Summary

Eligibility
for people ages 12 years and up (full criteria)
Location
at San Francisco, California and other locations
Dates
study started
estimated completion
Principal Investigator
by Tina Bhutani
Headshot of Tina Bhutani
Tina Bhutani

Description

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.

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

Keywords

Atopic Dermatitis, Eczema, Dermatitis, Lebrikizumab

Eligibility

You can join if…

Open to people ages 12 years and up

  • 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.

You CAN'T join if...

  • 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

Locations

  • UCSF Medical Center at Mission Bay not yet accepting patients
    San Francisco California 94115 United States
  • Center For Dermatology Clinical Research, Inc. not yet accepting patients
    Fremont California 94538 United States

Lead Scientist at UCSF

  • Tina Bhutani
    I am a dermatologist and clinical researcher in the Department of Dermatology at UCSF. I serve as co-director of the Psoriasis and Skin Treatment Center, a world-renowned clinic dedicated to the care of patients with psoriasis.

Details

Status
accepting new patients at some sites,
but this study is not currently recruiting here
Start Date
Completion Date
(estimated)
Sponsor
Eli Lilly and Company
Links
A Study of Lebrikizumab (LY3650150) in Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis Previously Treated With Dupilumab
ID
NCT05369403
Phase
Phase 3 Atopic Dermatitis (Eczema) Research Study
Study Type
Interventional
Participants
Expecting 120 study participants
Last Updated