NCT03497975

PRISM Study-Pruritus Relief Through Itch Scratch Modulation

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)

• Status: Completed
• Phase: Phase 2 / Phase 3
• Study type: Interventional
• Enrollment: 353 (actual)
• Sponsor: Trevi Therapeutics · Industry
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prurigo Nodularis

Interventions

Type	Name	Description
DRUG	Nalbuphine ER Tablets	Active Nalbuphine ER Tablets
DRUG	Placebo Tablets	Placebo matching NAL ER with no active substance

Timeline

• Start date: 2018-08-07
• Primary completion: 2022-05-10
• Completion: 2023-02-24
• First posted: 2018-04-13
• Last updated: 2025-06-24
• Results posted: 2025-06-24

Locations

70 sites across 5 countries: United States, Austria, France, Germany, Poland

Regulatory

• FDA-regulated drug study