Идёт набор NCT05327114

Efficacy and Safety Study of Nipocalimab for Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Фаза II / Фаза III С лечением Polyradiculoneuropathy, Chronic Inflammatory Demyelinating

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: Nipocalimab, Placebo.
Кому может быть актуально: Состояния в реестре: Polyradiculoneuropathy, Chronic Inflammatory Demyelinating. 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, Австралия, Канада, Китай +14
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

Phase 2/3, Multistage, Multicenter, Randomized, Double-Blind, Placebo-Controlled Parallel Group Withdrawal Study to Evaluate the Efficacy and Safety of Nipocalimab Administered to Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CIDP)

Обзор

The main purpose of this study is to evaluate the safety and efficacy of nipocalimab compared to placebo in delaying relapse in adults with chronic inflammatory demyelinating polyneuropathy (CIDP) who initially respond to nipocalimab in Stage A.

Вмешательства

Препарат Nipocalimab
Nipocalimab will be administered intravenously.
Препарат Placebo
Placebo will be administered intravenously.

Первичные конечные точки

Stage B: Time to First Occurrence of a Relapse Event [Срок оценки: Up to 52 weeks]

Вторичные конечные точки (12)

Stage A: Time to Initial Confirmed Evidence of Clinical Improvement (ECI) [Срок оценки: 12 weeks]
Stage A: Percentage of Responders as Determined by ECI [Срок оценки: 12 weeks]
Stage A: Change from Baseline Over Time in Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) Disability Scale Score [Срок оценки: Baseline to 12 weeks]
Stage A: Change from Stage A Baseline Over Time in Medical Research Council (MRC) Muscle Grading Scale Sum Score [Срок оценки: Baseline to 12 weeks]
Stage A: Change from Baseline Over Time in Inflammatory Rasch-Built Overall Disability Scale (I-RODS) Centile Score [Срок оценки: Baseline to 12 weeks]
Stage A: Change from Baseline Over Time in Mean Grip Strength (Dominant Hand) [Срок оценки: Baseline to 12 weeks]
Stage A: Change from Baseline Over Time in Mean Grip Strength (Non-Dominant Hand) [Срок оценки: Baseline to 12 weeks]
Stage B: Time to First Adjusted INCAT Disability Scale Score Deterioration Relative to Baseline [Срок оценки: Up to 52 weeks]
Stage B: Time to First Switch to Intravenous Immunoglobulin (IVIg) or Other Standard of Care (SoC) as a Result of Investigator-assessed Lack of Efficacy as Confirmed by an Independent RAC Relative to Baseline [Срок оценки: Up to 52 weeks]
Stage B: Change from Baseline Over Time in Adjusted INCAT Disability Score [Срок оценки: Up to 52 weeks]
Stage B: Change from Baseline Over Time in MRC Muscle Grading Scale Sum Score [Срок оценки: Up to 52 weeks]
Stage B: Change from Baseline Over Time in I-RODS Centile Score [Срок оценки: Up to 52 weeks]

Критерии участия

Критерии включения

Adults greater than or equal to (>=) 18 years of age at the time of consent and as applicable, must also meet the legal age of consent in the jurisdiction in which the study is taking place
Diagnosed with Chronic Inflammatory Demyelinating Polyneuropathy (CIDP) according to criteria of the European Academy of Neurology/Peripheral Nerve Society (EAN/PNS) 2021, progressing or relapsing forms. CIDP diagnosis to be adjudicated by independent committee during screening period
Inflammatory Neuropathy Cause and Treatment (INCAT) disability score between 2 and 9 at the Run-In Baseline visit for participants entering Run-In, or Stage A Baseline visit for participants directly entering Stage A. Participants with an INCAT score of 2 at trial entry must have this score exclusively from the leg disability score
Fulfilling any of the following treatment conditions: a) Currently treated with oral corticosteroids (CS) less than or equal to (<=) 20 milligrams (mg)/day; or b) Currently treated with pulsed CS, and/or intravenous immunoglobulin (IVIg) or subcutaneous immunoglobulin (SCIg) and the participant is willing to discontinue no later than the run-in baseline visit; or c) Currently treated with oral CS greater than (>) 20 mg/day and the participant is willing to taper to <=20 mg/day during the run-in period; or d) Without previous treatment (treatment naive); or treatment with CS and/or IVIg or SCIg discontinued at least 3 months prior to screening (untreated)
Active disease as determined by CIDP Disease Activity Status (CDAS) score >= 3
Other protocol-defined inclusion criteria will apply

Критерии исключения

Has a history of severe and/or uncontrolled hepatic (example, viral/alcoholic/autoimmune hepatitis/cirrhosis and/or metabolic liver disease), gastrointestinal, renal, pulmonary, cardiovascular, psychiatric, neurological or musculoskeletal disorder, hypertension and/or any other medical or uncontrolled autoimmune disorder(s) (example, diabetes mellitus) or clinically significant abnormalities in screening laboratory that, might interfere with the participants full participation in the study, or might jeopardize the safety of the participant or the validity of the study results
Pure sensory CIDP or chronic immune sensory polyradiculopathy (CISP) (EAN/PNS definition)
Any other disease that could better explain the participant's signs and symptoms, such as significant persisting neurological deficits from stroke or central nervous system (CNS) trauma or peripheral neuropathy from another cause such as connective tissue disease or systemic lupus erythematosus
Polyneuropathy of other causes, including the following: Multifocal motor neuropathy (MMN); Monoclonal gammopathy of uncertain significance with antimyelin associated glycoprotein (anti-MAG) immunoglobulin M (IgM) antibodies; Hereditary motor neuropathy; Hereditary neuropathy with liability to pressure palsies (HNPP); Polyneuropathy, organomegaly, endocrinopathy, monoclonal protein and skin change syndromes; Lumbosacral radiculoplexus neuropathy; Polyneuropathy most likely due to diabetes mellitus; Polyneuropathy most likely due to systemic illnesses; Drug- or toxin-induced polyneuropathy Note: A concomitant polyneuropathy of other causes (example, a mild, stable diabetic polyneuropathy) is not necessarily exclusionary if chronic inflammatory demyelinating polyneuropathy (CIDP) is confirmed as the main diagnosis, as determined by the investigator and confirmed by the adjudication committee
Has known allergies, hypersensitivity, or intolerance to nipocalimab or its excipients
Other protocol-defined exclusion criteria will apply

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: Двойное слепое
Основная цель: Лечение

Центры проведения

Китай · 19 центров

Peking University First Hospital — Пекин
Xuanwu Hospital ,Capital Medical University — Пекин
Beijing Tiantan Hospital, Capital Medical University — Пекин
Peking University Third Hospital — Пекин
The First Hospital of Jilin University — Changchun
The Third Xiangya Hospital of Central Sourth University — Чанша
Xiangya Hospital Central South University — Чанша
Sichuan Provincial Peoples Hospital — Чэнду
… и ещё 11 центров

Япония · 19 центров

National Hospital Organization Asahikawa Medical Center — Asahikawa
Institute of Science Tokyo Hospital — Bunkyō City
Chiba University Hospital — Chiba
Seirei Hamamatsu General Hospital — Hamamatsu
Tokai University Hospital — Isehara
Kobe City Medical Center General Hospital — Kobe
… и ещё 13 центров

США · 15 центров

IMMUNOe Health and Research Centers — Centennial
Healthcare Innovations Institute Inc — Coral Springs
Neurology Associates PA — Maitland
ALS Center at the University of Miami — Miami
University of Kansas Medical Center — Kansas City
Johns Hopkins Hospital — Baltimore
Boston Clinical Trials — Boston
Beaumont Hospital Royal Oak — Royal Oak
… и ещё 7 центров

Франция · 9 центров

CHU Bordeaux — Bordeaux
Hospices Civils de Lyon HCL — Bron
Hopital de Bicetre — Le Kremlin-Bicêtre
Hopital de la Timone — Marseille
Hopital PASTEUR — Nice
CHU Nimes Hopital Caremeau — Nîmes
Hopital de la Pitie Salpetriere — Paris
Fondation Adolphe de Rothschild Hospital — Paris
… и ещё 1 центр

Италия · 9 центров

Azienda Ospedaliero-Universitaria Policlinico di Catania — Catania
Azienda Ospedaliera Universitaria San Martino di Genova — Genova
Casa di Cura del Policlinico — Milan
Istituto Neurologico Carlo Besta — Milan
Azienda Ospedaliera di Rilievo Nazionale A Cardarelli — Naples
Aou San Luigi Gonzaga — Orbassano
Fondazione Istituto Neurologico Casimiro Mondino — Pavia
Fondazione Policlinico Universitario A Gemelli IRCCS — Roma
… и ещё 1 центр

Германия · 6 центров

Judisches Krankenhaus Berlin — Berlin
St. Josef-Hospital, Ruhr-Universität Bochum — Bochum
Städtisches Krankenhaus Martha-Maria Halle-Dölau gGmbH — Halle
Medizinische Hochschule Hannover — Hanover
Universitaetsklinikum Leipzig — Leipzig
St Josefs Krankenhaus Potsdam Sanssouci — Potsdam

Испания · 6 центров