Abstract

The primary objective of this study is to demonstrate the clinical efficacy of ORTHOCLONE OKTcdr4a in subjects with moderate to severe psoriasis. An additional objective is to demonstrate the safety and tolerability of ORTHOCLONE OKTcdr4a in this subject population. This is a multiple intravenous infusion, randomized, double-blind, placebo-controlled, multicenter study to demonstrate the clinical efficacy of ORTHOCLONE OKTcdr4a in subjects with moderate to severe psoriasis. Thirty-six subjects willbe randomized into three groups of 12 subjects each. There will be a maximum of two courses of study medication administration. Each group will receive a single course of three fixed dose infusions (total volume 50 mL) of study medication administered on Days 1,3, and 5, followed by a six month follow-up period. Group 1 will be randomized to receive placebo for the first course of study medication administration, Group 2 will be randomized to receive the low dose (225 mg/course) regimen of ORTHOCLONE OKTcdr4a, and Group 3 will be randomized to receive the high dose (750 mg/course) regimen of ORTHOCLONE OKTcdr4a. One retreatment course of high dose ORTHOCLONE OKTcdr4a (750 mg/course) will be allowed for any subject who does not have a >=50% decrease in their PASI score one month post-treatment. Subjects will be assessed for a period of six months after the last injection.

  Funding Agency

Agency
National Institute of Health (NIH)
Institute
National Center for Research Resources (NCRR)
Type
General Clinical Research Centers Program (M01)
Project #
3M01RR000102-35S1
Application #
6115902
Study Section
Project Start
1997-12-01
Project End
1999-11-30
Budget Start
1998-10-01
Budget End
1999-09-30
Support Year
35
Fiscal Year
1999
Total Cost
Indirect Cost

  Institution

Name
Rockefeller University
Department
Type
DUNS #
071037113
City
New York
State
NY
Country
United States
Zip Code
10065

  Publications

Bagdade, John D; Jilma, Bernd; Hudgins, Lisa C et al. (2018) LpA-II:B:C:D:E: a new immunochemically-defined acute phase lipoprotein in humans. Lipids Health Dis 17:127
Butelman, Eduardo Roque; Bacciardi, Silvia; Maremmani, Angelo Giovanni Icro et al. (2017) Can a rapid measure of self-exposure to drugs of abuse provide dimensional information on depression comorbidity? Am J Addict 26:632-639
Ansar, Muhammad; Raza, Syed Irfan; Lee, Kwanghyuk et al. (2015) A homozygous missense variant in type I keratin KRT25 causes autosomal recessive woolly hair. J Med Genet 52:676-80
Ohmatsu, Hanako; Humme, Daniel; Gulati, Nicholas et al. (2014) IL32 is progressively expressed in mycosis fungoides independent of helper T-cell 2 and helper T-cell 9 polarization. Cancer Immunol Res 2:890-900
Alemán, José O; Eusebi, Leonardo H; Ricciardiello, Luigi et al. (2014) Mechanisms of obesity-induced gastrointestinal neoplasia. Gastroenterology 146:357-373
Rosenbaum, Michael; Leibel, Rudolph L (2014) 20 years of leptin: role of leptin in energy homeostasis in humans. J Endocrinol 223:T83-96
Barbuto, Scott; Idoyaga, Juliana; Vila-Perelló, Miquel et al. (2013) Induction of innate and adaptive immunity by delivery of poly dA:dT to dendritic cells. Nat Chem Biol 9:250-6
Guo, Xiuyang; Dhodapkar, Kavita M (2012) Central and overlapping role of Cathepsin B and inflammasome adaptor ASC in antigen presenting function of human dendritic cells. Hum Immunol 73:871-8
Dustin, Lynn B; Charles, Edgar D (2012) Primary, post-primary and non-specific immunoglobulin M responses in HCV infection. Antivir Ther 17:1449-52
Pendyala, Swaroop; Walker, Jeanne M; Holt, Peter R (2012) A high-fat diet is associated with endotoxemia that originates from the gut. Gastroenterology 142:1100-1101.e2

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