MedPath

PRISM Study-Pruritus Relief Through Itch Scratch Modulation

Phase 2
Completed
Conditions
Prurigo Nodularis
Interventions
Drug: Nalbuphine ER Tablets
Other: Matching Placebo Tablets
Registration Number
NCT03497975
Lead Sponsor
Trevi Therapeutics
Brief Summary

To investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (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.

Detailed Description

This is a randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment, to investigate the anti-pruritic efficacy and safety of Nalbuphine Extended Release (ER) (NAL ER) tablets. Subjects will be randomized to NAL ER (2-week titration followed by 162 mg twice daily \[BID\] for 12 weeks) or matching placebo (14 weeks duration), with the primary endpoint evaluation at Week 14. During the open label extension, subjects who received NAL ER will continue on NAL ER total treatment duration 52 weeks including titration and subjects who received placebo will crossover to Nalbuphine ER Upon discontinuation of investigational product, all subjects will complete a 2-week off treatment Safety Follow-up Period, regardless of when and why the subject discontinued study treatment.

Recruitment & Eligibility

Status
COMPLETED
Sex
All
Target Recruitment
353
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.
Read More
Exclusion Criteria

  • Pruritus due to localized PN (only one body part affected), or less than 10 nodules

  • Active, uncontrolled, pruritic dermatoses in need of treatment (such as atopic dermatitis or bullous pemphigoid for example).

  • Unresolved acute secondary dermatoses active (unresolved) in the last (a) 4 weeks: localized contact dermatitis, environmental exposures, superficial burns, or viral exanthems; (b) 8 weeks: skin or environmental infestations, such as scabies, lice, or bed bugs.

  • Other non-dermatologic diseases 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 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

  • History of a major psychiatric disorder such as bipolar disorder or schizophrenia. History of active substance abuse in the last 3 years.

  • Known intolerance (GI, CNS symptoms) or hypersensitivity/drug allergy to opioids.

  • Use of certain concomitant medications and treatments within a period prior to the study, or requirement for these medications during the study:

    • Potential subjects taking opiates, gabapentin, pregabalin, calcineurin inhibitors, cannabinoid agonists, capsaicin, cryosurgery, topical doxepin, thalidomide or methotrexate, topical antihistamines or topical corticosteroids require a 14-day washout.
    • Within 4 weeks prior to screening: ultraviolet (UV)-therapy, exposure to any investigational medication, including placebo
    • Within 3 months prior to screening: Non-insulin biologics (including monoclonal antibodies) that modify the immune system,
    • Individuals taking monoamine oxidase inhibitors are excluded, as concomitant opiate use may increase the risk for serotonin syndrome.

  • Myocardial infarction or acute coronary syndrome within the previous 3 months, as reported by the subject.

  • Individuals with prolonged QTcF

Individuals with HIV can be included if they meet the following criteria: (a) currently on a stable (> 6 months stable use) and well tolerated highly active antiretroviral therapy regimen; (b) CD4 count > 500 cells/mL; and (c) HIV ribonucleic acid (RNA) < 50 copies/mL documented for at least 6 months prior to enrollment.

Read More

Study & Design

Study Type
INTERVENTIONAL
Study Design
CROSSOVER
Arm && Interventions
GroupInterventionDescription
Open Label ExtensionNalbuphine ER Tablets162 mg nalbuphine ER tablets, BID
ActiveNalbuphine ER Tablets162 mg nalbuphine ER tablets, BID
PlaceboMatching Placebo TabletsMatching placebo tablets
Primary Outcome Measures
NameTimeMethod
Comparison of percentage of responders by arm14 weeks

To evaluate the effect of NAL ER on itch as assessed by the percentage of Responders ('response' is defined as a ≥ 4-point reduction in the 7-day average Worst Itch - Numerical Rating Scale \[WI-NRS\])

Secondary Outcome Measures
NameTimeMethod
Change from baseline for itch-related quality of life: ItchyQoL total score14 weeks

To evaluate the effect of NAL ER on itch-related quality of life as assessed by the ItchyQoL total score

Change from baseline for sleep disturbanceat week 14

To evaluate the effect of NAL ER on sleep as assessed by the PROMIS Sleep Disturbance Short Form 8a

Change from baseline for Prurigo Nodularis skin lesions14 weeks

To evaluate the effect of NAL ER on Prurigo Nodularis (PN) skin lesions as assessed by the Prurigo Activity Score (PAS) Question 5a

Trial Locations

Locations (70)

Study Site 208

🇩🇪

Berlin, Germany

Study Site 221

🇩🇪

Düsseldorf, Germany

Study Site 212

🇩🇪

Heidelberg, Germany

Study Site 214

🇩🇪

Kiel, Germany

Study Site 314

🇵🇱

Lublin, Poland

Study Site 303

🇵🇱

Rzeszów, Poland

Study Site 120

🇺🇸

Cleveland, Ohio, United States

Study Site 146

🇺🇸

Las Vegas, Nevada, United States

Study Site 151

🇺🇸

Phoenix, Arizona, United States

Study Site 121

🇺🇸

Fremont, California, United States

Study Site 157

🇺🇸

Laguna Niguel, California, United States

Study Site 141

🇺🇸

North Hollywood, California, United States

Study Site 128

🇺🇸

Washington, District of Columbia, United States

Study Site 130

🇺🇸

San Francisco, California, United States

Study Site 102

🇺🇸

Rockville, Maryland, United States

Study Site 138

🇺🇸

Boca Raton, Florida, United States

Study Site 108

🇺🇸

South Miami, Florida, United States

Study Site 136

🇺🇸

Boston, Massachusetts, United States

Study Site 153

🇺🇸

Brighton, Massachusetts, United States

Study Site 139

🇺🇸

Troy, Michigan, United States

Study Site 118

🇺🇸

Saint Joseph, Missouri, United States

Study Site 144

🇺🇸

Henderson, Nevada, United States

Study Site 109

🇺🇸

Portsmouth, New Hampshire, United States

Study Site 159

🇺🇸

Hackensack, New Jersey, United States

Study Site 134

🇺🇸

Stony Brook, New York, United States

Study Site 101

🇺🇸

Wilmington, North Carolina, United States

Study Site 122

🇺🇸

Cincinnati, Ohio, United States

Study Site 132

🇺🇸

Hershey, Pennsylvania, United States

Study Site 106

🇺🇸

Philadelphia, Pennsylvania, United States

Study Site 131

🇺🇸

Johnston, Rhode Island, United States

Study Site 140

🇺🇸

Chattanooga, Tennessee, United States

Study Site 145

🇺🇸

Knoxville, Tennessee, United States

Study Site 103

🇺🇸

Webster, Texas, United States

Study Site 150

🇺🇸

West Jordan, Utah, United States

Study Site 135

🇺🇸

Spokane, Washington, United States

Study Site 148

🇺🇸

Morgantown, West Virginia, United States

Study Site 401

🇦🇹

Graz, Austria

Study Site 402

🇦🇹

Linz, Austria

Study Site 501

🇫🇷

Brest, France

Study Site 502

🇫🇷

Paris, France

Study Site 204

🇩🇪

Frankfurt, Hessen, Germany

Study Site 202

🇩🇪

Münster, North Rhine-Westphal, Germany

Study Site 213

🇩🇪

Dresden, Sachsen, Germany

Study Site 201

🇩🇪

Mainz, Rheinland-Pfalz, Germany

Study Site 205

🇩🇪

Bad Bentheim, Germany

Study Site 216

🇩🇪

Berlin, Germany

Study Site 209

🇩🇪

Berlin, Germany

Study Site 219

🇩🇪

Cologne, Germany

Study Site 215

🇩🇪

Hamburg, Germany

Study Site 222

🇩🇪

Hamburg, Germany

Study Site 220

🇩🇪

Muenchen, Germany

Study Site 206

🇩🇪

Stuttgart, Germany

Study Site 304

🇵🇱

Białystok, Poland

Study Site 306

🇵🇱

Katowice, Poland

Study Site 308

🇵🇱

Kraków, Poland

Study Site 313

🇵🇱

Poznań, Poland

Study Site 316

🇵🇱

Krakow, Poland

Study Site 305

🇵🇱

Ostrowiec Świętokrzyski, Poland

Study Site 315

🇵🇱

Poznań, Poland

Study Site 310

🇵🇱

Warsaw, Poland

Study Site 301

🇵🇱

Warsaw, Poland

Study Site 302

🇵🇱

Wrocław, Poland

Study Site 312

🇵🇱

Warsaw, Poland

Study Site 309

🇵🇱

Łódź, Poland

Study Site 158

🇺🇸

Orlando, Florida, United States

Study Site 142

🇺🇸

Tampa, Florida, United States

Study Site 143

🇺🇸

Ann Arbor, Michigan, United States

Study Site 147

🇺🇸

Charleston, South Carolina, United States

Study Site 107

🇺🇸

Charleston, South Carolina, United States

Study Site 137

🇺🇸

Austin, Texas, United States

© Copyright 2025. All Rights Reserved by MedPath
HomeTerms & ConditionsPrivacy Policy