PS-002 for the Treatment of IgA Nephropathy in Adults

Part of paid clinical trials in Miami, Florida.

Sponsor
Purespring Therapeutics Limited
Study ID
NCT07182227
Phase
PHASE1/PHASE2
Status
Recruiting
Apply to this trial

Conditions

  • Immunoglobulin A (IgA) Nephropathy

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • PS-002 — GENETIC
    Adeno-associated viral vector containing the human Complement Factor I (CFI) gene

Study Details

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).

Key Dates

Start date
Feb 28, 2026
Status verified
Feb 2026
Primary completion
Sep 30, 2028
Completion
Sep 30, 2029

Study Design

Enrollment
32 participants (estimated)
Allocation
NA
Intervention model
SEQUENTIAL
Primary purpose
TREATMENT

Arms

  • Experimental: PS-002
    Part 1: Dose escalation in three groups: Group 1: Low dose, Group 2: Intermediate Dose, Group 3: High Dose. Part 2: Dose expansion in a fourth group with a selected dose.

Primary Outcome Measure

Number of participants with: Treatment-Emergent Adverse Events (TEAEs) and serious TEAEs, TEAEs and serious TEAEs related to PS-002, TEAEs and serious TEAEs related to the PS-002 administration procedure [ Time Frame: Screening up to Week 48 ]

Central Contacts

Locations (3)

FacilityCityStateZIPSite coordinators
University of Miami HospitalMiamiFlorida33136-
The Johns Hopkins HospitalBaltimoreMaryland21287-
University of Michigan HospitalAnn ArborMichigan48109-

Find similar trials in Miami, FL

By research site
University of Miami Hospital· Miami, FLThe Johns Hopkins Hospital· Baltimore, MDUniversity of Michigan Hospital· Ann Arbor, MI

Related Studies