CM336 for Active Sjogren's Syndrome Study

Официальное название

Evaluation of CM336 Injection for Active Sjogren's Syndrome: an Open-Label Phase Ib Study

Обзор

The purpose of this study is to evaluate the safety, tolerability, pharmacokinetics, and efficacy of CM336 in adult participants with active primary Sjogren's Syndrome.

Подробное описание

An open-label, multicenter, multiple ascending dose study evaluating safety, tolerability,PK/ADA profile and efficacy of CM336 administered subcutaneously in active primary Sjogren's Syndrome.

Вмешательства

• Биопрепарат CM336
  Participants will receive CM336 via subcutaneous injection in ascending dose cohorts

Первичные конечные точки

• Incidence of Treatment-Emergent Adverse Events [Срок оценки: Throughout study (Up to 52 weeks)]

Критерии участия

Критерии включения

• Male or female, aged 18 to 75 years (inclusive) at the time of signing the informed consent form (ICF), and willing to comply with the study protocol requirements.
• Body weight ≥ 45 kg at screening.
• Voluntary compliance with the protocol requirements for permitted/prohibited concomitant therapies.
• Definitive diagnosis of primary Sjögren's disease (SjD) according to the 2016 American College of Rheumatology (ACR)/European League Against Rheumatism (EULAR) classification criteria, and meeting all of the following requirements:

• Seropositive for at least one SjD-related autoantibody.
• Prior treatment with at least two systemic therapies for SjD symptoms.
• Active disease at screening, defined as Clinical EULAR Sjögren's Syndrome Disease Activity Index(ClinESSDAI) ≥ 5.
• No better therapeutic alternative available for the study participant.

Критерии исключения

• Presence of other systemic autoimmune diseases besides primary Sjögren's disease.
• Presence of other autoimmune or inflammatory diseases.
• Presence of any other medical condition with clinical manifestations overlapping with primary Sjögren's disease or that may interfere with result interpretation.
• Presence of active, life-threatening, or organ-threatening SjD complications at screening.
• History of severe allergic reactions (as judged by the investigator), or history of hypersensitivity to monoclonal antibodies or any component of CM336.
• Presence of congenital immunodeficiency, or acquired immunodeficiency not related to the participant's autoimmune disease or its medical treatment.
• Positive HIV antibody, positive Treponema pallidum antibody, or history of hepatitis B virus (HBV) or hepatitis C virus (HCV) infection.
• History of tuberculosis infection.
• Active infection requiring intravenous anti-infective treatment within 3 months before first dose of study drug, or oral anti-infective treatment within 2 weeks before first dose of study drug.
• History of disseminated herpes zoster, or ocular/Central Nervous System herpes zoster, or systemic herpes simplex or symptomatic herpes zoster infection within 3 months before first dose of study drug.
• Deep vein thrombosis or pulmonary embolism within 6 months before first dose of study drug.
• History of severe cardiovascular or cerebrovascular disease, including but not limited to:

• Unstable arrhythmia, unstable angina pectoris.
• New York Heart Association (NYHA) functional class III or IV.
• Uncontrolled hypertension (average systolic blood pressure ≥160 mmHg or diastolic blood pressure ≥100 mmHg on two measurements despite optimal treatment).
• Fridericia-corrected QT interval(QTcF) >450 ms for males or >470 ms for females
• History of pulmonary arterial hypertension with WHO functional class II or above.
• Presence of uncontrolled asthma or chronic obstructive pulmonary disease (COPD); uncontrolled diabetes mellitus; uncontrolled thyroid or other endocrine disorders; uncontrolled psychiatric disorders.
• Presence of any of the following during screening:

• Neutrophil count <1×10⁹/L, platelet count <100×10⁹/L, or hemoglobin <80 g/L (applicable only to patients without hematologic involvement).
• Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) >2× upper limit of normal (ULN).
• estimated Glomerular Filtration Rate(eGFR) <40 mL/min/1.73m² (2021 Chronic Kidney Disease Epidemiology Collaboration formula).
• Prothrombin time (PT) or activated partial thromboplastin time (APTT) >1.5×Upper Limit of Normal.
• Major surgery within 3 months before screening or planned during the study period (requiring hospitalization and general anesthesia, excluding diagnostic procedures).
• History of malignancy within 5 years before first dose of study drug (except cured basal cell carcinoma, squamous cell carcinoma of the skin, and cervical carcinoma in situ without evidence of recurrence).
• Prior treatment with any anti-B-cell maturation antigen targeted therapy (including cell therapy or antibody therapy, etc.).
• Receipt of prohibited medications within the corresponding timeframes.

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

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07642843 · CM336-127001

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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