ClinicalTrials.gg
RecruitingNCT06858319Updated Aug 17, 2026

Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.

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.

Primary conditionGlomerulonephritis, IGARegistry: Kidney DiseasesReclassifiedWhy we changed it
Registry
Kidney Diseases — the first condition term the registry derived for this study.
ClinicalTrials.gg
Glomerulonephritis, IGA
Why
  1. The study's listed conditions name Glomerulonephritis, IGA, a narrower term within Kidney Diseases.
Confidence
High: the new condition is named in the study's own listed conditions. Of 351 hand-checked studies reclassified this way, 68% were exactly right and 84% in the right disease family; the registry's first term was right for 5% (measured 2026-10-21). How we classify →
Wrong?
Tell us the study's main condition →

Sponsored by Novartis Pharmaceuticals (part of Novartis) · Phase 3, Interventional, and Treatment

From the registry’s dates

  • Started Jul 2025; still recruiting 1 year 3 months later.
Phase
Phase 3
Study type
Interventional
Enrollment
220
Allocation
Not applicable
Ages
18 Years to 100 Years
Sex
All
01

Study summary

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.

Read the detailed description

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.

02

Conditions studied

  • Kidney Diseases
  • Kidney Diseases, Chronic
  • Urological Diseases
  • Glomerulonephritis
  • Glomerular Disease
  • Glomerulonephritis, IGA
  • Glomerulopathy
  • Immunoglobulin Disease

Keywords

  • Urologic Diseases
  • Female Urogenital Diseases
  • Female Urogenital Diseases and Pregnancy Complications
  • Urogenital Diseases
  • Male Urogenital Diseases
  • Glomerulonephritis
  • Nephritis
  • Autoimmune Diseases
  • Immune System Diseases
  • Kidney Diseases
  • Glomerulonephritis, IGA
  • Primary IgA / Immunoglobulin A nephropathy
  • eGFR
  • UPCR
  • UACR
  • FUB523
03

In context

Glomerulonephritis, IGA Reclassified

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 →

Lead sponsor

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 →

04

Who can participate

Ages eligible
18 Years to 100 Years
Sexes eligible
All
Accepts healthy volunteers
No

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.

Inclusion criteria

  1. Signed must be obtained prior to participation in the OLE study.
  2. Completion of the parent study (both participants assigned to receive the 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

Exclusion Criteria:

  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 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 therapy (including budesonide) or other 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), surface antigen (HBsAg), detectable hepatitis B virus (HBV) DNA, 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 -1 and/or HIV-2.
  9. Newly diagnosed (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 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 , defined as all women physiologically capable of becoming pregnant, from menarche until becoming unless they are using highly effective methods of (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.

Highly effective contraception methods for both women and men include:

  • Total abstinence (when this is in line with the preferred and usual lifestyle of the participant). Note that periodic abstinence (e.g., calendar, ovulation, symptothermal, post-ovulation methods) and withdrawal are not acceptable methods of contraception.
  • Bilateral oophorectomy with or without hysterectomy, total hysterectomy or bilateral salpingectomy at least six weeks before taking study treatment. In case of oophorectomy alone, only when the reproductive status of the woman has been confirmed by follow up hormone level assessment are they considered to be not of childbearing potential.
  • Bilateral tubal occlusion, bilateral tubal ligation (at least six weeks before taking study treatment).
  • Sterilization (vasectomy) of male partner(s) of the female participant at least 6 months prior to first study treatment provided partner(s) has(have) received medical confirmation of surgical success.
  • Use of hormonal contraception methods:
  • Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation; oral, intravaginal or transdermal.
  • Progestogen-only hormonal contraception (where inhibition of ovulation is not the primary or only mode of action): oral, injectable or implantable.
  • Intrauterine device (IUD) or intrauterine hormone-releasing system (IUS). In case of use of hormonal contraception, women should have been stable on the same method for a minimum of 3 months before taking study treatment.
Terms in these criteria, in plain language(13)

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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).

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.

05

Study design

Phase
Phase 3
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
220 participants (estimated)

Study arms

  • Experimental
    zigakibart

    Participants will receive zigakibart.

    Drug: zigakibart

Interventions

  • solution for subcutaneous injection

    Also known as: FUB523; BION-1301

06

What researchers measure

Primary outcomes

  1. 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

  2. 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

  3. 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

Secondary outcomes

  1. 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.

  2. 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.

  3. 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.

  4. 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.

  5. 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.

  6. 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.

  7. 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.

  8. 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.

07

Study locations

26 of 26 sites recruiting
  • Colorado Kidney Care Nephrology
    Denver, Colorado 80230, United States
    Recruiting
    • Laura Kooienga · Principal investigator
  • Nephrology Associates Of Central FL
    Orlando, Florida 32806, United States
    Recruiting
    • Arvind Madan · Principal investigator
  • University of Iowa Hospitals and Clinics
    Iowa City, Iowa 52242, United States
    Recruiting
    • Lama Noureddine · Principal investigator
  • NY Nephrology
    Clifton Park, New York 12065, United States
    Recruiting
    • · Contact+1 518 579 0017
    • Frank Cortazar · Principal investigator
  • Icahn School of Medicine at Mount Sinai
    New York, New York 10029, United States
    Recruiting
    • Kristin Meliambro · Principal investigator
  • Knoxville Kidney Center Pllc
    Brentwood, Tennessee 37027-4528, United States
    Recruiting
    • George Newman · Principal investigator
  • Dallas Renal Group
    Dallas, Texas 75230, United States
    Recruiting
    • Phuong Truong · Principal investigator
  • Dallas Renal Group
    Dallas, Texas 75230, United States
    Recruiting
    • · Contact+1 214 697 7187
    • Irfan Agha · Principal investigator
  • Nephro Asso North Illinois Indiana
    Houston, Texas 77024, United States
    Recruiting
    • Suneel Udani · Principal investigator
  • Novartis Investigative Site
    Caba, Buenos Aires 3375, Argentina
    Recruiting
  • Novartis Investigative Site
    La Plata, Buenos Aires B1902COS, Argentina
    Recruiting
  • Novartis Investigative Site
    Buenos Aires, Buenos Aires F.D. 1280, Argentina
    Recruiting
  • Novartis Investigative Site
    Catamarca, Catamarca Province K4700BTM, Argentina
    Recruiting
  • Novartis Investigative Site
    Santa Fe, S3000EPV, Argentina
    Recruiting
  • Novartis Investigative Site
    Gosford, New South Wales 2250, Australia
    Recruiting
  • Novartis Investigative Site
    Kogarah, New South Wales 2217, Australia
    Recruiting
  • Novartis Investigative Site
    Toronto, Ontario M4C 5T2, Canada
    Recruiting
  • Novartis Investigative Site
    Kuantan, Pahang 25100, Malaysia
    Recruiting
  • Novartis Investigative Site
    Kuala Lumpur, 59100, Malaysia
    Recruiting
  • Novartis Investigative Site
    Monterrey, Nuevo León 64060, Mexico
    Recruiting
  • Novartis Investigative Site
    Cheonan, Chungcheongnam-do 330-721, South Korea
    Recruiting
  • Novartis Investigative Site
    Guri-si, Gyeonggi-do 471-701, South Korea
    Recruiting
  • Novartis Investigative Site
    Seongnam-si, Gyeonggi-do 13620, South Korea
    Recruiting
  • Novartis Investigative Site
    Seoul, Seoul 03080, South Korea
    Recruiting
  • Novartis Investigative Site
    Girona, Catalonia 17007, Spain
    Recruiting
  • Novartis Investigative Site
    Taipei, 116081, Taiwan
    Recruiting
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

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.

Registered
Feb 21, 2025
First posted
Mar 5, 2025
StartActual
Jul 28, 2025
Primary completionEst.
Jun 25, 2031
CompletionEst.
Jun 25, 2031
Last update
Aug 17, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Aug 17, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT06858319
Responsible party
Sponsor
First posted
Mar 5, 2025
Start date
Jul 28, 2025
Primary completion
Jun 25, 2031 (estimated)
Completion
Jun 25, 2031 (estimated)
Last update
Aug 17, 2026

Study contacts

Novartis Pharmaceuticals
Contact
novartis.email@novartis.com
1-888-669-6682
Novartis Pharmaceuticals
Contact
+41613241111
Novartis Pharmaceuticals
study director · Novartis Pharmaceuticals

Oversight

Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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Studies of the drug tested here: Zigakibart

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