A Long-term Study to Assess the Safety and Efficacy of Lebrikizumab in Patients With Moderate-to-Severe Atopic Dermatitis (ADjoin) (ADjoin)

  • STATUS
    Recruiting
  • End date
    Sep 30, 2024
  • participants needed
    1000
  • sponsor
    Eli Lilly and Company
Updated on 28 October 2022
hormonal contraception
progestogen
atopy
eczema
lebrikizumab
topical agents

Summary

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

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.

Details
Condition Atopic Dermatitis
Treatment Lebrikizumab
Clinical Study IdentifierNCT04392154
SponsorEli Lilly and Company
Last Modified on28 October 2022

Eligibility

Yes No Not Sure

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

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.)
An investigational drug within 8 weeks or within 5 half-lives (if known), whichever is longer
Phototherapy and photochemotherapy (PUVA) for AD
B Cell-depleting biologics, including rituximab, within 6 months
Other Biologics within 5 half-lives (if known) or 8 weeks, whichever is longer
Treatment with the following prior to baseline
Uncontrolled chronic disease that might require multiple intermittent uses of oral corticosteroids, e.g., co-morbid severe uncontrolled asthma, (as defined by the investigator)
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
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
Pregnant or breastfeeding women, or women planning to become pregnant or breastfeed during the study
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Additional screening procedures may be conducted by the study team before you can be confirmed eligible to participate.

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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