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

Enrolling
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

48

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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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