Atopic Dermatitis, Healthy Volunteer
Conditions
Keywords
Eczema, Inflammatory skin disease
Brief summary
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
Interventions
DRUGREGN20423
Administered per the protocol
OTHERPlacebo
Administered per the protocol
Sponsors
Regeneron Pharmaceuticals
Study design
Allocation
RANDOMIZED
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Intervention model description
Part A is sequential Part B is parallel
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
Yes
Inclusion criteria
Part A: Enrolls healthy participants Part B: Enrolls participants with atopic dermatitis Key Inclusion Criteria: Part A: 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 Part B: 3. Has a history of AD for at least 6 months at screening 4. Has EASI score ≥5 at both the screening and baseline visits 5. Has IGA score ≥2 at both the screening and baseline visits Key
Exclusion criteria
Part A: 1. Hospitalized (\>24 hours) for any reason within 30 days prior to the screening visit 2. Hypersensitivity to the study treatment or any of its excipients 3. History of clinical parasite infection, except treated trichomoniasis 4. 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 5. History of alcohol or drug abuse as determined by the investigator Part B: 6. Known or suspected history of immunosuppression 7. Presence of skin comorbidities at screening that may interfere with study assessments 8. Inability to discontinue medications and treatments prior to baseline and during the study per the Excluded Medications and Treatments list 9. Uncontrolled chronic disease that might require bursts of oral corticosteroids during the study Note: Other protocol defined Inclusion/
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Occurrence of Treatment Emergent Adverse Events (TEAEs) | Up to 69 weeks |
| Severity of TEAEs | Up to 69 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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) | 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 | 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) |
| Percent change from baseline in EASI score | Up to 52 weeks | Part B |
| Achievement of EASI-50 | Up to 52 weeks | Part B |
| Achievement of EASI-75 | Up to 52 weeks | Part B |
| Achievement of EASI-90 | Up to 52 weeks | Part B |
| Achievement of Investigator's Global Assessment (IGA) 0-1 | 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 |
| Achievement of IGA 0-1 with reduction in IGA score by ≥2 | Up to 52 weeks | Part B |
| Achievement of a reduction in IGA score by ≥2 | Up to 52 weeks | Part B |
| Absolute change from baseline in % Body Surface Area (BSA) | Up to 52 weeks | Part B |
| Absolute change from baseline in EASI | Up to 52 weeks | Part B |
| Percent change from baseline in % BSA | Up to 52 weeks | Part B |
| Percent change from baseline in EASI | Up to 52 weeks | Part B |
Countries
Belgium
Contacts
CONTACTClinical Trials Administrator
STUDY_DIRECTORClinical Trial Management
Regeneron Pharmaceuticals
Outcome results
None listed