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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Lilly

Status and phase

Active, not recruiting
Phase 3

Conditions

Atopic Dermatitis

Treatments

Drug: Lebrikizumab

Study type

Interventional

Funder types

Industry

Identifiers

NCT05369403
18499
J2T-MC-KGBO (Other Identifier)

Details and patient eligibility

About

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.

Enrollment

120 estimated patients

Sex

All

Ages

12+ years old

Volunteers

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

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

120 participants in 1 patient group

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

Trial contacts and locations

42

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Central trial contact

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

Data sourced from clinicaltrials.gov

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