RecruitingPhase 1Phase 2NCT07182227

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


Sponsor

Purespring Therapeutics Limited

Enrollment

32 participants

Start Date

Mar 30, 2026

Study Type

INTERVENTIONAL

Conditions

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).


Eligibility

Min Age: 18 Years

Plain Language Summary

Simplified for easier understanding

This clinical trial is studying PS-002 for people with immunoglobulin a (iga) nephropathy. The study is currently recruiting participants at 11 locations.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

GENETICPS-002

Adeno-associated viral vector containing the human Complement Factor I (CFI) gene


Locations(10)

University of Miami Hospital

Miami, Florida, United States

The Johns Hopkins Hospital

Baltimore, Maryland, United States

Manchester University NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Salford Royal Hospital, Northern Care Alliance NHS Foundation Trust

Manchester, Greater Manchester, United Kingdom

Leicester General Hospital

Leicester, Leicestershire, United Kingdom

Nottingham University Hospitals NHS Trust

Nottingham, Nottinghamshire, United Kingdom

Southmead Hospital

Bristol, United Kingdom

Cardiff and Vale University Health Board

Cardiff, United Kingdom

Royal Infirmary of Edinburgh Clinical Research Facility

Edinburgh, United Kingdom

The Royal London Hospital

London, United Kingdom

View Full Details on ClinicalTrials.gov

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NCT07182227


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