Идёт набор NCT06419205

A Phase 2 Study to Evaluate the Safety, PD, PK, and Clinical Activity of ADX-097 in Participants With IgAN, LN or C3G

Фаза II С лечением IgA Nephropathy Lupus Nephritis (LN) C3 (Complement Component 3) Glomerulopathy

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: ADX-097.
Кому может быть актуально: Состояния в реестре: IgA Nephropathy, Lupus Nephritis (LN), C3 (Complement Component 3) Glomerulopathy. Базовые параметры: от 16 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, Бразилия
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 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older With Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)

Обзор

A Phase 2 Study to Evaluate the Safety, Pharmacodynamics, Pharmacokinetics, and Clinical Activity of ADX-097 Administered Subcutaneously in Male and Female Participants Aged 16 Years or Older with Immunoglobulin A Nephropathy (IgAN), Lupus Nephritis (LN), or Complement Component 3 Glomerulopathy (C3G)

Вмешательства

Препарат ADX-097
Subcutaneous Infusions

Первичные конечные точки

Number of participants reporting treatment emergent adverse events (TEAEs) [Срок оценки: Up to 30 weeks]

Вторичные конечные точки (3)

Change from baseline in urine protein-to-creatinine ratio (uPCR) [Срок оценки: Baseline and up to 26 weeks]
Change from baseline in estimated glomerular filtration rate (eGFR) [Срок оценки: Baseline and up to 26 weeks]
Trough plasma Concentration of ADX-097 [Срок оценки: At Days 1, 8, 22, 50, 78, 106, 134 and 176]

Критерии участия

Критерии включения

All participants

Male or female participants aged ≥16 years.
uPCR ≥0.5 g/g (from the average of 3 first morning voids \[FMVs\]).
Screening eGFR ≥30 mL/min/1.73m2 calculated by the Chronic Kidney Disease Epidemiology Collaboration creatinine equation (CKD-EPI GFR).
Participants receiving a renin-angiotensin-aldosterone system (RAAS) inhibitor, sodium-glucose cotransporter-2 (SGLT2) inhibitor, sparsentan, or atrasenten must have been on a stable dose (at the maximum recommended dose according to local guidelines or maximum tolerated dose) for at least 8 weeks prior to Study Day 1 and the dose is projected to remain stable until completion of the study.

Participants with IgAN only

Kidney biopsy-proven diagnosis of IgAN with a kidney biopsy that is obtained within 10 years of Day 1 or within 5 years of Day 1 if the participant is known or suspected of also having diabetic nephropathy.

Participants with LN only

Clinical diagnosis of systemic lupus erythematosus (SLE)
Kidney biopsy-proven diagnosis of LN with a kidney biopsy that is obtained within 24 weeks of Day 1.
Diagnosis of active focal or diffuse LN class III or IV

Participants with C3G only

Kidney biopsy-proven diagnosis of C3G, either dense deposit disease (DDD) or complement component 3 glomerulonephritis (C3GN), with a kidney biopsy that is obtained within 52 weeks of Day 1.
Participants receiving mycophenolate mofetil (MMF) (or mycophenolic acid) or prednisone ≥10 mg/d or equivalent must have been on a stable dose for at least 12 weeks before Day 1 that is projected to remain stable until completion of the study.

Key Exclusion Criteria All participants

Rapidly progressive glomerulonephritis defined as a 50% decline in eGFR within 12 weeks of screening.
Concomitant significant renal disease other than IgAN, C3G, or LN per investigator discretion.
Participants with a history of and/or presence of anti-factor H antibodies at screening.
Uncontrolled hypertension with mean seated systolic blood pressure (BP) ≥160 mmHg or diastolic BP ≥100 mmHg based on the average of 2 measurements obtained at approximately 2-minute intervals after the individual has been sitting for 5 minutes.
Kidney, other solid organs, or bone marrow transplantation prior to or expected to occur during the study.
History of splenectomy.

Participants with IgAN only

Secondary forms of IgAN
Received systemic corticosteroid therapy, oral budenoside, or any other form of immunosuppressive therapy within 12 weeks before Day 1.

Participants with LN only

Lymphocyte count below 0.5 × 109/L at screening.
Received any of Cyclophosphamide, Calcineurin inhibitors, IV methylprednisolone, IV immunoglobulin therapy, Belimumab, Obinutuzumab and Rituximab treatments at protocol specified time points.

Participants with C3G only

Evidence of monoclonal gammopathy of unclear significance, infections, malignancy, autoimmune diseases, or other conditions to which C3G is secondary.
Received systemic corticosteroid therapy, eculizumab, iptacopan, pegcetacoplan, or any other form of immunosuppressive therapy ≤12 weeks before Day 1, except for MMF (or mycophenolic acid), which is permitted.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет