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Apr 30, 2008
Investigators at 61 sites worldwide are recruiting 279 people with relapsing forms of MS for a study comparing two doses of oral CDP323 (UCB Pharma & Biogen Idec, Inc.) with inactive placebo. CDP323 is an alpha-4 integrin antagonist and may inhibit the movement of immune cells into the central nervous system. For the purposes of this study, “relapsing forms of MS” would include individuals who experience repeated, acute attacks or relapses of symptoms, followed by periods of full or partial recovery. The study is sponsored by UCB Pharma and Biogen Idec.
Multiple sclerosis occurs when the immune system attacks the brain and spinal cord. CDP323 is a molecule designed to hamper movement of potentially damaging immune cells from the bloodstream, across the “blood-brain barrier” into the brain and spinal cord. Three Phase I studies were conducted in 75 healthy volunteers to investigate the safety and tolerability of CDP323. The results indicate that the drug was well tolerated at doses up to 1000 mg (taken in two doses daily) for 7 consecutive days (Abstract #P392, 22nd Congress of the European Committee for the Treatment and Research in MS, 2006). Now the companies are funding a phase II, double-blind, placebo-controlled study of two CDP323 doses in people with MS.
People with relapsing forms of MS aged 18 to 55 are eligible to enroll in this study. Participants should have experienced at least one clinical relapse in the 12 months before screening, and have active disease as observed on MRI scans.
Participants will be randomly assigned to receive one of two CDP323 doses or inactive placebo for 24 weeks. The primary objective is to compare the effects of treatment on disease activity as observed on MRI. Secondary objectives are to determine the treatment’s safety and tolerability.
Because of an increased risk for certain infections that has been shown in drugs with similar mechanisms (e.g., intravenous Tysabri® [natalizumab, Biogen Idec & Elan Pharmaceuticals]), participants are being monitored closely through clinical visits and blood samples.
For site information, please call 877-822-9493, or visit the study Web site athttp://connect-to-ms.com/. Sites are located in the following states and countries.
United StatesAlabama Arizona District of Columbia Florida Georgia Illinois Indiana Kansas Kentucky Michigan North Carolina Ohio Rhode Island Washington Wisconsin
Other CountriesBelgium Finland France Germany Hungary Netherlands Spain Sweden United Kingdom
-- Research & Clinical Programs Department
Tysabri is a registered trademark of Biogen Idec and Elan.
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