A Study of Lebrikizumab (LY3650150) in Patients With Moderate-to-Severe Atopic Dermatitis
![]() |
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: NCT03443024 |
Recruitment Status :
Completed
First Posted : February 22, 2018
Last Update Posted : July 16, 2020
|
- Study Details
- Tabular View
- No Results Posted
- Disclaimer
- How to Read a Study Record
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Atopic Dermatitis | Biological: Lebrikizumab Drug: Placebos | Phase 2 |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 280 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Masking: | Triple (Participant, Investigator, Outcomes Assessor) |
Primary Purpose: | Treatment |
Official Title: | A Randomized, Double-Blind, Placebo-Controlled, Dose-Ranging Trial to Evaluate the Efficacy and Safety of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis |
Actual Study Start Date : | January 30, 2018 |
Actual Primary Completion Date : | February 7, 2019 |
Actual Study Completion Date : | May 23, 2019 |

Arm | Intervention/treatment |
---|---|
Experimental: Group 1
Lebrikizumab, 125 mg every 4 weeks
|
Biological: Lebrikizumab
Sterile liquid solution injected subcutaneously
Other Name: LY3650150 |
Experimental: Group 2
Lebrikizumab, 250 mg every 4 weeks
|
Biological: Lebrikizumab
Sterile liquid solution injected subcutaneously
Other Name: LY3650150 |
Experimental: Group 3
Lebrikizumab, 250 mg every 2 weeks
|
Biological: Lebrikizumab
Sterile liquid solution injected subcutaneously
Other Name: LY3650150 |
Placebo Comparator: Group 4
Placebos, every 2 weeks
|
Drug: Placebos
Solution injected subcutaneously |
- Percent change in Eczema Area and Severity Index (EASI) from baseline to Week 16. [ Time Frame: Week 16 ]
- Proportion of patients with a 75% improvement from baseline in EASI (EASI75) at Week 16. [ Time Frame: Week 16 ]
- Proportion of patient with an IGA score of 0 (clear) or 1 (almost clear) and a reduction ≥2 points from baseline to Week 16 (5-point scale). [ Time Frame: Week 16 ]
- Proportion of patients with EASI <7 at Week 16. [ Time Frame: Week 16 ]
- Proportion of patients achieving EASI50 and EASI90 at Week 16. [ Time Frame: Week 16 ]
- Percent change in the sleep loss numerical rating scale (NRS) score from baseline to Week 16. [ Time Frame: Week 16 ]
- Percent change in pruritus NRS score from baseline to Week 16. [ Time Frame: Week 16 ]
- Proportion of patients with pruritus NRS change of ≥3 from baseline to Week 16. [ Time Frame: Week 16 ]
- Proportion of patients with pruritus NRS change of ≥4 from baseline to Week 16. [ Time Frame: Week 16 ]
- Change in Body Surface Area (BSA) involved with AD from baseline to Week 16. [ Time Frame: Week 15 ]
- Change from Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) score. [ Time Frame: Week 16 ]

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: | 18 Years and older (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
Inclusion Criteria:
- Male or female, 18 years or older.
- Chronic AD as defined by Hanifin and Rajka (1980) that has been present for ≥1 year before the screening visit .
- Eczema Area and Severity Index (EASI) score ≥16 at the screening and the baseline visit.
- Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the screening and the baseline visit.
- ≥10% body surface area (BSA) of AD involvement at the screening and the baseline visit.
Exclusion Criteria:
- Treatment with any of the following agents within 4 weeks prior to the baseline visit:
- Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
- Phototherapy and photochemotherapy (PUVA) for AD.
- Treatment with topical corticosteroids (TCS) or topical calcineurin inhibitors (TCI) within 1 week prior to the baseline visit.
- Treatment with:
- An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer, prior to the baseline visit.
- Dupilumab within 3 months prior to baseline visit.
- Cell-depleting biologics, including rituximab, within 6 months prior to the baseline visit.
- Other biologics within 5 half-lives (if known) or 16 weeks prior to baseline visit (whichever is longer).
- Use of prescription moisturizers within 7 days of the baseline visit.

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): NCT03443024

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: | NCT03443024 |
Other Study ID Numbers: |
17826 J2T-DM-KGAF ( Other Identifier: Eli Lilly and Company ) DRM06-AD01 ( Other Identifier: Dermira, Inc ) |
First Posted: | February 22, 2018 Key Record Dates |
Last Update Posted: | July 16, 2020 |
Last Verified: | July 2020 |
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 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, Atopic Dermatitis Eczema Skin Diseases Skin Diseases, Genetic |
Genetic Diseases, Inborn Skin Diseases, Eczematous Hypersensitivity, Immediate Hypersensitivity Immune System Diseases |