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

NCT06858319 | Recruiting Phase 3 FDA Drug

• 1 other identifier: CFUB523A12302B
• Study Type: interventional
• Target: 220
• Locations: 5 countries
• Sites: 18

Brief 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.

Conditions

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

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

Outcome Measures

Primary Outcomes (3)

• Number of participants with adverse events.

  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.

  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.

  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 Outcomes (8)

• Change in UPCR from Baseline to Week 48 and Week 96.

  Baseline visit, Week 48 and Week 96.

• Change in eGFR from Baseline to Week 96.

  Baseline visit and Week 96.

• Change in eGFR from BEYOND parent study Baseline to Week 96 of OLE study.

  Baseline visit and Week 96.

• Serum concentration values of zigakibart at scheduled visits.

  Baseline visit, Week 24 and Week 96.

• Change from baseline in Immunoglobulin (IgA, IgG and IgM) levels.

  Baseline visit, Week 2, Week 4, Week 24, Week 48, Week 72, Week 96, then every 24 weeks after Week 96 through EOT.

Study Arms (1)

zigakibart

EXPERIMENTAL

Participants will receive zigakibart.

Drug: zigakibart

Interventions

zigakibart DRUG

solution for subcutaneous injection

Also known as: FUB523; BION-1301

zigakibart

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• Participants who prematurely withdrew from zigakibart parent studies in IgAN for any reason.
• Participants who at the time of first study treatment administration in the OLE are receiving chronic dialysis (≥30 days) or who require kidney transplantation.
• Acute kidney injury (AKI), defined by AKIN criteria (Mehta et al 2007) within 4 weeks of first study treatment administration in the OLE study.
• 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.
• 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.
• 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.
• 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.
• 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.
• 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).
• Pregnancy or breastfeeding or intent to become pregnant or to donate sperm during the study period and until 24 weeks after last dose.
• 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.
• Confirmed IgG levels \< 3 g/L prior to first study treatment administration in the OLE study.
• 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).
• 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:

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Sites (18)

Colorado Kidney Care Nephrology

Denver, Colorado, 80230, United States

RECRUITING

Nephrology Associates Of Central FL

Orlando, Florida, 32806, United States

RECRUITING

NY Nephrology

Clifton Park, New York, 12065, United States

RECRUITING

Icahn School of Medicine at Mount Sinai

New York, New York, 10029, United States

RECRUITING

Knoxville Kidney Center Pllc

Brentwood, Tennessee, 37027-4528, United States

RECRUITING

Dallas Renal Group

Dallas, Texas, 75230, United States

RECRUITING

Dallas Renal Group

Dallas, Texas, 75230, United States

RECRUITING

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

Santa Fe, S3000EPV, Argentina

RECRUITING

Novartis Investigative Site

Kogarah, New South Wales, 2217, Australia

RECRUITING

Novartis Investigative Site

Kuantan, Pahang, 25100, Malaysia

RECRUITING

Novartis Investigative Site

Kuala Lumpur, 59100, Malaysia

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

MeSH Terms

Conditions

Kidney Diseases; Renal Insufficiency, Chronic; Urologic Diseases; Glomerulonephritis; Glomerulonephritis, IGA; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Nephritis; Autoimmune Diseases; Immune System Diseases

Condition Hierarchy (Ancestors)

Renal Insufficiency; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Novartis Pharmaceuticals

  Novartis Pharmaceuticals

  STUDY DIRECTOR

Central Study Contacts

Novartis Pharmaceuticals

CONTACT

1-888-669-6682; novartis.email@novartis.com

Novartis Pharmaceuticals

CONTACT

+41613241111

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2025
• First Posted: March 5, 2025
• Study Start: July 28, 2025
• Primary Completion (Estimated): June 25, 2031
• Study Completion (Estimated): June 25, 2031
• Last Updated: June 1, 2026

Record last verified: 2026-05

Locations

AU (1); MY (2); KR (4); US (7); AR (4)