Janssen Research & Development has reported positive results from a Phase II clinical trial of Stelara (ustekinumab) in patients with active systemic lupus erythematosus (SLE or lupus).
Stelara is a fully human monoclonal antibody being developed as interleukin IL-12 and IL-23 antagonist.
The trial has met the primary endpoint with 60% of subjects experiencing a significant decrease in lupus disease activity at week 24, compared to 31% administered with placebo.
While significantly greater changes were observed in SLE disease activity-2K from baseline, Stelara is reported to have not met statistical significance for additional secondary endpoints.
Janssen Research & Development Immunology Development head Newman Yeilding said: “These findings, together with our knowledge of the IL-12/23 pathway and our commitment to transform the lives of patients with lupus, provide strong rationale for moving into a Phase III clinical development programme.”
The randomised, placebo-controlled Phase II trial investigated the safety and efficacy of ustekinumab in 102 subjects with seropositive SLE.
Patients were administered with intravenous (IV) 6mg/kg dose of Stelara at week zero and later with subcutaneous (SC) 90mg dose every eight weeks for a total of 24 weeks, in conjunction with standard of care therapy.
During the trial, adverse events (AEs) were observed to be in similar proportions with Stelara and placebo, and the drug candidate achieved a safety profile consistent with previous trials.
The results further revealed serious AEs in 8.3% of patients administered with Stelara compared to 9.5% given a placebo.
Currently, the firm is collecting long-term safety and efficacy data through 104 weeks.