CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 23 enrolled
Drug / intervention
IONIS-FB-LRxdrug
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04014335
NCT04014335Phase 2Completed
CompareCT.gov

An Open-Label Phase 2a Clinical Study to Evaluate the Effectiveness and Safety of IONIS-FB-LRx, an Antisense Inhibitor of Complement Factor B, in Adult Subjects With Primary IgA Nephropathy

Ionis Pharmaceuticals, Inc.·interventional·Posted Jul 10, 2019·Updated Jan 23, 2025

In Brief

A Phase 2 clinical trial evaluating IONIS-FB-LRx for Primary IgA Nephropathy. Completed, enrolled 23 participants across 7 sites in 4 countries.

Detailed Summary

The purpose of this study is to evaluate the effectiveness and safety of IONIS-FB-LRx, an antisense inhibitor of complement factor B messenger ribonucleic acid (CFB mRNA), and to evaluate the effect of IONIS-FB-LRx on plasma factor B (FB) levels and serum AH50, CH50 activity in participants with primary immunoglobulin A (IgA) nephropathy.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrimary IgA Nephropathy
CountriesAustralia, Canada, New Zealand, Singapore
Collaborators--

Timeline

Phase 2CompletedFinished
2020202120222023202420252026
First PostedJul 10, 2019
Enrollment StartDec 4, 2019
Primary CompletionFeb 8, 2024
Study CompletionApr 11, 2024
TodayJul 2, 2026
Enrollment to primary: 4.2 yearsPosted 7.0 years ago

Interventions

IONIS-FB-LRxdrug

Participants will receive IONIS-FB-LRx, by subcutaneous injection (SC) at Week 1 and every 4 weeks through Week 25. Optional 48-week Extension, with drug dosing continuing every 4 weeks.