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Recruiting
Sponsor ID
20250111

A Phase 3 Study of Inebilizumab in Participants with Primary Membranous NephropathyMOMENT

Sponsor ID
20250111
Clinicaltrials.gov ID
NCT07851220
EUCTIS ID
2025-523827-23-00
EudraCT ID
N/A
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Study Details

The primary objective of this study to evaluate the efficacy of inebilizumab on primary membranous nephropathy (PMN) disease activity as measured by complete remission in participants with PMN.

Additional Study Details

Phase
Phase 3
Product
AMG 335
Type
Interventional
Masking
None (Open Label)
Enrollment
159
Additional Study Details

Protocol Summary

Primary Outcome Measures

Percentage of Participants Achieving Complete Remission at Week 104

Timeframe: At Week 104

Secondary Outcome Measures

Percentage of Participants Achieving Complete Remission or Partial Remission at Week 104

Timeframe: At Week 104

Percentage of Participants Achieving Complete Remission or Partial Remission at Week 78

Timeframe: At Week 78

Percentage of Participants Achieving Complete Remission at Week 78

Timeframe: At Week 78

Time to First Complete Remission by Week 104

Timeframe: Up to Week 104

Time to First Complete Remission or Partial Remission by Week 104

Timeframe: Up to Week 104

Duration of Complete Remission in the Inebilizumab Arm

Timeframe: Up to Week 104

Percentage Change from Baseline in Anti-Phospholipase A2 Receptor (PLA2R) Antibody Levels in Anti-PLA2R Positive Participants at Week 26

Timeframe: From Baseline to Week 26

Number of Participants who Experienced Treatment-emergent Adverse Events, Treatment-emergent Serious Adverse Events, and Treatment-emergent Adverse Events of Interest

Timeframe: Up to Week 194

Number of Participants who Develop Anti-inebilizumab Antibodies

Timeframe: Up to Week 104

Serum Concentrations of Inebilizumab

Timeframe: Up to Week 160

Percentage Change from Baseline in Anti-PLA2R Antibody Levels at Week 78 and Week 104

Timeframe: From Baseline to Week 78 and Week 104

Time to First Relapse

Timeframe: From Day 1 to Week 104

Time to Initiate First Rescue Treatment

Timeframe: From day 1 to Week 104

Change From Baseline in Kidney Disease Quality of Life (KDQoL)-36 Domain Scores at Week 78 and at Week 104

Timeframe: From Baseline to Week 78 and Week 104

Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Fatigue 7a Score at Week 78 and at Week 104

Timeframe: From Baseline to Week 78 and Week 104

Change from baseline in the Estimated Glomerular Filtration Rate (eGFR)

Timeframe: From Baseline to Week 78 and Week 104

Percentage of Participants Achieving Stabilized eGFR at week 104, with a Decrease of ≤15 % From Baseline

Timeframe: From Baseline to Week 104

Locations

Location
Status
Contact Us
Location
Academic Medical Research Institute
Los Angeles, CA, United States, 90022
Status
Recruiting
Location
Bioresearch Partner- Pembroke Pines
Pembroke Pines, FL, United States, 33029
Status
Recruiting
Location
Bioresearch Partner-Jackson West
Doral, FL, United States, 33122
Status
Recruiting
Location
Bioresearch Partner- Martin Luther King Jr.
Miami, FL, United States, 33127
Status
Recruiting
Study Info
Age
18 - 79 Years
Condition
  • Unmapped
    • Sex
    All
    Trial Dates
    Oct 2026 - Sep 2031
    Inclusion and Exclusion Criteria
    Inclusion Criteria:
    -Adults aged ≥18 years and <80 years. -Able and willing to provide written informed consent. -Primary membranous nephropathy (PMN) confirmed by renal biopsy (performed during screening or within 5 years before screening), or biopsy exemption for participants with anti-PLA2R antibody ≥20 RU/mL at screening. -Participants with diabetes Hemoglobin A1c (HbA1c) <7.5% require a renal biopsy report within 2 years before screening (or biopsy during screening) demonstrating PMN without diabetic nephropathy. -Urine protein-to-creatinine ratio (UPCR) ≥3.5 from a 24-hour urine collection at screening. -Receiving a maximally tolerated Angiotensin-Converting Enzyme (ACE) inhibitor or (Angiotensin II receptor blocker) ARB for ≥3 months before randomization with adequately controlled blood pressure (<140/90 mmHg).
    Exclusion Criteria:
    -Secondary membranous nephropathy (e.g., due to autoimmune disease, infection, malignancy, or medications). -Estimated glomerular filtration rate (eGFR) <40 mL/min/1.73 m^2 , ≥30% decline in eGFR during the previous 24 weeks, need for dialysis, kidney replacement therapy, kidney transplant, or planned transplant during the study. -Recent thromboembolic event (within 3 months). -Active HIV, hepatitis B infection, Hepatitis B surface antigen (HBsAg) positive, active hepatitis C infection, uncontrolled diabetes (HbA1c ≥7.5%), active or inadequately treated tuberculosis, recurrent herpes zoster or opportunistic infections, clinically significant active infection, recurrent serious infections, or immunodeficiency disorders. -Clinically significant laboratory abnormalities, including severe anemia, neutropenia, thrombocytopenia, low Cluster of Differentiation (CD19+) B-cell count, hepatic dysfunction, or immunoglobulin G (IgG) <400 mg/dL. -History of solid organ or cell transplantation or progressive multifocal leukoencephalopathy. -Recent treatment with prohibited therapies, including: B-cell-depleting biologics or other biologic immunomodulators, calcineurin inhibitors, alkylating agents within 3 months;( except history of resistance to calcineurin inhibitors); other immunosuppressive agents within 4 weeks; glucocorticoids within 1 month, or live or live-attenuated vaccines (within 4 weeks before randomization). Note: Other protocol-defined Inclusion/Exclusion criteria may apply.