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

• Status: Not yet recruiting
• Trial end date: 2024-05-23
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Eli Lilly and Company

Criteria

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.