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

Last Updated: 2/19

Brief Summary

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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.

Interventions

Drug: APL-2

Phase

Status

Recruiting

Key Criteria

Conditions

IgA Nephropathy
Lupus Nephritis
Membranous Nephropathy
C3 Glomerulonephritis
Dense Deposit Disease

Ages

18 and older

Sexes

All

Inclusion Criteria

Patients of at least 18 years of age at screening, 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 high titer plus nephrotic range proteinuria (defined as uPCR >2350 mg/g)
C3G: Low serum C3 level and presence of C3 nephritic factor
Have proteinuria >750 mg/g (calculated by spot uPCR on 24 hour urine collection) collected during the first screening visit (Visits 1/3a)
If on immunosuppressive treatment (e.g. cyclophosphamide, mycophenolate mofetil, calcineurin inhibitors, steroids), have been on a stable dose for at least 2 months (6 months for 4-week screening period) prior to Screening Visit 1/3a with no expected change in the dose for the study duration
eGFR ≥ 30 mL/min/1.73 m² calculated by CKD-EPI creatinine equation at screening visit 1/3a
Have an average systolic blood pressure of < 140 mmHg and a diastolic blood pressure of < 90 mmHg at rest during the screening period and if on physician-directed, stable, optimized treatment with angiotensin converting enzyme inhibitors (ACEI) and/or angiotensin receptor blockers (ARB) have received treatment for at least 3 months (6 months for 4-week screening period) prior to the Screening Visit 1/3a
Willing to receive vaccinations against Neisseria meningitides 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
Women of child-bearing potential (WOCBP) must have a negative blood pregnancy test at screening and must agree to use protocol defined methods of contraception from screening through 3 months after last dose of APL-2
Males must agree to use protocol defined methods of contraception and agree to refrain from donating sperm from screening through 3 months after receiving last dose of APL-2
Willing and able to give informed consent
Willing and able to self-administer APL-2 (administration by caregiver will be allowed)

Exclusion Criteria

Hemoglobin < 9.0 g/dL at screening Visits 1/3a and 3b
Platelet count < 100,000/mm³ at screening Visits 1/3a and 3b
Absolute neutrophil count < 1000 cells/mm³ at screening Visits 1/3a and 3b
ALT or AST > 3.0 x the upper limit of normal at screening Visits 1/3a and 3b
Use of belimumab, eculizumab, or rituximab within 6 months prior to Screening Visit 1/3a
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 1/3a and 3b (previous HBV or HCV diagnosis cleared by treatment is allowed)
Malignancy except for cured basal or squamous cell skin cancer, curatively treated in situ disease or have been disease-free for ≥5 years or more from cancer
Secondary IgA nephropathy: e.g. due to lupus, liver cirrhosis, IgA Vasculitis (Henoch-Schonlein purpura)
Membranous Nephropathy secondary to another known disease
Current unstable kidney function for other reasons, e.g. toxin induced acute kidney injury
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
Pregnant, breast-feeding, or intending to conceive during the course of the study
Inability to cooperate or any condition that, in the opinion of the investigator, could increase the patient's risk by participating in the study or confound the outcome of the study
Unwillingness to receive or intolerant of SC infusions of study medication or known allergy to ingredients in APL-2
Positive results for drug abuse (upon urinary drug screen) or alcohol dependence at screening (Visit 1/3a). Documented evidence of prescribed marijuana use is not exclusionary

Trial Locations

United States

Apellis Investigational Site

Stanford, CA 94305

Apellis Investigational Site

Aurora, CO 80045

Apellis Investigational Site

Denver, CO 80205

Apellis Investigational Site

Washington, DC 20037

Apellis Investigational Site

Coral Gables, FL 33134

Apellis Investigational Site

Atlanta, GA 30322

Apellis Investigational Site

Louisville, KY 40203

Apellis Investigational Site

Shreveport, LA 71101

Apellis Investigational Site

Takoma Park, MD 20912

Apellis Investigational Site

Kansas City, MO 64111

Apellis Investigational Site

Bronx, NY 10461

Apellis Investigational Site

Valhalla, NY 10595

Apellis Investigational Site

Wilmington, NC 28401

Apellis Investigational Site

Memphis, TN 38103

Apellis Investigational Site

Alexandria, VA 22304

Apellis Investigational Site

Chesapeake, VA 23320

Apellis Investigational Site

Wauwatosa, WI 53226

Choosing to participate in a study is an important personal decision

Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contact information provided below.

Contact Information

Federico Grossi, MD, PhD | 617-977-5701

clinicaltrials@apellis.com

Sponsors and Collaborators

www.apellis.com

View complete study information on ClinicalTrials.gov