Felzartamab for IgA Nephropathy

(IGNAZ Trial)

No longer recruiting at 72 trial locations

Overseen By Morphosys Clinical Program Lead

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: HI-Bio, A Biogen Company

Must be taking: ACEi, ARB

Disqualifiers: Diabetes, Thrombocytopenia, Neutropenia, others

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

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new treatment called felzartamab for individuals with IgA nephropathy, a kidney disease that can lead to kidney damage. The study aims to evaluate the effectiveness and safety of felzartamab compared to a placebo (a harmless pill with no active drug). Participants will be randomly assigned to either the felzartamab group or the placebo group. The trial seeks individuals diagnosed with IgA nephropathy within the last 8 years who are already managing their condition with certain medications. As a Phase 2 trial, this research focuses on measuring the treatment's effectiveness in an initial, smaller group of participants.

Will I have to stop taking my current medications?

The trial requires that you continue taking an ACE inhibitor or angiotensin receptor blocker at the maximum or highest tolerated dose for at least 3 months before joining. The protocol does not specify if you need to stop other medications.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that felzartamab, a treatment under study for IgA nephropathy, is generally well tolerated. It targets and reduces CD38+ plasma cells, which are linked to the condition. In these studies, most patients did not experience serious side effects. Some patients reported infusion-related reactions and infections, but researchers carefully monitored and managed these. Overall, the evidence suggests that felzartamab is safe for humans, with manageable side effects. ^{1 2 3 4 5}

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

Felzartamab is unique because it specifically targets CD38, a protein found on the surface of certain immune cells, which plays a role in the development of IgA Nephropathy. Unlike standard treatments like corticosteroids and immunosuppressive drugs that broadly suppress the immune system, Felzartamab offers a more targeted approach, potentially reducing side effects. Researchers are excited about Felzartamab because it could improve kidney function while sparing patients from the widespread immune suppression associated with current therapies.

What evidence suggests that this trial's treatments could be effective for IgA Nephropathy?

Research has shown that felzartamab, a treatment under study in this trial for IgA nephropathy (a kidney disease), has produced promising results. Studies indicate that felzartamab targets and reduces specific cells involved in the disease. Participants in this trial may receive felzartamab and could experience improvements, suggesting the drug may help manage the disease. Most people tolerated the treatment well, as it did not cause serious side effects. These findings support the potential effectiveness of felzartamab for treating IgA nephropathy. ^{1 2 3 4 6}

Who Is on the Research Team?

Medical Director

Principal Investigator

HI-Bio, A Biogen Company

Are You a Good Fit for This Trial?

Adults aged 18-80 with a biopsy-confirmed diagnosis of IgA Nephropathy (IgAN) within the last 8 years, who have been on maximum or maximally tolerated doses of blood pressure medication for at least 3 months. Women must not be pregnant or breastfeeding and agree to use contraception during and post-trial for three months. Excluded are individuals with certain low blood counts, diabetes type 1, or elevated liver enzymes.

Inclusion Criteria

You have high levels of protein in your urine during the screening visit.

I've been on the highest dose possible of ACEi or ARB for my blood pressure for over 3 months.

I am not pregnant or breastfeeding and agree to use contraception as advised for 3 months after the last treatment.

Exclusion Criteria

Your hemoglobin level is less than 90 grams per liter.

Your neutrophil count is less than 1.5 x 10^9/L.

Your liver enzymes are higher than the normal range.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study medication or placebo in a double-blind manner

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Felzartamab
• Placebo

Trial Overview The trial is testing Felzartamab, an anti-CD38 antibody against a placebo in patients with IgAN. It's randomized (participants are assigned by chance), double-blind (neither participants nor researchers know who gets what treatment), multi-center, and aims to see how effective and safe the drug is.

How Is the Trial Designed?

Group I: Felzartamab Arm #3 Experimental Treatment 1 Intervention

Group II: Felzartamab Arm #2 Experimental Treatment 1 Intervention

Group III: Felzartamab Arm #1 Experimental Treatment 1 Intervention

Group IV: Placebo Placebo Group 1 Intervention

Who Is Running the Clinical Trial?

HI-Bio, A Biogen Company

Lead Sponsor

Trials

7

Recruited

300+

Biogen

Lead Sponsor

Trials

655

Recruited

468,000+

Daniel Quirk

Biogen

Chief Medical Officer

MD

Christopher A. Viehbacher

Biogen

Chief Executive Officer since 2022

Graduated from Queen's University, Kingston, Ontario, Canada

MorphoSys AG

Lead Sponsor

Trials

27

Recruited

6,600+

HI-Bio

Lead Sponsor

Trials

6

Recruited

180+

Published Research Related to This Trial

Recent randomized controlled trial results suggest that comprehensive supportive care is more beneficial than immunosuppressive therapy for patients with IgA nephropathy who are at high risk for disease progression.

The findings highlight the ongoing debate regarding the role of immunosuppressive therapy in treating IgA nephropathy, indicating a shift towards supportive care as a preferred approach.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Immunosuppression in IgA nephropathy: how certain are we? Floege, J., Rauen, T.[2017]

Citations

1. kidney-international.org kidney-international.org/article/S0085-2538(25)00488-0/fulltext

Randomized, double-blind, placebo-controlled phase 2a ... In the IGNAZ phase 2a study, treatment with felzartamab, which specifically depletes CD38+ plasma cells, was generally well tolerated and led to improvements in ...

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05065970

NCT05065970 | Clinical Trial to Assess Efficacy and Safety ... Clinical Trial to Assess Efficacy and Safety of the Human Anti-CD38 Antibody Felzartamab (MOR202) in IgA Nephropathy (IGNAZ). ClinicalTrials.gov ID ...

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40581166/

Randomized, double-blind, placebo-controlled phase 2a ... Randomized, double-blind, placebo-controlled phase 2a study assessing the efficacy and safety of felzartamab for IgA nephropathy. Kidney Int. 2025 Oct;108(4): ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S0085253825004880

Randomized, double-blind, placebo-controlled phase 2a ... In the IGNAZ phase 2a study, treatment with felzartamab, which specifically depletes CD38+ plasma cells, was generally well tolerated and led to improvements in ...

5. academic.oup.com academic.oup.com/ndt/article/39/Supplement_1/gfae069-0139-425/7678088

425 Felzartamab (anti-CD38) in patients with IgA Nephropathy ... This proof-of-concept study highlights the potential for disease modification in IgAN with the anti-CD38 mAb felza and supports continued research.

6. nejm.org nejm.org/doi/full/10.1056/NEJMoa2400763

A Randomized Phase 2 Trial of Felzartamab in Antibody ... Key prespecified safety outcomes were the number and per-patient incidence of serious adverse events, infusion-related reactions, and infections ...