ALXN1210-NEPH-202 - Ravulizumab in LN or IgAN
Research type
Research Study
Full title
A Phase 2, Double-Blind, Randomized, Placebo-Controlled Study to Evaluate the Efficacy and Safety of Ravulizumab in Adult Participants With Proliferative Lupus Nephritis (LN) or Immunoglobulin A Nephropathy (IgAN)
IRAS ID
294776
Contact name
Elizabeth Lightstone
Contact email
Sponsor organisation
Alexion Pharmaceuticals, Inc.
Eudract number
2020-001537-13
ISRCTN Number
ISRCTN00000000
Clinicaltrials.gov Identifier
Clinicaltrials.gov Identifier
148192, IND
Duration of Study in the UK
2 years, 2 months, 21 days
Research summary
This study involves an investigational treatment called ALXN1210, also known as ravulizumab, which is being developed for the treatment of Immunoglobulin A Nephropathy (IgAN) and Proliferative Lupus Nephritis (LN).
IgAN and LN are conditions that cause chronic kidney disease. Overtime, some patients develop end-stage renal disease (ESRD) requiring dialysis or kidney transplant.
The study treatment binds to the C5 protein of the complement system. The complement system is part of the body’s immune system (system that fights against infections). Dysregulation of the complement system is a contributing factor for the cause of IgAN and LN. The study treatment works by reducing complement activity. The purpose of the study is to evaluate the safety and efficacy of the study treatment in participants with IgAN and LN. It is expected that approximately 120 participants aged at least 18 years will take part in this study at approximately 105 Sites Globally.
ALXN1210 has been approved for the treatment of patients with Paroxysmal Nocturnal Hemoglobinuria (PNH) and patients with atypical hemolytic uremic syndrome (aHUS) under the brand Ultomiris®.Participants in this study will be required to:
• Attend all study visits and complete all tests throughout the study.
• Be honest and truthful about their medical history and current conditions and medicines they are taking.
• Tell the study doctor of any new medications they may take during their participation in this study.
• Tell the study doctor of any problems they may be having during the study, including any injuries or illnesses.
• Female patients of childbearing potential must use acceptable methods of contraception as discussed with the study doctor, starting at Screening and continuing for at least 8 months after the last dose of study treatment.
• Tell the study doctor if the participant or the participant’s partner becomes pregnant.
• Participants cannot take part in any other studies involving treatment with a drug or medical device as they may interfere with the results of this study
• Participant are required to carry the Patient Safety Card at all times.
The duration of participation in the study is anticipated up to 86 weeks (approximately 1.6 years)REC name
East Midlands - Nottingham 2 Research Ethics Committee
REC reference
21/EM/0102
Date of REC Opinion
9 Jun 2021
REC opinion
Further Information Favourable Opinion