A Study of Telitacicept in Lupus Nephritis

Официальное название

A Phase Ⅱ, Multicenter, Randomized, Double-blind, Placebo-controlled Study to Evaluate the Efficacy and Safety of Telitacicept in Lupus Nephritis

Обзор

The purpose of this study is to evaluate the safety and efficacy of Telitacicept in adult patients with active lupus nephritis.

Подробное описание

This is a phase 2, multicentre, randomised, double-blind, placebo-controlled study to evaluate the efficacy and safety of telitacicept versus placebo while taking standard of care (SOC) treatment in adult subjects with active proliferative lupus nephritis (LN).

Вмешательства

• Биопрепарат Telitacicept 240 mg
  Participants will receive Telitacicept 240mg weekly in addition to SOC for 48 weeks.
• Биопрепарат Telitacicept 160 mg
  Participants will receive Telitacicept 160mg weekly in addition to SOC for 48 weeks.
• Препарат Placebo
  Participants will receive placebo weekly in addition to SOC for 48 weeks.

Первичные конечные точки

• Percentage of Participants with Complete Renal Response (CRR) [Срок оценки: Week 48]

Вторичные конечные точки (2)

• Percentage of participants with Partial Renal Response (PRR) [Срок оценки: Week 24 and Week 48]
• Incidence of AE, SAE [Срок оценки: Up to Week 48]

Критерии участия

Main Inclusion Criteria:

• Males or females aged 18-75 years of age, inclusive.
• Diagnosis of systemic lupus erythematosus according to American College of Rheumatology criteria (1997).
• Active, biopsy-proven proliferative lupus nephritis Class III or IV with/without the presence of Class V, or pure Class V according to the 2003 ISN/RPS classification. The renal biopsy must be performed within 1 year prior to the screening visit or during screening period. The biopsy report will be used to confirm subject eligibility.
• Positive serum antibody results, defined as positive anti-nuclear antibody (ANA) and/or a positive anti-dsDNA serum antibody based on the study\'s central laboratory results.
• Active renal disease at screening requiring induction therapy with high dose corticosteroids (HDCS) with mycophenolate mofetil (MMF) or other oral forms of mycophenolate.
• Induction therapy for active renal disease: HDCS with mycophenolate mofetil (MMF) or other oral forms of mycophenolate should be initiated within 60 days prior to or on Day 1 (baseline). Initiation of induction is when both HDCS and MMF have been started.
• Able to understand the requirements of the study and provide written informed consent.

Main Exclusion Criteria:

• Known hypersensitivity or contraindication to any drug products they plan to receive (e.g., MMF, corticosteroids).
• History of allergy to parenteral administration of contrast agents, human or murine proteins or monoclonal antibodies.
• Received any of the following therapies:

• Treatment with any B cell targeted therapy (e.g., rituximab), unless it can be shown that B cells have returned to baseline level or normal;
• Received tumor necrosis factor inhibitors, interleukin receptor blockers, or other small molecules or biologics (including Belimumab) during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
• Received any experimental drugs during the 12 weeks prior to screening or the 5 half-lives of the drug, whichever is longer;
• Received plasma separation or plasma exchange during the 6 weeks prior to screening;
• Subjects who required dialysis within 1 year prior to screening.
• Received a live vaccine or live-attenuated vaccine within 4 weeks prior to screening or expected to vaccinate during the study.
• Received BCG Vaccine within 1 year prior to screening.
• History of severe active central nervous system (CNS) lupus (including seizures, psychosis, organic brain syndrome, cerebrovascular accident, cerebritis, or CNS vasculitis) requiring intervention within 60 days of baseline (Day 1).
• History of a major organ transplant (e.g., heart, lung, kidney, liver) or hematopoietic stem cell/marrow transplant or are due to receive transplantation.
• Significant, unstable or uncontrolled acute or chronic diseases not due to SLE (i.e., cardiovascular, pulmonary, hematologic, gastrointestinal, hepatic, renal, neurological, malignancy, or infectious diseases) which, in the opinion of the principal investigator, could confound the results of the study or put the subject at undue risk.
• Plan to undergo surgery or have any medical disease, laboratory abnormality, or condition that, in the opinion of the principal investigator, makes the subject unsuitable for the study.
• History of drug or alcohol abuse or dependence within 364 days prior to baseline (Day 1).
• Nursing or pregnant female, or male or female who prepared for parenthood during the study.
• History of malignant tumors within the last 5 years, excluding adequately treated skin cancer (basal or squamous cell) or carcinoma in situ of cervix.
• Have acute or chronic infection requiring treatment.
• HIV positive.
• Hepatitis B: Patients positive for HBsAg are excluded; Patients negative for HBsAg but positive for Anti-HBc, regardless of Anti-HBs antibody status, will require test for HBV DNA: if HBV DNA positive, patients will be excluded; if HBV DNA negative, patients will be eligible to enroll.
• Hepatitis C antibody positive.
• History of COVID-19 within 4 weeks prior to screening or history of hospitalization due to severe Covid-19 within 12 months prior to screening.
• eGFR\<30 mL/min/1.73 m2 using CKD-EPI.
• Renal biopsy showed 50% glomerulosclerosis.
• Have a Grade 3 or greater laboratory abnormality based on the Adverse Event Severity Grading Tables.
• Subjects who in the opinion of the investigator are not suitable to participate.

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

Четверное слепое

Основная цель

Лечение

Центры проведения

Китай · 45 центров

• The First Affiliated Hospital of University of Science and Technology of China (Anhui Prov — Хэфэй
• Peking University People's Hospital — Пекин
• The First Hospital Affiliated to the Army Medical University — Чунцин
• The First Affiliated Hospital of Xiamen University — Xiamen
• Zhongshan Hospital Affiliated to Xiamen University — Xiamen
• Guangdong Provincial People's Hospital — Гуанчжоу
• The First Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• The Third Affiliated Hospital of Sun Yat-sen University — Гуанчжоу
• … и ещё 37 центров

Публикации

• Ahmad SB, Jefferson JA. Targeting B Cells and Plasma Cells in Glomerular Disease. J Am Soc Nephrol. 2025 Jun 4;36(9):1844-1857. doi: 10.1681/ASN.0000000772. PMID 40465397

Идентификаторы

NCT: NCT05680480 · 18C030

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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