PRISM Study-Pruritus Relief Through Itch Scratch Modulation
United States353 participantsStarted 2018-08-07
Plain-language 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.
Who can participate
Age range18 Years
SexALL
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Inclusion Criteria:
* Individuals diagnosed with generalized nodular PN, covering 2 separate body parts, and 10 or more pruriginous nodules
* Severe itch due to PN
* Age 18 years and older at the time of consent, and a life expectancy of at least 18 months.
* Individuals using antidepressants must be on a stable dose for a minimum of 4 weeks prior to screening.
* Participants with a history of acute secondary dermatoses within the preceding 6 months may enroll only if the dermatosis has resolved completely as follows per medical history or participant self-report and current clinical assessment: (a) Localized contact dermatitis, environmental exposures, superficial burns, or viral exanthems must have been resolved for at least 4 weeks prior to screening. (b) Skin or environmental infestations, such as scabies, lice, or bed bugs, must have been resolved for at least 8 weeks prior to screening.
* Any identified systemic, non-dermatologic disease that could be a potential cause of concomitant pruritus (e.g., thyroid disease, celiac disease, hepatitis C virus \[HCV\]) must either have resolved, been successfully treated \[i.e., HCV ribonucleic acid (RNA) negative\], or must be successfully managed with stable, optimized treatment (e.g., thyroid replacement, dietary management with resolution of symptoms, respectively) for at least 3 months prior to screening.
* Participants who are human immunodeficiency virus (HIV) positive may enroll if they meet the following criteria: (a) cuā¦
What they're measuring
1
Percentage of Participants With ā„ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14