Recruiting
Phase 1

REGN20423

Sponsor:

Regeneron Pharmaceuticals

Code:

NCT07527923

Conditions

Healthy Volunteer

Atopic Dermatitis

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

Interventions

REGN20423

Placebo

Study Details

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

Conditions

Healthy Volunteer

Atopic Dermatitis

Study ID

NCT07527923

Start date

May 22, 2026

Status verified date

Sep, 2026

Completion date

Jun 23, 2028

Anticipated

Primary completion date

Jun 23, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 65

Healthy Volunteers: Accepted

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

Study Design

Enrollment

144 participants

Anticipated

Allocation

Randomized

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Part A

experimental: Part B

Interventions

REGN20423

Administered per the protocol

Placebo

Administered per the protocol

Primary outcome measure

  • Occurrence of Treatment Emergent Adverse Events (TEAEs) [ Time Frame: Up to 69 weeks ]
  • Severity of TEAEs [ Time Frame: Up to 69 weeks ]

Central Contacts and Locations

Central contacts

Clinical Trials Administrator

844-734-6643clinicaltrials@regeneron.com

Locations

Cahaba Dermatology & Skin Health Center, LLC

Recruiting

Birmingham, Alabama, United States, 35244

Alliance Clinical West Hills (Focus Clinical Research)

Recruiting

West Hills, California, United States, 91307

National Allergy and Asthma Research, LLC

Recruiting

North Charleston, South Carolina, United States, 29420

Texas Dermatology and Laser Specialists

Recruiting

San Antonio, Texas, United States, 78218

More Information

Sponsor

Regeneron Pharmaceuticals

Last update posted

Sep 25, 2026

Last verified

Sep, 2026

Keywords

  • Eczema
  • Inflammatory skin disease

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-26. This information was provided to ClinicalTrials.gov by Regeneron Pharmaceuticals on 2026-09-25. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.