A study to assess the effects of zigakibart on IgA nephropathy.

Overview

Sponsor-declared trial summary

Key facts

Sponsor

Novartis Pharma AG

Participant type

Patients

Age range

18-64 years, 65+ years

Gender

Male and Female

Therapeutic area

Diseases [C] - Immune System Diseases [C20]

Trial duration

23 Apr 2026 → ongoing

Decision date (initial)

2026-03-17

Transition trial

No

Low-intervention

No

Rare-disease indication

Yes

Vulnerable population

Yes

Funding sources

Novartis Pharma AG

External identifiers

EU CT number

2024-519699-24-00

WHO UTN

U1111-1323-5075

ClinicalTrials.gov

NCT07146906

Trial design

CTIS Part I — objectives, methods, condition coding

Main objective

Scope: Safety, Pharmacokinetic, Pharmacogenetic, Efficacy, Pharmacodynamic

Does zigakibart treatment alter the course of disease in adults with IgAN?

Secondary objectives 4

1. Is zigakibart treatment safe and tolerable in adults with IgAN?
2. What other impact does zigakibart have on kidney tissue, kidney function, and disease status in adults with IgAN?
3. What are the pharmacokinetics of zigakibart in adults with IgAN (i.e., how the body processes the treatment)?
4. Is zigakibart immunogenic in adults with IgAN (i.e., does the treatment trigger antibodies against itself)?

Conditions and MedDRA coding

IgA nephropathy

Eligibility criteria

Principal inclusion / exclusion criteria as submitted by sponsor

Inclusion criteria 3

1. Male or female adults 18 years of age or older who weigh at least 45 kg with a BMI no greater than 35.0 kg/m2 and were diagnosed with IgAN within the past 5 years.
2. Moderate kidney function (eGFR ≥45 mL/min/1.73 m²).
3. Persistent protein in urine defined as total urine protein ≥0.5 g/day or urine protein-creatinine ratio (UPCR) ≥0.5 g/g despite supportive therapy, or total urine protein >1.5 g/day or UPCR >1.5 g/g at the time of clinical presentation or diagnosis if diagnosed within the past 6 months.

Exclusion criteria 5

1. Does not have IgA vasculitis.
2. Does not have a weakened immune system or unacceptably low immunoglobulin levels Total IgG (<6.0 g/L).
3. Does not have urinary problems such as frequent urinary tract infections (UTIs) or trouble emptying the bladder.
4. Does not have high blood pressure that is not well controlled.
5. Has not used medications suppressing or affecting the immune system (not including short-term use of corticosteroids) in the past year.

Endpoints

Primary and secondary outcome measures (English text)

Primary endpoints 1

1. Change in the level of IgA deposition in kidney tissue after 1 or 2 years of zigakibart treatment, compared to before treatment.

Secondary endpoints 7

1. Clinical/laboratory assessments and adverse events.
2. Impact on immune response to vaccination, during the period of 6 to 23 months after the first treatment.
3. Kidney biopsy measures: changes in MEST- C score (an established measure of IgAN severity) and CD68 and C3c (inflammation markers), after 1 or 2 years of zigakibart treatment compared to before treatment.
4. Kidney function tests: urine protein and blood presence and estimated glomerular filtration rate (a blood test assessing kidney’s filtering function), at multiple timepoints during the 2- year zigakibart treatment compared to before treatment.
5. IgAN markers in blood: Immunoglobulin levels (IgA, IgM, IgG) at multiple timepoints during the 2-year zigakibart treatment compared to before treatment.
6. Zigakibart concentrations in blood at multiple timepoints during the 2-year treatment.
7. Presence of antibodies against zigakibart in blood before and at multiple timepoints during the 2-year zigakibart treatment.

Investigational products

Investigational medicinal products (IMPs), comparators, placebo, auxiliary

Test 1

Sponsors and contacts

Sponsor organisations, regulatory contacts, third parties

Novartis Pharma AG

Sponsor organisation

Novartis Pharma AG

Address

Lichtstrasse 35

City

Basel

Postcode

4056

Country

Switzerland

Scientific contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Public contact point

Organisation

Novartis Pharma AG

Contact name

Novartis Pharma Arzneimittel GmbH

Third parties 9

Locations

5 EU/EEA countries · 14 investigational sites

By country

Investigational sites

Country notifications

Trial-start, recruitment-start, end and early-termination notifications submitted per Member State

Results and documents

Annex IV summary of results, Annex V layperson summary, and all documents registered in CTIS for this trial

Documents 63 files

Public protocol annexes, IB summaries, regulatory submissions and post-authorisation documents registered in CTIS.

Application history

1 submissions — initial application plus substantial / non-substantial modifications