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)

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.