Phase II Study Assessing Safety and Efficacy of APL-2 in Glomerulopathies

Completed · Phase 2

Conditions studied: IgA Nephropathy, Lupus Nephritis, Membranous Nephropathy, C3 Glomerulonephritis, Dense Deposit Disease

In brief

This is a Phase II trial assessing the safety and preliminary efficacy of daily APL-2 subcutaneous infusion administered for 16 weeks with a 6 month safety follow up, in patients with glomerulopathies

Key facts

Study ID

NCT03453619

Run by

Apellis Pharmaceuticals, Inc.

People needed

21

Starts

2018-02-26

Expected to finish

2023-08-26

Last updated by the study team

2025-02-13

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Patients of at least 18 years of age at screening (16 years of age for C3G), able to provide written informed consent, and able to understand and comply with all scheduled procedures and other requirements of the study by the opinion of Principal Investigator (PI)
• Patients must have a diagnosis of IgAN, LN, Primary MN, or C3G confirmed by renal biopsy and required measurements performed prior to study participation
• IgAN: Prior biopsy results for C3 and C4d staining should be made available
• LN: Diagnostic biopsy showing proliferative focal, diffuse, or membranous lesions (Class III, IV or V, respectively) by renal biopsy. Subject should have either a biopsy in the last 6 months, or evidence of disease activity (nephritic changes on urinalysis or nephrotic changes)
• Primary MN: PLA2R positive titer plus nephrotic range proteinuria (defined as uPCR >2350 mg/g)
• C3G plus one of the following: Low serum C3 level or historical renal biopsy within the last 3 years
• Have proteinuria >750 mg/g (calculated by uPCR on 24 hour urine collection) collected during the first screening visit (Visit 3a).
• eGFR≥30mL/min/1.73 m2 calculated by CKD-EPI creatinine equation at screening visit 3a and currently not on dialysis
• Must have stable or worsening renal disease, on stable and optimized treatment, in the opinion of the PI, for at least 2 months prior to the first dose of APL-2 (Visit 4); treatments may include, but are not limited to, immunosuppressive agents, anti-hypertensives and/or anti-proteinurics.
• Willing to receive vaccinations against Neisseria meningitidis at least 2 weeks prior to dosing on Day 1 with a booster on Day 56 (for both vaccinations) and Pneumococcal and Hib vaccines at least 2 weeks prior to dosing on Day 1.

You may not qualify if…

• Absolute neutrophil count <1000 cells/mm3 at screening Visits 3a and 3b
• ALT or AST >3.0 x the upper limit of normal at screening Visits 3a and 3b
• Previous treatment with APL-2
• History of solid organ transplant
• Diagnosis of human immunodeficiency virus (HIV), hepatitis B, or hepatitis C infection, or positive serology at screening Visits 3a and 3b (previous HBV or HCV diagnosis cleared by treatment is allowed)
• Renal disease secondary to another condition (e.g. infection, malignancy, monoclonal gammopathy, or a medication)
• Presence or suspicion of active bacterial or viral infection or severe recurrent bacterial infections
• Participation in any other investigational drug trial or exposure to other investigational agent, device, or procedure within 30 days prior to screening period
• Unwillingness to receive or intolerant of SC infusions of study medication or known allergy to ingredients in APL-2.

Where it is running

• Stanford University — Stanford, California, United States
• Children's Hospital Colorado — Aurora, Colorado, United States
• HealthONE Physician Care, Rocky Mountain Hospital for Children — Denver, Colorado, United States
• Washington Nephrology Associates — Washington D.C., District of Columbia, United States
• Horizon Research Group — Coral Gables, Florida, United States
• Emory University — Atlanta, Georgia, United States
• American Research LLC — Jeffersonville, Indiana, United States
• Northwest Louisiana Nephrology LLC — Shreveport, Louisiana, United States
• Washington Nephrology Associates — Takoma Park, Maryland, United States
• Clinical Research Consultants — Kansas City, Missouri, United States
• Davita Clinical Research — The Bronx, New York, United States
• Westchester Medical Center — Valhalla, New York, United States
• Southeastern Nephrology Associates — Wilmington, North Carolina, United States
• University Clinical Health — Memphis, Tennessee, United States
• Washington Nephrology Associates — Alexandria, Virginia, United States
• Davita Clinical Research — Chesapeake, Virginia, United States
• Milwaukee Nephrologists — Wauwatosa, Wisconsin, United States

Full record on ClinicalTrials.gov

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