Phase 2 Study of VIS649 for IgA Nephropathy

• Research type

  Research Study

• Full title

  A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Multiple Dose Study to Evaluate the Efficacy and Safety of VIS649 in Participants with Immunoglobulin A (IgA) Nephropathy

• IRAS ID

  272228

• Contact name

  Chee Kay Cheung

• Contact email

  jonathan.barratt@uhl-tr.nhs.uk

• Sponsor organisation

  Visterra, Inc.

• Eudract number

  2019-002531-29

• Duration of Study in the UK

  2 years, 1 months, 0 days

• Research summary

  Summary of Research
  The purpose of this study is to find out about the safety and efficacy of VIS649 for the treatment of IgAN. Approximately 144 participants will be enrolled from approximately 97 global sites in approximately 15 countries. The total study duration for each participant from the initial screening visit to the end-of-study visit will be up to 17 months which assumes up to 1 month for screening, once a month dosing for 12 months and follow-up visits through 5months (155) days after the last dose of study drug.

  The study will evaluate 3 dose levels for VIS649 (2 mg/kg, 4 mg/kg and 8 mg/kg) versus placebo (will not have an active drug substance and will appear similar to the study drug VIS649).

  Participants who qualify for this study will be randomized (assigned by chance – like flipping a coin) to one of following four treatment groups (approximately 36 participants per group):
  • Group 1 - monthly dose of VIS649 2mg/kg
  • Group 2 - monthly dose of VIS649 4mg/kg
  • Group 3 - monthly dose of VIS649 8mg/kg
  • Group 4 - monthly dose of placebo (no active drug)
  VIS649 or placebo will be administered in a single intravenous (IV) infusion once a month for 12 months. The IV infusion will last approximately 1 hour each time

  Summary of Results
  https://gbr01.safelinks.protection.outlook.com/?url=https%3A%2F%2Fclick.pstmrk.it%2F3ts%2Fclinicaltrials.gov%252Fstudy%252FNCT04287985%2FNBTI%2F_yW2AQ%2FAQ%2F890e62f3-842e-4374-8ebd-b9338c81d9c8%2F1%2Fo8bHvkux5s&data=05%7C02%7Csheffield.rec%40hra.nhs.uk%7C1814b2a7907f48fe2a2808dc92018344%7C8e1f0acad87d4f20939e36243d574267%7C0%7C0%7C638545782393108068%7CUnknown%7CTWFpbGZsb3d8eyJWIjoiMC4wLjAwMDAiLCJQIjoiV2luMzIiLCJBTiI6Ik1haWwiLCJXVCI6Mn0%3D%7C0%7C%7C%7C&sdata=QYYrMkK5MPtYNmFHv2WtHV47F017SPc289iTeG7waSE%3D&reserved=0

• REC name

  Yorkshire & The Humber - Sheffield Research Ethics Committee

• REC reference

  20/YH/0077

• Date of REC Opinion

  24 Mar 2020

• REC opinion

  Favourable Opinion