An Exploratory Study of Obinutuzumab β in the Treatment of Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Официальное название

Safety and Efficacy of Obinutuzumab β in Chronic Inflammatory Demyelinating Polyradiculoneuropathy

Обзор

This clinical trial aims to evaluate the safety and efficacy of obinutuzumab β in patients with chronic inflammatory demyelinating polyradiculoneuropathy (CIDP). The key research objectives are as follows:1. To assess the efficacy of obinutuzumab β for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy.2. To assess the safety of obinutuzumab β for the treatment of chronic inflammatory demyelinating polyradiculoneuropathy.Study participants are required to:Receive two intravenous infusions of obinutuzumab β.Attend follow-up examinations and laboratory tests at the study site at Week 1, Week5, Week9, Week 13, Week 25, Week 37, Week 49, Week 61, Week 73.Maintain a daily symptom diary and record the number of rescue treatments.

Вмешательства

• Препарат Obinutuzumab β
  Administer Obinutuzumab β Injection 600mg intravenously on W1D1, W25D1 of the treatment period

Первичные конечные точки

• Within 49 weeks, relapse risk is defined as a ≥1-point increase from baseline in INCAT score. The primary outcome is the proportion of patients meeting this criterion, with 95% CI. [Срок оценки: Within 49 weeks]

Критерии участия

Критерии включения

• Aged ≥ 18 and ≤ 75 years at screening.
• Diagnosed with definite chronic inflammatory demyelinating polyradiculoneuropathy (CIDP) according to the 2021 criteria of the European Federation of Neurological Societies/Peripheral Nerve Society (EFNS/PNS).
• CIDP Disease Activity Status (CDAS) score ≥ 2 at screening.
• Inflammatory Neuropathy Cause and Treatment (INCAT) disability scale score ≥ 2 at the initial screening.
• Voluntarily sign the informed consent form.
• Female participants of childbearing potential must have a negative pregnancy test (serum β-HCG)at screening .Effective contraception shall be used during the study period and for 12 months after the last dose. Male participants and their partners must also agree to use effective contraception.

Критерии исключения

• Pure sensory atypical CIDP (as defined by EFNS/PNS).
• Polyneuropathy due to other causes, including but not limited to: multifocal motor neuropathy, monoclonal gammopathy of undetermined significance with anti-myelin-associated glycoprotein (MAG) IgM antibodies, hereditary demyelinating neuropathy, polyneuropathy, organomegaly, endocrinopathy, monoclonal protein, and skin changes (POEMS) syndrome, lumbosacral radiculoplexus neuropathy, polyneuropathy most likely caused by diabetes mellitus, polyneuropathy most likely caused by systemic diseases, and drug- or toxin-induced polyneuropathy.
• Any other disease that could better account for the patient's symptoms and signs.
• History of any myelopathy or evidence of central demyelination.
• Current or history of alcohol, drug, or substance abuse within 12 months prior to screening.
• Severe psychiatric disorders (e.g., major depressive disorder, psychosis, bipolar disorder), history of suicide attempt, or current suicidal ideation that, in the opinion of the investigator, may place the patient at undue risk or interfere with the patient's compliance with the study protocol.
• Any uncontrolled active infection or serious infection within 8 weeks prior to screening; clinically significant active or chronic uncontrolled bacterial, viral, or fungal infections, including patients with active viral infection detected at screening: active hepatitis B virus (as indicated by serological tests showing active \[acute or chronic\] infection), active hepatitis C virus (positive HCV-Ab serology), or human immunodeficiency virus (HIV)-positive serology associated with acquired immunodeficiency syndrome (AIDS)-defining conditions or with a CD4 count ≤ 200 cells/mm³.
• Total immunoglobulin G (IgG) level < 6 g/L at screening.
• Received the following treatments within 6 months prior to screening: any other investigational drug; any anti-CD20 monoclonal antibody or other biologic agents (e.g., rituximab); alemtuzumab; any other monoclonal antibody; cyclophosphamide; interferon; tumor necrosis factor-α inhibitors; fingolimod; methotrexate; azathioprine; mycophenolate mofetil; any other immunomodulatory or immunosuppressive drugs; and oral corticosteroids > 10 mg/day.
• Presence of any other known autoimmune disease that, in the investigator's opinion, may interfere with the accurate assessment of CIDP clinical symptoms.
• Receipt of live-attenuated vaccine within 1 month prior to screening (patients who have received inactivated, subunit, polysaccharide, or conjugate vaccines at any time prior to screening are not excluded).
• History of malignancy, unless the patient is considered cured by adequate treatment with no evidence of recurrence for ≥ 3 years before the first dose. Patients with the following cancers may be included at any time: adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, carcinoma in situ of the breast, or prostate cancer (TNM stage T1a or T1b).
• Patients who have previously participated in an obinutuzumab beta trial and have received at least one dose of obinutuzumab beta.
• Known history of allergy to any component of obinutuzumab beta.
• Clinical evidence of other significant severe diseases; patients who have recently undergone major surgery or are scheduled for major surgery; or any other condition that, in the investigator's judgment, may confound the trial results or place the patient at undue risk.

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

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT07696377 · 2026-205-02

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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