NCT06407934进行中（未招募）3 期
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
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 进行中（未招募）
- 发起方
- Sanofi
- 入组人数
- 1,541
- 试验地点
- 650
- 主要终点
- US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY
研究概览
简要总结
This is a multinational, multicenter, randomized, double-blind, placebo-controlled, parallel, Phase 3 study for treatment of participants aged 12 years and older diagnosed with moderate-to-severe atopic dermatitis (AD).
The primary objective of ESTUARY is to assess the maintenance of treatment response on continued Q12W dosing compared to treatment withdrawal.
Study details include:
The study duration will be up to 68 weeks including a 52-week randomized double-blind period, and a 16-week safety follow-up for participants not entering the LTS17367 (RIVER-AD).
The study duration will be up to 52 weeks for participants entering the LTS17367 [RIVER-AD] study at the Week 52 visit of EFC17600 (ESTUARY).
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 12 Years 至 —（Child, Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Participants must be at least 12 years of age inclusive, at the time the informed consent is signed.
- •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.
- •Able and willing to comply with requested study visit and procedures.
- •Body weight must be ≥ 25 kg.
排除标准
- •Participants are excluded from the study if any of the following criteria apply:
- •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.
- •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).
- •Participants who, during their participation in the parent study EFC17559 (COAST-1) /EFC17560 (COAST-2)/EFC17561 (SHORE), developed an adverse event (AE) or a serious adverse event (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.
- •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.
- •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.).
- •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.
- •The above information is not intended to contain all considerations relevant to a patient's potential participation in a clinical trial.
研究组 & 干预措施
Placebo
Placebo Comparator
Subcutaneous injection as per protocol
干预措施: Placebo (Drug)
Amlitelimab dose 1
Experimental
Subcutaneous injection as per protocol
干预措施: Amlitelimab (Drug)
Amlitelimab dose 2
Experimental
Subcutaneous injection as per protocol
干预措施: Amlitelimab (Drug)
结局指标
主要结局
US and US reference countries: Proportion of participants who are responders AND maintained vIGA-AD ≤2 without experiencing relapse among participants who were responders at baseline of ESTUARY
时间窗: Week 24
Clinical response is defined as having vIGA-AD 0 or 1. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^. The validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The Eczema Area and Severity Index (EASI) is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline".
EU, EU Reference Countries, and Japan: Proportion of participants who maintain treatment response in ESTUARY without experiencing relapse
时间窗: Week 48
Maintenance of clinical response is defined as having vIGA-AD 0 or 1 OR EASI-75\^ OR vIGA-AD 0 or 1 and EASI-75\^. Relapse is defined as having vIGA-AD ≥3 or loss of EASI-75\^ The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD. EASI-75 is 75% reduction from baseline in EASI score. The symbol \^ represents "based on parent study baseline".
Responders from parent studies: Proportion of participants who maintain treatment response in ESTUARY.
时间窗: Week 48
Maintenance of clinical response is defined as having validated Investigator Global Assessment scale for atopic dermatitis (vIGA-AD) 0 (clear) or 1 (almost clear) OR 75% reduction in Eczema Area and Severity Index (EASI) compared to parent study baseline EASI (EASI-75\^) OR vIGA-AD 0 (clear) or 1 (almost clear) and EASI-75\^. The vIGA-AD is an Investigator-completed assessment scale used to determine severity of AD and clinical response to treatment. It is based on a 5-point scale, ranging from 0 (clear) to 4 (severe). The EASI is an Investigator-assessed validated tool used to measure the extent (area) and severity of AD. Total score ranges from 0 to 72 with a higher score indicating increased extent and severity of AD.
次要结局
- Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who continue to be vIGA-AD 0 or 1 among participants who met vIGA-AD 0 or 1 at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among the participants who were vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY(Up to Week 48)
- 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(Up to Week 48)
- Proportion of participants who maintain treatment response without experiencing relapse(Up to Week 48)
- Percent change in EASI from parent study baseline(Parent study baseline to Week 48)
- Proportion of participants who maintained EASI-75^ without experiencing relapse among the participants who met EASI-75^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants with EASI-75^(Up to Week 48)
- Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants with EASI-90^(Up to Week 48)
- Time to the first event of vIGA-AD ≥3 or loss of EASI-75^ among the participants who were vIGA-AD 0 or EASI-75^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants with vIGA-AD 0 or 1(Up to Week 48)
- Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting)(Up to Week 48)
- EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 or 1 at baseline of ESTUARY(Up to Week 48)
- EU, EU Reference Countries, and Japan: Time to first event of vIGA-AD ≥3 or loss of EASI^75 among those participants who were vIGA-AD 0 at baseline of ESTUARY(Up to Week 48)
- Proportion of participants with weekly average of daily PP-NRS reduction of ≥4^(Parent study baseline to Week 48)
- Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY(Up to Week 48)
- EU, EU Reference Countries, and Japan: Proportion of participants who maintain reduction in POEM ≥4^ among the participants with reduction in POEM ≥4^ at baseline of ESTUARY(Up to Week 48)
- EU, EU Reference Countries, and Japan: Proportion of participants with a reduction in CDLQI ≥6^ among participants aged ≥12 to <16 years old and with reduction in CDLQI ≥6^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who achieve PP-NRS reduction of ≥4(Up to Week 48)
- EU, EU Reference Countries, and Japan: Proportion of participants with ≥ 4 reduction in DLQI ≥4^ among the participants aged ≥16 years old and with reduction in DLQI ≥4^ at baseline of ESTUARY(Up to Week 48)
- 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)(Up to week 68)
- Pharmacokinetic: Serum amlitelimab concentrations(Up to Week 68)
- Incidence of antidrug antibodies (ADAs) of amlitelimab(Up to Week 68)
- Pharmacokinetic: maximum plasma concentration (Cmax)(Up to Week 68)
- Pharmacokinetic: AUC4W and AUC12W(Up to Week 4 and 12)
- Proportion of participants who are EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and did not relapse by Week 12(Up to Week 48)
- Time to first recapture of EASI-75^ among participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed(Up to Week 48)
- Proportion of participants who recapture EASI-75^ by visit among the participants who had EASI-75^ at baseline of ESTUARY and subsequently relapsed(Up to Week 48)
- Proportion of participants who are EASI 90^ AND who maintain EASI-75^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who are EASI 90^ without experiencing relapse among participants who had EASI-90^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who are EASI-90^ among participants who had EASI-90^ at baseline of ESTUARY and did not relapse by Week 12.(Up to Week 48)
- Proportion of participants who are vIGA-AD 0 or 1 AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who maintain vIGA-AD response within 1 point of baseline without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who maintain vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who are vIGA-AD 0 or 1 without experiencing relapse among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY(Up to Week 48)
- Time to first recapture of vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed(Up to Week 48)
- Proportion of participants who recapture vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and subsequently relapsed(Up to Week 48)
- Proportion of participants who are vIGA-AD 0 or 1 among participants who had vIGA-AD 0 or 1 at baseline of ESTUARY and did not relapse by Week 12(Up to Week 48)
- Proportion of participants who are vIGA-AD 0 or 1 with only barely perceptible erythema AND who maintain vIGA-AD ≤2 without experiencing relapse among participants who had vIGA-AD 0 or 1 with only barely perceptible erythema at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema among participants who had vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY and did not relapse by Week 12(Up to Week 48)
- Proportion of participants who maintain weekly average of daily PP-NRS reduction of ≥4^ without experiencing relapse among participants with weekly average of daily PP NRS reduction of ≥4^ at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who maintain PP NRS ≤4 without experiencing relapse among participants who had PP-NRS ≤4 at baseline of ESTUARY(Up to Week 48)
- Proportion of participants who achieve PP-NRS ≤4(Up to Week 48)
- Duration of maintained response without relapse(Up to Week 48)
- Percent change in Head & Neck EASI sub-score from the parent study baseline among participants with Head & Neck EASI sub-score >0 at baseline of the parent study(From parent study baseline to Week 48)
- Proportion of participants Head & Neck EASI sub-score EASI-75^ among participants with Head & Neck EASI sub-score >0 at baseline of the parent study(From parent study baseline to Week 48)
- Proportion of participants with Head & Neck EASI sub-score EASI-90^ among participants with Head & Neck EASI sub-score >0 at baseline of parent study(From parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants who continue to be EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline(Parent study baseline to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants who continue to be vIGA-AD 0 or 1 with presence of only barely perceptible erythema among those who are vIGA-AD 0 or 1 with presence of only barely perceptible erythema at baseline of ESTUARY(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants who maintain treatment response(Up to Week 44)
- Responders from parent studies: Percent change in EASI from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants who maintained EASI-75^ among the participants who met EASI-75^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants with EASI-75^(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants who continue to be EASI-50^ among the participants who met EASI-50^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants with EASI-90^(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants with EASI-50^(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants who continue to be EASI-90^ among the participants who met EASI-90^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants who continue to be EASI-100^ among the participants who met EASI-100^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants with EASI-100^(Parent study baseline to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Time to the first event of loss of EASI-100^ among participants who were EASI-100^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)(Up to Week 48)
- 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)(Up to Week 48)
- Responders from parent studies: Change in POEM from parent study baseline(Parent study baseline to Week 48)
- 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(Parent study baseline to Week 48)
- Responders from parent studies: Change in Dermatology Life Quality Index (DLQI^) in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline(Parent study baseline to Week 48)
- 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(Parent study baseline to Week 48)
- Responders from parent studies: Time to first rescue medication initiation(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies:Proportion of participants who maintained vIGA-AD 0 or 1 and/or EASI-75^ and weekly average of daily (WAD) PP-NRS reduction ≥4^ among those who were vIGA-AD 0 or 1 and/or EASI-75^ and WAD PP-NRS reduction ≥4^ at ESTUARY BL(Up to Week 48)
- Responders from parent studies: Change in percent Body Surface Area (BSA) affected by AD from parent study baseline(Parent study baseline to Week 48)
- 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(Up to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants who maintain PP-NRS ≤4 among participants who were PP-NRS ≤4 at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline(Parent study baseline to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants with ≥4 points reduction in weekly average of daily SP-NRS from parent study baseline(Parent study baseline to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants who maintained SCORAD ≥8.7^ among participants with reduction in SCORAD ≥8.7^ at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Percent change in SCORAD index from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Absolute change in SCORAD index from parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants who maintained POEM ≥4 among the participants with reduction in POEM ≥4 at baseline of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline(Parent study baseline to Week 48)
- Responders from parent studies: Proportion of participants requiring rescue medication during the study up to Week 48 of ESTUARY(Up to Week 48)
- Responders from parent studies: Proportion of participants who are vIGA-AD ≤1 and PP-NRS ≤1(Up to Week 48)
- Responders from parent studies: Proportion of participants who are vIGA-AD ≤2 and PP-NRS ≤4(Up to Week 48)
- Responders from parent studies: Proportion of participants who are "vIGA-AD ≤1 or EASI ≤3" and PP-NRS ≤1(Up to Week 48)
- Responders from parent studies: Proportion of participants who are "vIGA-AD ≤ 2 or EASI ≤7" AND PP-NRS ≤4(Up to Week 48)
- 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(Up to Week 48)
- Responders from parent studies: Proportion of participants who are flare free over the 48-week period(Up to Week 48)
- 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(Up to Week 48)
- Non-responders from parent studies: Percent change in EASI from parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with ≥3 points reduction in weekly average of daily SD-NRS from parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily SP-NRS from parent study baseline [(Parent study baseline to Week 48)
- Responders from parent studies: For those participants who experience flare, time to first flare(Up to Week 48)
- Non-responders from parent studies: Proportion of participants with EASI-50^(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with EASI-75^(Parent study baseline to Week 48)
- 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(Up to Week 48)
- Non-responders from parent studies: Proportion of participants with EASI-90^(Parent study baseline to Week 48)
- 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(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with EASI-100^(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear)(Up to Week 48)
- 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)(Up to Week 48)
- Non-responders from parent studies: Proportion of participants with ≥ 4 points reduction in weekly average of daily PP-NRS from parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Percent change in weekly average of daily PP-NRS from parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Absolute change in weekly average of daily PP-NRS from parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Absolute change in weekly average of daily SD-NRS from parent study baseline(Parent study baseline to Week 48)
- All participants: Incidence of antidrug antibodies (ADAs) of amlitelimab(Up to Week 68)
- Non-responders from parent studies: Absolute change in weekly average of daily SP-NRS from parent study baseline(Parent study baseline to Week 48)
- 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(Parent study baseline to Week 48)
- Non-responders from parent studies: Change in CDLQI^ in participants with age ≥12 to <16 years old(Parent study baseline to Week 48)
- Non-responders from parent studies: Change in DLQI^ in participants with age ≥16 years among the participants with DLQI ≥4 at parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with HADS-D <8 among the participants who had HADS-D ≥8 at parent study baseline(Parent study baseline to Week 48)
- Non-responders from parent studies: Proportion of participants with HADS-A <8 among the participants who had HADS-A ≥8 at parent study baseline(Parent study baseline to Week 48)
- 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)(Up to week 68)
- All participants: Serum amlitelimab concentrations measured at prespecified timepoints(Up to Week 68)
研究者
研究点 (650)
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A Study to Evaluate the Efficacy, Response Duration and Safety of Xolair (Omalizumab) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine Treatment (H1)Chronic Idiopathic UrticariaNCT01292473Genentech, Inc.323
已完成
3 期
A Study of the Efficacy and Safety of Omalizumab (Xolair) in Patients With Chronic Idiopathic Urticaria (CIU)/Chronic Spontaneous Urticaria (CSU) Who Remain Symptomatic Despite Antihistamine (H1) TreatmentChronic Idiopathic UrticariaNCT01287117Genentech, Inc.319