A Phase 3 interventional study of zigakibart in Kidney Diseases, Kidney Diseases, Chronic and Urological Diseases, sponsored by Novartis Pharmaceuticals. Recruiting at 26 sites in 9 countries. Open to participants aged 18 Years to 100 Years. Per ClinicalTrials.gov, last updated 2026-08-17.
Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment
The purpose of this study is to determine if zigakibart is safe and effective for long-term use in patients with immunoglobulin A nephropathy (IgAN). This is an extension study for patients who have already completed an another zigakibart study.
This is a non-randomized, multicenter, open-label extension (OLE) study to Phase 3, randomized CHK02-02 (CFUB523A12301)-BEYOND clinical study, Phase 1/2 ADU-CL-19 (CFUB523A12103) clinical study, and any other Novartis-sponsored clinical study of zigakibart in IgAN.
275 studies on the registry are indexed under Glomerulonephritis, IGA; 107 are open to participants now.
This study's planned enrollment of 220 is above the median of 62 across 221 interventional studies indexed under Glomerulonephritis, IGA.
Browse Glomerulonephritis, IGA studies →Novartis Pharmaceuticals is the lead sponsor of 2,718 studies on the registry; 221 are open to participants now.
Of its 585 completed or terminated interventional studies of FDA-regulated products, 438 (75%) have results posted.
Compared within Glomerulonephritis, IGA, this study's primary condition as ClinicalTrials.gg classifies it; the registry's first condition term is Kidney Diseases. The counts are of registry records indexed under each term, refreshed daily. How we classify →
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Highly effective contraception methods for both women and men include:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Live vaccines
Vaccines made with a weakened form of the germ, such as measles–mumps–rubella (MMR), chickenpox and yellow fever. They can be risky when the immune system is weakened. Flu injections are not live; the nasal flu spray is.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis B tests
Hepatitis B is a virus that infects the liver. These are separate tests: HBsAg positive usually means a current infection (a recent vaccination can briefly cause it too); total anti-HBc (HBcAb) positive means an infection now or in the past; HBV DNA measures how much virus is in the blood.
Some studies accept a past infection if HBV DNA is undetectable, sometimes with antiviral medicine during the study. Check what this study allows.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hepatitis C tests
Hepatitis C is a virus that infects the liver. An HCV antibody test can stay positive after an infection has cleared (and is occasionally positive without one); an HCV RNA test shows whether the virus is there now.
After treatment, hepatitis C counts as cured when HCV RNA is still undetectable 12 weeks or more after the treatment ended. Studies often accept people cured this way.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Childbearing potential
Able to become pregnant: from the first period until menopause, unless permanently unable to through surgery (removal of the womb, or of both ovaries or both fallopian tubes).
Criteria for people of childbearing potential usually ask for a negative pregnancy test and for contraception during the study and for a time after it.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Postmenopausal
Periods have stopped for good: usually no period for 12 months in a row without another medical reason, sometimes confirmed by a blood test (FSH).
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants will receive zigakibart.
Drug: zigakibart
solution for subcutaneous injection
Also known as: FUB523; BION-1301
Number of participants with adverse events.
Number of participants with adverse events will be provided.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with serious adverse events.
Number of participants with serious adverse events will be provided.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Number of participants with adverse events of special interest.
Number of participants with adverse events of special interest will be provided.
Time frame: Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment
Change in UPCR from Baseline to Week 48 and Week 96.
The change in the ratio of urine protein to urine creatinine (UPCR), based on 24-hour urine collection, from Baseline to Week 48 and to Week 96.
Time frame: Baseline visit, Week 48 and Week 96.
Change in eGFR from Baseline to Week 96.
Estimated glomerular filtration rate (eGFR) will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline and Week 96 timepoints will then be calculated.
Time frame: Baseline visit and Week 96.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
eGFR will be calculated using the chronic kidney disease-epidemiology collaboration (CKD-EPI) creatinine equation. The change (difference) in eGFR between Baseline in the BEYOND study and Week 96 in OLE study will then be calculated.
Time frame: Baseline visit and Week 96.
Serum concentration values of zigakibart at scheduled visits.
Serum concentration values will be provided for the following scheduled visits: Day 1, Week 24 and Week 96.
Time frame: Baseline visit, Week 24 and Week 96.
Change from baseline in Immunoglobulin (IgA, IgG and IgM) levels.
Immunoglobulin (IgA, IgG and IgM) levels will be assessed from samples collected at Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT. The change (difference) in immunoglobulin levels between Baseline and the noted timepoints will then be calculated.
Time frame: Baseline visit, Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT.
Presence of circulating binding and neutralizing anti- drug antibodies (ADA/Nab).
Number of participants with circulating binding and neutralizing anti-drug antibodies (ADA/Nab) in blood will be provided at the following scheduled visits: Day 1, Week 24, Week 96.
Time frame: Baseline visit, Week 24 and Week 96.
Number of participants with abnormal safety laboratory parameters.
Number of participants with abnormal safety laboratory parameters will be provided.
Time frame: Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Number of participants with abnormal vital sign measurements.
Number of participants with abnormal vital sign measurements will be provided.
Time frame: Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Started Jul 2025 (actual). Primary completion is estimated for Jun 2031, 70 months after the start.
Of 26 phase 3 interventional studies under Glomerulonephritis, IGA, half reached primary completion within 55 months of starting (the median), counting those still running; a quarter within 39 and three quarters within 70. This study's planned 70 months is above that.
How these figures are worked out, and which studies are left out of them.
Eligibility is decided by the study team. Share this record with your doctor or contact the team directly.
Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Studies of the drug tested here: Zigakibart