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Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis (ADore)

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
Sponsor:
Collaborator:
Dermira, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This is an open-label, single arm study of 52 weeks duration. The study will assess the safety and efficacy of lebrikizumab in adolescent participants (≥12 to <18 years weighing ≥40 kilograms) with moderate-to-severe atopic dermatitis (AD) who are candidates for systemic therapy.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Lebrikizumab Phase 3

Study Design
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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

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema

Arms and Interventions
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Arm Intervention/treatment
Experimental: Lebrikizumab
every 2 weeks (Q2W)
 Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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

  2. 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

  3. Percentage Change from Baseline in EASI score [ Time Frame: Baseline, Week 52 ]
    Percentage Change from Baseline in EASI score

  4. 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)

  5. 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)

  6. Change from Baseline in Body Surface Area (BSA) [ Time Frame: Baseline, Week 52 ]
    Change from Baseline in BSA

  7. 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

  8. 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

  9. Pharmacokinetics (PK): Average Serum Concentration of Lebrikizumab [ Time Frame: Baseline through Week 52 ]
    PK: Average Serum Concentration of Lebrikizumab


Eligibility Criteria
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Ages Eligible for Study:   12 Years to 17 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Male or female adolescent (≥12 years to <18 years, and weighing ≥40 kg).
  2. Chronic AD (according to American Academy of Dermatology Consensus Criteria) that has been present for ≥1 year before the screening visit.
  3. Eczema Area and Severity Index (EASI) score ≥16 at the baseline visit.
  4. Investigator Global Assessment (IGA) score ≥3 (scale of 0 to 4) at the baseline visit
  5. ≥10% body surface area (BSA) of AD involvement at the baseline visit.
  6. History of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.

Exclusion Criteria:

  1. Participation in a prior lebrikizumab clinical study.

  2. Treatment with the following prior to the baseline visit:

    1. An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
    2. Dupilumab within 8 weeks.
    3. B-cell-depleting biologics, including to rituximab, within 6 months.
    4. Other biologics within 5 half-lives (if known) or 16 weeks, whichever is longer.
  3. Treatment with a live (attenuated) vaccine within 12 weeks of the baseline visit or planned during the study.
  4. Uncontrolled chronic disease that might require bursts of oral corticosteroids.
  5. Evidence of active acute or chronic hepatitis
  6. History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  7. 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.
  8. Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
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): NCT04250350


Locations
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Sponsors and Collaborators
Eli Lilly and Company
Dermira, Inc.
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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Additional Information:

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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/

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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
Dermatitis
Dermatitis, Atopic
Skin Diseases
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