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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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04250337
Recruitment Status : Recruiting
First Posted : January 31, 2020
Last Update Posted : October 19, 2020
Sponsor:
Collaborator:
Dermira, Inc. a wholly owned subsidiary of Eli Lilly and Company
Information provided by (Responsible Party):
Eli Lilly and Company

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.

Condition or disease Intervention/treatment Phase
Atopic Dermatitis Biological: Lebrikizumab Other: Placebo Other: Topical Corticosteroid Phase 3

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 225 participants
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
Official Title: 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
Actual Study Start Date : February 3, 2020
Estimated Primary Completion Date : August 4, 2021
Estimated Study Completion Date : October 13, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Eczema Steroids

Arm Intervention/treatment
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, as needed, based on treatment response.
Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06

Other: Topical Corticosteroid
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, as needed, based on treatment response
Other: Placebo
Subcutaneous injection

Other: Topical Corticosteroid
Topical Corticosteroid




Primary Outcome Measures :
  1. 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 ]
  2. Percentage of participants achieving EASI-75 (≥75% reduction from Baseline in EASI score) at Week 16. [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Percentage of participants achieving EASI-90 (≥90% reduction from Baseline in EASI score) at Week 16 [ Time Frame: Baseline to Week 16 ]
  2. Percentage change in Pruritus Numerical Rating Scale (NRS) score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  3. 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 ]
  4. Percentage change in EASI score from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]
  5. Change from Baseline to Week 16 in percent BSA [ Time Frame: Baseline, Week 16 ]
  6. Percentage of participants achieving EASI-90 at Week 4 [ Time Frame: Baseline to Week 4 ]
  7. 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

  8. 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

  9. 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 ]
  10. 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 ]
  11. 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 ]
  12. Proportion of TCS / TCI-free days from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  13. Time (days) to TCS / TCI-free use from Baseline to Week 16 [ Time Frame: Baseline to Week 16 ]
  14. Percentage Change in SCORing Atopic Dermatitis (SCORAD) from Baseline to Week 16 [ Time Frame: Baseline, Week 16 ]


Information from the National Library of Medicine

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.


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Ages Eligible for Study:   12 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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; 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.

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): NCT04250337


Contacts
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Contact: There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or 1-317-615-4559 clinicaltrials.gov@lilly.com

Locations
Show Show 68 study locations
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
Additional Information:
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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04250337    
Other Study ID Numbers: 17803
2019-004300-34 ( EudraCT Number )
J2T-DM-KGAD ( Other Identifier: Eli Lilly and Company )
DRM06-AD06 ( Other Identifier: Dermira, Inc. )
First Posted: January 31, 2020    Key Record Dates
Last Update Posted: October 19, 2020
Last Verified: October 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
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