Healthy VolunteerPhase 1AURA-ADNCT07527923
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
A Phase 1 study testing REGN20423 in people with Healthy Volunteer and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 9 sites in 2 countries.
Trial summary
This study will test an experimental 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. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteer, Atopic Dermatitis
- What is being tested?
- REGN20423
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 160 participants
- Where
- 9 sitesin 2 countries
- Study dates
- 22 May 2026to 14 Aug 2028
- Phase
- Phase 1
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Part A:
- Maximum age of 65 years of age (Part A Only)
- 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
Who cannot join
- 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
Show all 12Show fewer
- 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
Trial locations and contacts
9 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
9 sites in 2 countries
United States8 sites, 8 recruiting
- Recruiting
Cahaba Dermatology & Skin Health Center, LLC
Birmingham, Alabama, 35244
- Recruiting
Florida International Research Center
Miami, Florida, 33173
- Recruiting
National Allergy and Asthma Research, LLC
North Charleston, South Carolina, 29420
- Recruiting
Arkansas Research Trials
North Little Rock, Arkansas, 72117
- Recruiting
Texas Dermatology and Laser Specialists
San Antonio, Texas, 78218
- Recruiting
Rophe Adult and Pediatric Medicine
Union City, Georgia, 30291
- Recruiting
Alliance Clinical, Focus Clinical Research
West Hills, California, 91307
- Recruiting
Encore Medical Research of Weston LLC
Weston, Florida, 33331
Belgium1 site, 1 recruiting
- Recruiting
Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)
Leuven, Vlaams-Brabant, 3000
About this study
Official title: 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
This study will test an experimental 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
- Conditions
- Healthy Volunteer, Atopic Dermatitis
- Being tested
- REGN20423, Placebo
- Keywords
- Eczema, Inflammatory skin disease
- Medical subject headings
- Dermatitis, Atopic, Eczema, Dermatitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
REGN20423Drug
Administered per the protocol
PlaceboOther
Administered per the protocol
| Study group | Role | What they receive |
|---|---|---|
| Part A | Experimental | Not described Receives: Drug: REGN20423; Other: Placebo |
| Part B | Experimental | Not described Receives: Drug: REGN20423; Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Measured: Up to 69 weeks
Severity of TEAEs
Measured: Up to 69 weeks
Secondary outcomes (25)
Concentrations of REGN20423 in serum
Measured: Up to 57 weeks
Absolute values from baseline of total Interleukin 13 (IL-13)
Measured: Up to 52 weeks
Absolute values from baseline of total Immunoglobulin E (IgE)
Measured: Up to 52 weeks
Absolute values from baseline of total eosinophil counts in blood
Measured: Up to 52 weeks
Absolute values from baseline of total periostin
Measured: Up to 52 weeks
Absolute values from baseline of total Thymus and Activation-Regulated Chemokine (TARC)
Measured: Up to 52 weeks
Percent change from baseline of total IL-13
Measured: Up to 52 weeks
Percent change from baseline of total IgE
Measured: Up to 52 weeks
Percent change from baseline of total eosinophil counts in blood
Measured: Up to 52 weeks
Percent change from baseline of total periostin
Measured: Up to 52 weeks
Percent change from baseline of total TARC
Measured: Up to 52 weeks
Occurrence of Anti-Drug Antibodies (ADA) to REGN20423
Measured: Up to 57 weeks
Magnitude of ADA to REGN20423
Measured: 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)
Measured: Up to 52 weeks
Percent change from baseline in EASI score
Part B
Measured: Up to 52 weeks
Achievement of EASI-50
Part B
Measured: Up to 52 weeks
Achievement of EASI-75
Part B
Measured: Up to 52 weeks
Achievement of EASI-90
Part B
Measured: 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
Measured: Up to 52 weeks
Achievement of IGA 0-1 with reduction in IGA score by ≥2
Part B
Measured: Up to 52 weeks
Achievement of a reduction in IGA score by ≥2
Part B
Measured: Up to 52 weeks
Absolute change from baseline in % Body Surface Area (BSA)
Part B
Measured: Up to 52 weeks
Absolute change from baseline in EASI
Part B
Measured: Up to 52 weeks
Percent change from baseline in % BSA
Part B
Measured: Up to 52 weeks
Percent change from baseline in EASI
Part B
Measured: Up to 52 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Apr 2026
- Study start22 May 2026
- Primary completion14 Aug 2028 (estimated)
- Study completion14 Aug 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy VolunteerStudies of the same condition, open and under way.
- More trials run by Regeneron PharmaceuticalsThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Part A is sequential Part B is parallel
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 160 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Regeneron Pharmaceuticals
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trial Management, Study director, Regeneron Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07527923
- Sponsor's protocol ID
- R20423-HV-2555
- Other IDs
- 2025-524205-32-00, 2025
- Acronym
- AURA-AD
- Status last verified
- Oct 2026
- First submitted
- 7 Apr 2026
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07527923
- Acronym / sponsor ID
- AURA-AD / R20423-HV-2555
- Conditions
- Healthy Volunteer, Atopic Dermatitis
- Keywords
- Eczema, Inflammatory skin disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 160 participants (estimated)
- Lead sponsor
- Regeneron PharmaceuticalsIndustry (pharma, biotech, devices)
- Study start
- 22 May 2026 (actual)
- Primary completion
- 14 Aug 2028 (estimated)
- Study completion
- 14 Aug 2028 (estimated)
- First posted
- 14 Apr 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study will test an experimental 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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Part A is sequential Part B is parallel
| Arm | Type | Receives |
|---|---|---|
| Part A | Experimental | Drug: REGN20423, Other: Placebo |
| Part B | Experimental | Drug: REGN20423, Other: Placebo |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Maximum age of 65 years of age (Part A Only)
- 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
- Has a history of AD for at least 6 months at screening
- Has EASI score ≥5 at both the screening and baseline visits
Key exclusion criteria (12 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| REGN20423Administered per the protocol | Drug | Part A, Part B |
| PlaceboAdministered per the protocol | Other | Part A, Part B |
Primary outcome
Occurrence of Treatment Emergent Adverse Events (TEAEs)
Time frame: Up to 69 weeks
Severity of TEAEs
Time frame: Up to 69 weeks
25 secondary outcomes
Concentrations of REGN20423 in serum
Time frame: Up to 57 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 57 weeks
Magnitude of ADA to REGN20423
Time frame: Up to 57 weeks
Absolute change from baseline in Eczema Area and Severity Index (EASI) score
Time frame: Up to 52 weeks
Percent change from baseline in EASI score
Time frame: Up to 52 weeks
Achievement of EASI-50
Time frame: Up to 52 weeks
Achievement of EASI-75
Time frame: Up to 52 weeks
Achievement of EASI-90
Time frame: Up to 52 weeks
Achievement of Investigator's Global Assessment (IGA) 0-1
Time frame: Up to 52 weeks
Achievement of IGA 0-1 with reduction in IGA score by ≥2
Time frame: Up to 52 weeks
Achievement of a reduction in IGA score by ≥2
Time frame: Up to 52 weeks
Absolute change from baseline in % Body Surface Area (BSA)
Time frame: Up to 52 weeks
Absolute change from baseline in EASI
Time frame: Up to 52 weeks
Percent change from baseline in % BSA
Time frame: Up to 52 weeks
Percent change from baseline in EASI
Time frame: Up to 52 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Individual participant dataSharing planned: Yes. All Individual Patient Data (IPD) that underlie publicly available results will be considered for sharing
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Clinical Trial Management study director
Regeneron Pharmaceuticals
9 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing REGN20423 in people with Healthy Volunteer and Atopic Dermatitis, run by Regeneron Pharmaceuticals at 9 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in United States, Belgium. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Clinical Trials Administrator (844-734-6643, clinicaltrials@regeneron.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Occurrence of Treatment Emergent Adverse Events (TEAEs) (time frame: Up to 69 weeks). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Nov 2026.