Efficacy and Safety Results From a Completed Phase 2a Study in Patients With Systemic Lupus Erythematosus Sample Clauses

Efficacy and Safety Results From a Completed Phase 2a Study in Patients With Systemic Lupus Erythematosus. The Phase 2a study (study IP-002) was an open-label, multiple-dose, 12-week study conducted in Bulgaria to evaluate the efficacy and safety of treatment with IPP-201101 in 20 patients with SLE who had elevated anti-dsDNA Ab titers (more than 70 IU/mL by enzyme-linked immunosorbent assay [ELISA]) at study entry. Two dose levels of IPP-201101 (200 and 1000 mcg) were evaluated in 2 cohorts of 10 patients each. Patients were administered 3 sc injections of IPP-201101 (either 200 or 1000 mcg) on study days 1, 15, and 29, with follow-up visits on study days 8, 43, and 57. For the 200-mcg treatment group, long-term follow-up visits were also conducted at months 4, 5, and 6. Study treatment with 1000 mcg was initiated after the planned interim review of the safety data, up to and including day 15, by the Interim Safety Review Board (ISRB) from all patients receiving 200 mcg. In this study, there was a clinically meaningful response for patients who received 2 sc injections of 200 mcg of IPP-201101 on study days 1, 15, and 29, as assessed by decrease in anti-dsDNA Ab levels (7 patients had reductions in anti-dsDNA Ab titer of least 20% at study day 43, and 5 patients had a reduction of at least 20% at study day 57; response was sustained in 3 patients at month 6) and reduction from baseline of at least 4 points in the Systemic Lupus Erythematosus Disease Activity Index (SLEDAI) score (6 patients). In the 1000-mcg treatment group, 1 patient had a reduction of at least 20% in anti-dsDNA Ab titer at study day 43 or study day 57. The average value for anti-dsDNA Ab titer was unchanged over the 6-week follow-up period after completion of study treatment in the 1000-mcg treatment group. In addition to the 6 patients in the 200-mcg treatment group who were responders by SLEDAI (defined as a reduction from baseline of at least 4 points in the SLEDAI score), 4 patients in the 1000-mcg treatment group were responders by SLEDAI. Five of the 6 responding patients in the 200-mcg treatment group also had at least a 20% reduction in anti-dsDNA Ab titer, whereas 1 of 4 patients in the 1000-mcg treatment group had both a reduction in SLEDAI score and a reduction in anti-dsDNA Ab titer at study day 57. There were no serious adverse events or withdrawals because of adverse events in the study. Nine (45%) patients experienced a total of 12 adverse events during the course of the study. Adverse events attributed to IPP-201101 treatment were mild dose-related injection site reactions. I...
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