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
Sponsor organisation
Novartis Pharma AG
Eudract number
2020-001049-38
Clinicaltrials.gov Identifier
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.
Lay summary of study results: The English lay summary will be available one year post global LPLV (03-Sep-26). It will be available to PIs to share with patients and posted in the public domain on Novartis public website https://gbr01.safelinks.protection.outlook.com/?url=http%3A%2F%2Fwww.novctrd.com%2F&data=05%7C02%7Clondonsoutheast.rec%40hra.nhs.uk%7C66912cdf41af49be491008def27ab478%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C639214805995111190%7CUnknown%7CTWFpbGZsb3d8eyJFbXB0eU1hcGkiOnRydWUsIlYiOiIwLjAuMDAwMCIsIlAiOiJXaW4zMiIsIkFOIjoiTWFpbCIsIldUIjoyfQ%3D%3D%7C0%7C%7C%7C&sdata=A4RRwBlsMv9J8rp7CAoJXQy5MPClVGSB9lyIx%2Bak%2Fs8%3D&reserved=0“
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