VALE
Research type
Research Study
Full title
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
IRAS ID
1007633
Contact name
Melanie Govignon
Contact email
Sponsor organisation
Apellis Pharmaceuticals, Inc.
Eudract number
2022-002833-33
Research summary
In this research study, the long-term effects of an investigational medicine named pegcetacoplan (peg-set-a-koé-plan) is being tested in participants with complement 3 glomerulopathy (C3G) or immune-complex mediated membranoproliferative glomerulonephritis (ICMPGN). Participants who have completed study APL2-C3G-310 will be eligible to take part in this trial. The number of participants will therefore not exceed the maximum number of participants planned for study APL2-C3G-310, which is approximately 80 to 100 participants, aged 18 yrs and over will participate globally. Young persons (aged 12-17yrs) weighing at least 30 kg may also be enrolled.
The Trial is divided into the below periods:
• A 120-week Open-label treatment period - all participants will receive pegcetacoplan
• An 8-week Follow-up period (to check your overall health and safety)
The study medicine will be administered under the skin in 30-minute infusions, twice a week. Side effects will be monitored throughout the study.
Participation in the study will last up to approximately 128 weeks. Participation is voluntary.
Participants will be expected to attend clinic visits whereby study assessments will take place e.g. blood and urine collection, physical examinations, vital signs, completion of questionnaires and diaries.REC name
North West - Liverpool Central Research Ethics Committee
REC reference
23/NW/0190
Date of REC Opinion
21 Aug 2023
REC opinion
Further Information Favourable Opinion