Mezagitamab for Berger's Disease

Recruiting at 54 trial locations

Age: 18+

Sex: Any

Trial Phase: Phase 3

Sponsor: Takeda

Must be taking: RAAS inhibitors

Must not be taking: Immunosuppressants, Corticosteroids

Disqualifiers: Secondary IgAN, Nephrotic syndrome, Transplant, others

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: Unknown

Duration: 22 weeks

347 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the effectiveness of a drug called mezagitamab for individuals with Berger's Disease, also known as IgAN. The trial aims to determine if mezagitamab can reduce protein levels in urine and maintain kidney function over time compared to a placebo. Participants will be randomly assigned to receive either the drug or the placebo, while a smaller group with specific kidney conditions will receive only mezagitamab. Ideal participants are adults diagnosed with IgAN who have been managing it with specific kidney-related medications. As a Phase 3 trial, this study represents the final step before FDA approval, offering participants a chance to contribute to potentially groundbreaking treatment advancements.

Will I have to stop taking my current medications?

The trial requires participants to be on stable RAAS inhibitor therapy (a type of blood pressure medication) for at least 12 weeks before joining and to continue it during the trial. If you are intolerant to this therapy, you may still be eligible after consulting with the medical monitor.

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

Research has shown that mezagitamab is generally well tolerated. An earlier study used it alongside standard treatments and found it mostly safe, with no major safety issues reported. The study also found that kidney function remained stable for up to 18 months after treatment. This suggests that mezagitamab could be a safe option for patients with IgA nephropathy, a kidney condition. However, as with any medical treatment, each person's experience may vary. ^{1 2 3 4 5}

Why do researchers think this study treatment might be promising for IgAN?

Researchers are excited about mezagitamab because it introduces a new approach to treating Berger's Disease, also known as IgA nephropathy. Unlike traditional treatments like corticosteroids or immunosuppressants, mezagitamab acts on a different target by focusing on modulating the immune system more precisely. This innovative mechanism could potentially reduce inflammation and kidney damage more effectively and with fewer side effects. Additionally, mezagitamab is administered via subcutaneous injections, which may offer more convenience compared to other therapies that require oral medications or more invasive methods.

What evidence suggests that mezagitamab might be an effective treatment for IgAN?

Research has shown that mezagitamab can help maintain kidney function in people with IgA nephropathy (IgAN). One study found that kidney function remained stable for up to 18 months after treatment. Additionally, previous patients experienced quick and lasting reductions in urine protein levels, indicating less kidney damage. In this trial, participants will receive either mezagitamab or a placebo. Overall, mezagitamab was well tolerated when used with standard treatments, making it a promising option for managing IgAN. ^{1 2 3 5 6}

Who Is on the Research Team?

Study Director

Principal Investigator

Takeda

Are You a Good Fit for This Trial?

Adults with primary IgA Nephropathy (kidney condition) who have certain levels of protein in their urine and a minimum kidney function. They must not have had previous anti-CD38 therapy, agree to use contraception if applicable, and be on stable kidney medication for at least 12 weeks prior. Those previously in study TAK-079-1006 may also qualify.

Inclusion Criteria

I have signed the consent form and understand the trial's procedures.

My kidney tests show protein in my urine but my kidney function is still okay.

My urine protein levels are high, based on recent tests.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive either mezagitamab or placebo for approximately 22 weeks in each 52-week period

22 weeks

Monthly check-ups

Observation

Participants are observed for another half year in each 1-year cycle

26 weeks

Monthly check-ups

Open-label extension

Participants in the open-label group receive mezagitamab treatment

22 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Mezagitamab

Trial Overview The trial is testing mezagitamab against a placebo to see if it can reduce protein levels in the urine of IgAN patients, which indicates better kidney health. Participants are randomly assigned to receive either mezagitamab or placebo for two cycles of one year each, with follow-ups every month.

How Is the Trial Designed?

Group I: Open-label Mezagitamab Experimental Treatment 1 Intervention

Participants will receive mezagitamab injections, SC for approximately 22 weeks in each 52-week period.

Group II: Mezagitamab Experimental Treatment 1 Intervention

Participants will receive mezagitamab injections, subcutaneously (SC), for approximately 22 weeks in each 52-week period.

Group III: Placebo Placebo Group 1 Intervention

Participants will receive mezagitamab-matching placebo injections, SC for approximately 22 weeks in each 52-week period.

Who Is Running the Clinical Trial?

Takeda

Lead Sponsor

Trials

1,255

Recruited

4,219,000+

Dr. Naoyoshi Hirota

Takeda

Chief Medical Officer since 2020

MD from University of Tokyo

Christophe Weber

Takeda

Chief Executive Officer since 2015

PhD in Molecular Biology from Université de Montpellier

Citations

1. takeda.com takeda.com/newsroom/newsreleases/2025/new-data-mezagitamab/

Mezagitamab Stablized eGFR 18 Months After Treatment ... Data from the study showed that kidney function (eGFR) remained stable in patients with IgA nephropathy through Week 96 – up to 18 months after ...

2. journals.lww.com journals.lww.com/10.1681/ASN.20243d4074tq

Interim Results from an Open-Label Phase 1b Study Conclusion: Mezagitamab was generally well tolerated as an add-on to standard of care therapy. Rapid and sustained reductions in UPCR, serum IgA, and Gd ...

3. clinicaltrials.gov clinicaltrials.gov/study/NCT06963827

NCT06963827 | A Study of Mezagitamab in Adults With ... The main aim of this study is to check how well mezagitamab changes protein levels in the urine (proteinuria) compared to placebo in adults with primary IgAN. A ...

4. finance.yahoo.com finance.yahoo.com/news/takeda-presents-data-showing-mezagitamab-160000736.html

Takeda Presents New Data Showing Mezagitamab (TAK ... Data from the study showed that kidney function (eGFR) remained stable in patients with IgA nephropathy through Week 96 – up to 18 months after ...

5. 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 ...

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

The Rapidly Changing Treatment Landscape of IgA ... A meta-analysis of 13 controlled trials in IgAN of various interventions demonstrated a strong association between treatment effects on early (9-month) ...