A Phase 2 clinical trial testing the safety and efficacy of hCDR1 (Edratide) in patients with systemic lupus erythematosus (SLE) met its secondary endpoint, but not its first endpoint, suggesting that SLE patients may benefit from treatment. However, additional studies are required to be definitive. “A Study to Evaluate the Tolerability, Safety and Effectiveness of Edratide in the Treatment of Lupus (PRELUDE)” was terminated due to the failure to reach its primary endpoint, with study results published in the journal Lupus Science & Medicine.
As discussed in “Safety and Efficacy of hCDR1 (Edratide) in Patients with Active Systemic Lupus Erythamatosus: Results of Phase II Study,” patients in the trial met the secondary endpoint of improvement in British Isles Lupus Assessment Group (BILAG) Responder Index. This tool for measuring SLE disease activity is based on responses to 86 questions, which are used to determine an activity score. In the study, patients were placed into score groups (A through D/E), and substantial responders shifted into an improved score group during the course of treatment.
When researchers analyzed data for the primary endpoint, it revealed a different story. There was no significant difference in SLE Disease Activity Index (SLEDAI) between Edratide and placebo-treated patients. Both groups saw a 35% reduction in SLEDAI-2K scores during the course of the study.
There were a total of 340 patients enrolled in this study. Three doses (0.5, 1.0, and 2.5 mg) of Edratide and one dose of placebo were used to determine a benefit from Edratide treatment. Some patients withdrew from the study, but there was no significant difference between the number of patients taking placebo who withdrew and the number of patients taking Edratide who withdrew.
“The favorable safety profile and encouraging clinically significant effects noted in some of the endpoints support the need for additional longer term Edratide studies that incorporate recent advances in the understanding and treatment of SLE,” stated the study authors. Already, there are suggestions for future clinical trials that are larger in scale and longer in duration. It is likely that BILAG will be included in the primary endpoints for these trials.