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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
Sponsor:
Collaborator:
Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The purpose of this study is to evaluate the safety and efficacy of lebrikizumab compared with placebo in patients with moderate-to-severe atopic dermatitis.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Lebrikizumab Drug: Placebos Phase 2

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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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


Outcome Measures
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Primary Outcome Measures :
  1. Percent change in Eczema Area and Severity Index (EASI) from baseline to Week 16. [ Time Frame: Week 16 ]

Secondary Outcome Measures :
  1. Proportion of patients with a 75% improvement from baseline in EASI (EASI75) at Week 16. [ Time Frame: Week 16 ]
  2. 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 ]
  3. Proportion of patients with EASI <7 at Week 16. [ Time Frame: Week 16 ]
  4. Proportion of patients achieving EASI50 and EASI90 at Week 16. [ Time Frame: Week 16 ]
  5. Percent change in the sleep loss numerical rating scale (NRS) score from baseline to Week 16. [ Time Frame: Week 16 ]
  6. Percent change in pruritus NRS score from baseline to Week 16. [ Time Frame: Week 16 ]
  7. Proportion of patients with pruritus NRS change of ≥3 from baseline to Week 16. [ Time Frame: Week 16 ]
  8. Proportion of patients with pruritus NRS change of ≥4 from baseline to Week 16. [ Time Frame: Week 16 ]
  9. Change in Body Surface Area (BSA) involved with AD from baseline to Week 16. [ Time Frame: Week 15 ]
  10. Change from Baseline in Atopic Dermatitis Impact Questionnaire (ADIQ) score. [ Time Frame: Week 16 ]

Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

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


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company
Investigators
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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
More Information
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Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

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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/

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eli Lilly and Company:
Eczema
Additional relevant MeSH terms:
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Dermatitis, Atopic
Dermatitis
Eczema
Skin Diseases
Skin Diseases, Genetic
 Genetic Diseases, Inborn
Skin Diseases, Eczematous
Hypersensitivity, Immediate
Hypersensitivity
Immune System Diseases