PRISM Study-Pruritus Relief Through Itch Scratch Modulation
Summary
To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets in Prurigo Nodularis. Participants were randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, participants who received NAL ER were continued on NAL ER and participants who received placebo would then shift to NALER.
Timeline
- Start
- 2018-08-07
- Primary completion
- 2022-05-10
- Completion
- 2023-02-24
Outcome
Met primary endpoint
registry NUMBER NAL ER: 24.24 percentage of participants NUMBER Placebo: 14.50 percentage of participants analysis (superiority test); NAL ER vs Placebo; p = 0.0309 NCT03497975 ↗
release “Trevi Therapeutics Ph2b/3 PRISM trial of Haduvio achieves statistical significance for the treatment of Prurigo Nodularis” trevitherapeutics.com ↗
release “Haduvio (oral nalbuphine ER) demonstrated statistically significant results on the primary efficacy endpoint” trevitherapeutics.com ↗
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | Nalbuphine | Small molecule | 162 mg | Oral |