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A phase I trial of an interleukin-12/23 monoclonal antibody in relapsing multiple sclerosis.

Abstract：

OBJECTIVE:To assess the safety, tolerability and pharmacokinetics of an interleukin (IL)-12/23 monoclonal antibody (mAb) in subjects with a relapsing form of multiple sclerosis (MS). METHODS:A phase I, double-blind, placebo-controlled, sequential dose escalation study was conducted in 20 subjects with MS. Subjects were randomized (4:1) to receive a single subcutaneous injection of either IL-12/23 mAb (0.3, 0.75, 1.5, and 3.0 mg/kg) or placebo. Clinical and laboratory evaluations were performed through 16 weeks following administration. RESULTS:IL-12/23 mAb was well tolerated in this study. Adverse events were generally mild or moderate, with no apparent dose-related trends. One subject with a family history of breast cancer was diagnosed during the study with breast cancer 21 days after IL-12/23 mAb administration. There were no significant changes in laboratory indicators of systemic or neurotoxicity. There was a large degree of variability in T2 lesion volume and total number of gadolinium-positive lesions, both unaffected by dose escalation. Three relapses of MS occurred in two placebo-treated subjects. Over the range of single doses studied, the median Tmax ranged from 9.0 to 16.5 days, and the median T1/2 ranged from 20.2 to 30.9 days. CONCLUSION:Single subcutaneous administrations of IL-12/23 mAb in this first study of relapsing MS were generally well tolerated. Safety of the agent will need to be tested in a study of longer duration and involving a larger cohort of subjects.

journal_name

Curr Med Res Opin

journal_title

Current medical research and opinion

authors

Kasper LH,Everitt D,Leist TP,Ryan KA,Mascelli MA,Johnson K,Raychaudhuri A,Vollmer T,Multiple Sclerosis Investigators.

doi

10.1185/030079906X120931

subject

Has Abstract

pub_date

2006-09-01 00:00:00

pages

1671-8

issue

9

eissn

0300-7995

issn

1473-4877

journal_volume

22

pub_type

杂志文章,多中心研究,随机对照试验

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