A Long-Term Extension Study to Learn More About the Safety of Litifilimab (BIIB059) Injections and Whether They Can Improve Symptoms of Adult Participants Who Have Active Cutaneous Lupus Erythematosus
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: BIIB059 (litifilimab).
- Кому может быть актуально
- Состояния в реестре: Subacute Cutaneous Lupus Erythematosus, Chronic Cutaneous Lupus Erythematosus. Базовые параметры: от 18 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, Бразилия, Болгария, Канада +20
- 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 Multicenter, Open-Label, Single-Arm, Phase 3, Long-Term Extension Study to Evaluate Continuous Safety and Efficacy of BIIB059 (Litifilimab) in Adult Participants With Active Subacute Cutaneous Lupus Erythematosus and/or Chronic Cutaneous Lupus Erythematosus With or Without Systemic Manifestations and Refractory and/or Intolerant to Antimalarial Therapy
Обзор
In this study, researchers will learn more about a study drug called BIIB059 (litifilimab) in participants with cutaneous lupus erythematosus (CLE). The study will focus on participants who have either active subacute CLE or chronic CLE, or both. They may also have systemic lupus erythematosus (SLE). The participants did not respond to antimalarial therapy or had problems with the treatment that made it hard to continue. The study will enroll only those participants who have completed treatment with litifilimab in the parent study, 230LE301. The main objective of the study is to learn more about the long-term safety of litifilimab. The main question researchers want to answer is: * How many participants have adverse events and serious adverse events after taking litifilimab? Adverse events are health problems that may or may not be caused by the study drug. Researchers will also learn more about the effect of litifilimab on CLE. They will do this by measuring the symptoms of CLE over time using a variety of scoring tools. These include the Cutaneous Lupus Erythematosus Disease Area and Severity Index (CLASI), the Cutaneous Lupus Activity of Investigator's Global Assessment-Revised (CLA-IGA-R), and the SELENA-SLEDAI Flare Index (SFI). Researchers will look at how litifilimab and CLE affect the quality of life of participants using a group of questionnaires. They will also look at how litifilimab affects laboratory tests and how participants' immune systems respond to litifilimab. The study will be done as follows: * The last visit of parent study 230LE301 will be the first visit of study 230LE305. * All participants will receive litifilimab as an injection under the skin once every 4 weeks. Both researchers and participants will know the dose and identity of the study drug. * Globally, the treatment period will last up to 208 weeks, or 4 years. Participants will have up to 53 study visits during this time.
Подробное описание
The primary objective of the study is to evaluate the long-term safety and tolerability BIIB059 (litifilimab) in participants who completed the parent study 230LE301 (NCT05531565) with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarial therapy.
The secondary objectives of the study are to evaluate the long-term effect of litifilimab on disease activity and the effect of litifilimab in preventing disease damage in participants with active subacute CLE and/or chronic CLE with or without systemic manifestations and refractory and/or intolerant to antimalarials; to evaluate the long-term effect of litifilimab on preventing lupus flare in participants with CLE with SLE; to assess long-term use of oral corticosteroid (OCS) in participants receiving litifilimab treatment; to assess the impact of litifilimab on participant-reported health-related quality of life (HRQoL); to evaluate long-term effect of litifilimab on laboratory parameters; to evaluate the immunogenicity and pharmacokinetics (PK) of litifilimab.
Вмешательства
- Препарат BIIB059 (litifilimab)
Administered as specified in the treatment arm.
Первичные конечные точки
- Number of Participants With Treatment-Emergent Adverse Events (TEAEs) and Serious Adverse Events (SAEs) [Срок оценки: Up to 232 weeks]
Вторичные конечные точки (12)
- Percentage of Participants who Achieve a Cutaneous Lupus Erythematosus Disease Area and Severity Index Activity Score (CLASI)-70 Response, Defined as a 70% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) [Срок оценки: Up to 232 weeks]
- Percentage of Participants who Achieve a CLASI-50 Response, Defined as a 50% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) [Срок оценки: Up to 232 weeks]
- Percentage of Participants who Achieve a CLASI-90 Response, Defined as a 90% Decrease in CLASI-A Score From the Baseline Value (Parent Study [NCT05531565]) [Срок оценки: Up to 232 weeks]
- Percentage of Participants who Achieve a Cutaneous Lupus Activity of Physician's Global Assessment-Revised (CLA-IGA-R) Erythema Score of 0 or 1 [Срок оценки: Up to 232 weeks]
- Percentage of Participants who Achieve a CLA-IGA-R Other Morphologic Characteristics (OMC) Score of 0 [Срок оценки: Up to 232 weeks]
- Percentage of Participants With a CLASI-70 Response Among CLASI-70 Responders at Long-Term Extension (LTE) Baseline [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
- Percentage of Participants With a CLASI-50 Response Among CLASI-50 Responders at LTE Baseline [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
- Percentage of Participants With a CLASI-90 Response Among CLASI-90 Responders at LTE Baseline [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
- Percentage of Participants With a CLA-IGA-R Erythema Score of 0 or 1 Among Participants With a CLA-IGA-R Erythema Score of 0 or 1 at LTE Baseline [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
- Percentage of Participants With CLA-IGA-R OMC Score of 0 or 1 and at Least 1 Level of Improvement From Baseline Value(Parent Study) Among Participants With CLA IGA R OMC Score of 0 or 1 and at Least 1 Level Improvement From Baseline Value(Parent Study) [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
- Percentage of Participants With a CLASI-70 Response Among CLASI-50 Responders at LTE Baseline [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
- Percentage of Participants With Loss of Response, Defined as an Increase of ≥ 7 Points in CLASI-A Total Score From Baseline [Срок оценки: Day 1 (LTE Baseline) up to 232 weeks]
Критерии участия
Критерии включения
- Participants who completed the parent study (230LE301 \[NCT05531565\], Part A or Part B) on study treatment (received treatment through Week 48 and attended the last study assessment visit at Week 52).
- Ability of the participant to understand the purpose and risks of the study, to provide informed consent, and to authorize the use of confidential health information in accordance with national and local privacy regulations.
Критерии исключения
- Early Part A or Part B parent study (230LE301 \[NCT05531565\]) treatment terminators (participants who discontinued study treatment before Week 48).
- Early Part A or Part B parent study terminators \[participants who withdrew from parent study participation before Week 52 and did not complete the parent study extended treatment period (ETP)\].
- Participants who have developed any other medical diseases, conditions, or abnormalities, rendering their participation in the long-term extension (LTE) study unsuitable in the opinion of the Investigator.
NOTE: Other protocol-defined Inclusion/Exclusion criteria may apply.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Нет
Дизайн исследования
- Распределение
- Не применимо
- Модель
- Одна группа
- Маскирование
- Открытое
- Основная цель
- Лечение
Центры проведения
Япония · 14 центров
- JCHO Chukyo Hospital — Nagoya
- NHO Nagoya Medical Center — Nagoya
- University of Fukui Hospital — Yoshida-gun
- Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi
- Kakogawa Central City Hospital — Kakogawa-shi
- Kanazawa University Hospital — Kanazawa
- St. Marianna University Hospital — Kawasaki-shi
- Yokohama City University Hospital — Yokohama
- … и ещё 6 центров
США · 13 центров
- University of Alabama at Birmingham - (UAB) — Birmingham
- Arizona Arthritis & Rheumatology Research, PLLC — Phoenix
- Dermatology Research Associates — Los Angeles
- Inland Rheumatology Clinical Trials, Inc. — Upland
- David Fivenson, MD, Dermatology, PLLC — Ann Arbor
- Revival Research Institute, LLC — Troy
- Saint Louis University — St Louis
- Thurston Arthritis Research Center — Chapel Hill
- … и ещё 5 центров
Бразилия · 9 центров
- Clínica SER da Bahia — Salvador
- L2IP - Instituto de Pesquisas Clínicas Ltda. — Brasília
- IPC MT Instituto de Pesquisas Clinicas do Mato Grosso — Santo Ângelo
- CMiP - Centro Mineiro de Pesquisa — Juiz de Fora
- Hospital de Clínicas de Porto Alegre — Porto Alegre
- Nucleo de Pesquisa Clinica do Rio Grande do Sul — Porto Alegre
- LMK Serviços Médicos S/S Ltda — Porto Alegre
- CEPIC - Centro Paulista de Investigação Clínica e Serviços Médicos — São Paulo
- … и ещё 1 центр
Китай · 8 центров
- Beijing Tongren Hospital, Capital Medical University — Пекин
- Shenzhen Second People's Hospital — Шэньчжэнь
- Dongguan People's Hospital — Дунгуань
- Nanfang Hospital of Southern Medical University — Гуанчжоу
- The second Xiangya Hospital of Central South University — Чанша
- Hospital for Skin Diseases, Chinese Academy of Medical Sciences — Нанкин
- Shanghai Skin Disease Hospital — Шанхай
- The Second Affiliated Hospital of Kunming Medical University — Куньмин
Германия · 7 центров
- Universitaetsklinikum Erlangen — Erlangen
- Fachklinik Bad Bentheim Dermatologie — Bad Bentheim
- Klinikum Oldenburg AoeR — Oldenburg
- Universitaetsklinikum Muenster — Münster
- Universitaetsklinikum Carl Gustav Carus TU — Dresden
- Universitaetsklinikum Halle (Saale) — Halle
- Charité - Campus Charité Mitte — Berlin
Испания · 6 центров
Список центров уточняется — проверьте первичный протокол.
Франция · 5 центров
- CHU de Caen - Hopital de la Cote de Nacre — Caen
- Hopital Larrey — Toulouse
- Hopital Saint Eloi — Montpellier
- Hopital Edouard Herriot - CHU Lyon — Lyon
- Hopital Tenon — Paris
Филиппины · 5 центров
- Mary Mediatrix Medical Center — Lipa City
- Lorma Medical Center — San Fernando City, La Union
- St. Luke's Medical Center — Quezon City
- University of the Philippines Manila - Philippine General Hospital — Manila
- … и ещё 1 центр
Аргентина · 4 центра
- Instituto CAICI — Rosario
- Investigaciones Clinicas Tucuman — San Miguel de Tucumán
- Centro de Investigaciones Medicas Tucuman — San Miguel de Tucumán
- APRILLUS Asistencia e Investigacion — Buenos Aires
Болгария · 3 центра
- University Multiprofile Hospital for Active Treatment Sv Ivan Rilski EAD — Sofia
- DCC 'Alexandrovska', EOOD — Sofia
- DCC Focus 5 - MEOH OOD — Sofia
Чили · 3 центра
- Centro Medico SkinMed — Las Condes
- CIEC - Centro Internacional de Estudios Clínicos — Santiago
- Clinical Research Chile SpA — Valdivia
Мексика · 3 центра
- Clinstile, S.A. de C.V. — Mexico City
- Investigacion y Biomedicina de Chihuahua, S.C. — Chihuahua City
- Centro de investigacion medica y reumatologia — Guadalajara
South Korea · 3 центра
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Великобритания · 3 центра
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Канада · 2 центра
- Laser Rejuvenation Clinics, Inc. — Calgary
- DIEX Recherche Sherbrooke Inc. — Sherbrooke
Колумбия · 2 центра
- Healthy Medical Center — Zipaquirá
- Centro de Investigacion Medico Asistencial S.A.S — Barranquilla
Италия · 2 центра
- Università degli studi di Firenze — Florence
- Fondazione IRCCS CA' Granda Ospedale Maggiore Policlinico — Milan
Польша · 2 центра
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Сербия · 2 центра
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Швейцария · 2 центра
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Тайвань · 2 центра
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Венгрия · 1 центр
- Pecsi Tudomanyegyetem Klinikai Kozpont — Pécs
Португалия · 1 центр
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Словакия · 1 центр
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Швеция · 1 центр
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Идентификаторы
NCT: NCT06044337 · 230LE305 · 2023-504863-17