Phase 2 study evaluating safety and efficacy Daxdilimab in adults with active proliferative LN
Research type
Research Study
Full title
A Multicenter, Randomized, Double-Blind, Placebo Controlled, Phase 2 Study Evaluating the Efficacy and Safety of Daxdilimab in Adult Participants with Active Proliferative Lupus Nephritis
IRAS ID
1005959
Contact name
Stephanie Bekker-Njehia
Contact email
Sponsor organisation
Horizon Therapeutics Ireland DAC
Eudract number
2022-001377-31
Clinicaltrials.gov Identifier
Research summary
This is a randomised, double-blind, placebo-controlled, parallel-group study in patients with Lupus Nephritis (LN). LN is a disease affecting the kidneys and occurs when the immune system produces autoantibodies that attack the body’s own tissues and organs. LN affects approximately 31-60% of lupus patients and although patient survival has improved with the introduction of immunosuppressive treatment, LN still represents a major risk factor. The purpose of this study is to obtain information on the safety and tolerability of daxdilimab, and to learn about the effect it has on LN when combined with standard treatment when compared to combination of placebo and standard treatment. The study consists of Screening Period, a 104-week Treatment Period and a Safety Follow-Up Period of 8 weeks. Study procedures include vital signs, physical examination, questionnaires, ECGs, blood, renal biopsies and urine samples. The maximum study duration per participant will be 116 weeks.
You may qualify to participate in this study if you:
• Are between 18 and 80 years of age
• Have confirmed diagnosis of systemic lupus erythematosus
• Have confirmed diagnosis of lupus nephritis
• Have undergone renal biopsy within 6 months or willing to undergo it during screening period
• Haven’t had dialysis in last 12 months or you are not scheduled for dialysis or renal transplant in next 12 months
Approximately 210 participants will be randomised in a ratio of 1:1:1 (70 participants per group) to receive either 100mg or 300mg daxdilimab or placebo subcutaneously in addition to standard-of-care (SOC) treatment at Day 1, Week 2, and Week 4, then every 4 weeks through to Week 52. At Week 64, participants will receive daxdilimab or placebo every 12 weeks based on kidney response observed at Week 48 and Week 52 Visits.
This study will be conducted worldwide with two (2) hospitals in the UK. The Sponsor of this study is Horizon Therapeutics Ireland DAC.REC name
North East - Newcastle & North Tyneside 2 Research Ethics Committee
REC reference
22/NE/0216
Date of REC Opinion
25 Apr 2023
REC opinion
Further Information Unfavourable Opinion