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The trial is taking place at:
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Skin Care Physicians of Georgia | Macon, GA

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A Study of (LY3650150) Lebrikizumab to Assess the Safety and Efficacy of Adult and Adolescent Participants With Moderate-to-Severe Atopic Dermatitis and Skin of Color (ADmirable)

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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

NCT05372419
J2T-MC-KGBP (Other Identifier)
18500

Details and patient eligibility

About

The main purpose of this study is to determine the safety and efficacy lebrikizumab in adolescent and adult participants with moderate-to-severe atopic dermatitis (AD) and skin of color.

Enrollment

80 estimated patients

Sex

All

Ages

12+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Participants must be ≥12 years of age inclusive, at the time of signing the informed consent/assent.

  • Participants who are self-reported race other than White, including but not limited to persons who self-identify as Black or African American, American Indian or Alaska Native, Asian, Native Hawaiian, or Other Pacific Islander.

  • Participants who are Fitzpatrick phototype IV-VI

  • 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.

  • Are willing and able to comply with all clinic visits and study-related procedures and questionnaires.

  • Contraceptive use - Male and/or female

    • Male participants are not required to use any contraception except in compliance with specific local government study requirements.
    • Female participants of child-bearing potential: must 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 study drug. Women of non-child-bearing potential (non-WOCBP) may participate without any contraception requirements.

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 (HBsAg) 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 prior treatment with dupilumab

  • Had prior treatment with tralokinumab

  • Treatment with topical agents (corticosteroids, calcineurin inhibitors, JAK inhibitors, or phosphodiesterase-4 inhibitors) within 2 weeks prior to baseline.

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

    • systemic immunosuppressive/immunomodulating drugs (for example, systemic corticosteroids, cyclosporine, mycophenolate mofetil, IFN-gamma, azathioprine, methotrexate, and other immunosuppressants);
    • small molecules (for example, Janus Kinase (JAK) inhibitors);
    • phototherapy and photochemotherapy for AD.
  • History of malignancy, including mycosis fungoides or cutaneous T-cell lymphoma, within 5 years before the screening, except completely treated in situ carcinoma of the cervix of completely treated and resolved non-metastatic squamous or basal cell carcinoma of the skin with no evidence of recurrence in the past 12 weeks.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

80 participants in 1 patient group

Lebrikizumab
Experimental group
Description:
Participants will receive Lebrikizumab subcutaneously (SC).
Treatment:
Drug: Lebrikizumab

Trial contacts and locations

37

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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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