A clinical trial to learn about the long-term safety of FUB523 (zigakibart) in people with immunoglobulin A (IgA) nephropathy who have completed previous zigakibart trials

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Decision date (initial)

2026-05-04

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Novartis Pharma AG with OMS ID: ORG-100003908

External identifiers

EU CT number

2024-519638-22-00

WHO UTN

U1111-1323-5099

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Others, Pharmacokinetic, Efficacy, Safety, Therapy, Pharmacodynamic

The primary objective of this study is to evaluate the long-term safety and tolerability of zigakibart in eligible participants receiving open-label zigakibart.

Secondary objectives 4

1. To evaluate the effect of zigakibart on proteinuria
2. To evaluate the effect of zigakibart on estimated glomerular filtration rate (eGFR)
3. To characterize the PK, PD and immunogenicity of zigakibart
4. To evaluate the safety and tolerability of zigakibart

Conditions and MedDRA coding

IgA nephropathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Signed informed consent must be obtained prior to participation in the OLE study.
2. Completion of the parent study (both participants assigned to receive the investigational product and placebo) as defined by the respective protocol
3. Per Investigator’s clinical judgment, the participant may benefit from receiving open-label treatment of zigakibart 600 mg s.c. Q2W.

Exclusion criteria 14

1. Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason
2. Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥ 30 days) or who require kidney transplantation.
3. Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
4. Clinical suspicion or diagnosis of rapidly progressive glomerulonephritis (RPGN), defined by KDIGO guidelines, or another glomerulopathy at the time of first study treatment administration in the OLE study.
5. Received a live vaccination within 12 weeks prior to first study treatment administration in the OLE study or plan to have a live vaccination within 6 months after the last dose of study treatment.
6. Use of systemic corticosteroid therapy (including budesonide) or other immunosuppressive therapy such as but not limited to mycophenolate, azathioprine, cyclosporine, tacrolimus, cyclophosphamide, etc., and herbs such as Tripterygium Wilfordii Hook F, Caulis sinomenii, and Sinomenium acutum for > 2 weeks in the 12 weeks prior to first study treatment administration in the OLE study; use of rituximab within 180-days of first study treatment administration in the OLE study.
7. Current severe infection at the time of first study treatment in the OLE study or history of recurrent, severe, infections as determined by the Investigator.
8. Newly diagnosed positive serology for hepatitis A virus IgM antibodies (anti-HAV IgM), hepatitis B surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, hepatitis C virus (HCV) antibodies (participants who completed treatment and are persistently antibody positive but have documentation of negative HCV polymerase chain reaction [PCR] will be allowed), or antibodies to HIV-1 and/or HIV-2.
9. Newly diagnosed malignancy (participants with basal cell carcinoma that was completely resected or curatively treated cervical carcinoma in situ or low-risk prostate cancer (i.e., Gleason score < 7 and prostate specific antigen < 10 ng/mL) are eligible for the study).
10. Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
11. History or evidence of any other clinically significant medical or psychiatric disorder, condition, disease, or laboratory finding that, in the discretion of the Investigator, constitutes an uncertain or unfavorable benefit-risk for continued long-term therapy with zigakibart.
12. Confirmed IgG levels < 3 g/L prior to first study treatment administration in the OLE study.
13. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, from menarche until becoming post-menopausal unless they are using highly effective methods of contraception (failure rate < 1% per year) while taking study treatment and for 24 weeks after stopping study treatment. Women are considered post-menopausal if they have had 12 months of natural (spontaneous) amenorrhea with an appropriate clinical profile (e.g., hormonal profile confirming menopause and/or age-appropriate history of vasomotor symptoms).
14. Sexually active males unwilling to use a highly effective methods of contraception during intercourse while taking study treatment and for 24 weeks after stopping study treatment. In addition, male participants must not donate sperm for the time period specified above.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 2

1. Type, incidence, severity, seriousness, and relatedness of treatment-emergent adverse events (TEAEs)
2. Incidence, severity, seriousness, and relatedness of adverse events of special interest (AESI)

Secondary endpoints 7

1. Change from Baseline to Weeks 48 and 96 in UPCR based on 24h-urine collection
2. Change from Baseline to Week 96 in eGFR, using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation
3. Change from BEYOND parent study Baseline to Week 96 of OLE study in eGFR
4. Serum concentrations of zigakibart
5. Changes from baseline in immunoglobulin levels
6. Presence of circulating binding and neutralizing antidrug antibodies (ADA/Nab)
7. Safety laboratory parameters and vital signs

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 9

Locations

8 EU/EEA countries · 34 investigational sites

By country

Investigational sites

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 108 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications