Birmingham, Alabama (PRWEB) March 11, 2014
*To see if you qualify for this Lupus Clinical Trial in Birmingham, visit Achieve Clinical Research on the web (http://www.achieveclinical.com/) or contact us directly at (205) 380-6434. There is no cost to participate, no insurance is required, and you may receive compensation for time and travel.
This is a Phase IIb, multicenter, double-blind, placebo controlled (DBPC) parallel-arm research study in which participants are planned to be randomized in a ratio of 1:1:1 to receive placebo, or 75 mg or 150 mg of the experimental lupus drug, administered via weekly subcutaneous (SC) injections for 24 weeks.
The trial is composed of a screening period, a DBPC treatment period, and a safety follow-up (FU) period. The trial will be conducted on an outpatient basis and treatment duration will be 24 weeks. A long-term extension (LTE) trial will be offered to completers of the 24-week treatment period as part of a separate protocol.
BACKGROUND & RATIONALE
This experimental lupus medication is a novel immunomodulator with B-cell targeting properties that is being developed for the treatment of SLE. It inhibits BLyS and APRIL. It ameliorates lupus disease progression animal models by reducing B-cell numbers and consequently the level of anti-dsDNA antibodies. In animal models where soluble TACI receptors were administered, decreases in disease manifestations were also observed. In addition, inhibition of BLyS with belimumab (an anti-BLyS monoclonal antibody), approved by the FDA in 2011, was shown to be safe and effective for lupus treatment.
This Phase IIb clinical trial is being conducted to evaluate the efficacy and safety of a new lupus drug compared to placebo in reducing the level of SLE disease activity in subjects with active lupus symptoms and to select a dose for further development in Phase III. This trial will recruit subjects with moderate to severe SLE, but treatment will be initiated at the time of active disease (rather than low disease activity and evaluating prevention of flares as was studied in previous trials). The APRIL-SLE trial suggested efficacy of this medication in preventing flares of SLE. However, efficacy in reducing active disease is critical information for the medical community and patients. The time at which patients have active disease manifestations is often a treatment decision point. In addition, since the activity of SLE fluctuates over time, it is important to evaluate during clinical development whether this lupus drug has efficacy during both periods of low as well as moderate-severe disease activity.
The primary objective of this trial is to evaluate the efficacy of this experimental lupus medication compared to a placebo in reducing SLE disease activity in subjects treated with SoC therapy and to investigate the dose response relationship.
*Achieve Clinical Research conducts Phase II-IV Clinical Research Studies in Alabama. For more information about participating in a Lupus Clinical Study, please visit our website or contact us directly at (205) 380-6434.