A Multicenter Open-label Extension Study to Evaluate the Long-term Safety and Tolerability of Zigakibart in Adults With Primary IgA Nephropathy.
Status: Recruiting
Location: See location...
Intervention Type: Drug
Study Type: Interventional
Study Phase: Phase 3
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.
Eligibility
Participation Requirements
Sex: All
Minimum Age: 18
Maximum Age: 100
Healthy Volunteers: f
View:
• 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.
Locations
United States
Colorado
Colorado Kidney Care Nephrology
RECRUITING
Denver
Contact Information
Primary
Novartis Pharmaceuticals
novartis.email@novartis.com
1-888-669-6682
Backup
Novartis Pharmaceuticals
Time Frame
Start Date: 2025-07-28
Estimated Completion Date: 2031-06-25
Participants
Target number of participants: 223
Treatments
Experimental: zigakibart
Participants will receive zigakibart.
Related Therapeutic Areas
Sponsors
Leads: Novartis Pharmaceuticals