MASter-1 PoC study: NLRC4-GOF XIAP-deficiency & CDC42-mutations - MAS825D12201

• Research type

  Research Study

• Full title

  A three-period multicenter study, with a randomized-withdrawal, double-blinded, placebo-controlled design to evaluate the clinical efficacy, safety and tolerability of MAS825 in patients with monogenic IL-18 driven autoinflammatory diseases, including NLRC4-GOF, XIAP deficiency, or CDC42 mutations.

• IRAS ID

  1007086

• Contact name

  Lead of Regulatory Affairs Lead of Regulatory Affairs

• Contact email

  novartis.email@novartis.com

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2020-003596-17

• Clinicaltrials.gov Identifier

  NCT04641442

• Research summary

  Please see document - Protocol Summary in Lay Language Version Number: 00

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  23/YH/0214

• Date of REC Opinion

  30 Oct 2023

• REC opinion

  Further Information Favourable Opinion