ALXN2050 in Proliferative LN and IgAN
Research type
Research Study
Full title
A Phase 2, Randomized, Double-blind, Placebo-controlled, Dose-finding Study to Evaluate the Efficacy and Safety of ALXN2050 in Adult Participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
IRAS ID
306485
Contact name
Stephanie Haller
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2021-001426-22
Clinicaltrials.gov Identifier
Duration of Study in the UK
4 years, 6 months, 22 days
Research summary
This is a research study to evaluate the safety and efficacy of a study drug called ALXN2050 against placebo (looks like the study drug but contains no active ingredient) in adult participants with Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN). Since chronic kidney disease has become a worldwide public health issue due to its high incidence, poor prognosis and substantial economic burden, there is a significant unmet need for interventions that allow more novel, definitive and tolerable treatments for patients with both LN and IgAN.
Adult participants between 18 and 75 years of age who are living with either LN or IgAN and who are receiving treatment with standard or care therapy, may be eligible to take part in this research study and they would stay in the study for about 158 weeks (about 3 years).
The study has 4 different phases, and participants would be allocated to different cohorts depending on whether they have LN or IgAN.
In the LN cohort, participants will be randomised to one of three different treatment groups:
1) ALXN2050 180mg + background therapy
2) ALXN2050 120mg + background therapy
3) placebo + background therapy (until they reach the open label extension period, where they will continue taking the background therapy)
In the IgAN cohort, participants will be randomised to the following treatment groups:
1) ALXN2050 180mg + background therapy
2) ALXN2050 120mg + background therapy
3) placebo + background therapy (until they reach the blinded extended treatment and the open label extension period, where they will be placed in one of the study drug treatment arms detailed above)
A total of 126 participants will take part in this research study that will take place in several countries, including in the United Kingdom.
The research sites participating in the UK are NHS Hospitals.REC name
East Midlands - Leicester South Research Ethics Committee
REC reference
22/EM/0040
Date of REC Opinion
28 Apr 2022
REC opinion
Further Information Favourable Opinion