First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

Phase 1Not Yet RecruitingNCT07527923

Regeneron Pharmaceuticals136 enrolled

Overview

This clinical trial will evaluate REGN20423, an investigational medicine that has not previously been studied in humans and is used only in clinical studies. The study will assess the safety, how the body processes the medicine, and the dose levels that may work best. It will also test whether REGN20423 can help treat adults with atopic dermatitis. This is a two-part study: Part A includes healthy adult participants. Part B includes adults with atopic dermatitis. 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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

136

Conditions

Healthy Volunteer Atopic Dermatitis

Interventions

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 YearsHealthy volunteers:

Medical Language ↔ Plain English

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/ Exclusion criteria apply

Outcomes

Primary Outcomes

Occurrence of Treatment Emergent Adverse Events (TEAEs)

Time frame: Up to 52 weeks

Severity of TEAEs

Time frame: Up to 52 weeks

Secondary Outcomes

Concentrations of REGN20423 in serum

Time frame: Up to 52 weeks

Absolute values from baseline of total Interleukin 13 (IL-13)

Time frame: Up to 52 weeks

Absolute values from baseline of total Immunoglobulin E (IgE)

Time frame: Up to 52 weeks

Absolute values from baseline of total eosinophil counts in blood

Time frame: Up to 52 weeks

Absolute values from baseline of total periostin

Time frame: Up to 52 weeks

Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC)

Time frame: Up to 52 weeks

Percent change from baseline of total IL-13

Time frame: Up to 52 weeks

Percent change from baseline of total IgE

Time frame: Up to 52 weeks

Percent change from baseline of total eosinophil counts in blood

Time frame: Up to 52 weeks

Percent change from baseline of total periostin

Time frame: Up to 52 weeks

Percent change from baseline of total TARC

Time frame: Up to 52 weeks

Occurrence of Anti-Drug Antibodies (ADA) to REGN20423

Time frame: Up to 52 weeks

Magnitude of ADA to REGN20423

Time frame: Up to 52 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)

Time frame: Up to 52 weeks

Percent change from baseline in EASI score

Part B

Time frame: Up to 52 weeks

Achievement of EASI-50

Part B

Time frame: Up to 52 weeks

Achievement of EASI-75

Part B

Time frame: Up to 52 weeks

Achievement of EASI-90

Part B

Time frame: 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

Time frame: Up to 52 weeks

Achievement of IGA 0-1 with reduction in IGA score by ≥2

Part B

Time frame: Up to 52 weeks

Achievement of a reduction in IGA score by ≥2

Part B

Time frame: Up to 52 weeks

Absolute change in % Body Surface Area (BSA)

Part B

Time frame: From baseline up to 52 weeks

Absolute change in EASI

Part B

Time frame: From baseline up to 52 weeks

Percent change in % BSA

Part B

Time frame: From baseline up to 52 weeks

Percent change in EASI

Part B

Time frame: From baseline up to 52 weeks

First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis

Overview

Conditions

Interventions

Eligibility

Outcomes

Primary Outcomes

Secondary Outcomes

Central Contacts