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A Study of Zigakibart in Adults With IgA Nephropathy

NCT05852938

Active Not RecruitingPhase 3

Sponsor: Novartis Pharmaceuticals

Conditions: IgA Nephropathy, Immunoglobulin A Nephropathy

Interventions: BION-1301, Placebo

Countries: United States, Argentina, Australia, Belgium, Brazil, Canada, China, Croatia

Safety and Efficacy of BION-1301 in Adults with IgA Nephropathy

Eligibility overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

Eligibility criteria

Inclusion Criteria:

* Male and female participants aged ≥ 18 years at the time of signing the informed consent form (ICF) prior to initiation of any study specific activities/procedures.
* Biopsy-proven IgAN diagnosed within the past 10 years prior to Screening, that, in the opinion of the Investigator, is not due to secondary causes. A pseudonymized copy of the report must be available for review by the Sponsor or designee prior to randomization. If biopsy report within 10 years is not available, re-biopsy may be permitted upon discussion with the Sponsor.
* eGFR ≥ 30 mL/min/1.73m\^2 at Screening based on the 2021 CKD-EPI equation.
* Total urine protein ≥ 1.0 g/day or UPCR ≥ 0.7 g/g (700 mg/g), as measured from an adequate 24-hour urine collection at Screening by a central laboratory.
* Stable on a maximally tolerated dose of angiotensin-converting enzyme inhibitors (ACEi) and/or angiotensin II receptor blockers (ARB) for at least 12 weeks prior to Screening unless intolerant to ACEi and ARB. May also be on a stable and well tolerated dose of sodium glucose cotransporter-2 inhibitors (SGLT2i), endothelin receptor antagonists (ERAs) and/or mineralocorticoid receptor antagonists (MRAs) for at least 12 weeks prior to Screening for the treatment of IgAN. Subjects are expected to stay on a stable dose of ACEi, ARB, SGLT2i, ERAs, and/or MRAs for the duration of the study.

Exclusion Criteria:

* Secondary forms of IgAN as determined by the Investigator, in the setting of systemic disorders, infections, autoimmune disorders or neoplasias.
* Diagnosis of IgA Vasculitis.
* Current or history of nephrotic syndrome.
* Received systemic corticosteroid therapy including budesonide (Tarpeyo/Kinpeygo) for \> 14 days within 12 weeks prior to Screening.
* Use of systemic immunosuppressant medications.
* IgG levels \< 6 g/L at Screening.

Other protocol-defined inclusion/exclusion criteria may apply

Locations (200)

Birmingham, Alabama, United States
Huntsville, Alabama, United States
San Francisco, California, United States
South Gate, California, United States
Aurora, Colorado, United States
Denver, Colorado, United States
Pembroke Pines, Florida, United States
Evanston, Illinois, United States
Hinsdale, Illinois, United States
Fort Wayne, Indiana, United States
Iowa City, Iowa, United States
Edina, Minnesota, United States
Clifton Park, New York, United States
Flushing, New York, United States
New York, New York, United States
Cincinnati, Ohio, United States
Cleveland, Ohio, United States
Portland, Oregon, United States
Bethlehem, Pennsylvania, United States
Columbia, South Carolina, United States
Knoxville, Tennessee, United States
Dallas, Texas, United States
Dallas, Texas, United States
El Paso, Texas, United States
Houston, Texas, United States
Lufkin, Texas, United States
Fairfax, Virginia, United States
Seattle, Washington, United States
La Plata, Buenos Aires, Argentina
Catamarca, Catamarca Province, Argentina
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