Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan
Research type
Research Study
Full title
An Open-Label, Randomized, Controlled, Phase 2 Study to Evaluate the Safety and Efficacy of Pegcetacoplan in the Treatment of Post Transplant Recurrence of C3G or IC-MPGN
IRAS ID
286210
Contact name
David Kavanagh
Contact email
Sponsor organisation
Apellis Pharmaceuticals, Inc.
Eudract number
2020-002637-15
Clinicaltrials.gov Identifier
IND: 136409, Regulatory Agency Identifier Number(s)
Duration of Study in the UK
1 years, 10 months, 1 days
Research summary
Two similar diseases, complement component 3 glomerulopathy (C3G) and immune complex
membranoproliferative glomerulonephritis (IC-MPGN), will be studied in this clinical trial. C3 refers to a blood protein and the 'G' refers to glomerulopathy, meaning damage to the part of the kidney that filters blood, called glomeruli, in the kidney] and IC-MPGN (glomerulonephritis is a group of diseases that injure the glomeruli) are rare, chronic diseases that are a result of over-activation of part of the immune system. This system is called the complement system. When the complement system is not well controlled, this can result in damage to the glomerulus, a network of small blood vessels in the kidney, which filters (cleans) the blood. Over time, this stops the kidneys from removing waste in the blood. This waste, if not removed from the blood, builds up in the body and may lead to kidney failure.
Pegcetacoplan (APL-2) is being studied in this clinical trial and works by turning down the complement system, a part of your immune system that is over-activated in people with C3G or IC-MPGN, and causing damage to the kidneys. Under normal conditions, the complement system will help remove pathogens and damaged cells without hurting the body. However, sometimes uncontrolled or improper activation of the complement system can damage the body.
Up to 12 adults who have been diagnosed with post-transplant recurrence of C3G or IC MPGN will be enrolled in this study across 25 study centers globally.
The participation in this study could last up to 84 weeks (approximately 1 year and 8 months) and include at least 22 study clinic visits. After completion of the 52-week (1 year) treatment period the patient may be offered to enter into an open-label extension study.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
20/NE/0283
Date of REC Opinion
22 Dec 2020
REC opinion
Favourable Opinion