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A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab (ADapt)

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ClinicalTrials.gov Identifier: NCT05369403
Recruitment Status : Active, not recruiting
First Posted : May 11, 2022
Last Update Posted : April 16, 2024
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
The study will assess the safety and efficacy of lebrikizumab in adult and adolescent participants with moderate-to-severe atopic dermatitis (AD) previously treated with Dupilumab.

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

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 120 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-Label, Study to Evaluate the Safety and Efficacy of Lebrikizumab in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
Actual Study Start Date : December 19, 2022
Actual Primary Completion Date : January 11, 2024
Estimated Study Completion Date : December 2024

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
Participants will receive Lebrikizumab by subcutaneous (SC) injection.
 Drug: Lebrikizumab
Administered SC
Other Names:
  • LY3650150
  • DRM06


Outcome Measures
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Primary Outcome Measures :
  1. Percentage of Participants Achieving Eczema Area and Severity Index-75 (EASI-75) >75% Reduction in EASI Score [ Time Frame: Baseline to Week 16 ]

Secondary Outcome Measures :
  1. Percentage of Participants Achieving EASI-75 [ Time Frame: Baseline to Week 24 ]
  2. Percentage of Participants with an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction ≥2 Points from Baseline [ Time Frame: Baseline to Week 16 ]
  3. Percentage of Participants with an IGA Score of 0 or 1 and a Reduction ≥2 Points from Baseline [ Time Frame: Baseline to Week 24 ]
  4. Percentage Change from Baseline in EASI [ Time Frame: Baseline, Week 16 ]
  5. Percentage Change from Baseline in EASI [ Time Frame: Baseline, Week 24 ]
  6. Change from Baseline in EASI [ Time Frame: Baseline, Week 16 ]
  7. Change from Baseline in EASI [ Time Frame: Baseline, Week 24 ]
  8. Percentage of Participants Achieving EASI-90 (≥90% Reduction in EASI Score) from Baseline [ Time Frame: Baseline to Week 16 ]
  9. Percentage of Participants Achieving EASI-90 from Baseline [ Time Frame: Baseline to Week 24 ]
  10. Percentage of Participants with a Pruritus Numeric Rating Scale (NRS) of ≥4 points at Baseline Who Achieve at least 4-point Reduction [ Time Frame: Baseline to Week 16 ]
  11. Percentage of Participants with a Pruritus NRS of ≥4 points at Baseline Who Achieve at least 4-point Reduction [ Time Frame: Baseline to Week 24 ]
  12. Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction [ Time Frame: Baseline to Week 16 ]
  13. Percentage of Participants with a Pruritus NRS of ≥3 points at Baseline Who Achieve at least 3-point Reduction [ Time Frame: Baseline to Week 24 ]
  14. Percentage Change from Baseline in Pruritus NRS Score [ Time Frame: Baseline, Week 16 ]
  15. Percentage Change from Baseline in Pruritus NRS Score [ Time Frame: Baseline, Week 24 ]
  16. Percentage of Participants with a Sleep-Loss Scale of ≥2 points at Baseline Who Achieve at least 2-point Reduction [ Time Frame: Baseline to Week 16 ]
  17. Percentage of Participants with a Sleep-Loss Scale of ≥2 points at Baseline Who Achieve at least 2-point Reduction [ Time Frame: Baseline to Week 24 ]
  18. Change from Baseline in Sleep-Loss Scale [ Time Frame: Baseline, Week 16 ]
  19. Change from Baseline in Sleep-Loss Scale [ Time Frame: Baseline, Week 24 ]
  20. Change from Baseline in Skin Pain NRS [ Time Frame: Baseline, Week 16 ]
  21. Change from Baseline in Skin Pain NRS [ Time Frame: Baseline, Week 24 ]
  22. Change from Baseline in Dermatology Life Quality Index (DLQI) [ Time Frame: Baseline, Week 16 ]
    Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.

  23. Change from Baseline in DLQI [ Time Frame: Baseline, Week 24 ]
    Participants ≥16 years will complete the DLQI and should continue to complete the DLQI for the duration of the study.

  24. Change from Baseline in Children's Dermatology Life Quality Index (cDLQI) [ Time Frame: Baseline, Week 16 ]
    Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.

  25. Change from Baseline in cDLQI [ Time Frame: Baseline, Week 24 ]
    Participants <16 years will complete the cDLQI and should continue to complete the cDLQI for the duration of the study.

  26. Percentage Change from Baseline in SCORing Atopic Dermatitis (SCORAD) [ Time Frame: Baseline, Week 16 ]
  27. Percentage Change from Baseline in SCORAD [ Time Frame: Baseline, Week 24 ]

Eligibility Criteria
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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:

  • All participants must have prior treatment with dupilumab meeting one of the following conditions:

    • Participants who stopped dupilumab treatment due to non-response, partial response, loss of efficacy must have been previously treated with dupilumab (at labeled dose level) for at least 4 months.
    • Participants who stopped dupilumab treatment due to intolerance or adverse events (AEs) to the drug may enter the study with no required prior length of dupilumab treatment.
    • Participants who stopped dupilumab treatment due to cost or loss of access to dupilumab (for example, insurance coverage) may enter the study with no required prior length of dupilumab treatment.
  • Participants who have chronic AD that has been present for ≥1 year before screening.
  • Have EASI ≥16 at baseline
  • Have IGA score ≥3 (Scale of 0 to 4) at baseline
  • Have ≥10% body surface area (BSA) of AD involvement at baseline
  • Have a history of inadequate response to treatment with topical medications; or determination that topical treatments are otherwise medically inadvisable.
  • Adolescents body weight must be ≥40 kg at baseline.

Exclusion Criteria:

  • History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  • Have a current infection or chronic infection with hepatitis B virus (HBV) at screening (that is, positive for hepatitis B surface antigen and/or polymerase chain reaction positive for HBV DNA
  • Have a current infection with hepatitis C virus (HCV) at screening (that is, positive for HCV RNA
  • Have an uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids at screening, as defined by the investigator.

  • Have uncontrolled asthma that

    • might require bursts of oral or systemic corticosteroids, or

    • required the following due to ≥1 exacerbations within 12 months before baseline

      • systemic (oral and/or parenteral) corticosteroid treatment, or
      • hospitalization for >24 hours.
  • Have known liver cirrhosis and/or chronic hepatitis of any etiology.
  • Had Dupilumab treatment within 4 weeks prior to baseline
  • Had prior treatment with tralokinumab.
  • Treatment with topical agents: corticosteroids, calcineurin inhibitors, Janus Kinase (JAK) inhibitors, or phosphodiesterase-4 inhibitors, such as crisaborole within 2 weeks prior to baseline

  • Treatment with any of the following agents within 4 weeks prior to the baseline

    • systemic immunosuppressive or immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants)
    • small molecules (e.g. JAK inhibitors)
    • phototherapy and photochemotherapy for AD
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): NCT05369403


Locations
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Sponsors and Collaborators
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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Additional Information:

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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT05369403    
Other Study ID Numbers: 18499
J2T-MC-KGBO ( Other Identifier: Eli Lilly and Company )
First Posted: May 11, 2022    Key Record Dates
Last Update Posted: April 16, 2024
Last Verified: April 2024
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Anonymized individual participant 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: http://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