Recent Updates
Recently added Catalysts

zigakibart

Phase 3

Kidney Diseases | Small molecule | Rare Disease |Novartis AG|Last Updated: Jul 20, 2026

Success Probability
Subscribe to view
Market & Valuation
Subscribe to view
Trial Design
UNCONTROLLED
Total Trials1
Total Enrollment220
FDA Designations
No designations recorded
Clinical trial landscape

zigakibart · 2 trials · 9 indications

Phase 3 1Phase 2 1
NCT06858319Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.Kidney Diseases
RECRUITING220 Analytics
PHASE3RECRUITING
Open-label Extension Study of Zigakibart in Adults With IgA Nephropathy.
Kidney Diseases
NCT06858319220
Unlock trial analytics
Study Endpoints
Primary Endpoints
Number of participants with adverse events.
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.

Number of participants with serious adverse events.
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.

Number of participants with adverse events of special interest.
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.

Change in mesangial IgA deposition
Baseline to Week 53 or 105

Change in mesangial IgA deposition as assessed by intensity of immunofluorescence staining

Secondary Endpoints
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.
Unlock Study Endpoints
Study Design & Arms
AllocationNA
MaskingNONE
ModelSINGLE_GROUP
PurposeTREATMENT
Treatment Arms
ArmTypeDescription
zigakibartEXPERIMENTALParticipants will receive zigakibart.
Interventions
NameTypeDescription
zigakibartDRUGsolution for subcutaneous injection
Unlock Study Design Details
Eligibility Criteria
Age Range18 Years to 100 Years
SexALL
Healthy VolunteersNo
Study Sites21

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, ...

Countries:United StatesArgentinaAustraliaCanadaMalaysiaSouth KoreaBrazilChinaGermanyItalyJapanPolandSpainTaiwan
Unlock Eligibility Criteria
Recent Changes (Last 90 Days)
LOWJul 20, 2026NCT06858319lastUpdatePostDate: changed
LOWJul 20, 2026NCT06858319lastUpdatePostDate: changed
LOWJun 23, 2026NCT07146906lastUpdatePostDate: changed
LOWJun 23, 2026NCT07146906lastUpdatePostDate: changed
LOWJun 2, 2026NCT06858319lastUpdatePostDate: changed
LOWJun 2, 2026NCT06858319lastUpdatePostDate: changed
LOWJun 2, 2026NCT06858319lastUpdatePostDate: changed
LOWMay 28, 2026NCT07146906lastUpdatePostDate: changed
LOWMay 28, 2026NCT07146906lastUpdatePostDate: changed
LOWMay 26, 2026NCT07146906Status: NOT_YET_RECRUITING → RECRUITING
LOWMay 26, 2026NCT06858319primaryCompletionDate: changed
LOWMay 24, 2026NCT06858319studyFirstPostDate: changed
LOWMay 24, 2026NCT07146906studyFirstPostDate: changed