The trial is taking place at:

International Clinical Research | Murfreesboro, TN

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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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Status and phase

Active, not recruiting
Phase 3


Atopic Dermatitis


Drug: Lebrikizumab

Study type


Funder types



J2T-MC-KGBO (Other Identifier)

Details and patient eligibility


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.


120 estimated patients




12+ years old


No Healthy Volunteers

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

Trial design

Primary purpose




Interventional model

Single Group Assignment


None (Open label)

120 participants in 1 patient group

Experimental group
Participants will receive Lebrikizumab by subcutaneous (SC) injection.
Drug: Lebrikizumab

Trial contacts and locations



Central trial contact

There may be multiple sites in this clinical trial. 1-877-CTLILLY (1-877-285-4559) or

Data sourced from

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