Zigakibart for Berger's Disease

Recruiting at 4 trial locations

Overseen By Novartis Pharmaceuticals

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Novartis Pharmaceuticals

Must not be taking: Corticosteroids, Immunosuppressives

Disqualifiers: Dialysis, AKI, Severe infection, others

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

Pivotal Trial (Near Approval) This treatment is in the last trial phase before FDA approval

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

Compensation: Varies

Number of Visits: 24

223 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if zigakibart is safe and effective for long-term use in individuals with immunoglobulin A nephropathy (IgAN), a condition that can affect kidney function. Participants must have completed a previous zigakibart study. Those who have finished the prior trial and whose doctors believe zigakibart could help manage their IgAN might be suitable candidates.

As a Phase 3 trial, this study serves as the final step before FDA approval, providing an opportunity to contribute to the potential availability of a new treatment for IgAN.

Will I have to stop taking my current medications?

The trial requires that you stop using systemic corticosteroids, certain immunosuppressive therapies, and herbs for more than 2 weeks in the 12 weeks before starting the study. If you're on rituximab, you must not have used it within 180 days before starting the study.

Is there any evidence suggesting that zigakibart is likely to be safe for humans?

Research has shown that zigakibart is well-tolerated by people with IgA nephropathy, a kidney disease that can cause kidney damage over time. In earlier studies, patients who took zigakibart for more than 100 weeks experienced good safety outcomes. These studies included both healthy volunteers and patients with IgA nephropathy and found no major safety concerns. This suggests that zigakibart could be a safe option for long-term treatment of IgA nephropathy. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising?

Researchers are excited about Zigakibart because it offers a new approach to treating Berger's Disease, also known as IgA nephropathy. Unlike current treatments, which primarily focus on managing symptoms with medications like corticosteroids or immunosuppressants, Zigakibart targets the underlying disease process. It works by modulating the immune response, potentially reducing kidney inflammation and damage more effectively. This innovative mechanism could lead to better long-term outcomes for patients, making it a promising new option in the fight against this condition.

What evidence suggests that zigakibart might be an effective treatment for Berger's Disease?

Research has shown that zigakibart holds promise for treating IgA nephropathy, a kidney condition. In a previous study, zigakibart reduced excess protein in urine by 60% after 100 weeks, which is crucial for kidney health. More than half of the patients achieved normal protein levels. Long-term studies suggest that zigakibart remains effective and safe over time. These findings indicate that zigakibart could be a strong option for managing IgA nephropathy. Participants in this trial will receive zigakibart to further evaluate its effectiveness and safety. ^{1 2 4 6 7}

Who Is on the Research Team?

Novartis Pharmaceuticals

Principal Investigator

Novartis Pharmaceuticals

Are You a Good Fit for This Trial?

This trial is for adults with IgA Nephropathy who have finished a previous zigakibart study. They must understand and agree to the study's terms, and their doctor should believe they could benefit from continued treatment every two weeks.

Inclusion Criteria

My doctor thinks I might benefit from a specific treatment given every 2 weeks.

I have signed the consent form for the study.

I completed the initial study, whether I received the actual treatment or a placebo.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Open-label Extension

Participants receive zigakibart for long-term safety and tolerability assessment

96 weeks

Scheduled visits at Baseline, Week 24, and Week 96

Follow-up

Participants are monitored for safety and effectiveness after treatment

24 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Zigakibart

Trial Overview The trial is testing the safety and effectiveness of long-term use of zigakibart in patients with IgA Nephropathy. It's an open-label extension, meaning everyone knows they're getting zigakibart, not a placebo.

How Is the Trial Designed?

Group I: zigakibart Experimental Treatment 1 Intervention

Participants will receive zigakibart.

Who Is Running the Clinical Trial?

Novartis Pharmaceuticals

Lead Sponsor

Trials

2,963

Recruited

4,275,000+

Founded

1996

Headquarters

Basel, Switzerland

Known For

Precision medicine

Top Products

Gleevec, Cosentyx, Entresto, Kisqali

Dr. Vas Narasimhan

Novartis Pharmaceuticals

Chief Executive Officer since 2018

MD from Harvard Medical School

Dr. Shreeram Aradhye

Novartis Pharmaceuticals

Chief Medical Officer since 2021

MD

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40482854/

Zigakibart demonstrates clinical safety and efficacy in a ... Zigakibart demonstrates clinical safety and efficacy in a Phase 1/2 trial of healthy volunteers and patients with IgA nephropathy · Abstract.

2. era-online.org era-online.org/wp-content/uploads/2025/06/Long-term-data-show-sustained-efficacy-and-safety-of-zigakibart-in-patients-with-IgA-nephropathy.pdf

Long-term-data-show-sustained-efficacy-and-safety-of- ... Sustained Long-Term Efficacy and Safety of Zigakibart Over 100 Weeks in Patients with IgA Nephropathy. Presented at ERA Congress; 5 June 2025; ...

3. news-medical.net news-medical.net/news/20250605/New-data-shows-zigakibart-sustains-proteinuria-remission-and-kidney-function-in-IgA-nephropathy.aspx

New data shows zigakibart sustains proteinuria remission ... At Week 100, proteinuria was reduced by 60% from baseline. Over half of patients (55%) reached <500 mg/24 h, and 31% achieved <300 mg/24 h, ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0270929525000105

The Rapidly Changing Treatment Landscape of IgA ... Interim results combined from both cohorts demonstrated that treatment of patients with IgAN with zigakibart led to a reduction in proteinuria from baseline ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT05852938

A Study of Zigakibart in Adults With IgA Nephropathy The primary objective of the study is to evaluate the effect of BION-1301 versus placebo on proteinuria in adults with IgA nephropathy.

6. kireports.org kireports.org/article/S2468-0249(25)00599-6/fulltext

Defining Disease Modification in IgA Nephropathy IgA nephropathy (IgAN) is a rare, chronic, immune-mediated kidney disease characterized by a slow, progressive decline in kidney function.

7. hcplive.com hcplive.com/clinical/berger-disease

IgA Nephropathy | Clinical New 100-week data reveals zigakibart's significant efficacy and safety in reducing proteinuria for IgA nephropathy. Digital illustration with a cross ...