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

C3 Glomerulopathy Clinical Trial

— VALE  

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05809531
• Other study ID #: APL2-C3G-314
• Secondary ID: 2023-504625-39-0
• Status: Active, not recruiting
• Phase: Phase 3
• Start date: May 29, 2023
• Est. completion date: July 2027

Study information

• Verified date: March 2024
• Source: Apellis Pharmaceuticals, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 100
• Est. completion date: July 2027
• Est. primary completion date: July 2027
• Accepts healthy volunteers: No
• Gender: All
• Age group: 12 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Pegcetacoplan
Complement (C3) Inhibitor

Locations

Country	Name	City	State
Australia	St. Vincent's Hospital Melbourne (61003)	Fitzroy
Brazil	Santa Casa de Misericordia de Belo Horizonte (55017)	Belo Horizonte	Minas Gerais
Brazil	HC UNESP Botucatu (55010)	Botucatu
Brazil	Hospital de Clinicas de Porto Alegre (55018)	Porto Alegre
Brazil	Irmandade da Santa Casa Misericordia Porto Alegre (55016)	Porto Alegre	RS
Brazil	Ruschel Medicina E Pesquisa Clinica (55012)	Rio De Janeiro
Brazil	Hospital do Rim - Fundacao Oswaldo Ramos (55005)	São Paulo
Czechia	Institute for Clinical and Experimental Medicine (42001)	Prague
France	CHU de Bordeaux - Hopital Pellegrin (33010)	Bordeaux
Italy	Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico (39004)	Milano
Italy	Istituto di Ricerche Farmacologiche Mario Negri IRCCS (39003)	Ranica
Korea, Republic of	Yonsei University College of Medicine, Sinchon Severance Hospital (82002)	Seoul
Korea, Republic of	Seoul National University Hospital (82002)	Soeul
Netherlands	Radboud University Medical Center (31003)	Nijmegen
Spain	Hosp. Universit. Materno-Infantil Vall d' Hebron (34006)	Barcelona
Spain	Hospital Universitario 12 de Octubre (34008)	Madrid
Spain	Hospital Universitario Dr Peset (34009)	Valencia
Switzerland	CHUV Lausanne (41002)	Lausanne
United Kingdom	Royal Manchester Children's Hospital (44011)	Manchester
United Kingdom	Nottingham University Hospitals NHS Trust (44012)	Nottingham
United States	University of Michigan Hospital (01008)	Ann Arbor	Michigan
United States	Emory Investigational Drug Service (01021)	Atlanta	Georgia
United States	Northeast Clinical Research Center LLC (01009)	Bethlehem	Pennsylvania
United States	Hackensack Meridian Health (01036)	Hackensack	New Jersey
United States	University of Iowa Hospital and Clinics (01030)	Iowa City	Iowa
United States	Columbia Nephrology (01039)	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
Apellis Pharmaceuticals, Inc.

Countries where clinical trial is conducted

United States,  Australia,  Brazil,  Czechia,  France,  Italy,  Korea, Republic of,  Netherlands,  Spain,  Switzerland,  United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Proportion of participants with a reduction in urine protein-to-creatinine ratio (uPCR) of at least 50% from the pretreatment value over time.		2.5 years