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Long-term Safety and Efficacy Study of Lebrikizumab (LY3650150) in Participants With Moderate-to-Severe Atopic Dermatitis (ADjoin) (ADjoin)

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ClinicalTrials.gov Identifier: NCT04392154
Recruitment Status : Recruiting
First Posted : May 18, 2020
Last Update Posted : March 4, 2021
Sponsor:
Collaborator:
Dermira, Inc.
Information provided by (Responsible Party):
Eli Lilly and Company

Study Description
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Brief Summary:
This 110-week study is designed to assess the long-term safety and efficacy of lebrikizumab for moderate-to-severe atopic dermatitis.

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

Detailed Description:

Participants who have completed participation in a Dermira- or Lilly-sponsored lebrikizumab study (parent study), DRM06-AD04, DRM06-AD05, DRM06-AD06, DRM06-AD17 or DRM06- AD18, will be offered the opportunity to enroll in this study. Participants may either be blinded or not blinded, depending on their parent study assignment.

This study will also be open to an additional approximately 100 participants in the United States (addendum) who have not completed participation in a Dermira- or Lilly-sponsored lebrikizumab study. Treatment will not be blinded.

Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1000 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin)
Actual Study Start Date : June 15, 2020
Estimated Primary Completion Date : May 30, 2024
Estimated Study Completion Date : May 30, 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 Q2W (Open-Label) from Parent Study
Participants assigned to lebrikizumab Q2W (once every 2 weeks) arm will receive investigational product Q2W by subcutaneous (SC) injection.
 Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06
Experimental: Lebrikizumab Q2W (Blinded) from Parent Study
Participants assigned to lebrikizumab Q2W arm will receive investigational product Q2W by SC injection. Some participants will receive loading doses.
 Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06
Experimental: Lebrikizumab Q2W (Open-Label Addendum)
Participants enrolling in Open-Label Addendum will receive lebrikizumab Q2W by SC injection after loading doses.
 Biological: Lebrikizumab
Subcutaneous injection
Other Names:
  • LY3650150
  • DRM06
Experimental: Lebrikizumab Q4W

Participants assigned to lebrikizumab Q4W (once every 4 weeks) arm will receive investigational product Q4W by SC injection.

Intervention assigned: Lebrikizumab balanced with Placebo to maintain the blind between treatment arms.

 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 through the Last Treatment Visit [ Time Frame: Baseline to Week 100 ]

Secondary Outcome Measures :
  1. Percentage of Participants with a Response of Investigator Global Assessment (IGA) Score 0 or 1 [ Time Frame: Baseline to Week 100 ]
  2. Percentage of Participants Achieving Response of Eczema Area and Severity Index-75 (EASI-75) from Baseline of Parent Study [ Time Frame: Baseline to Week 100 ]

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 for participants coming from a parent study:

Participants must meet all the following criteria to be eligible for this study:

  • Received treatment in a lebrikizumab study, NCT04146363, NCT04178967, NCT04250337, NCT04250350 and have adequately completed the study treatments and last patient visit of the parent trial.
  • For women of childbearing potential: agree to remain abstinent (refrain from heterosexual intercourse) or use a highly effective contraceptive method during the treatment period and for at least 18 weeks after the last dose of lebrikizumab or placebo.

Exclusion Criteria for participants coming from a parent study:

Participants meeting any of the criteria below will not be included in this study:

  • Participants who, during their participation in the parent trial, developed a serious adverse event (SAE) deemed related to lebrikizumab, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. *
  • Participants who, during their participation in the parent trial, developed an AE that was deemed related to lebrikizumab and led to study treatment discontinuation, which in the opinion of the investigator or of the medical monitor could indicate that continued treatment with lebrikizumab may present an unreasonable risk for the participant. *
  • Conditions in the previous parent study consistent with protocol-defined criteria for permanent study drug discontinuation, if deemed related to lebrikizumab or led to investigator - or sponsor-initiated withdrawal of participant from the study (e.g., non-compliance, inability to complete study assessments, etc.). *
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.

Open-Label Addendum Inclusion Criteria:

Participants must meet all the following criteria to be eligible for this study addendum:

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

Open-Label Addendum Exclusion Criteria:

Participants meeting any of the criteria below will be excluded from this study addendum:

  • Have received a dose of lebrikizumab in any prior lebrikizumab clinical study.
  • History of anaphylaxis
  • Treatment with topical prescription moisturizers, corticosteroids, calcineurin inhibitors, or phosphodiesterase-4 inhibitors such as crisaborole within 1 week prior to baseline.

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

    • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
    • Phototherapy and photochemotherapy (PUVA) for AD.

  • Treatment with the following prior to baseline:

    • Immunosuppressive/immunomodulating drugs (e.g., systemic corticosteroids, cyclosporine, mycophenolate-mofetil, IFN-γ, Janus kinase inhibitors, azathioprine, methotrexate, etc.)
    • Phototherapy and photochemotherapy (PUVA) for AD.

  • Treatment with the following prior to baseline:

    • An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer.
    • B Cell-depleting biologics, including rituximab, within 6 months.
    • Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer.
  • Regular use (more than 2 uses per week) of a tanning booth/parlor within 4 weeks of baseline.
  • Treatment with a live (attenuated) vaccine within 12 weeks of the baseline or planned during the study.
  • Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator).
  • Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study.
  • Evidence of active acute or chronic hepatitis
  • History of human immunodeficiency virus (HIV) infection or positive HIV serology at screening.
  • History of malignancy, including mycosis fungoides, within 5 years before screening, except completely treated in situ carcinoma of the cervix, completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.
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): NCT04392154


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
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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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Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT04392154    
Other Study ID Numbers: 17789
2020-001211-24 ( EudraCT Number )
J2T-DM-KGAA ( Other Identifier: Eli Lilly and Company )
DRM06-AD07 ( Other Identifier: Dermira, Inc. (A wholly owned subsidiary of Lilly) )
First Posted: May 18, 2020    Key Record Dates
Last Update Posted: March 4, 2021
Last Verified: March 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 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