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An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis

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Trial Profile

An international, double-blind, randomised, placebo-controlled phase IIb trial to assess the efficacy, safety, and pharmacokinetics of GNbAC1 in patients with relapsing remitting multiple sclerosis

Status: Completed
Phase of Trial: Phase II

Latest Information Update: 30 Mar 2022

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At a glance

  • Drugs Temelimab (Primary)
  • Indications Multiple sclerosis
  • Focus Proof of concept; Therapeutic Use
  • Acronyms CHANGE-MS
  • Sponsors GeNeuro

    • Most Recent Events

    • 01 Mar 2022 Primary endpoint (Cumulative number of Gd-enhancing T1 lesions in brain MRI) has not been met according to the results published in the Multiple Sclerosis Journal
    • 01 Mar 2022 Results from randomized phase 2b and extension study published in the Multiple Sclerosis Journal
    • 11 Jul 2019 According to a GeNeuro media release, the company today announced publication of a review in Frontiers in Genetics that includes results from this trial and ANGEL-MS trial.

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