Идёт набор NCT06858579

A Study to Evaluate the Efficacy and Safety of DNTH103 in Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Фаза III С лечением Chronic Inflammatory Demyelinating Polyneuropathy

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: Claseprubart, Claseprubart, Placebo.
Кому может быть актуально: Состояния в реестре: Chronic Inflammatory Demyelinating Polyneuropathy. Базовые параметры: 18 лет — 75 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, Бельгия, Бразилия +24
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 Study To Evaluate The Efficacy And Safety Of DNTH103 In Adults With Chronic Inflammatory Demyelinating Polyneuropathy (CAPTIVATE)

Обзор

The purpose of this Phase 3 study is to demonstrate the efficacy of claseprubart (DNTH103) as compared to placebo in participants with chronic inflammatory demyelinating polyneuropathy (CIDP).

Подробное описание

The study includes the following periods:

* Part A: An open-label period (up to 13 weeks) * Part B: A randomized, placebo-controlled, double-blind treatment period (up to 52 weeks) for participants who respond to DNTH103 in Part A * Optional open-label extension (OLE) for eligible participants (up to 104 weeks) * Safety follow-up (40 weeks)

Вмешательства

Препарат Claseprubart
IV Infusion
Препарат Claseprubart
SC injection
Препарат Placebo
SC injection

Первичные конечные точки

Part B: Time From First Dose to Relapse as Assessed by the Adjusted Inflammatory Neuropathy Cause and Treatment (INCAT) [Срок оценки: Part B baseline to Part B end of treatment period (up to Week 52)]

Вторичные конечные точки (12)

Part B: Time to Decrease of ≥ 4 Points (Centile Metric) in Inflammatory Rasch-built Overall Disability Scale (I-RODS) Score [Срок оценки: Part B baseline to Part B end of treatment period (up to Week 52)]
Part B: Time to Decrease of ≥ 8 kilopascal (kPa) in Grip Strength in the Dominant Hand [Срок оценки: Part B baseline to Part B end of treatment period (up to Week 52)]
Part B: Percentage of Participants who Relapse as Assessed by the Adjusted INCAT [Срок оценки: Part B baseline to end of treatment period for Part B (up to Week 52)]
Parts A and B: Change in I-RODS Score (Centile Metric) [Срок оценки: Part A baseline up to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Parts A and B: Change in Grip Strength in the Dominant Hand [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Parts A and B: Change in Adjusted INCAT Score [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Parts A and B: Change in Grip Strength in the Nondominant Hand [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Parts A and B: Change in Medical Research Council Sum Score (MRC-SS) [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Part A: Percentage of Participants with a Confirmed Response to DNTH103 as Assessed by the Adjusted INCAT [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13)]
Parts A and B: Change in Euro-Quality of Life Visual Analogue Scale (EQ-VAS) [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Parts A and B: Change in Fatigue Severity Scale (FSS) [Срок оценки: Part A baseline to Part A end of treatment period (up to Week 13); Part B baseline to Part B end of treatment period (up to Week 52); Part A baseline to Part B end of treatment period (up to Part B Week 52)]
Parts A and B and OLE: Change in Adjusted INCAT Score [Срок оценки: Part A baseline to OLE Week 52 and Week 104; Part B baseline to OLE Week 52 and Week 104; OLE baseline to OLE Week 52 and Week 104]

Критерии участия

Критерии включения

Must have given written informed consent before any study-related activities are carried out.
Weight range between 40 kilograms (kg) and 120 kg.
Confirmed diagnosis of CIDP or possible CIDP. Participants must have either typical CIDP or one of the following variants: motor or multifocal CIDP. Diagnosis must be confirmed by the Independent CIDP Review Panel.
CIDP Disease Activity Status (CDAS) score ≥ 3 at screening.
Must be neurologically stable.
Must have an INCAT score between 2 and 9 inclusive.
Must fulfill one of the following treatment conditions for CIDP:

Currently treated with and responded to immunoglobulin (Ig) (intravenous immunoglobulin \[IVIg\] or subcutaneous immunoglobulin \[SCIg\]) alone or Ig (IVIg or SCIg) plus oral corticosteroids, or previously treated with and responded to, but are no longer being treated with (eg, lost access to), a maintenance regimen of Ig (IVIg or SCIg) alone or Ig (IVIg or SCIg) plus oral corticosteroids.
Currently treated with and responded to oral corticosteroids alone or oral corticosteroids in combination with azathioprine or mycophenolate mofetil.
Refractory participants who have had treatment failure (worsening) or an inadequate response to Ig and/or oral corticosteroids (defined as no clinically meaningful improvement after a period of a minimum of 12 weeks, which may include both active treatment and observation to assess response), or who at any time were unable to tolerate these treatments, experienced adverse effects, or have documented contraindications.
Treatment naïve with no history of prior treatment for CIDP.
Documented vaccinations against encapsulated bacteria in accordance with local requirements and vaccine availability.
Female participants must be of nonchildbearing potential or if of childbearing potential, must agree not to donate ova, not to attempt to become pregnant and, if engaging in sexual intercourse with a male partner, must agree to use a highly effective method of contraception.
Male participants must agree not to donate sperm and, if engaging in sexual intercourse with a female partner who could become pregnant, must agree to use an acceptable method of contraception or be surgically sterile for at least 90 days prior to Screening.

Критерии исключения

Clinical signs or symptoms suggestive of polyneuropathy of causes other than CIDP.
Known evidence of central demyelination or known history of myelopathy.
History or presence of significant medical/surgical condition including any acute illness or major surgery considered to be clinically significant or that could have a potential impact on safety/efficacy or study procedures.
Any other condition, including mental illness or prior therapy that would make the participant unsuitable for this study.
Known complement deficiency or history of positive titer for anti-C1 antibodies.
Diagnosis of systemic lupus erythematosus (SLE) or family history of SLE (defined as a parent, sibling, or child).
Participants with an autoimmune disease affecting joints, muscle or nervous system.
Any coexisting or overlapping condition, which may interfere with outcome assessments, such as severe diabetic neuropathy, fibromyalgia, inflammatory arthritis or osteoarthritis affecting the hands and feet.
Prior history of N. meningitidis infection.
History of active malignancy within 5 years prior to screening, except basal cell carcinoma of the skin, curatively resected squamous cell carcinoma of the skin, cervical carcinoma in situ curatively treated or low-grade prostate adenocarcinoma for which appropriate management is observation alone.
Positive test results for active human immunodeficiency virus (HIV-1 or HIV-2), hepatitis B surface antigen (HBsAg), or hepatitis C virus (HCV) antibodies.

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: Тройное слепое
Основная цель: Лечение

Центры проведения

США · 32 центра

Clinical Study Site — Birmingham
Clinical Study Site — Phoenix
Clinical Study Site — Scottsdale
Clinical Study Site — Los Angeles
Clinical Study Site — San Francisco
Clinical Study Site — San Francisco
Cinical Study Site — New Haven
Clinical Study Site — Washington D.C.
… и ещё 24 центра

Китай · 19 центров

Clinical Study Site — Хэфэй
Clinical Study Site — Гуанчжоу
Clinical Study Site — Чанша
Clinical Study Site — Чанша
Clinical Study Site — Ухань
Clinical Study Site — Chifeng
Clinical Study Site — Сучжоу
Clinical Study Site — Пекин
… и ещё 11 центров

Италия · 14 центров