Try the modernized ClinicalTrials.gov beta website. Learn more about the modernization effort.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    DRM06-AD06
Previous Study | Return to List | Next Study

Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis. (ADhere)

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: NCT04250337
Recruitment Status : Completed
First Posted : January 31, 2020
Last Update Posted : October 20, 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 October 20, 2021
Actual Study Start Date  ICMJE February 3, 2020
Actual Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 24, 2020)
  • The primary efficacy endpoint is the percentage of participants with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16. [ Time Frame: Baseline to Week 16 ]
  • Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 16. [ Time Frame: Baseline to Week 16 ]
Original Primary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
The primary efficacy endpoint is the percentage of patients with an IGA score of 0 or 1 and a reduction ≥2-points from Baseline to Week 16. [ Time Frame: Baseline to Week 16 ]
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: August 20, 2021)
  • Percentage of participants achieving EASI-90 (≥90% reduction from Baseline in EASI score) at Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  • Percentage of participants with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of participants with a Pruritus NRS of ≥5-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage change in EASI score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change from Baseline to Week 16 in percent BSA [ Time Frame: Baseline, Week 16 ]
  • Percentage of participants achieving EASI-90 at Week 4 [ Time Frame: Baseline to Week 4 ]
  • Percentage change in Sleep-loss score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
    Name of PRO: Sleep Loss Scale Minimum value (better outcome) = 0 Maximum value (worse outcome) = 4
  • Change from Baseline in Sleep-loss score at Week 16 [ Time Frame: Baseline, Week 16 ]
    Name of PRO: Sleep Loss Scale Minimum value (better outcome) = 0 Maximum value (worse outcome) = 4
  • Percentage of participants with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  • Percentage of participants with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  • Percentage of participants with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  • Percentage of participants with a Pruritus NRS of ≥5-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  • Percentage of participants with a Pruritus NRS of ≥5-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  • Percentage of participants with a Pruritus NRS of ≥5-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  • Proportion of TCS/topical calcineurin inhibitors (TCI) free days from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Median time (days) to TCS/TCI-free use from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change from baseline in Dermatology Life Quality Index (DLQI) at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Percentage of participants with a DLQI score ≥4 points at Baseline who achieve a ≥4 points [ Time Frame: Baseline to Week 16 ]
  • Change from Baseline in European Quality of Life-5 Dimensions (EQ-5D) at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change from Baseline in Patient Oriented Eczema Measure (POEM) at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change from Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Anxiety at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change from Baseline in PROMIS Depression at Week 16 [ Time Frame: Baseline, Week 16 ]
  • Change from Baseline in Asthma Control Questionnaire (ACQ-5) score at Week 16 in participants who have self-reported comorbid asthma [ Time Frame: Baseline, Week 16 ]
  • Change from Baseline in Children's Dermatology Life Quality Index (CDLQI) at Week 16 [ Time Frame: Baseline, Week 16 ]
Original Secondary Outcome Measures  ICMJE
 (submitted: January 30, 2020)
  • Percentage of patients achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 16. [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients achieving EASI-90 (≥90% reduction from Baseline in EASI score) at Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage change in EASI score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Change from Baseline to Week 16 in percent BSA [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients achieving EASI-90 at Week 4 [ Time Frame: Baseline to Week 4 ]
  • Percentage change in Sleep-loss score from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Change from Baseline in Sleep-loss score at Week 16 [ Time Frame: Baseline to Week 16 ]
  • Percentage of patients with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 4 [ Time Frame: Baseline to Week 4 ]
  • Percentage of patients with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 2 [ Time Frame: Baseline to Week 2 ]
  • Percentage of patients with a Pruritus NRS of ≥4-points at Baseline who achieve a ≥4-point reduction from Baseline to Week 1 [ Time Frame: Baseline to Week 1 ]
  • Proportion of TCS / TCI-free days from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  • Total amount of TCS used over the 16-week study period per patient [ Time Frame: Baseline to Week 16 ]
  • Time (days) to TCS / TCI-free use from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Safety and Efficacy of Lebrikizumab (LY3650150) in Combination With Topical Corticosteroid in Moderate-to-Severe Atopic Dermatitis.
Official Title  ICMJE A Randomized, Double-Blind, Placebo-Controlled Trial To Evaluate The Efficacy and Safety of Lebrikizumab When Used In Combination With Topical Corticosteroid Treatment In Patients With Moderate-To-Severe Atopic Dermatitis
Brief Summary This is a randomized, double-blind, placebo-controlled, parallel-group study which is 16 weeks in duration. The study is designed to evaluate the safety and efficacy of lebrikizumab when used in combination with topical corticosteroid (TCS) treatment compared with placebo in combination with TCS treatment for moderate-to-severe atopic dermatitis.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description:
Randomized, double-blind, parallel group, placebo controlled
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Atopic Dermatitis
Intervention  ICMJE
  • Biological: Lebrikizumab
    Subcutaneous injection
    Other Names:
    • LY3650150
    • DRM06
  • Other: Placebo
    Subcutaneous injection
  • Other: Topical Corticosteroid
    Topical Corticosteroid
Study Arms  ICMJE
  • Experimental: Lebrikizumab + Topical Corticosteroid
    Two subcutaneous (SC) injections of lebrikizumab as a loading dose at Baseline and Week 2 followed by a single injection of lebrikizumab every 2 weeks (Q2W) from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response.
    Interventions:
    • Biological: Lebrikizumab
    • Other: Topical Corticosteroid
  • Placebo Comparator: Placebo + Topical Corticosteroid
    Two subcutaneous (SC) injections of placebo as a loading dose at Baseline and Week 2 followed by a single injection of placebo every 2 weeks (Q2W) from Week 4 until Week 14. TCS will be initiated at Baseline in all participants and may be tapered or stopped, or restarted as needed, based on treatment response
    Interventions:
    • Other: Placebo
    • Other: Topical Corticosteroid
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 Completed
Actual Enrollment  ICMJE
 (submitted: October 19, 2021)
228
Original Estimated Enrollment  ICMJE
 (submitted: January 30, 2020)
200
Actual Study Completion Date  ICMJE September 16, 2021
Actual Primary Completion Date August 11, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  1. Male or female adult and adolescents (≥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.

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 and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Canada,   Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04250337
Other Study ID Numbers  ICMJE 17803
2019-004300-34 ( EudraCT Number )
J2T-DM-KGAD ( Other Identifier: Eli Lilly and Company )
DRM06-AD06 ( Other Identifier: Dermira, Inc. )
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 October 2021

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