Atopic Dermatitis Clinical Trials

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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

Status: Recruiting
Location: See location...
Intervention Type: Other, Drug
Study Type: Interventional
Study Phase: Phase 1
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

Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 65
Healthy Volunteers: t
View:

⁃ 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

Locations
Other Locations
Belgium
Center for Clinical Pharmacology University Hospitals Leuven (UZ Leuven)
RECRUITING
Leuven
Contact Information
Primary
Clinical Trials Administrator
clinicaltrials@regeneron.com
844-734-6643
Time Frame
Start Date: 2026-05-22
Estimated Completion Date: 2028-06-23
Participants
Target number of participants: 144
Treatments
Experimental: Part A
Experimental: Part B
Related Therapeutic Areas
Sponsors
Leads: Regeneron Pharmaceuticals

This content was sourced from clinicaltrials.gov

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