New shot could tame tough eczema Flare-Ups

NCT ID NCT06280716

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

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

Summary

This phase 3 trial tests a drug called lebrikizumab, given as a shot, for people with moderate-to-severe eczema that hasn't improved with standard creams. Some participants also use a steroid cream. The study involves 301 adults and lasts about 62 weeks. Researchers are checking if the drug clears skin and reduces itching better than a placebo.

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 biologic drug given as a shot) and topical corticosteroid cream
What this could lead to: If it works, this could offer a new treatment option for people with moderate-to-severe eczema that hasn't responded to standard creams.
What could go wrong: This is a late-stage trial, but results are not yet available. The drug may not work for everyone, and side effects like injection reactions or infections are possible.

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

301 people

The number who actually took part.

Started

Apr 2024

Expected to finish

Aug 2026

An estimate. End dates often move.

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: * Have chronic AD that has been present for ≥1 year before the screening period or have chronic eczema and meet the AAD criteria. * Have moderate-to-severe AD, including all of the following at the baseline: EASI score ≥16, IGA score ≥3 (scale of 0 to 4), ≥10% BSA of AD involvement. * Have a documented history provided by a physician and/or investigator of inadequate response to existing topical medications within 6 months preceding screening as defined by at least 1 of the following: 1. Inability to achieve good disease control, defined as mild disease or better after use of at least a medium-potency TCS for at least 4 weeks, or for the maximum duration recommended by the product prescribing information, whichever is shorter. TCS may be used with or without TCIs and/or topical Janus kinase (JAK) inhibitors. 2. Participants who failed systemic therapies intended to treat AD within 6 months preceding screening, such as cyclosporine, MTX, azathioprine, and MMF, will also be considered as surrogates for having inadequate response to topical therapy. * Adolescents body weight must be ≥40 kg at baseline. * Males may participate in this trial and comply with specific local government study requirements. Females of childbearing potential and females not of childbearing potential may participate in this trial. Exclusion Criteria: * Have received a dose of lebrikizumab in any prior lebrikizumab clinical study. * Have a history of anaphylaxis or uncontrolled chronic disease that might require bursts of oral corticosteroids. * Have a current or recent acute, active infection. For at least 30 days before screening and up to the randomization, participants must have no symptoms or signs of confirmed or suspected infection and must have completed any appropriate anti-infective treatment. * Have had Serious, Opportunistic, Chronic and Recurring infection within 3 months prior to the screening or develops any of these infections before the randomization. * Have active tuberculosis (TB) or latent tuberculosis infection (LTBI) that has not been treated with a complete course of appropriate therapy or such treatment is underway. * Have a current infection with HBV, HCV, human immunodeficiency virus (HIV) infection. * Have presence of skin comorbidities that may interfere with study assessments. * Have a diagnosis or history of malignant disease within 5 years before screening, with the following exceptions: 1. basal cell or squamous epithelial carcinomas of the skin that have been resected with no evidence of metastatic disease for 3 years, and 2. cervical carcinoma in situ, with no evidence of recurrence within 5 years before screening visit. * Pregnant or breastfeeding women or women planning to become pregnant or breastfeed during the study.

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Conditions

The condition(s) this trial relates to.

atopic eczema

As listed by the trial registrant

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

Atopic dermatitis

Contacts and locations

Locations

Affiliated Hospital of Jiangsu University

Zhenjiang, Jiangsu, 212000, China
Asan Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 05505, South Korea
Beijing Children's hospital, Capital Medical University

Beijing, Beijing Municipality, 100045, China
Beijing Friendship Hospital Affiliate of Capital University

Beijing, Beijing Municipality, 100050, China
Beijing Tongren Hospital affiliated to Capital Medical University

Beijing, Beijing Municipality, 100730, China
Beijing Tsinghua Changgung Hospital

Beijing, Beijing Municipality, 102202, China
Children's Hospital of Shanxi

Taiyuan, Shanxi, 030013, China
China-Japan Friendship Hospital

Beijing, Beijing Municipality, 100029, China
Guangdong Province Dermatology Hospital

Guangzhou, Guangdong, 510018, China
Hainan General Hospital

Haikou, Hainan, 570311, China
Hallym University Kangnam Sacred Heart Hospital

Seoul, Seoul-teukbyeolsi [Seoul], 07441, South Korea
Huashan Hospital, Fudan University

Shanghai, Shanghai Municipality, 200040, China
Hunan Children's Hospital

Changsha, Hunan, 410007, China
Korea University Ansan Hospital

Ansan-si, Kyǒnggi-do, 15355, South Korea
National Medical Center

Seoul, Seoul-teukbyeolsi [Seoul], 01812, South Korea
Peking University People's Hospital

Beijing, Beijing Municipality, 100034, China
Peking University Shenzhen Hospital

Shenzhen, Guangdong, 518036, China
Peking University Third Hospital

Beijing, Beijing Municipality, 100091, China
Renmin Hospital of Wuhan University

Wuhan, Hubei, 430060, China
Shanghai Sixth People's Hospital

Shanghai, Shanghai Municipality, 200030, China
Shanghai Skin Disease Hospital

Shanghai, 200071, China
Shanghai Tenth People's Hospital

Shanghai, Shanghai Municipality, 200072, China
Shenzhen Children's Hospital

Shenzhen, Guangdong, 518026, China
Sir Run Run Shaw Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310016, China
The Catholic University of Korea, Incheon St. Mary's Hospital

Bupyeong-gu, Incheon-gwangyeoksi [Incheon], 21431, South Korea
The Children's Hospital of Chongqing Medical University

Chongqing, Chongqing Municipality, 400065, China
The First Affiliated Hospital Of Fujian Medical University

Fuzhou, 350005, China
The First Affiliated Hospital of Soochow University

Suzhou, Jiangsu, 215006, China
The First Affiliated Hospital, Sun Yat-sen University

Guangzhou, Guangdong, 510180, China
The First Hospital of Hebei Medical University

Shijiazhuang, Hebei, 050031, China
The First Hospital of Jilin University

Changchun, Jilin, 130021, China
The First Hospital of Wuhan

Wuhan, Hubei, 430022, China
The First People's Hospital of Hangzhou

Hangzhou, Zhejiang, 310000, China
The Second Affiliated Hospital of Xi'an Jiaotong University

Xi'an, Shaanxi, 710004, China
The Second Hospital of Jilin University

Changchun, Jilin, 130000, China
The Second Xiangya Hospital of Central South University

Changsha, Hunan, 410011, China
The University of Hong Kong-Shenzhen Hospital

Shenzhen, Guangdong, 518053, China
The first Affiliated Hospital, Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310003, China
Tianjin Medical University General Hospital

Tianjin, Tianjin Municipality, 300052, China
Union Hospital Tongji Medical College Huazhong University of Science and Technology

Wuhan, Hubei, 430022, China
Wannan Medical College Yijishan Hospital

Wuhu, Anhui, 241001, China
West China Hospital, Sichuan University

Chengdu, Sichuan, 610041, China
Wuxi No.2 People's Hospital

Wuxi, Jiangsu, 214000, China
Xiangya Hospital Central South University

Changsha, Hunan, 410008, China
Zhejiang University School of Medicine - The Fourth Affiliated Hospital

Yiwu, Zhejiang, 322000, China
Zhongshan Hospital Fudan University (Xiamen Branch)

Xiamen, Fujian, 361015, China

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