A 2-year Open-label Extension Study to Assess the Long-term Safety and Efficacy of Lebrikizumab in Adult and Adolescent Patients with Moderate-to-Severe Atopic Dermatitis

Conditions

Atopic Dermatitis

Brief summary

Proportion of patients discontinued from study treatment due to treatment-emergent AEs through the last study visit.

Detailed description

Percentage of patients with EASI 50, EASI 75, and EASI 90 (≥50%, ≥75%, and ≥90% reduction in EASI scores from baseline of parent study, respectively) by visit., Percentage change from baseline of parent study in EASI score by visit., Percentage of patients with EASI score ≤7 by visit., Percentage of patients achieving IGA 0/1 by visit., Percentage of patients achieving Pruritus NRS score of 0/1 by visit., Percentage of patients achieving Pruritus NRS score ≤4 by visit., Percentage change from baseline of parent study* in POEM by visit., Percentage change from baseline of parent study* in BSA involvement by visit., Proportion of TCS-free days from baseline by visit., Percentage of patients with DLQI ≥4 at baseline achieving ≥ 4-point improvement from baseline of parent study in DLQI score by visit, Percentage of patients with CDLQI ≥6 at baseline achieving ≥6-point improvement from baseline of parent study* in CDLQI score by visit., Percentage of participants achieving DLQI ≤5 by visit, Percentage of participants achieving CDLQI ≤6 by visit.

Related papers

No related papers found yet.

Interventions

DRUGLebrikizumab

Eligibility

Sex/Gender

All

Age

0 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Proportion of patients discontinued from study treatment due to treatment-emergent AEs through the last study visit.	—

Secondary

Measure	Time frame
Percentage of patients with EASI 50, EASI 75, and EASI 90 (≥50%, ≥75%, and ≥90% reduction in EASI scores from baseline of parent study, respectively) by visit., Percentage change from baseline of parent study in EASI score by visit., Percentage of patients with EASI score ≤7 by visit., Percentage of patients achieving IGA 0/1 by visit., Percentage of patients achieving Pruritus NRS score of 0/1 by visit., Percentage of patients achieving Pruritus NRS score ≤4 by visit., Percentage change from baseline of parent study* in POEM by visit., Percentage change from baseline of parent study* in BSA involvement by visit., Proportion of TCS-free days from baseline by visit., Percentage of patients with DLQI ≥4 at baseline achieving ≥ 4-point improvement from baseline of parent study in DLQI score by visit, Percentage of patients with CDLQI ≥6 at baseline achieving ≥6-point improvement from baseline of parent study* in CDLQI score by visit., Percentage of participants achieving DLQI ≤5 by visit,	—

Measure

Time frame

Percentage of patients with EASI 50, EASI 75, and EASI 90 (≥50%, ≥75%, and ≥90% reduction in EASI scores from baseline of parent study, respectively) by visit., Percentage change from baseline of parent study in EASI score by visit., Percentage of patients with EASI score ≤7 by visit., Percentage of patients achieving IGA 0/1 by visit., Percentage of patients achieving Pruritus NRS score of 0/1 by visit., Percentage of patients achieving Pruritus NRS score ≤4 by visit., Percentage change from baseline of parent study* in POEM by visit., Percentage change from baseline of parent study* in BSA involvement by visit., Proportion of TCS-free days from baseline by visit., Percentage of patients with DLQI ≥4 at baseline achieving ≥ 4-point improvement from baseline of parent study in DLQI score by visit, Percentage of patients with CDLQI ≥6 at baseline achieving ≥6-point improvement from baseline of parent study* in CDLQI score by visit., Percentage of participants achieving DLQI ≤5 by visit,

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Countries

Germany, Poland

Outcome results

None listed