An Open-Label, Nonrandomized, Multicenter Extension Study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Participants With C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis

Running, not enrolling · Phase 3

Conditions studied: C3G, IC-MPGN, C3 Glomerulopathy, C3 Glomerulonephritis, Complement 3 Glomerulopathy, Complement 3 Glomerulopathy (C3G), Complement 3 Glomerulonephritis, Dense Deposit Disease, DDD, Membranoproliferative Glomerulonephritis, Membranoproliferative Glomerulonephritis (MPGN), Immune Complex Membranoproliferative Glomerulonephritis (IC-MPGN)

In brief

This study is designed as a long-term extension to Study APL2-C3G-310, and is being conducted to establish the long-term safety and efficacy of pegcetacoplan in patients with C3 glomerulopathy (C3G) or immune-complex membranoproliferative glomerulonephritis (IC-MPGN).

Key facts

Study ID

NCT05809531

Run by

Apellis Pharmaceuticals, Inc.

People needed

100

Starts

2023-05-29

Expected to finish

2027-07-01

Last updated by the study team

2026-04-02

Who can join

Age: 12 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Completed participation in Study APL2-C3G-310 through the week 52 visit requirements
• Experienced clinical benefit from pegcetacoplan while participating in the previous trial, in the opinion of the investigator
• Must remain on a stable regimen for C3G or IC-MPGN treatment according to the requirements of Study APL2-C3G-310
• Received vaccinations against S pneumoniae, N meningitidis (types A, C, W, Y, and B), and H influenzae (type B) according to the requirements of Study APL2-C3G-310 and agree to receive any additional vaccinations recommended according to ACIP recommendations for adults or children with complement deficiencies and/or immunocompromising conditions or other similar local applicable guidelines
• Female participants of childbearing potential, defined as any woman who has experienced menarche and who is not permanently sterile or postmenopausal, must have a negative urine pregnancy test at visit 1 and must agree to use protocol-defined methods of contraception for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
• Male participants must agree to use protocol-defined methods of contraception and agree to refrain from donating semen for the duration of the study through at least 90 days after receiving the last dose of pegcetacoplan
• Participants above the legal age of consent, in accordance with local regulations, must be willing and able to provide informed consent. The legally authorized representative of participants under the legal age of consent must be willing and able to provide informed consent; where appropriate, participants under the legal age of consent must also give their assent to participation in the study
• Willing and able to self-administer pegcetacoplan or have an identified caregiver who can perform the administration

You may not qualify if…

• Female participants who are or are planning to become pregnant or who are currently breastfeeding and are unwilling to discontinue for the duration of the study and for at least 90 days after the final dose of study drug
• Inability or unwillingness to cooperate with the requirements of the protocol
• Any condition that, in the opinion of the investigator, creates an undue risk for the participant by participating in the study or is likely to confound interpretation of the study results
• Evidence of ongoing drug or alcohol abuse or dependence, in the opinion of the investigator

Where it is running

• Academic Medical Research Institute (01034) — Los Angeles, California, United States
• Children's Hospital Colorado (01037) — Aurora, Colorado, United States
• University of Florida, Department of Pediatric Nephrology (01010) — Gainsville, Florida, United States
• Emory Investigational Drug Service (01021) — Atlanta, Georgia, United States
• University of Iowa Hospital and Clinics (01030) — Iowa City, Iowa, United States
• University of Michigan Hospital (01008) — Ann Arbor, Michigan, United States
• Hackensack Meridian Health (01036) — Hackensack, New Jersey, United States
• Cohen Children Hospital, Pediatric Pharmacy (01022) — Hyde Park, New York, United States
• Columbia Nephrology (01039) — New York, New York, United States
• Oregon Health & Science Univ., Dept. Pediatrics (01038) — Portland, Oregon, United States
• Northeast Clinical Research Center LLC (01009) — Bethlehem, Pennsylvania, United States
• Texas Children's Hospital (01027) — Houston, Texas, United States
• Hospital Privado-Universitario de Cordoba (54004) — Córdoba, Argentina
• Clinica Privada Velez Sarsfield (54007) — Córdoba, Argentina
• Kidney Trials Unit, Princess Alexandra Hospital (61007) — Woolloongab, Queensland, Australia
• St. Vincent's Hospital Melbourne (61003) — Fitzroy, Australia
• Catholic University of Leuven (32001) — Leuven, Belgium
• Santa Casa de Misericordia de Belo Horizonte (55017) — Belo Horizonte, Minas Gerais, Brazil
• Irmandade da Santa Casa Misericordia Porto Alegre (55016) — Porto Alegre, Rio Grande do Sul, Brazil
• HC UNESP Botucatu (55010) — Botucatu, Brazil
• Hospital de Clinicas de Porto Alegre (55018) — Porto Alegre, Brazil
• Real Hospital Portugues de Beneficencia (55015) — Recife, Brazil
• Ruschel Medicina E Pesquisa Clinica (55012) — Rio de Janeiro, Brazil
• Hospital De Base (55014) — São José do Rio Preto, Brazil
• Hospital do Rim - Fundacao Oswaldo Ramos (55005) — São Paulo, Brazil

Full record on ClinicalTrials.gov

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