Affinity

A global phase 2 clinical trial for people with relapsing multiple sclerosis (RMS)

Status
Start Date
Condition
Estimated
enrollment
Age Range
Phase
Study Type

Objective

To learn if an investigational drug (opicinumab) can potentially repair tissue damage and reduce disability in people with RMS when used as an add-on therapy to DMTs.

The investigational drug

Opicinumab is an antibody that targets a protein only expressed in the central nervous system (brain and spinal cord) called LINGO-1. LINGO-1 inhibits the generation of new myelin and the repair of damaged myelin sheath. It is hypothesized that, by blocking the activity of LINGO-1, opicinumab may potentially enhance the repair of myelin sheath, protect nerve fibers, and reverse deficits in neurological functions due to MS.

Key eligibility criteria

  • Men and women
  • 18-58 years old
  • Less than 20 years from the first symptoms of MS
  • Able to walk at least 50 meters with single-side walking aid or at least 120 meters with walking aids on both sides
  • Have been receiving a DMT for at least six months

Trial length

  • Approximately 2 years