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ACTIVE NOT RECRUITING

NCT05809531

PHASE3

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

Sponsor: Apellis Pharmaceuticals, Inc.

View on ClinicalTrials.gov

Summary

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).

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

Key Details

Gender

All

Age Range

12 Years - Any

Study Type

INTERVENTIONAL

Enrollment

100

Start Date

2023-05-29

Completion Date

2027-07

Last Updated

2026-04-02

Healthy Volunteers

Conditions

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)

Interventions

DRUG

Pegcetacoplan

Complement (C3) Inhibitor

Inclusion Criteria: * 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 Exclusion Criteria: * 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

Locations (47)

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

Univ Sao Paulo, Av. Dr Eneas Carvalho de Aguiar, 155 (55007)

São Paulo, Brazil

Institute for Clinical and Experimental Medicine (42001)

Prague, Czechia

CHU de Bordeaux - Hopital Pellegrin (33010)

Bordeaux, France

Institut de transplantation urologie-nephrologie (33011)

Nantes, France

Schneider Childrens Medical Center (97204)

Petah Tikva, Israel

Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (39004)

Milan, Italy

Istituto di Ricerche Farmacologiche Mario Negri IRCCS (39003)

Ranica, Italy

Ospesale Pediatrico bambino Gesu (39005)

Rome, Italy

Nagasaki University Hospital (81005)

Nagasaki, Nagasaki, Japan

Seirei Hamamatsu General Hospital (81004)

Hamamatsu, Shizuoka, Japan

AMC Apotheek Goederenontvangst (31002)

Amsterdam, Netherlands

University Medical Center Groningen (31004)

Groningen de Brug, Netherlands

Radboud University Medical Center (31003)

Nijmegen, Netherlands

Yonsei University College of Medicine, Sinchon Severance Hospital (82002)

Seoul, South Korea

Seoul National University Hospital (82003 & 82005)

Soeul, South Korea

Hosp. Universit. Materno-Infantil Vall d' Hebron (34006)

Barcelona, Spain

Hospital Universitario 12 de Octubre (34008)

Madrid, Spain

Hospital Universitario Dr Peset (34009)

Valencia, Spain

CHUV Lausanne (41002)

Lausanne, Switzerland

Imperial College Hammersmith Hospital (44013)

London, United Kingdom

Royal Manchester Children's Hospital (44011)

Manchester, United Kingdom

Nottingham University Hospitals NHS Trust (44012)

Nottingham, United Kingdom