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New eczema drug shows promise for people with darker skin

NCT ID NCT05372419

Disease control Sponsor: Eli Lilly and Company Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested the drug lebrikizumab in 90 adults and teens with moderate-to-severe eczema who have skin of color. The goal was to see if the drug is safe and helps clear skin. Participants received injections over 24 weeks, and doctors measured improvement using a standard eczema severity score.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
Lebrikizumab (a drug given as an injection under the skin)
What this could lead to
If successful, this could provide a treatment option specifically tested for people with skin of color who have moderate-to-severe eczema.
What could go wrong
This is a single-arm, open-label study with only 90 participants, so results may not apply to everyone. Lebrikizumab may cause side effects and is not a cure.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

90 people

The number who actually took part.

Started

Jan 2023

Finished

Feb 2025

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

12 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent. * Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander. * Participants who are Fitzpatrick phototype IV-VI * Participants who have chronic AD that has been present for ≥1 year before screening. * Have EASI ≥16 at baseline * Have IGA score ≥3 (Scale of 0 to 4) at baseline * Have ≥10% body surface area (BSA) of AD involvement at baseline * Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable. * Adolescents body weight must be ≥40 kg at baseline. * Are willing and able to comply with all clinic visits and study-related procedures and questionnaires. * Contraceptive use - Male and/or female * Male participants are not required to use any contraception except in compliance with specific local government study requirements. * Female participants of child-bearing potential: must agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of study drug. Women of non-child-bearing potential (non-WOCBP) may participate without any contraception requirements. Exclusion Criteria: * History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening. * Have a current infection or chronic infection with hepatitis B virus (HBV) at screening, that is, positive for hepatitis B surface antigen (HBsAg) and/or polymerase chain reaction positive for HBV DNA * Have a current infection with hepatitis C virus (HCV) at screening, that is, positive for HCV RNA * Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening (as defined by the investigator). * Have uncontrolled asthma that * might require bursts of oral or systemic corticosteroids, or * required the following due to ≥1 exacerbations within 12 months before baseline * systemic (oral and/or parenteral) corticosteroid treatment, or * hospitalization for \>24 hours. * Have known liver cirrhosis and/or chronic hepatitis of any etiology. * Had prior treatment with dupilumab * Had prior treatment with tralokinumab * Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline. * Treatment with any of the following agents within 4 weeks prior to the baseline: * systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants); * small molecules (for example, Janus Kinase (JAK) inhibitors); * phototherapy and photochemotherapy for AD. * History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

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Conditions

The condition(s) this trial relates to.

atopic eczema Eczema

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Atopic dermatitis

Contacts and locations

Locations

  • Advanced Medical Research

    Sandy Springs, Georgia, 30328, United States

  • Allcutis Research, Inc.

    Beverly, Massachusetts, 01915, United States

  • Arlington Research Center, Inc

    Arlington, Texas, 76011, United States

  • Avance Clinical Trials Inc

    Laguna Niguel, California, 92677, United States

  • Axon Clinical Research

    Inglewood, California, 90301, United States

  • Center For Dermatology Clinical Research, Inc.

    Fremont, California, 94538, United States

  • Clinical Science Institute

    Santa Monica, California, 90404, United States

  • Clinical Trial Network

    Houston, Texas, 77074, United States

  • Complete Dermatology

    Sugar Land, Texas, 77479, United States

  • Cura Clinical Research

    Palmdale, California, 93551, United States

  • Cura Clinical Research

    Sherman Oaks, California, 91403, United States

  • Dawes Fretzin Clinical Research Group, LLC

    Indianapolis, Indiana, 46250, United States

  • Dermatology & Laser Center of Charleston

    Charleston, South Carolina, 29407, United States

  • Dermatology Clinical Research Center of San Antonio

    San Antonio, Texas, 78229, United States

  • Dermatology Research Associates

    Los Angeles, California, 90045, United States

  • Encore Medical Research of Boynton Beach

    Boynton Beach, Florida, 33436, United States

  • First OC Dermatology

    Fountain Valley, California, 92708, United States

  • Miami Dermatology and Laser Research

    Miami, Florida, 33173, United States

  • Oakland Hills Dermatology

    Auburn Hills, Michigan, 48326, United States

  • Progressive Clinical Research

    San Antonio, Texas, 78213, United States

  • PureSkin Dermatology

    Orlando, Florida, 32819, United States

  • Revival Research Institute - Troy

    Troy, Michigan, 48084, United States

  • Sadick Research Group

    New York, New York, 10075, United States

  • Savin Medical Group, LLC

    Miami Lakes, Florida, 33014, United States

  • Skin Care Physicians of Georgia

    Macon, Georgia, 31217, United States

  • Skin Care Research, Inc

    Hollywood, Florida, 33021, United States

  • Skin Specialists, P.C

    Omaha, Nebraska, 68144, United States

  • Solutions Through Advanced Research

    Jacksonville, Florida, 32256, United States

  • Texas Dermatology and Laser Specialists

    San Antonio, Texas, 78218, United States

  • Total Skin and Beauty Dermatology Center, PC

    Birmingham, Alabama, 35205, United States

  • UConn Health

    Farmington, Connecticut, 06030-2840, United States

  • University of California Davis (UC Davis) Comprehensive Cancer Center

    Sacramento, California, 95816, United States

  • Virginia Clinical Research, Inc.

    Norfolk, Virginia, 23502, United States

  • Wallace Medical Group, Inc.

    Los Angeles, California, 90056, United States

  • Washington University School of Medicine

    St Louis, Missouri, 63110, United States

  • Wilmington Health Family Medicine

    Wilmington, North Carolina, 28411, United States

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