Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

Официальное название

A Multicenter, Open-label Phase Ⅱ Study to Evaluate the Efficacy and Safety of LP-005 Injection in Patients With Complement-Mediated Kidney Disease

Обзор

This is a multicenter, open-label, proof-of-concept, phase Ⅱ adaptive basket clinical trial designed to evaluate the efficacy, safety, and pharmacokinetic profile of LP-005 Injection as add-on therapy to standard treatment in patients with complement-mediated renal diseases.

Вмешательства

• Биопрепарат LP-005 Injection
  IV, Q4W

Первичные конечные точки

• Change from baseline in 24-hour urinary protein-to-creatinine ratio (UPCR) in Basket 1 cohort [Срок оценки: Week 24]
• Proportion of patients with a ≥25% reduction in serum creatinine (SCr) from baseline in Basket 2 cohort [Срок оценки: Week 24]
• Proportion of patients without dialysis requirement in Basket 3 cohort [Срок оценки: Week 24]

Вторичные конечные точки (5)

• Change from baseline in serum creatinine (SCr) [Срок оценки: Up to approximately 64 weeks]
• Change from baseline in estimated glomerular filtration rate (eGFR) [Срок оценки: Up to approximately 64 weeks]
• Incidence of AEs [Срок оценки: Up to approximately 64 weeks]
• Serum concentrations of LP-005 [Срок оценки: Up to approximately 64 weeks]
• Number of patients with anti-drug antibodies (ADA) [Срок оценки: Up to approximately 64 weeks]

Критерии участия

Критерии включения

• Males or females aged 18 to 65 years at screening.
• Body weight of ≥ 40 kg and a body mass index (BMI) within the range of 15 to 35 kg/m\^2 (inclusive).
• Patients with complement-mediated renal disease.
• Females and males of childbearing potential (including the participants' partners) must agree to use effective contraceptive measures during the trial and for 3 months after the trial ends.
• Willing to participate in this clinical trial and voluntarily sign the informed consent form; additionally, be assessed by the investigator as being able to fully understand and comply with all planned study procedures and other requirements.

Критерии исключения

• Pregnant or lactating female.
• History of meningococcal infection.
• Active, uncontrolled acute, chronic, or recurrent infection within 4 weeks prior to screening.
• Other severe, poorly controlled comorbidities within 3 months prior to screening.
• Patients with known hypersensitivity to any component of LP-005 or a history of atopic diathesis.
• History of malignancy within 5 years prior to screening, except for resected cutaneous basal cell carcinoma, resected cutaneous squamous cell carcinoma, and completely resected carcinoma in situ without evidence of local recurrence or metastasis (e.g., cervical carcinoma in situ or breast carcinoma in situ).
• Prior use of any complement inhibitor within 3 months prior to screening or 5 half-lives of the drug, whichever is longer.
• Participation in another clinical trial with administration of investigational drug or medical device within 4 weeks prior to screening or 5 half-lives of the administered product, whichever applies.
• Any condition that, in the investigator's judgment, may impede study participation, pose a safety risk to the participant, or confound the interpretation of study results.

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 University First Hospital — Пекин

Идентификаторы

NCT: NCT07363265 · P10-LP005-06

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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