25 Participants Needed

Sibeprenlimab for IgA Nephropathy

Recruiting at 5 trial locations
OC
Overseen ByOtsuka Call Center
Age: Any Age
Sex: Any
Trial Phase: Phase 2
Sponsor: Otsuka Pharmaceutical Development & Commercialization, Inc.
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot be on systemic corticosteroids or immunosuppressants within 24 weeks before starting the trial. Other forms of corticosteroids like topical or inhaled are allowed.

What data supports the effectiveness of the drug Sibeprenlimab for IgA Nephropathy?

Research shows that Sibeprenlimab, a drug that blocks a protein called APRIL, can significantly reduce levels of certain antibodies (proteins made by the immune system) in the blood, which are involved in IgA Nephropathy. In studies with healthy participants, it was found to be safe and effectively lowered these antibodies in a dose-dependent manner, meaning higher doses led to greater reductions.12345

Is Sibeprenlimab safe for humans?

In studies with healthy volunteers, Sibeprenlimab was generally safe, with no serious side effects reported. Some participants experienced mild adverse events, but none were severe enough to stop the study.23467

How is the drug Sibeprenlimab different from other drugs for IgA Nephropathy?

The research provided does not contain specific information about Sibeprenlimab, so I cannot determine how it differs from other treatments for IgA Nephropathy.5891011

What is the purpose of this trial?

This is a phase 2b open-label trial to characterize histopathological biomarkers of disease in immunoglobulin A nephropathy (IgAN) and demonstrate potential changes in response to sibeprenlimab.

Eligibility Criteria

This trial is for individuals at least 16 years old with a confirmed diagnosis of IgA Nephropathy and a kidney function (eGFR) above 45 mL/min/1.73 m2. It's not for those with other chronic kidney diseases, low serum IgG levels, uncontrolled high blood pressure, pregnant or breastfeeding women, or anyone who has used systemic corticosteroids or immunosuppressants within the last 24 weeks.

Inclusion Criteria

Source-verified kidney biopsy confirmed diagnosis of IgAN
My kidney function, measured by eGFR, is above 45 mL/min/1.73 m2.
I am 16 years old or older.

Exclusion Criteria

I have chronic kidney disease not caused by IgA nephropathy.
Participant has a serum IgG value <600 mg/dL at screening
Participant has uncontrolled hypertension (defined as systolic blood pressure > 140 mmHg or diastolic blood pressure > 90 mmHg)
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Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive sibeprenlimab to evaluate its impact on kidney histopathology in IgAN

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

  • Sibeprenlimab
Trial Overview The trial studies Sibeprenlimab's effects on kidney tissue in patients with IgA Nephropathy. As an open-label phase 2b study, it aims to identify disease biomarkers and observe changes after treatment without hiding which participants receive the drug.
Participant Groups
1Treatment groups
Experimental Treatment
Group I: SibeprenlimabExperimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Otsuka Pharmaceutical Development & Commercialization, Inc.

Lead Sponsor

Trials
271
Recruited
170,000+
John Kraus profile image

John Kraus

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Medical Officer since 2023

MD, PhD

Tarek Rabah profile image

Tarek Rabah

Otsuka Pharmaceutical Development & Commercialization, Inc.

Chief Executive Officer since 2022

BS in Biology and BA in Business from the American University of Beirut, MBA from McGill University

Findings from Research

A patient with IgA nephropathy and Crohn disease showed clinical improvement and remission of nephropathy after treatment with a combination of prednisolone, cyclophosphamide, warfarin, and an ACE inhibitor, indicating the effectiveness of this therapy.
The recurrence of IgA nephropathy with the onset of Crohn disease suggests a potential link between the two conditions, possibly due to an IgA immune response triggered by intestinal challenges, which was successfully managed with an elemental diet and oral prednisolone.
An adolescent with IgA nephropathy and Crohn disease: pathogenetic implications.Takemura, T., Okada, M., Yagi, K., et al.[2013]
VIS649 (sibeprenlimab) was found to be safe and well tolerated in a phase 1 study involving 51 healthy adults, with no serious adverse events reported, indicating a favorable safety profile for further development.
The drug effectively suppressed APRIL and various immunoglobulins in a dose-dependent manner, while still allowing for a normal immune response to a tetanus/diphtheria vaccine, suggesting it may be a promising treatment for IgA nephropathy without compromising vaccine efficacy.
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers.Mathur, M., Barratt, J., Suzuki, Y., et al.[2022]
Sibeprenlimab effectively reduces levels of the cytokine APRIL and immunoglobulin A (IgA) in a dose-dependent manner, with significant reductions observed at doses of 400 mg and 600 mg, indicating its potential efficacy in treating conditions like immunoglobulin A nephropathy.
The phase 1 study involving 48 healthy participants showed that sibeprenlimab was well-tolerated, with no serious adverse events reported, and demonstrated a favorable pharmacokinetic profile, with a mean elimination half-life of 8-10 days.
Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Sibeprenlimab in Healthy Participants.Zhang, X., Wang, Y., Yarbrough, J., et al.[2023]

References

An adolescent with IgA nephropathy and Crohn disease: pathogenetic implications. [2013]
Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of VIS649 (Sibeprenlimab), an APRIL-Neutralizing IgG2 Monoclonal Antibody, in Healthy Volunteers. [2022]
Safety, Pharmacokinetics, and Pharmacodynamics of Subcutaneous Sibeprenlimab in Healthy Participants. [2023]
A Phase 2 Trial of Sibeprenlimab in Patients with IgA Nephropathy. [2023]
Comparison of the therapeutic effects of leflunomide and mycophenolate mofetil in the treatment of immunoglobulin A nephropathy manifesting with nephrotic syndrome. [2019]
Comparative effectiveness and safety for the treatments despite optimized renin-angiotensin system blockade among IgA nephropathy patients at high-risk of disease progression: A network meta-analysis of randomized controlled trials. [2023]
Budesonide versus systemic corticosteroids in IgA Nephropathy: A retrospective, propensity-matched comparison. [2021]
[Effects of leflunomide combined with hormone therapy for refractory IgA nephropathy]. [2018]
Randomised controlled trial of leflunomide in the treatment of immunoglobulin A nephropathy. [2018]
IgA nephropathy in a child: Crohn's disease-associated or adalimumab induced? [2022]
Corticosteroids in IgA nephropathy: a randomised controlled trial. [2022]
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