NCT07182227

PS-002 for the Treatment of IgA Nephropathy in Adults

A Phase 1/2 Multicenter, Open Label, Two-part Study (Single Ascending Dose [Part 1], and Dose Expansion [Part 2]) to Evaluate Safety, Tolerability and Efficacy of PS-002, a Gene Therapy for the Treatment of Adult Participants With Primary IgA Nephropathy

• Status: Recruiting
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 32 (estimated)
• Sponsor: Purespring Therapeutics Limited · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

The purpose of the study is to evaluate safety, tolerability, and preliminary effectiveness following administration of PS-002 in adults with primary Immunoglobulin A (IgA) nephropathy. This will be a first-in-human study and will include participants at high risk of disease progression despite receiving current standard-of-care treatment. Participants will be monitored for up to one year after receiving PS-002 and invited to take part in a long-term follow-up study (total follow-up: 5 years).

Conditions

• Immunoglobulin A (IgA) Nephropathy

Interventions

Type	Name	Description
GENETIC	PS-002	Adeno-associated viral vector containing the human Complement Factor I (CFI) gene

Timeline

• Start date: 2026-02-01
• Primary completion: 2028-09-01
• Completion: 2029-09-01
• First posted: 2025-09-19
• Last updated: 2026-03-20

Locations

11 sites across 2 countries: United States, United Kingdom

Regulatory

• FDA-regulated drug study