deltatrials
Completed PHASE2/PHASE3 INTERVENTIONAL 2-arm NCT03497975

PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PRISM)

A Phase 2b/3, Randomized, Double-Blind, Placebo-Controlled, 2-Arm, Efficacy and Safety Study in Prurigo Nodularis (PN) With Nalbuphine ER Tablets for Pruritus Relief Through Itch Scratch Modulation (PRISM Study)

Sponsor: Trevi Therapeutics

Updated 25 times since 2018 Last updated: Jun 5, 2025 Started: Aug 7, 2018 Primary completion: May 10, 2022 Completion: Feb 24, 2023
This information is for research purposes only and is not medical advice. Consult a healthcare provider before making any medical decision.

Listed as NCT03497975, this PHASE2/PHASE3 trial focuses on Prurigo Nodularis and remains completed. Sponsored by Trevi Therapeutics, it has been updated 25 times since 2018, reflecting substantial change activity. This study adds to the evidence base for this therapeutic area through structured, versioned documentation.

Status Flow

~May 2018 – ~Jun 2018 · 31 days · monthly snapshot~Jun 2018 – ~Sep 2018 · 3 months · monthly snapshot~Sep 2018 – ~Aug 2019 · 11 months · monthly snapshot~Aug 2019 – ~Apr 2020 · 8 months · monthly snapshot~Apr 2020 – ~Sep 2020 · 5 months · monthly snapshot~Sep 2020 – ~Oct 2020 · 30 days · monthly snapshot~Oct 2020 – ~Jan 2021 · 3 months · monthly snapshot~Jan 2021 – ~Feb 2021 · 31 days · monthly snapshot~Feb 2021 – ~Apr 2021 · 59 days · monthly snapshot~Apr 2021 – ~May 2021 · 30 days · monthly snapshot~May 2021 – ~Sep 2021 · 4 months · monthly snapshot~Sep 2021 – ~Oct 2021 · 30 days · monthly snapshot~Oct 2021 – ~Mar 2022 · 5 months · monthly snapshot~Mar 2022 – ~Sep 2022 · 6 months · monthly snapshot~Sep 2022 – ~Nov 2022 · 2 months · monthly snapshot~Nov 2022 – ~Dec 2022 · 30 days · monthly snapshot~Dec 2022 – ~Feb 2023 · 2 months · monthly snapshot~Feb 2023 – ~Mar 2023 · 28 days · monthly snapshot~Mar 2023 – ~May 2023 · 2 months · monthly snapshot~May 2023 – ~Jun 2023 · 31 days · monthly snapshot~Jun 2023 – ~Jul 2024 · 13 months · monthly snapshot~Jul 2024 – ~Sep 2024 · 2 months · monthly snapshot~Sep 2024 – ~Jul 2025 · 10 months · monthly snapshot~Jul 2025 – ~Sep 2025 · 2 months · monthly snapshot~Sep 2025 – present · 10 months · monthly snapshot

Change History

25 versions recorded
  1. Sep 2025 — Present [monthly]

    Completed PHASE2/PHASE3

  2. Jul 2025 — Sep 2025 [monthly]

    Completed PHASE2/PHASE3

  3. Sep 2024 — Jul 2025 [monthly]

    Completed PHASE2/PHASE3

  4. Jul 2024 — Sep 2024 [monthly]

    Completed PHASE2/PHASE3

    Phase: PHASE2_PHASE3PHASE2/PHASE3

  5. Jun 2023 — Jul 2024 [monthly]

    Completed PHASE2_PHASE3

Show 20 earlier versions
  1. May 2023 — Jun 2023 [monthly]

    Completed PHASE2_PHASE3

    Status: Active Not RecruitingCompleted

  2. Mar 2023 — May 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  3. Feb 2023 — Mar 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  4. Dec 2022 — Feb 2023 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  5. Nov 2022 — Dec 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  6. Sep 2022 — Nov 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

  7. Mar 2022 — Sep 2022 [monthly]

    Active Not Recruiting PHASE2_PHASE3

    Status: RecruitingActive Not Recruiting

  8. Oct 2021 — Mar 2022 [monthly]

    Recruiting PHASE2_PHASE3

  9. Sep 2021 — Oct 2021 [monthly]

    Recruiting PHASE2_PHASE3

  10. May 2021 — Sep 2021 [monthly]

    Recruiting PHASE2_PHASE3

  11. Apr 2021 — May 2021 [monthly]

    Recruiting PHASE2_PHASE3

  12. Feb 2021 — Apr 2021 [monthly]

    Recruiting PHASE2_PHASE3

  13. Jan 2021 — Feb 2021 [monthly]

    Recruiting PHASE2_PHASE3

  14. Oct 2020 — Jan 2021 [monthly]

    Recruiting PHASE2_PHASE3

  15. Sep 2020 — Oct 2020 [monthly]

    Recruiting PHASE2_PHASE3

  16. Apr 2020 — Sep 2020 [monthly]

    Recruiting PHASE2_PHASE3

  17. Aug 2019 — Apr 2020 [monthly]

    Recruiting PHASE2_PHASE3

  18. Sep 2018 — Aug 2019 [monthly]

    Recruiting PHASE2_PHASE3

    Status: Not Yet RecruitingRecruiting

  19. Jun 2018 — Sep 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

  20. May 2018 — Jun 2018 [monthly]

    Not Yet Recruiting PHASE2_PHASE3

    First recorded

Eligibility Summary

No eligibility information available.

Contact Information

Sponsor contact:
  • Trevi Therapeutics
Data source: Trevi Therapeutics

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