Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)
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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. |
ClinicalTrials.gov Identifier: NCT04250350 |
Recruitment Status :
Active, not recruiting
First Posted : January 31, 2020
Last Update Posted : September 2, 2021
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Biological: Lebrikizumab | Phase 3 |
Study Type : | Interventional (Clinical Trial) |
Estimated Enrollment : | 200 participants |
Allocation: | N/A |
Intervention Model: | Single Group Assignment |
Masking: | None (Open Label) |
Primary Purpose: | Treatment |
Official Title: | An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis |
Actual Study Start Date : | February 11, 2020 |
Estimated Primary Completion Date : | April 13, 2022 |
Estimated Study Completion Date : | July 6, 2022 |

Arm | Intervention/treatment |
---|---|
Experimental: Lebrikizumab
every 2 weeks (Q2W)
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Biological: Lebrikizumab
Subcutaneous injection
Other Names:
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- Percentage of Participants Discontinued from Study Treatment Due to Adverse Events [ Time Frame: Baseline to Week 52 ]Percentage of Participants Discontinued from Study Treatment Due to Adverse Events
- Percentage of Participants with an Investigator Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2-points from Baseline [ Time Frame: Week 52 ]Percentage of Participants with an IGA Score of 0 or 1 and a Reduction ≥2-points from Baseline
- Percentage of Participants Achieving ≥75% Reduction from Baseline in Eczema Area and Severity Instrument (EASI) Score (EASI75) [ Time Frame: Week 52 ]Percentage of Participants Achieving EASI75
- Percentage Change from Baseline in EASI score [ Time Frame: Baseline, Week 52 ]Percentage Change from Baseline in EASI score
- Percentage of Participants Achieving EASI-50 (≥50 reduction from Baseline in EASI score) [ Time Frame: Week 52 ]Percentage of Participants Achieving EASI-50 (≥50 reduction from Baseline in EASI score)
- Percentage of Participants Achieving EASI-90 (≥90% reduction from baseline in EASI score) [ Time Frame: Week 52 ]Percentage of Participants Achieving EASI-90 (≥90% reduction from baseline in EASI score)
- Change from Baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Week 52 ]Change from Baseline in BSA
- Change from Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety and Depression Measures [ Time Frame: Baseline, Week 52 ]Change from Baseline in Patient-Reported Outcomes Information System (PROMIS) Anxiety and Depression Measures
- Change from Baseline in Dermatology Life Quality Index (DLQI)/Children's Dermatology Life Quality Index (CDLQI) [ Time Frame: Baseline, Week 52 ]Change from Baseline in DLQI/CDLQI
- Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab [ Time Frame: Baseline through Week 52 ]PK: Average Serum Concentration of Lebrikizumab

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 12 Years to 17 Years (Child) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
- Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
- Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
- ≥10% body surface area (BSA) of AD involvement at the baseline visit.
- History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
Exclusion Criteria:
- Participation in a prior lebrikizumab clinical study.
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Treatment with the following prior to the baseline visit:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
- Dupilumab within 8 weeks.
- B-cell-depleting biologics, including to rituximab, within 6 months.
- Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
- Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
- Uncontrolled chronic disease that might require bursts of oral corticosteroids.
- Evidence of active acute or chronic hepatitis
- History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
- History of malignancy, including mycosis fungoides, within 5 years before the screening visit, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin.
- Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04250350

Study Director: | Call 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 Mon - Fri 9 AM - 5 PM Eastern time (UTC/GMT - 5 hours, EST) | Eli Lilly and Company |
Responsible Party: | Eli Lilly and Company |
ClinicalTrials.gov Identifier: | NCT04250350 |
Other Study ID Numbers: |
17804 J2T-DM-KGAE ( Other Identifier: Eli Lilly and Company ) DRM06-AD17 ( Other Identifier: Dermira, Inc ) 2019-004301-28 ( EudraCT Number ) |
First Posted: | January 31, 2020 Key Record Dates |
Last Update Posted: | September 2, 2021 |
Last Verified: | August 15, 2021 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | Yes |
Plan Description: | Anonymized individual patient level data will be provided in a secure access environment upon approval of a research proposal and a signed data sharing agreement. |
Supporting Materials: |
Study Protocol Statistical Analysis Plan (SAP) Clinical Study Report (CSR) |
Time Frame: | Data are available 6 months after the primary publication and approval of the indication studied in the US and European Union (EU), whichever is later. Data will be indefinitely available for requesting. |
Access Criteria: | A research proposal must be approved by an independent review panel and researchers must sign a data sharing agreement. |
URL: | https://vivli.org/ |
Studies a U.S. FDA-regulated Drug Product: | Yes |
Studies a U.S. FDA-regulated Device Product: | No |
Eczema Dermatitis Dermatitis, Atopic Skin Diseases |
Dermatitis, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |