BridgeMD
A study to Evaluate the Long-term Safety and Efficacy of Pegcetacoplan in Patients with C3 Glomerulopathy or Immune-Complex Membranoproliferative Glomerulonephritis (VALE)
EU CTIS ID: 2023-504625-39-00
What this study is testing
The primary objective of this study is to establish the long-term safety and efficacy of pegcetacoplan in participants with C3G or IC-MPGN.
- Therapeutic confirmatory (Phase III)
A plain-language read of the study's public EU CTIS listing. The study team confirms the details.
Who can take part
You may be able to join 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 Advisory Committee on Immunization Practices 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.
You likely can't join 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.
See the full eligibility 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 Advisory Committee on Immunization Practices 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- United Kingdom
- Israel
- Switzerland
- Canada
- Argentina
- Australia
- Korea, Republic of
- Japan
- United States
- Brazil
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18-64 years, 65+ years, 0-17 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include United Kingdom; Israel; Switzerland; Canada; Argentina; Australia and 4 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from EU CTIS; the study team decides eligibility.