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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

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Trial Profile

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: Not yet recruiting
Phase of Trial: Phase I/II

Latest Information Update: 23 Sep 2025

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At a glance

  • Drugs PS 002 (Primary)
  • Indications IgA nephropathy
  • Focus Adverse reactions; First in man

Most Recent Events

  • 19 Sep 2025 Status changed from planning to not yet recruiting.
  • 09 Jul 2025 According to a Purespring Therapeutics media release, Phase I/II clinical trial is expected to initiate in Q4 2025
  • 09 Jul 2025 According to a Purespring Therapeutics media release, the company announced that the U.S. Food and Drug Administration (FDA) has cleared its Investigational New Drug (IND) application for PS-002, enabling the initiation of a Phase I/II clinical trial in patients with primary IgA nephropathy (IgAN).

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