A Randomized, Double-Blind, Placebo-Controlled, Multicenter Trial to Evaluate the Efficacy and Safety of Eblasakimab in Male or Female Moderate-to-Severe Atopic Dermatitis Patients Previously Treated with Dupilumab.

Conditions

Atopic Dermatitis

Brief summary

Percentage change in EASI score from Baseline to Week 16

Detailed description

• Proportion of participants achieving vIGA response of 0 (clear) or 1 (almost clear) [5-point scale] at Week 16, • Proportion of participants with a 75% reduction from Baseline in EASI (EASI 75) at Week 16, • Proportion of participants achieving EASI 50 and EASI 90 at Week 16, • Proportion of participants with EASI <7 at Week 16, • Absolute and percent change in peak P-NRS from Baseline to Week 16, • Proportion of participants achieving a 4-point reduction in peak PNRS at Week 16, • Change in BSA affected with AD from Baseline to Week 16, • Change in SCORAD from Baseline to Week 16, • Change in DLQI from Baseline to Week 16, • Change in POEM from Baseline to Week 16, • Change in EQ-5D-5L from Baseline to Week 16, • Absolute and percent change in SD-NRS from Baseline to Week 16, •Proportion of participants achieving a 4-point reduction in SD-NRS at Week 16, • Change in all efficacy endpoints from Baseline over time, • AEs and SAEs, including incidence of clinically significant changes in vital signs, clinical laboratory tests, and ECGs.

Related papers

No related papers found yet.

Papers published before 2007-09-01 may not appear yet. Historical indexing is in progress.

Interventions

DRUGThe placebo will consist solely of the excipients of eblasakimab

DRUGi.e.

DRUGthe same formulation without the active ingredient and will be identical in appearance to eblasakimab. Pharmaceutical form: Solution for SC injection

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
Percentage change in EASI score from Baseline to Week 16	—

Secondary

Measure	Time frame
• Proportion of participants achieving vIGA response of 0 (clear) or 1 (almost clear) [5-point scale] at Week 16, • Proportion of participants with a 75% reduction from Baseline in EASI (EASI 75) at Week 16, • Proportion of participants achieving EASI 50 and EASI 90 at Week 16, • Proportion of participants with EASI <7 at Week 16, • Absolute and percent change in peak P-NRS from Baseline to Week 16, • Proportion of participants achieving a 4-point reduction in peak PNRS at Week 16, • Change in BSA affected with AD from Baseline to Week 16, • Change in SCORAD from Baseline to Week 16, • Change in DLQI from Baseline to Week 16, • Change in POEM from Baseline to Week 16, • Change in EQ-5D-5L from Baseline to Week 16, • Absolute and percent change in SD-NRS from Baseline to Week 16, •Proportion of participants achieving a 4-point reduction in SD-NRS at Week 16, • Change in all efficacy endpoints from Baseline over time, • AEs and SAEs, including incidence of clinically significant changes	—

Measure

Time frame

• Proportion of participants achieving vIGA response of 0 (clear) or 1 (almost clear) [5-point scale] at Week 16, • Proportion of participants with a 75% reduction from Baseline in EASI (EASI 75) at Week 16, • Proportion of participants achieving EASI 50 and EASI 90 at Week 16, • Proportion of participants with EASI <7 at Week 16, • Absolute and percent change in peak P-NRS from Baseline to Week 16, • Proportion of participants achieving a 4-point reduction in peak PNRS at Week 16, • Change in BSA affected with AD from Baseline to Week 16, • Change in SCORAD from Baseline to Week 16, • Change in DLQI from Baseline to Week 16, • Change in POEM from Baseline to Week 16, • Change in EQ-5D-5L from Baseline to Week 16, • Absolute and percent change in SD-NRS from Baseline to Week 16, •Proportion of participants achieving a 4-point reduction in SD-NRS at Week 16, • Change in all efficacy endpoints from Baseline over time, • AEs and SAEs, including incidence of clinically significant changes

—

Countries

Germany, Poland

Outcome results

None listed