| Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC) | Up to 52 weeks |
| Percent change from baseline of total IL-13 | Up to 52 weeks |
| Percent change from baseline of total IgE | Up to 52 weeks |
| Percent change from baseline of total eosinophil counts in blood | Up to 52 weeks |
| Percent change from baseline of total periostin | Up to 52 weeks |
| Percent change from baseline of total TARC | Up to 52 weeks |
| Occurrence of Anti-Drug Antibodies (ADA) to REGN20423 | Up to 57 weeks |
| Magnitude of ADA to REGN20423 | Up to 57 weeks |
| Absolute change from baseline in Eczema Area and Severity Index (EASI) score | 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) | Up to 52 weeks |
| Percent change from baseline in EASI score | Part B | Up to 52 weeks |
| Achievement of EASI-50 | Part B | Up to 52 weeks |
| Achievement of EASI-75 | Part B | Up to 52 weeks |
| Achievement of EASI-90 | Part B | Up to 52 weeks |
| Achievement of Investigator's Global Assessment (IGA) 0-1 | 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 | Up to 52 weeks |
| Achievement of IGA 0-1 with reduction in IGA score by ≥2 | Part B | Up to 52 weeks |
| Achievement of a reduction in IGA score by ≥2 | Part B | Up to 52 weeks |
| Absolute change from baseline in % Body Surface Area (BSA) | Part B | Up to 52 weeks |
| Absolute change from baseline in EASI | Part B | Up to 52 weeks |
| Percent change from baseline in % BSA | Part B | Up to 52 weeks |
| Percent change from baseline in EASI | Part B | Up to 52 weeks |
| D017437 | Skin and Connective Tissue Diseases |
| D017443 | Skin Diseases, Eczematous |
| D006969 | Hypersensitivity, Immediate |
| D006967 | Hypersensitivity |
| D007154 | Immune System Diseases |