SuppreMol GmbH initiated a Phase IIa clinical trial with SM101 in Systemic Lupus Erythematosus (SLE).
The multi-centric, randomized, double-blind, placebo-controlled, parallel group Phase IIa study will enroll 50 SLE patients with or without a history of Lupus Nephritis and a SELENA-SLEDAI score of ? 6 and active serological status.
Over four weeks, two groups of 20 patients each will intravenously receive 6 or 12 mg/kg/week of SM101, while 10 patients will receive placebo. Thirty clinical sites in Australia, Belgium, the Czech Republic, France, Germany, Italy, Poland, Spain, and the United Kingdom will participate.
The primary endpoint of the proof-of-concept trial is safety based on the incidence of adverse events according to the Common Terminology Criteria for Adverse Events (CTCAE).
Further safety endpoints include vital signs, body temperature, body weight, electrocardiogram, safety laboratory assessments, and the occurrence of anti-drug antibodies (ADAs). Efficacy is determined by overall and renal disease score assessments, proteinuria, urine sediment, a number of biochemical, biological and molecular markers, and use of rescue medication.
Results of the trial are expected for 2013.
Release Date: July 11, 2011
Source: SuppreMol GmbH
Filed Under: Drug Discovery
