AMLITELIMAB for Atopic dermatitis

Inclusion criteria

• {"criterion_text":"- Participants must be at least 12 years of age inclusive, at the time the informed consent is signed."}
• {"criterion_text":"- Must have participated, received study treatment without permanent investigational medicinal product (IMP) discontinuation, and adequately completed the assessments required for the treatment period in one of the three 24-week parent studies EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE) for moderate- to-severe AD."}
• {"criterion_text":"- Able and willing to comply with requested study visit and procedures."}
• {"criterion_text":"- Body weight must be ≥ 25 kg."}

Exclusion criteria

• {"criterion_text":"- Developed a medical condition that would preclude participation as described in Exclusion Criteria or Permanent Discontinuation of EFC17559 (COAST-1)/EFC17560 (COAST- 2)/EFC17561 (SHORE) clinical trial protocols."}
• {"criterion_text":"- Having received any prohibited medication or procedure for AD that resulted in IMP discontinuation in the parent study EFC17559 (COAST-1), EFC17560 (COAST-2) or EFC17561 (SHORE)."}
• {"criterion_text":"- Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an AE or a SAE deemed related to amlitelimab, which in the opinion of the Investigator could indicate that continued treatment with amlitelimab may present an unreasonable risk for the participant."}
• {"criterion_text":"- Participants who have had IMP permanently discontinued for any reason before or at the time of the planned first dose in the EFC17600 (ESTUARY) study."}
• {"criterion_text":"- Conditions in the parent study EFC17559 (COAST-1)/EFC17560 (COAST- 2)/EFC17561 (SHORE) that led to Investigator - or Sponsor-initiated withdrawal of participant from the study (eg, non-compliance, inability to complete study assessments, etc.)."}
• {"criterion_text":"- Participant not suitable for participation, whatever the reason, as judged by the Investigator, including medical or clinical conditions, or participants potentially at risk of noncompliance to study procedures."}

Primary endpoints

• {"endpoint_text":"- Responders from parent studies: Proportion of participants who maintain treatment response in ESTUARY.","definition_or_measurement_approach":"Proportion (percentage) of responders from parent studies who maintain treatment response during the ESTUARY extension study (binary responder status assessed during the study as per the study's responder definition)."}

Secondary endpoints

• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion of participants sustaining EASI-75 relative to parent study baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion of participants maintaining vIGA-AD score 0 or 1 from ESTUARY baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion endpoint describing maintenance of a specific vIGA-AD phenotype (only barely perceptible erythema)."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion of participants maintaining weekly average daily PP-NRS reduction ≥4 (relative to parent study baseline)."}
• {"endpoint_text":"- Responders from parent studies: Percent change in EASI from parent study baseline","definition_or_measurement_approach":"Percent change in EASI score compared to parent study baseline."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with EASI-75^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑75 relative to parent study baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining EASI‑50 relative to parent study baseline."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with EASI-50^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑50 relative to parent study baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining EASI‑90 relative to parent study baseline."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with EASI-90^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑90 relative to parent study baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining EASI‑100 relative to parent study baseline."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with EASI-100^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑100 relative to parent study baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Time-to-event (time from baseline to first loss of EASI‑75 response)."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Time-to-event (time to loss of EASI‑50 response)."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Time-to-event (time to loss of EASI‑90 response)."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Time-to-event (time to loss of EASI‑100 response)."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)","definition_or_measurement_approach":"Proportion of participants with vIGA‑AD score 0 or 1."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion meeting detailed vIGA‑AD criteria (only barely perceptible erythema)."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time-to-event for worsening to vIGA‑AD ≥3."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time to worsening to vIGA‑AD ≥3 in participants who were clear at baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion with ≥2-point increase in vIGA‑AD from baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion with ≥2‑point increase in vIGA‑AD in subgroup vIGA‑AD 3 at parent baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion with ≥2‑point increase in vIGA‑AD in subgroup vIGA‑AD 4 at parent baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Composite proportion endpoint (vIGA‑AD 0/1 and/or EASI‑75 relative to parent baseline)."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline","definition_or_measurement_approach":"Proportion achieving ≥4-point reduction in weekly average of daily PP‑NRS vs parent baseline."}
• {"endpoint_text":"- Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline","definition_or_measurement_approach":"Percent change in weekly average daily PP‑NRS vs parent baseline."}
• {"endpoint_text":"- Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline","definition_or_measurement_approach":"Absolute change in weekly average daily PP‑NRS vs parent baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining PP‑NRS 0 or 1 from baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Composite proportion combining vIGA‑AD, EASI‑75 and PP‑NRS criteria."}
• {"endpoint_text":"- Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline","definition_or_measurement_approach":"Absolute change in weekly average daily SD‑NRS vs parent baseline (sleep disturbance)."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining weekly average SD‑NRS reduction ≥3."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline","definition_or_measurement_approach":"Proportion achieving ≥3‑point reduction in weekly average SD‑NRS vs parent baseline."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline","definition_or_measurement_approach":"Proportion achieving ≥4‑point reduction in weekly average SP‑NRS (skin pain) vs parent baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining weekly average SP‑NRS reduction ≥4."}
• {"endpoint_text":"- Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline","definition_or_measurement_approach":"Absolute change in weekly average SP‑NRS vs parent baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining predefined SCORAD reduction threshold."}
• {"endpoint_text":"- Responders from parent studies: Percent change in SCORAD index from parent study baseline","definition_or_measurement_approach":"Percent change in SCORAD vs parent baseline."}
• {"endpoint_text":"- Responders from parent studies: Absolute change in SCORAD index from parent study baseline","definition_or_measurement_approach":"Absolute change in SCORAD vs parent baseline."}
• {"endpoint_text":"- Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline","definition_or_measurement_approach":"Change in percent BSA affected vs parent baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining POEM improvement threshold."}
• {"endpoint_text":"- Responders from parent studies: Change in POEM from parent study baseline","definition_or_measurement_approach":"Change in POEM score vs parent baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion with ≥6‑point CDLQI reduction in adolescent subgroup."}
• {"endpoint_text":"- Responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Change in CDLQI in adolescent subgroup vs parent baseline."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Change in DLQI in adult subgroup with baseline DLQI ≥4."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion achieving ≥4‑point DLQI reduction in subgroup with baseline DLQI ≥4."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline","definition_or_measurement_approach":"Proportion with HADS‑D <8 among those with baseline HADS‑D ≥8."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline","definition_or_measurement_approach":"Proportion with HADS‑A <8 among those with baseline HADS‑A ≥8."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY","definition_or_measurement_approach":"Proportion of participants who required rescue medication through Week 48."}
• {"endpoint_text":"- Responders from parent studies: Time to first rescue medication initiation","definition_or_measurement_approach":"Time-to-event until first rescue medication use."}
• {"endpoint_text":"- Non-responders from parent studies: Percent change in EASI from parent study baseline","definition_or_measurement_approach":"Percent change in EASI in non-responder population vs parent baseline."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with EASI-75^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑75 in non-responder population."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining EASI‑50 in non-responder subgroup."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with EASI-50^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑50 in non-responder population."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with EASI-90^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑90 in non-responder population."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with EASI-100^. The symbol ^ represents \"based on parent study baseline”.","definition_or_measurement_approach":"Proportion achieving EASI‑100 in non-responder population."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)","definition_or_measurement_approach":"Proportion achieving vIGA‑AD 0 or 1 in non-responder population."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Proportion meeting specific vIGA‑AD phenotype in non-responders."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline","definition_or_measurement_approach":"Proportion achieving ≥4‑point reduction in weekly average PP‑NRS in non-responders."}
• {"endpoint_text":"- Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline","definition_or_measurement_approach":"Percent change in weekly average PP‑NRS in non-responders vs parent baseline."}
• {"endpoint_text":"- Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline","definition_or_measurement_approach":"Absolute change in weekly average PP‑NRS in non-responders."}
• {"endpoint_text":"- Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline","definition_or_measurement_approach":"Absolute change in weekly average SD‑NRS in non-responders."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline","definition_or_measurement_approach":"Proportion achieving ≥3‑point reduction in weekly average SD‑NRS in non-responders."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline [","definition_or_measurement_approach":"Proportion achieving ≥4‑point reduction in weekly average SP‑NRS in non-responders."}
• {"endpoint_text":"- Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline","definition_or_measurement_approach":"Absolute change in weekly average SP‑NRS in non-responders."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion achieving ≥6‑point CDLQI reduction in adolescent non-responders."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Change in CDLQI in adolescent non-responders."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Change in DLQI in adult non-responders with baseline DLQI ≥4."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion achieving ≥4‑point DLQI reduction in non-responder subgroup."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline","definition_or_measurement_approach":"Proportion with HADS‑D <8 in non-responder subgroup with baseline HADS‑D ≥8."}
• {"endpoint_text":"- Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline","definition_or_measurement_approach":"Proportion with HADS‑A <8 in non-responder subgroup with baseline HADS‑A ≥8."}
• {"endpoint_text":"- 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)","definition_or_measurement_approach":"Safety endpoint: percentage of participants with TEAEs, TESAEs and AESIs (occurrence during treatment)."}
• {"endpoint_text":"- All participants: Serum amlitelimab concentrations measured at prespecified timepoints","definition_or_measurement_approach":"Pharmacokinetic endpoint: serum amlitelimab concentrations at prespecified PK timepoints."}
• {"endpoint_text":"- All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab","definition_or_measurement_approach":"Immunogenicity endpoint: incidence of ADA positivity."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who maintain treatment response","definition_or_measurement_approach":"Proportion maintaining treatment response (as defined by study) among responders."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining both vIGA‑AD ≤1 and PP‑NRS ≤1 at Week 48 in baseline responders."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining vIGA‑AD ≤2 and PP‑NRS ≤4 at Week 48 in baseline responders."}
• {"endpoint_text":"- 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”.","definition_or_measurement_approach":"Proportion maintaining EASI‑75 in baseline responders."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time-to-event: first vIGA‑AD ≥1 in participants who were clear at baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Time-to-event: first vIGA‑AD ≥2 among participants with baseline vIGA‑AD 0 or 1."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining vIGA‑AD 0 from baseline."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining vIGA‑AD 0–2 category."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY","definition_or_measurement_approach":"Proportion maintaining PP‑NRS ≤4 from baseline."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who are vIGA-AD ≤1 and PP-NRS ≤","definition_or_measurement_approach":"Proportion meeting combined vIGA‑AD ≤1 and PP‑NRS criteria (text truncated in source)."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who are vIGA-AD ≤2 and PP-NRS ≤4","definition_or_measurement_approach":"Proportion meeting combined vIGA‑AD ≤2 and PP‑NRS ≤4."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who are \"vIGA-AD ≤1 or EASI ≤3\" and PP-NRS ≤1","definition_or_measurement_approach":"Composite responder proportion combining vIGA‑AD or EASI criteria with PP‑NRS."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who are \"vIGA-AD ≤ 2 or EASI ≤7\" AND PP-NRS ≤4","definition_or_measurement_approach":"Composite responder proportion combining vIGA‑AD or EASI criteria with PP‑NRS."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining combined VLDA criteria at baseline through follow-up."}
• {"endpoint_text":"- 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","definition_or_measurement_approach":"Proportion maintaining combined LDA criteria at baseline through follow-up."}
• {"endpoint_text":"- Responders from parent studies: Proportion of participants who are flare free over the 48-week period","definition_or_measurement_approach":"Proportion without flare over 48 weeks."}
• {"endpoint_text":"- Responders from parent studies: For those participants who experience flare, time to first flare","definition_or_measurement_approach":"Time-to-event: time from baseline to first flare among those who flare."}

Primary sponsor

Full Name

Sanofi-Aventis Recherche & Developpement

Organisation Type

Pharmaceutical company

Country Of Registered Address

France

Contract research organisations

Name

Pharmaceutical Product Development LLC

Name

MARKEN Germany GmbH

Name

Sermes CRO

Responsibilities

patient reimbursement

Name

Signant Health Management Limited

Name

Labcorp Central Laboratory Services LP

Third parties

• {"country":"Germany","full_name":"MARKEN Germany GmbH","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Pharmaceutical Product Development LLC","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Italy","full_name":"Depo-pack S.r.l.","duties_or_roles":"Local Depot: werehousing, labeling, transportation (GDP)","organisation_type":"Pharmaceutical company"}
• {"country":"Germany","full_name":"Azenta Germany GmbH","duties_or_roles":"Cryo Storage Provider","organisation_type":"Pharmaceutical company"}
• {"country":"Spain","full_name":"Sermes CRO","duties_or_roles":"patient reimbursement","organisation_type":"Pharmaceutical company"}
• {"country":"United Kingdom","full_name":"Signant Health Management Limited","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"United States","full_name":"Labcorp Central Laboratory Services LP","duties_or_roles":"","organisation_type":"Pharmaceutical company"}
• {"country":"Czechia","full_name":"PHOENIX lekarensky velkoobchod s.r.o.","duties_or_roles":"","organisation_type":"Pharmaceutical company"}