APPLAUSE

• Research type

  Research Study

• Full title

  A multi-center, randomized, double-blind, placebo-controlled, parallel group, phase III study to evaluate the efficacy and safety of LNP023 in primary IgA nephropathy patients

• IRAS ID

  291610

• Contact name

  Chee Kay Cheung

• Contact email

  ckc15@le.ac.uk

• Sponsor organisation

  Novartis Pharma AG

• Eudract number

  2020-001049-38

• Clinicaltrials.gov Identifier

  NCT04578834

• Clinicaltrials.gov Identifier

  NA, NA

• Duration of Study in the UK

  3 years, 11 months, 15 days

• Research summary

  This is a multi-center, randomized, double-blinded, placebo controlled study, which comprises a screening visit, followed by a run in period of 14 to approximately 90 days. Thereafter, eligible participants will be randomized in a 1:1 ratio to either LNP023 200mg or matching placebo b.i.d. for a 24 month treatment period.

• REC name

  London - South East Research Ethics Committee

• REC reference

  20/LO/1307

• Date of REC Opinion

  8 Feb 2021

• REC opinion

  Further Information Favourable Opinion