IONIS-FB-LRx for IgA Nephropathy

Recruiting at 6 trial locations

Overseen By Ionis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: Ionis Pharmaceuticals, Inc.

Must not be taking: Immunosuppressives

Disqualifiers: Diabetes, Lupus, HIV, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Compensation: Varies

Number of Visits: Unknown

Duration: 24 weeks

23 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial tests IONIS-FB-LRx, a drug that lowers harmful protein levels, in people with IgA nephropathy to see if it can protect their kidneys.

Eligibility Criteria

Adults with confirmed primary IgA nephropathy, a kidney disease marked by blood and protein in urine, can join this trial. They must not be pregnant or breastfeeding and should use effective birth control if necessary. People with recent major health events, certain immune deficiencies, severe infections, very low kidney function, or other specific kidney diseases cannot participate.

Inclusion Criteria

You have been diagnosed with primary immunoglobulin A (IgA) nephropathy through a biopsy.

Presence of blood in the urine

Presence of protein in the urine.

Exclusion Criteria

Treatment with another investigational drug, biological agent, or device within 6 months of screening, or 5 half-lives of investigational agent, whichever is longer

I haven't taken long-term immune system medications in the last year.

I have not had any infections in the last 30 days.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive IONIS-FB-LRx for 24 weeks to evaluate its effectiveness and safety

24 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 weeks

Optional Treatment Extension

Participants may opt into an additional 48 weeks of treatment with IONIS-FB-LRx

48 weeks

Treatment Details

Interventions

• IONIS-FB-LRx

Trial Overview The trial is testing IONIS-FB-LRx's ability to safely treat IgA nephropathy by inhibiting complement factor B. It will also assess how the drug affects plasma factor B levels and serum activity related to the body's defense (complement) system.

Participant Groups

Group I: IONIS-FB-LRx Experimental Treatment 1 Intervention

Who Is Running the Clinical Trial?

Ionis Pharmaceuticals, Inc.

Lead Sponsor

Trials

151

Recruited

27,800+

Dr. Brett P. Monia

Ionis Pharmaceuticals, Inc.

Chief Executive Officer since 2020

PhD in Pharmacology from the University of Pennsylvania, BSc in Molecular Biology and Analytical Chemistry from Stockton State College

Dr. Eric Bastings

Ionis Pharmaceuticals, Inc.

Chief Medical Officer

MD