Phase III ECZTRA 6 trial of Adtralza meets its primary endpoints at 16 weeks for atopic dermatitis.- LEO Pharma
The 16-week initial treatment period of the ECZTRA 6 trial (NCT03526861) assessed the efficacy and safety of tralokinumab 150 mg (n=98) or 300 mg (n=97) every two weeks (Q2W) compared to placebo (n=94) in adolescents. At week 16, tralokinumab met its primary and secondary endpoints, showing that significantly more patients treated with tralokinumab achieved a clinical response, compared to placebo, defined as achieving an IGA 0/1 and/or an EASI 751: 21.4% (p<0.001) of the tralokinumab 150 mg group and 17.5% (p="0.002)" of the tralokinumab 300 mg group achieved clear or almost-clear skin compared to 4.3% with placebo as measured by iga. in addition, 28.6% (p><0.001) of the tralokinumab 150 mg group and 27.8% (p="0.001)" of the tralokinumab 300 mg group achieved 75% or greater disease improvement from baseline compared to 6.4% with placebo as measured by easi.></0.001)></0.001)>
Secondary endpoints were all met, addressing extent and severity of atopic dermatitis (SCORAD), achieving at least a 4-point improvement in adolescent weekly average worst daily pruritus NRS score, and health-related quality of life related to dermatological conditions (CDLQI). The safety and tolerability of tralokinumab compared with placebo, when used to treat adolescents with moderate-to-severe atopic dermatitis, was also investigated. The overall frequency and severity of adverse events (AEs) in the trial were comparable across the treatment groups over 16 weeks (67% for tralokinumab 150 mg, 65% for tralokinumab 300 mg, and 62% for placebo). The week 16 results were shared during the 2021 Fall Clinical Dermatology Conference held virtually and with a hybrid option in Las Vegas.
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