Commodore 2

• Research type

  Research Study

• Full title

  A PHASE III, RANDOMIZED, OPEN-LABEL, ACTIVE-CONTROLLED, MULTICENTER STUDY EVALUATING THE EFFICACY AND SAFETY OF CROVALIMAB VERSUS ECULIZUMAB IN ADULT AND ADOLESCENT PATIENTS WITH PAROXYSMAL NOCTURNAL HEMOGLOBINURIA (PNH) NOT PREVIOUSLY TREATED WITHCOMPLEMENT INHIBITORS

• IRAS ID

  1003396

• Contact name

  Trial Information Support Line-TISL

• Contact email

  global.rochegenentechtrials@roche.com

• Sponsor organisation

  F. Hoffman-La Roche Ltd.

• Eudract number

  2019-004931-21

• Clinicaltrials.gov Identifier

  NCT04434092

• Research summary

  This study is comparing a new medication against Soliris, a already approved medication, after treatment with complement inhibitors (medication that helps our body to not self attack but defend against harmful intruders) to evaluate which treatment is safer and more effective for patients with Paroxysmal Nocturnal Hemoblobinuria (PNH), a rare blood disease that causes the red blood cells to break apart, due to a missing protein on the patients blood cells surface.

• REC name

  West of Scotland REC 1

• REC reference

  21/WS/0009

• Date of REC Opinion

  30 Mar 2021

• REC opinion

  Further Information Favourable Opinion