Safety and in vivo immune assessment of escalating doses of oral laquinimod in patients with RRMS.

ABSTRACT:

Background

Laquinimod is an oral immunomodulator in clinical development to treat relapsing-remitting multiple sclerosis (RRMS). Laquinimod is in clinical development for the treatment of multiple sclerosis and Huntington Disease (HD). The objective of this study is to assess the safety, tolerability, pharmacokinetics (PK) and cytoimmunologic effects following escalating doses of laquinimod in patients with RRMS.

Methods

One hundred twelve patients were randomly assigned to laquinimod/placebo in a series of separate dose-escalating cohorts starting from a daily oral dose of 0.9 mg/1.2 mg escalating to 2.7 mg, in 0.3 mg increments.

Results

Twenty-eight patients received placebo and 84 received laquinimod ranging from 0.9 to 2.7 mg. No deaths occurred. One serious adver

SUBMITTER: Ziemssen T 

PROVIDER: S-EPMC5577769 | biostudies-literature | 2017 Aug

REPOSITORIES: biostudies-literature