Alexion to Discontinue its P-III CHAMPION-ALS Trial of Ultomiris (ravulizumab) for Amyotrophic Lateral Sclerosis

August 23, 2021 Auto Bot Alexion, amyotrophic lateral sclerosis, Clinical Trials, P-III, Ultomiris 0

Shots:

  • The IDMC has recommended the discontinuation of the P-III CHAMPION-ALS trial for Ultomiris (IV, q8w) in adults with ALS. Additionally, enrolled patients will discontinue the study medication and complete any required follow-up assessment
  • The discontinuation is due to lack of efficacy based on the pre-specified interim analysis. No new safety was identified while the results were consistent with the established safety profile of Ultomiris
  • Ultomiris is the 1st long-acting C5 complement inhibitor & is approved in the US, EU & Japan for PNH & aHUS in adults and children aged ≥1mos.

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