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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)
To investigate the anti-pruritic efficacy and safety of Nalbuphine ER (NAL ER) tablets in Prurigo Nodularis. Subjects will be randomized to NAL ER (or matching placebo) with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER and subjects who received placebo will crossover to NAL ER.
18 Years to N/A
1. Individuals diagnosed with generalized nodular PN
2. Severe itch due to PN
3. Age 18 years and older at the time of consent, and a life expectancy of at least 18
1. Pruritus due to localized PN (only one body part affected)
2. Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic
dermatitis, bullous pemphigoid for example) or other dermatologic conditions that in
the opinion of the Investigator could confound the ability to assess PN related itch..
3. Exposure to any investigational medication, including placebo, within 4 weeks (3
months for biologics).
Please refer to this study by its ClinicalTrials.gov identifier: NCT03497975
Dermatology and Skin Cancer Specialists, LLC dba US Dermatology Partners
Rockville, Maryland 20850