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

August 14, 2026 updated by: Novartis Pharmaceuticals

A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

220

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Novartis Pharmaceuticals
  • Phone Number: +41613241111

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  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:

  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.

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: zigakibart
Participants will receive zigakibart.
Drug: zigakibart
solution for subcutaneous injection
Other Names:
  • FUB523; BION-1301

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with adverse events.
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 will be provided.
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.
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 will be provided.
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.
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 will be provided.
Date of first administration of study treatment to 24 weeks after the date of the last actual administration of study treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of participants with abnormal safety laboratory parameters.
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 safety laboratory parameters will be provided.
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.
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 will be provided.
Date of first administration of study treatment to the date that study treatment is discontinued, assessed up to approximately 5 years.
Change in UPCR from Baseline to Week 48 and Week 96.
Time Frame: Baseline visit, 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.
Baseline visit, Week 48 and Week 96.
Change in eGFR from Baseline to Week 96.
Time Frame: Baseline visit and 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.
Baseline visit and Week 96.
Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.
Time Frame: Baseline visit and Week 96.
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.
Baseline visit and Week 96.
Serum concentration values of zigakibart at scheduled visits.
Time Frame: Baseline visit, Week 24 and Week 96.
Serum concentration values will be provided for the following scheduled visits: Day 1, Week 24 and Week 96.
Baseline visit, Week 24 and Week 96.
Change from baseline in Immunoglobulin (IgA, IgG and IgM) levels.
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.
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.
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).
Time Frame: Baseline visit, Week 24 and Week 96.
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.
Baseline visit, Week 24 and Week 96.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Novartis Pharmaceuticals

Investigators

  • Study Director: Novartis Pharmaceuticals, Novartis Pharmaceuticals

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

July 28, 2025

Primary Completion (Estimated)

June 25, 2031

Study Completion (Estimated)

June 25, 2031

Study Registration Dates

First Submitted

February 21, 2025

First Submitted That Met QC Criteria

March 3, 2025

First Posted (Actual)

March 5, 2025

Study Record Updates

Last Update Posted (Actual)

August 17, 2026

Last Update Submitted That Met QC Criteria

August 14, 2026

Last Verified

August 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CFUB523A12302B

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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