deltatrials
Recruiting PHASE2/PHASE3 INTERVENTIONAL 1-arm NCT05710692

Study to Evaluate the Safety, PK, PD, and Efficacy of PRX-102 in Japanese Patients With Fabry Disease (RISE)

A Multicenter Open-Label Study to Evaluate the Safety, Pharmacokinetics, Pharmacodynamics, and Efficacy of Pegunigalsidase Alfa (PRX-102) in Japanese Patients With Fabry Disease (RISE)

Sponsor: Chiesi Farmaceutici S.p.A.

Conditions Fabry Disease
Updated 12 times since 2023 Last updated: Nov 24, 2025 Started: Aug 1, 2023 Primary completion: Oct 31, 2027 Completion: Aug 31, 2029
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

This PHASE2/PHASE3 trial investigates Fabry Disease and is currently actively recruiting participants. Chiesi Farmaceutici S.p.A. leads this study, which shows 12 recorded versions since 2023 — indicating substantial longitudinal coverage. The change history captured here reflects the iterative nature of clinical trial conduct.

Status Flow

~Mar 2023 – ~Jun 2023 · 3 months · monthly snapshotNot Yet Recruiting~Jun 2023 – ~Aug 2023 · 2 months · monthly snapshotNot Yet Recruiting~Aug 2023 – ~Sep 2023 · 31 days · monthly snapshotNot Yet Recruiting~Sep 2023 – ~Oct 2023 · 30 days · monthly snapshotRecruiting~Oct 2023 – ~Mar 2024 · 5 months · monthly snapshotRecruiting~Mar 2024 – ~Jul 2024 · 4 months · monthly snapshotRecruiting~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshotRecruiting~Sep 2024 – ~Nov 2024 · 2 months · monthly snapshotRecruiting~Nov 2024 – ~May 2025 · 6 months · monthly snapshotRecruiting~May 2025 – ~Sep 2025 · 4 months · monthly snapshotRecruiting~Sep 2025 – ~Dec 2025 · 3 months · monthly snapshotRecruiting~Dec 2025 – present · 9 months · monthly snapshotRecruiting

Change History

12 versions recorded
  1. Dec 2025 — Present [monthly]

    Recruiting PHASE2/PHASE3

  2. Sep 2025 — Dec 2025 [monthly]

    Recruiting PHASE2/PHASE3

  3. May 2025 — Sep 2025 [monthly]

    Recruiting PHASE2/PHASE3

  4. Nov 2024 — May 2025 [monthly]

    Recruiting PHASE2/PHASE3

  5. Sep 2024 — Nov 2024 [monthly]

    Recruiting PHASE2/PHASE3

Show 7 earlier versions
  1. Jul 2024 — Sep 2024 [monthly]

    Recruiting PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  2. Mar 2024 — Jul 2024 [monthly]

    Recruiting PHASE2_PHASE3

  3. Oct 2023 — Mar 2024 [monthly]

    Recruiting PHASE2_PHASE3

  4. Sep 2023 — Oct 2023 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet RecruitingRecruiting

  5. Aug 2023 — Sep 2023 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  6. Jun 2023 — Aug 2023 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  7. Mar 2023 — Jun 2023 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Chiesi Farmaceutici S.p.A.
  • ICON plc
Data source: Chiesi Farmaceutici S.p.A.

For direct contact, visit the study record on ClinicalTrials.gov .