854
Participants
Start Date
September 30, 2004
Primary Completion Date
June 30, 2005
Study Completion Date
June 30, 2005
Onercept
Onercept will be administered subcutaneously three times a week at a dose of 150 mg, for 12 weeks of first treatment (FT) period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment or until relapse, whichever occurs first. Subjects then will be reassigned to either Onercept (150 mg) or placebo, subcutaneously three times a week, for 16 weeks. Subjects not showing 75 percent improvement in PASI score at Week 12 will receive only Onercept (150 mg) subcutaneously three times a week, for 40 weeks as open-label treatment.
Placebo
Matching Placebo will be administered subcutaneously three times a week, for 12 weeks in the FT period. Subjects showing 75 percent improvement in PASI score at Week 12 will be observed for 24 weeks without treatment and then again assigned to either placebo or Onercept (150 mg), subcutaneously three times a week, for 16 weeks.
Dermatology Associates, P.C. at the Washington Hospital CTR, Washington D.C.
Virginia Clinical Research, Inc, Norfolk
Piedmont Medical Research Associates, Winston-Salem
Wake Forest Univ School of Medicine, Winston-Salem
Atlanta Dermatology Vein & Research Center, Alpharetta
North Florida Dermatology Associates, P.A., Jacksonville
Jacksonville Center for Clinical Research, Jacksonville
International Dermatology Research, Miami
Rivergate Dermatology, Goodlettsville
Tennessee Clinical Research Center, Nashville
Saint Mary's Centeral Wing Annex, Knoxville
Midwest Cutaneous Research Corporation, Clinton Township
University of Michigan Department of Dermatology, Ann Arbor
Minnesota Clinical Study Center, Fridley
Scott D. Glazer, MD, Buffalo Grove
Bressnick Gibson Parker Dinehart Sangster Dermatology, P.A., Little Rock
Texas Dermatology Research Institute, Dallas
Center For Clinical Studies, Houston
University Texas M.D. Anderson Cancer Center, Houston
Center for Clinical Studies, Houston
DermResearch Inc, Austin
Colorado Medical Research Center, Denver
Cherry Creek Research, Inc., Denver
Longmont Clinic PC, Longmont
Academic Dermatology Associates, Albuquerque
Clinical Research Specialists Inc., Santa Monica
Therapeutics Clinical Research, La Jolla
Dermatology Specialists Inc, Vista
University of California, Irvine, Irvine
Associates in Research Inc., Fresno
University of California, San Francisco
Solano Clinical Research, Vallejo
Northwest Cutaneous Research Specialist, Portland
Oregon Medical Research Center, P.C., Portland
Dermatology Associates P.L.L.C., Seattle
Rockwood Clinic, PS, Spokane
The Savin Center P.C., New Haven
Probity Medical Research, Edmonton
Guenther Dermatology Research Center, London
Probity Medical Research, Waterloo
Lead Sponsor
EMD Serono
INDUSTRY