CMBG453B12206B: Roll-over study for patients who have completed a prior Novartis-sponsored

• Research type

  Research Study

• Full title

  An open-label, multicenter, roll-over study for patients who have completed a prior Novartis-sponsored sabatolimab (MBG453) study and are judged by the investigator to benefit from continued treatment with sabatolimab

• IRAS ID

  1008767

• Contact name

  Monica Dressler-Meyer

• Contact email

  monica.dressler-meyer@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2021-004422-30

• Clinicaltrials.gov Identifier

  NCT05201066

• Research summary

  A study to provide access and to continue to collect and assess the safety of Sabatolimab, in participants who are currently receiving treatment with Sabatolimab in a Novartis parent study. Eligible participants from those studies would be enrolled, who in the opinion of the investigator, would benefit from continued study treatment including Sabatolimab.

• REC name

  East of England - Cambridge East Research Ethics Committee

• REC reference

  24/EE/0044

• Date of REC Opinion

  25 Mar 2024

• REC opinion

  Further Information Unfavourable Opinion