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Alexion to Initiate P-III CHAMPION-ALS Study Evaluating Ultomiris (ravulizumab) in Amyotrophic Lateral Sclerosis

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Alexion to Initiate P-III CHAMPION-ALS Study Evaluating Ultomiris (ravulizumab) in Amyotrophic Lateral Sclerosis

Shots:

  • The P-III CHAMPION-ALS study will assess Ultomiris vs PBO (every q8w following an initial loading dose) in ~350 patients in a ratio (2:1) with sporadic or familial ALS for 50wks. Following 50wks. study- Ultomiris will be evaluated in a 2yr. open-label extension study at 90 sites across NA- EU and Asia-Pacific
  • The 1EPs will be changed in ALSFRS-R score and 2EPs include VAFS- respiratory capacity- muscle strength- neurofilament light chain (NfL) serum concentrations and safety
  • Ultomiris is a mAb targeting C5 protein in the terminal complement cascade and is an approved therapy in the US- EU and Japan for PNH and in the US for aHUS with the expected initiation of its P-III study in Q1’20

Click here to­ read full press release/ article | Ref: Alexion | Image: The Street


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