Идёт набор NCT06241118

A Study to Evaluate the Efficacy and Safety of Subcutaneous Amlitelimab on Background Topical Corticosteroids Therapy in Participants Aged 12 Years and Older With Moderate-to-severe AD Who Have Had an Inadequate Response to Prior Biologic Therapy or an Oral JAK Inhibitor

Фаза III С лечением Dermatitis Atopic

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают: В протоколе указаны: Amlitelimab, Placebo, Topical corticosteroids, Topical tacrolimus or pimecrolimus.
Кому может быть актуально: Состояния в реестре: Dermatitis Atopic. Базовые параметры: от 12 лет · Все.
Что важно проверить: Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится: США, Аргентина, Австралия, Бразилия, Канада +18
Следующий шаг: Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

A Phase 3, Randomized, Double-blind, Placebo-controlled, Parallel-group, 3-arm, Multinational, Multicenter Study to Evaluate the Efficacy and Safety of Amlitelimab by Subcutaneous Injection in Participants Aged 12 Years and Older With Moderate-to-severe Atopic Dermatitis (AD) Who Are on Background Topical Corticosteroids and Have Had an Inadequate Response to Prior Biologic Therapy or Oral Janus Kinase (JAK) Inhibitor Treatment

Обзор

This is a parallel group, Phase 3, multinational, multicenter, randomized, double-blind, placebo-controlled, 3-arm study for treatment of participants diagnosed with moderate-to-severe AD on background TCS who have had inadequate response to prior biologic or oral JAKi therapy. The purpose of this study is to measure the efficacy and safety of treatment with amlitelimab solution for subcutaneous (SC) injection compared with placebo in participants with moderate-to-severe AD aged 12 years and older on background TCS and have had an inadequate response to prior biologic or an oral JAKi therapy. Study details include: At the end of the treatment period, participants will have the option to enter the Long-Term Safety Study LTS17367 (RIVER-AD). The study duration will be up to 56 weeks for participants not entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening, a 36-week randomized double-blind period, and a 16-week safety follow-up. The study duration will be up to 40 weeks for participants entering the long-term safety study (LTS17367 \[RIVER-AD\]) including a 2 to 4-week screening and a 36-week randomized double-blind period. The total treatment duration will be up to 36 weeks. The total number of visits will be up to 13 visits (or 12 visits for those entering the long-term safety study LTS17367 \[RIVER-AD\] study).

Вмешательства

Препарат Amlitelimab
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Препарат Placebo
Pharmaceutical form: Injection solution Route of administration: Subcutaneous
Препарат Topical corticosteroids
Pharmaceutical form: Various Topical formulation Route of administration: Topical
Препарат Topical tacrolimus or pimecrolimus
Pharmaceutical form: Various Topical formulation Route of administration: Topical

Первичные конечные точки

EU, EU reference countries, and Japan: Proportion of participants with Validated Investigator Global Assessment scale for Atopic Dermatitis (vIGA-AD) of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36 [Срок оценки: Week 36]
EU, EU reference countries, and Japan: Proportion of participants reaching 75% reduction from baseline in Eczema Area and Severity Index (EASI) score (EASI75) at Week 36 [Срок оценки: Week 36]
US and US reference countries: Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points at Week 36 [Срок оценки: Week 36]

Вторичные конечные точки (12)

Proportion of participants reaching EASI-75 at Week 36 (for US and US reference countries only) [Срок оценки: Week 36]
Proportion of participants with vIGA-AD 0 (clear) or 1 (almost clear) with presence of only barely perceptible erythema (no induration/papulation, no lichenification, no oozing or crusting and a reduction from baseline of ≥2 points) [Срок оценки: Baseline to Week 36]
Proportion of participants with ≥4-point reduction in weekly average of daily Peak Pruritus-Numerical Rating Scale (PP-NRS) from baseline in participants with baseline weekly average of daily PP-NRS ≥4 [Срок оценки: Baseline to Week 36]
Proportion of participants reaching EASI-75 [Срок оценки: Baseline to Week 24]
Proportion of participants with vIGA-AD of 0 (clear) or 1 (almost clear) and a reduction from baseline of ≥2 points [Срок оценки: Baseline to Week 24]
Proportion of participants reaching EASI-90 [Срок оценки: Baseline to Week 36]
Proportion of participants reaching EASI-100 [Срок оценки: Baseline to Week 36]
Proportion of participants with PP-NRS ≤1 [Срок оценки: Baseline to Week 36]
Change in Dermatology Life Quality Index (DLQI) from baseline in participants with age ≥16 years old [Срок оценки: Baseline to Week 36]
Proportion of participants with a reduction in DLQI ≥4 from baseline in participants with age ≥16 years old and with DLQI baseline ≥4 [Срок оценки: Baseline to Week 36]
Change in Children Dermatology Life Quality Index (CDLQI) from baseline in participants with age ≥12 to <16 years [Срок оценки: Baseline to Week 36]
Proportion of participants with a reduction in CDLQI ≥6 from baseline in participants with age ≥12 to <16 years old and with CDLQI baseline ≥6 [Срок оценки: Baseline to Week 36]

Критерии участия

Критерии включения

Participants must be 12 years of age (when signing informed consent form)
Diagnosis of AD for at least 1 year (defined by the American Academy of Dermatology Consensus Criteria)
Documented history prior to screening visit of inadequate response to a biologic AD medication or an oral JAKi therapy.
v-IGA-AD of 3 or 4 at baseline visit
EASI score of 16 or higher at baseline
AD involvement of 10% or more of BSA at baseline
Weekly average of daily PP-NRS of ≥ 4 at baseline visit.
Able and willing to comply with requested study visits and procedures
Body weight ≥25 kg

Критерии исключения

Participants are excluded from the study if any of the following criteria apply:

Skin co-morbidity that would adversely affect the ability to undertake AD assessments
Known history of or suspected significant current immunosuppression
Any malignancies or history of malignancies prior to baseline (with the exception of non-melanoma skin cancer excised and cured >5 years prior to baseline)
History of solid organ or stem cell transplant
Any active or chronic infection including helminthic infection requiring systemic treatment within 4 weeks prior to baseline
Positive for human immunodeficiency virus (HIV), Hepatitis B or hepatitis C at screening visit
Having active tuberculosis (TB), latent TB, a history of incompletely treated TB, suspected extrapulmonary TB infection, or who are at high risk of contracting TB
Having received any of the specified therapy within the specified timeframe(s) prior to the baseline visit
In the Investigator's opinion, any clinically significant laboratory results or protocol specified laboratory abnormalities at screening
History of hypersensitivity or allergy to any of the excipients or investigational medicinal product (IMP)

The above information is not intended to contain all considerations relevant to a potential participation in a clinical trial

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение: Рандомизированное
Модель: Параллельные группы
Маскирование: Четверное слепое
Основная цель: Лечение

Центры проведения

США · 43 центра

University of Alabama at Birmingham- Site Number : 8401267 — Birmingham
Center for Dermatology and Plastic Surgery- Site Number : 8401119 — Scottsdale
Arkansas Dermatology - North Little Rock- Site Number : 8401244 — North Little Rock
Encino Research Center- Site Number : 8401042 — Encino
Center for Dermatology Clinical Research- Site Number : 8401018 — Fremont
Long Beach Clinical Trials- Site Number : 8401188 — Long Beach
Dermatology Research Associates - Los Angeles- Site Number : 8401092 — Los Angeles
LA Universal Research Center- Site Number : 8401064 — Los Angeles
… и ещё 35 центров

Китай · 15 центров

Investigational Site Number : 1560031 — Changchun
Investigational Site Number : 1560057 — Чунцин
Investigational Site Number : 1560021 — Гуанчжоу
Investigational Site Number : 1560036 — Гуанчжоу
Investigational Site Number : 1560044 — Ханчжоу
Investigational Site Number : 1560002 — Ханчжоу
Investigational Site Number : 1560009 — Ханчжоу
Investigational Site Number : 1560034 — Nanyang
… и ещё 7 центров

Канада · 8 центров

Investigational Site Number : 1240019 — Calgary
Investigational Site Number : 1240016 — Edmonton
Investigational Site Number : 1240058 — Burlington
Investigational Site Number : 1240020 — Hamilton
Investigational Site Number : 1240053 — London
Investigational Site Number : 1240035 — Toronto
Investigational Site Number : 1240054 — Toronto
Investigational Site Number : 1240028 — Regina

Великобритания · 8 центров