Dermatology Clinical Research Center of San Antonio | San Antonio, TX
Status and phase
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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
Sex
Ages
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
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
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:
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.
Primary purpose
Allocation
Interventional model
Masking
80 participants in 1 patient group
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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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