30 Participants NeededMy employer runs this trial

JADE101 for Immunoglobulin A Nephropathy

Recruiting at 12 trial locations
JS
Overseen ByJADE101 Study Contact
Age: 18 - 65
Sex: Any
Trial Phase: Phase 2
Sponsor: Jade Biosciences, Inc.
Must be taking: ACEi, ARB
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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called JADE101 for individuals with IgA nephropathy, a kidney disease that can progressively damage the kidneys. Researchers aim to assess the safety and effectiveness of JADE101 in managing this condition. Participants must have a confirmed diagnosis of IgA nephropathy and must have been on stable doses of certain medications, such as ACE inhibitors, for at least three months. As a Phase 2 trial, the research focuses on evaluating the treatment's effectiveness in an initial, smaller group of participants.

Do I have to stop taking my current medications for the trial?

The trial requires that you continue taking stable doses of either ACE inhibitors or ARBs, which are common medications for IgA nephropathy, for at least 12 weeks before starting the trial. There is no mention of stopping other medications, so it's best to discuss your specific situation with the trial team.

Is there any evidence suggesting that JADE101 is likely to be safe for humans?

Research has shown that JADE101 is safe and well-tolerated in both early human studies and animal tests. In past studies, about 70% of participants experienced a decrease in IgA levels, indicating potential for treating IgA nephropathy. Importantly, the treatment was well-tolerated at all tested doses.

Animal studies also demonstrated that JADE101 was well-tolerated, even at high doses, suggesting safety at levels higher than those required for humans. While more data from human trials is necessary, these results are promising for the safety of JADE101 in treating IgA nephropathy.12345

Why do researchers think this study treatment might be promising?

Unlike the standard treatments for Immunoglobulin A Nephropathy, which often involve corticosteroids or immunosuppressants, JADE101 is unique because it is administered through a subcutaneous injection. This method can potentially offer more consistent delivery and absorption compared to oral medications. Additionally, researchers are excited about JADE101 because it may work through a novel mechanism, targeting specific pathways in the immune system that current treatments do not address. This could lead to more effective management of the condition with fewer side effects.

What evidence suggests that JADE101 might be an effective treatment for IgA nephropathy?

Research has shown that JADE101, the treatment under study in this trial, may help treat IgA nephropathy, a kidney condition. In earlier studies, JADE101 reduced IgA levels by 70% for 12 weeks in healthy individuals. This reduction is significant because high IgA levels can harm the kidneys in this disease. The treatment targets a protein called APRIL, which aids in IgA production, aiming to lower these levels. The results in healthy individuals align with expectations for patients with IgA nephropathy, suggesting JADE101 might help manage the disease and slow kidney damage.12467

Who Is on the Research Team?

LL

Li Li, MD

Principal Investigator

Jade BioSciences

Are You a Good Fit for This Trial?

This trial is for adults aged 18-60 who have biopsy-confirmed IgA nephropathy, decent kidney function (eGFR ≥30), and are already on stable doses of certain blood pressure medicines (ACEi or ARB). Participants must be able to follow study rules and agree to use contraception.

Inclusion Criteria

Willing and able to comply with contraceptive and lifestyle requirements
I am between 18 and 60 years old and can legally give consent.
eGFR ≥ 30 mL/min/1.73 m2
See 5 more

Exclusion Criteria

I have kidney disease other than IgA nephropathy.
My IgA nephropathy is caused by another underlying condition.
I have or may have rapidly worsening kidney inflammation.
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive subcutaneous injections of JADE101

100 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4-8 weeks

What Are the Treatments Tested in This Trial?

Interventions

  • JADE101

Trial Overview

The study is testing a new drug called JADE101 in people with IgA nephropathy. All participants will receive the drug, and researchers will monitor its safety and how well it works at improving kidney health.

How Is the Trial Designed?

1

Treatment groups

Experimental Treatment

Group I: JADE101Experimental Treatment1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Jade Biosciences, Inc.

Lead Sponsor

Citations

Jade Biosciences Announces Positive Interim Phase 1 ...

“With JADE101, IgA reductions of approximately 70% sustained at 12 weeks in healthy volunteers are both biologically and clinically meaningful, ...

A Study of JADE101 in Participants With Immunoglobulin ...

This open-label Phase 2 study will characterize the safety and efficacy of JADE101 in participants with IgA nephropathy, and the results will contribute to the ...

Jade Biosciences Initiates Phase 2 Trial of JADE101 in IgA ...

The therapy is designed with high binding strength to enhance potency and durability, with the goal of producing sustained reductions in ...

IgA Nephropathy: An Overview of the Clinical Trials - PMC

In the IGNAZ trial, felzartamab led to a 35% reduction in UPCR at month 6 in the highest-dose group, compared to a 9% increase with placebo. The effect was ...

First participant dosed in Jade's Phase II JUNIPER trial for ...

Jade Biosciences has dosed the first participant in its Phase II JUNIPER clinical trial, evaluating JADE101 for immunoglobulin A nephropathy ...

Nonclinical Safety Profile of JADE101, a Half-Life Extended ...

JADE101 was well tolerated in NHP studies up to the highest dose tested providing wide safety margins above the anticipated therapeutic dose. JADE101 ...

Jade Biosciences Announces First Participant Dosed in ...

JUNIPER is an open-label Phase 2 clinical trial designed to evaluate JADE101 in approximately 30 participants with IgAN, including its safety ...