A Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, parallel group 52-week extension study to evaluate the treatment response and safety of two amlitelimab dose regimens administered by subcutaneous injection in participants aged 12 years and older with moderate-to-severe atopic dermatitis

atopic dermatitis

Responders from parent studies: Proportion of participants who maintain treatment response in ESTUARY.

Responders from parent studies: Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) among participants who met vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) among the participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintained weekly average of daily PP-NRS reduction of ≥4^ among the participants with weekly average of daily PP-NRS reduction of ≥ 4^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Percent change in EASI from parent study baseline, Responders from parent studies: Proportion of participants with EASI-75^. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants who continue to be EASI-50^ among the participants who met EASI-50^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with EASI-50^. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with EASI-90^. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants who continue to be EASI-100^ among the participants who met EASI-100^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with EASI-100^. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Time to the first event of loss of EASI-75^ response among the participants who were EASI-75^ responders at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Time to the first event of loss of EASI-50^ response among the participants who were EASI-50^ responders at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Time to the first event of loss of EASI-90^ response among the participants who were EASI-90^ responders at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Time to the first event of loss of EASI-100^ among participants who were EASI-100^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear), Responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting), Responders from parent studies: Time to first event of vIGA-AD ≥3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY, Responders from parent studies: Time to first event of vIGA-AD ≥3 (moderate or severe) among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 3 (moderate) at baseline of parent study, Responders from parent studies: Proportion of participants who have an increase of ≥2 points in vIGA-AD from ESTUARY baseline among the participants who were vIGA-AD 4 (severe) at baseline of parent study, Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75^ among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline, Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline, Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline, Responders from parent studies: Proportion of participants who maintained PP-NRS 0 or 1 among the participants who were PP-NRS 0 or 1 at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintained vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI‑75^ and weekly average of daily PP‑NRS reduction ≥4 among the participants who were vIGA-AD 0 (clear) or 1 (almost clear) and/or EASI-75^ and weekly average of daily PP‑NRS reduction ≥4 at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline, Responders from parent studies: Proportion of participants who maintained weekly average of daily SD-NRS reduction of ≥ 3^ among the participants with weekly average of daily SD-NRS reduction of ≥3^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline, Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline, Responders from parent studies: Proportion of participants who maintained weekly average of daily SP-NRS reduction of ≥ 4^ among the participants with weekly average of daily SP-NRS reduction of ≥4^ at ESTUARY baseline. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline, Responders from parent studies: Proportion of participants who maintained SCORAD ≥ 8.7^ among participants with reduction in SCORAD ≥ 8.7^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Percent change in SCORAD index from parent study baseline, Responders from parent studies: Absolute change in SCORAD index from parent study baseline, Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline, Responders from parent studies: Proportion of participants who maintained POEM ≥4^ among the participants with reduction in POEM ≥4^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Change in POEM from parent study baseline, Responders from parent studies: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with CDLQI baseline ≥6. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Change in DLQI^ in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Proportion of participants with ≥ 4 points reduction in DLQI from parent study baseline among the participants with DLQI ≥4 at parent study baseline, Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline, Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline, Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY, Responders from parent studies: Time to first rescue medication initiation, Non-responders from parent studies: Percent change in EASI from parent study baseline, Non-responders from parent studies: Proportion of participants with EASI-75^. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Proportion of participants who continue to be EASI-50^ among the participants who met EASI-50^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Proportion of participants with EASI-50^. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Proportion of participants with EASI-90^. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Proportion of participants with EASI-100^. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear), Non-responders from parent studies: Proportion of participants who are vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting), Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline, Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline, Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline, Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline, Non-responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline, Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline [, Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline, Non-responders from parent studies: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with CDLQI ≥6 at parent study baseline. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Change in DLQI^ in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline. The symbol ^ represents "based on parent study baseline”., Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in DLQI from parent study baseline among the participants with DLQI ≥4 at parent study baseline, Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline, Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline, All participants: Percentage of participants who experienced Treatment-Emergent Adverse Events (TEAEs), Treatment-Emergent Serious Adverse Events (TESAEs) and/or Treatment- Emergent Adverse Events of Special Interest (AESI), All participants: Serum amlitelimab concentrations measured at prespecified timepoints, All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab, Responders from parent studies: Proportion of participants who maintain treatment response, Responders from parent studies: Proportion of participants who maintain vIGA-AD ≤1 and PP-NRS ≤1 at Week 48 of ESTUARY among participants who were vIGA-AD ≤1 and PP-NRS ≤1 at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintain vIGA-AD ≤2 and PP-NRS ≤4 at Week 48 of ESTUARY among participants who were vIGA-AD ≤2 and PP-NRS ≤4 at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintained EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY. The symbol ^ represents "based on parent study baseline”., Responders from parent studies: Time to first event of vIGA-AD ≥1 among those participants who were vIGA-AD 0 (clear) at baseline of ESTUARY, Responders from parent studies: Time to first event of vIGA-AD ≥2 among those participants who were vIGA AD 0 (clear) or 1 (almost clear) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 (clear) among the participants who were vIGA- AD 0 (clear) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintain vIGA-AD 0 to 2 (clear, almost clear, and mild disease) among participants who were vIGA-AD 0 to 2 (clear, almost clear, and mild disease) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY, Responders from parent studies: Proportion of participants who are vIGA-AD ≤1 and PP-NRS ≤, Responders from parent studies: Proportion of participants who are vIGA-AD ≤2 and PP-NRS ≤4, Responders from parent studies: Proportion of participants who are "vIGA-AD ≤1 or EASI ≤3" and PP-NRS ≤1, Responders from parent studies: Proportion of participants who are "vIGA-AD ≤ 2 or EASI ≤7" AND PP-NRS ≤4, Responders from parent studies: Proportion of participants who maintain "vIGA-AD ≤1 or EASI ≤3" AND PP-NRS ≤1 among participants who were "vIGA-AD ≤1 or EASI ≤3" and PP-NRS ≤1 (VLDA) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who maintain "vIGA-AD ≤2 or EASI ≤7" AND PP-NRS ≤4 among participants who were "vIGA-AD ≤2 or EASI ≤7" AND PP-NRS ≤4 (LDA) at baseline of ESTUARY, Responders from parent studies: Proportion of participants who are flare free over the 48-week period, Responders from parent studies: For those participants who experience flare, time to first flare

No related papers found yet.

Bulgaria, Czechia, Denmark, France, Germany, Greece, Italy, Poland, Portugal, Spain, Sweden