A Study of Obexelimab in Patients With Systemic Lupus Erythematosus

Официальное название

A Phase 2, Multicenter, Randomized, Double-Blind, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Obexelimab in Patients With Systemic Lupus Erythematosus

Обзор

This study aims to examine the efficacy and safety of obexelimab in participants with systemic lupus erythematosus (SLE).

Подробное описание

This study consists of a 24-week treatment period followed by a 12-week follow-up period. Patients must have a clinical diagnosis of SLE at least 24 weeks prior to screening and meet the 2019 European League Against Rheumatism (EULAR)/American College of Rheumatology (ACR) Classification Criteria. To enter the Screening Period (Day -28 to Day -1) patients will have active SLE as defined by having: a) hybrid Systemic Lupus Erythematosus Disease Activity Index (hSLEDAI) ≥ 6 and clinical hSLEDAI ≥ 4, and b) British Isles Lupus Assessment Group (BILAG)-2004 Grade A or B in ≥ 1 organ system. Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.

On Day 1, patients will be randomized 1:1 to obexelimab or placebo subcutaneous (SC) injection once per week (QW) for 24 weeks. All patients will return to the study site for scheduled visits at Week 2, Week 4, and then every 4 weeks thereafter until study completion. During the study, patients will undergo assessments for efficacy, safety, PK, PD, and immunogenicity.

Including screening and follow-up, the maximum duration of participation in this study for an individual patient is approximately 40 weeks (i.e., up to a 28-day Screening Period, 24-week Treatment Period, and a 12-week follow-up).

Вмешательства

• Препарат Obexelimab
  Obexelimab is a monoclonal antibody that simultaneously binds CD19 and FcyRllb, resulting in down regulation of B cell activity.
• Препарат Placebo
  Placebo

Первичные конечные точки

• Primary Outcome Measure [Срок оценки: 24 weeks]

Вторичные конечные точки (1)

• Secondary Outcome Measures [Срок оценки: 24 weeks]

Критерии участия

Критерии включения

• Males and females, ≥ 18 to ≤ 70 years of age
• Diagnosed with SLE at least 24 weeks prior to screening and meets the 2019 EULAR/ACR classification criteria.
• Patient has all 3 of the following based on features active on the day of the visits:

• hSLEDAI ≥ 6 and clinical hSLEDAI ≥ 4 at screening, and clinical hSLEDAI ≥ 4 at Day 1 Note: Clinical points exclude laboratory tests, except proteinuria.
• BILAG-2004 Grade A or B in ≥ 1 organ system at screening and Day 1.
• In the opinion of the investigator and the central adjudicator, there is sufficient disease activity to warrant enrollment into a clinical study with an investigational agent.
• Patients must be treated with one or more of the following background nonbiologic lupus standard of care therapies: oral corticosteroid, antimalarial, and/or immunosuppressant.

Критерии исключения

• Active lupus nephritis for which, in the opinion of the investigator or the central adjudicator, current medications are insufficient for patient's safety or additional therapy that is not permitted in the protocol is needed.
• A history of thrombosis or embolism in the previous 6 months before the Screening visit, or previous 12 months associated with antiphospholipid syndrome (APS) or another relevant hypercoagulable state.
• Any active skin conditions other than cutaneous lupus erythematosus (CLE) that may interfere with the study assessment of CLE such as, but not limited to, psoriasis, dermatomyositis, and systemic sclerosis.
• Active severe neuropsychiatric or central nervous system SLE.
• Current inflammatory disease other than SLE (including, but not limited to, rheumatoid arthritis, psoriatic arthritis, spondyloarthropathy, reactive arthritis, scleroderma, dermatomyositis) that may interfere with the assessment of lupus signs and symptoms in the opinion of the investigator or central adjudicator.

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 · 16 центров

• Sierra Pacific Arthritis and Rheumatology Centers — Fresno
• California Research Institute — Huntington Park
• University of California, San Diego — La Jolla
• Clinical Research of West Florida, Inc — Clearwater
• Clinical Research of West Florida, Inc. — Tampa
• Emory University — Atlanta
• Accurate Clinical Research — Lake Charles
• Henry Ford Hospital — Detroit
• … и ещё 8 центров

Китай · 13 центров

• Anhui Provincial Hospital (The First Affiliated Hospital of USTC) — Хэфэй
• Beijing Friendship Hospital, Capital Medical University — Пекин
• Peking University People's Hospital — Пекин
• The First Affiliated Hospital, Sun Yat-sen University — Гуанчжоу
• Shenzhen People's Hospital — Шэньчжэнь
• The Second Hospital of Hebei Medical University — Shijiazhuang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• The Second Affiliated Hospital of Nanchang University — Nanchang
• … и ещё 5 центров

Польша · 8 центров

• Prywatna Praktyka Lekarska Prof Hab Med Pawel Hrycaj — Poznan
• Centrum Medyczne Plejady — Krakow
• MICS Centrum Medyczne Warszawa — Warsaw
• MICS Centrum Medyczne Bydgoszcz — Bydgoszcz
• Krakowskie Centrum Medyczne — Krakow
• SOMED CR — Lodz
• SPZOZ Uniwersytecki Szpital Kliniczny nr 1 im Norberta Barlickiego Uniwersytetu Medycznego — Lodz
• Pracownia Badan Klinicznych Salus — Wroclaw

Греция · 6 центров

• Attikon University General Hospital — Chaïdári
• General Hospital Asklepieio Voulas — Voula
• University General Hospital of Heraklion — Heraklion
• Olympion General Clinic — Pátrai
• Kianous Stavros — Thessaloniki
• General Hospital of Thessaloniki ''Hippokration'' — Thessaloniki

Тайвань · 6 центров

• Buddhist Tzu Chi General Hospital — Chiayi City
• Kaohsiung Veterans General Hospital — Kaohsiung City
• Chung Shan Medical University Hospital — Taichung
• Taipei Medical University Hospital — Taipei
• … и ещё 2 центра

Япония · 5 центров

• Hospital of Japan Community Health Care Organization Chukyo Hospital — Nagoya
• Hospital of the University of Occupational and Environmental Health — Kitakyushu-shi
• Hospital of Shinkenko Clinic — Naha
• Hokkaido University Hospital — Kita-ku
• Juntendo University Hospital — Bunkyō City

Мексика · 5 центров

• Clinstile, S.A. de C.V. — Mexico City
• PanAmerican Clinical Research — Guadalajara
• Eme Red Hospitalaria — Mérida
• Kohler and Milsten Research — Mérida
• Oaxaca Site Management Organization — Oaxaca City

Испания · 4 центра

• FutureMeds DKF — Madrid
• Hospital Universitario Ramón y Cajal — Madrid
• Hospital Universitario La Paz — Madrid
• Hospital Universitario Virgen del Rocío — Seville

Португалия · 3 центра

• Hospital Egas Moniz — Lisbon
• ULS de Santa Maria, EPE - Hospital de Santa Maria — Lisbon
• ULS da Arrábida, E.P.E. - Hospital de São Bernardo — Setúbal

Болгария · 2 центра

• Medical Center Medtech Services EOOD — Haskovo
• University Multiprofile Hospital for Active Treatment "Eurohospital Plovdiv" — Plovdiv

Канада · 2 центра

• Richmond Clinical Trials — Richmond
• Riverside Professional Centre — Sydney

Германия · 2 центра

• Medicover Munchen Ost MVZ — München
• Uniklinik Koln — Cologne

Италия · 2 центра

• Policlinico Universitario Campus Biomedico Di Roma — Roma
• Centro Ricerche Cliniche Di Verona S.r.l. — Verona

Пуэрто-Рико · 2 центра

• Centro Reumatologico de Caguas — Caguas
• Latin Clinical Trial Center — San Juan

Румыния · 2 центра

• Centrul Medical de Diagnostic si Tratament Ambulator NEOMED SRL — Brasov
• Dr I Cantacuzino Clinical Hospital — Bucharest

ЮАР · 2 центра

• FARMOVS — Bloemfontein
• Panorama Medical Centre — Cape Town

Бельгия · 1 центр

• CHU de Liege — Liège

Дания · 1 центр

• Sjaellands Universitetshospital, Koge — Køge

Идентификаторы

NCT: NCT06559163 · ZB012-02-001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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