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Trial record 1 of 1 for:    DRM06-AD17
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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

Tracking Information
First Submitted Date  ICMJE January 30, 2020
First Posted Date  ICMJE January 31, 2020
Last Update Posted Date September 2, 2021
Actual Study Start Date  ICMJE February 11, 2020
Estimated Primary Completion Date April 13, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
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
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Number of adverse events from Baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
  • Number of subjects with adverse events from Baseline to Week 52 [ Time Frame: Baseline to Week 52 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 30, 2021)
  • 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
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study to Assess the Safety and Efficacy of Lebrikizumab (LY3650150) in Adolescent Participants With Moderate-to-Severe Atopic Dermatitis
Official Title  ICMJE An Open-Label, Single-Arm Study to Assess the Safety and Efficacy of Lebrikizumab in Adolescent Patients With Moderate-to-Severe Atopic Dermatitis
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06
Study Arms  ICMJE Experimental: Lebrikizumab
every 2 weeks (Q2W)
Intervention: Biological: Lebrikizumab
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Active, not recruiting
Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
200
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE July 6, 2022
Estimated Primary Completion Date April 13, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 12 Years to 17 Years   (Child)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Australia,   Canada,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250350
Other Study ID Numbers  ICMJE 17804
J2T-DM-KGAE ( Other Identifier: Eli Lilly and Company )
DRM06-AD17 ( Other Identifier: Dermira, Inc )
2019-004301-28 ( EudraCT Number )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
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
Supporting Materials: Statistical Analysis Plan (SAP)
Supporting Materials: 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/
Responsible Party Eli Lilly and Company
Study Sponsor  ICMJE Eli Lilly and Company
Collaborators  ICMJE Dermira, Inc.
Investigators  ICMJE
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
PRS Account Eli Lilly and Company
Verification Date August 15, 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP