Assessment of immunogenicity from galcanezumab phase 3 trials in patients with episodic or chronic migraine.

ABSTRACT:

Background

This analysis characterizes the immunogenicity profile of galcanezumab, a humanized monoclonal antibody that selectively binds calcitonin gene-related peptide and inhibits its activity, in phase 3 migraine trials.

Methods

Immunogenicity data were analyzed from baseline and double-blind, placebo-controlled phases of the 3-month chronic migraine study REGAIN, the 6-month episodic migraine studies EVOLVE-1 and EVOLVE-2, and from baseline and open-label phases of the 12-month chronic and episodic migraine Study CGAJ. The incidence of baseline antidrug antibodies, treatment-emergent antidrug antibodies, neutralizing antidrug antibodies, and the effect of antidrug antibody titer on pharmacokinetics and pharmacodynamics were assessed. The relationship between antidrug an

SUBMITTER: Martinez JM 

PROVIDER: S-EPMC7469706 | biostudies-literature | 2020 Aug

REPOSITORIES: biostudies-literature