> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# FDA. Omeros Agree on Phase 3 IgAN Trial
- URL: https://www.fdaweb.com/fda-omeros-agree-on-phase-3-igan-trial/
- Published: 2019-01-17T12:00:00.000Z
- Updated: 2026-09-15T00:55:03.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5143169

As a result of a meeting with FDA staff, Omeros and the agency have finalized the company’s clinical plan for its OMS721 submission and approval in immunoglobulin A nephropathy (IgAN). The company [says](https://www.marketwatch.com/press-release/omeros-finalizes-with-fda-clinical-plan-for-oms721-approval-in-iga-nephropathy-2019-01-17?ref=fdaweb.com) OMS721 is its lead human monoclonal antibody targeting MASP-2, the effector enzyme of the complement system’s lectin pathway. Omeros says there is no approved treatment for IgAN nephropathy.

At the meeting, participants reportedly agreed that the Phase 3 primary endpoint of proteinuria would be extended from 24 to 36 weeks at Omeros’ request to allow for additional OMS721 dosing, if needed. Also, given investigators’ concerns about extending withholding of OMS721 treatment from any high-risk study patient initially randomized to the placebo-treated group, patients in that subpopulation will be allowed open-label treatment with OMS721 after at least one year of blinded treatment, the company says.