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PRISM Study-Pruritus Relief Through Itch Scratch Modulation (PRISM)

Primary Purpose

Prurigo Nodularis

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
Nalbuphine ER Tablets
Matching Placebo Tablets
Nalbuphine ER Tablets
Sponsored by
Trevi Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Prurigo Nodularis

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

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.

Sites / Locations

  • Study Site 151
  • Study Site 121
  • Study Site 157
  • Study Site 141
  • Study Site 130
  • Study Site 128
  • Study Site 138
  • Study Site 158
  • Study Site 108
  • Study Site 142
  • Study Site 102
  • Study Site 136
  • Study Site 153
  • Study Site 143
  • Study Site 139
  • Study Site 118
  • Study Site 144
  • Study Site 146
  • Study Site 109
  • Study Site 159
  • Study Site 134
  • Study Site 101
  • Study Site 122
  • Study Site 120
  • Study Site 132
  • Study Site 106
  • Study Site 131
  • Study Site 147
  • Study Site 107
  • Study Site 140
  • Study Site 145
  • Study Site 137
  • Study Site 103
  • Study Site 150
  • Study Site 135
  • Study Site 148
  • Study Site 401
  • Study Site 402
  • Study Site 501
  • Study Site 502
  • Study Site 204
  • Study Site 202
  • Study Site 201
  • Study Site 213
  • Study Site 205
  • Study Site 216
  • Study Site 209
  • Study Site 208
  • Study Site 219
  • Study Site 221
  • Study Site 215
  • Study Site 222
  • Study Site 212
  • Study Site 214
  • Study Site 220
  • Study Site 206
  • Study Site 304
  • Study Site 306
  • Study Site 316
  • Study Site 308
  • Study Site 314
  • Study Site 305
  • Study Site 313
  • Study Site 315
  • Study Site 303
  • Study Site 310
  • Study Site 301
  • Study Site 312
  • Study Site 302
  • Study Site 309

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Placebo Comparator

Experimental

Arm Label

Active

Placebo

Open Label Extension

Arm Description

162 mg nalbuphine ER tablets, BID

Matching placebo tablets

162 mg nalbuphine ER tablets, BID

Outcomes

Primary Outcome Measures

Comparison of percentage of responders by arm
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

Change from baseline for itch-related quality of life: ItchyQoL total score
To evaluate the effect of NAL ER on itch-related quality of life as assessed by the ItchyQoL total score
Change from baseline for Prurigo Nodularis skin lesions
To evaluate the effect of NAL ER on Prurigo Nodularis (PN) skin lesions as assessed by the Prurigo Activity Score (PAS) Question 5a
Change from baseline for sleep disturbance
To evaluate the effect of NAL ER on sleep as assessed by the PROMIS Sleep Disturbance Short Form 8a

Full Information

First Posted
March 22, 2018
Last Updated
May 2, 2023
Sponsor
Trevi Therapeutics
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1. Study Identification

Unique Protocol Identification Number
NCT03497975
Brief Title
PRISM Study-Pruritus Relief Through Itch Scratch Modulation
Acronym
PRISM
Official Title
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)
Study Type
Interventional

2. Study Status

Record Verification Date
January 2023
Overall Recruitment Status
Completed
Study Start Date
August 7, 2018 (Actual)
Primary Completion Date
May 10, 2022 (Actual)
Study Completion Date
February 24, 2023 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Trevi Therapeutics

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Prurigo Nodularis

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Crossover Assignment
Model Description
Randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment.
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Matching Placebo
Allocation
Randomized
Enrollment
353 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Active
Arm Type
Experimental
Arm Description
162 mg nalbuphine ER tablets, BID
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Matching placebo tablets
Arm Title
Open Label Extension
Arm Type
Experimental
Arm Description
162 mg nalbuphine ER tablets, BID
Intervention Type
Drug
Intervention Name(s)
Nalbuphine ER Tablets
Other Intervention Name(s)
NAL ER Tablets
Intervention Description
Active Nalbuphine ER Tablets
Intervention Type
Other
Intervention Name(s)
Matching Placebo Tablets
Intervention Description
Matching Tablets with no active substance
Intervention Type
Drug
Intervention Name(s)
Nalbuphine ER Tablets
Other Intervention Name(s)
NAL ER Tablets
Intervention Description
Open Label Extension
Primary Outcome Measure Information:
Title
Comparison of percentage of responders by arm
Description
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])
Time Frame
14 weeks
Secondary Outcome Measure Information:
Title
Change from baseline for itch-related quality of life: ItchyQoL total score
Description
To evaluate the effect of NAL ER on itch-related quality of life as assessed by the ItchyQoL total score
Time Frame
14 weeks
Title
Change from baseline for Prurigo Nodularis skin lesions
Description
To evaluate the effect of NAL ER on Prurigo Nodularis (PN) skin lesions as assessed by the Prurigo Activity Score (PAS) Question 5a
Time Frame
14 weeks
Title
Change from baseline for sleep disturbance
Description
To evaluate the effect of NAL ER on sleep as assessed by the PROMIS Sleep Disturbance Short Form 8a
Time Frame
at week 14

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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. 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
David Clark, MD
Organizational Affiliation
Trevi Therapeutics
Official's Role
Study Director
Facility Information:
Facility Name
Study Site 151
City
Phoenix
State/Province
Arizona
ZIP/Postal Code
85006
Country
United States
Facility Name
Study Site 121
City
Fremont
State/Province
California
ZIP/Postal Code
94538
Country
United States
Facility Name
Study Site 157
City
Laguna Niguel
State/Province
California
ZIP/Postal Code
92677
Country
United States
Facility Name
Study Site 141
City
North Hollywood
State/Province
California
ZIP/Postal Code
91606
Country
United States
Facility Name
Study Site 130
City
San Francisco
State/Province
California
ZIP/Postal Code
94115
Country
United States
Facility Name
Study Site 128
City
Washington
State/Province
District of Columbia
ZIP/Postal Code
20037
Country
United States
Facility Name
Study Site 138
City
Boca Raton
State/Province
Florida
ZIP/Postal Code
33433
Country
United States
Facility Name
Study Site 158
City
Orlando
State/Province
Florida
ZIP/Postal Code
32819
Country
United States
Facility Name
Study Site 108
City
South Miami
State/Province
Florida
ZIP/Postal Code
33143
Country
United States
Facility Name
Study Site 142
City
Tampa
State/Province
Florida
ZIP/Postal Code
33615
Country
United States
Facility Name
Study Site 102
City
Rockville
State/Province
Maryland
ZIP/Postal Code
20850
Country
United States
Facility Name
Study Site 136
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
Facility Name
Study Site 153
City
Brighton
State/Province
Massachusetts
ZIP/Postal Code
02135
Country
United States
Facility Name
Study Site 143
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48103
Country
United States
Facility Name
Study Site 139
City
Troy
State/Province
Michigan
ZIP/Postal Code
48084
Country
United States
Facility Name
Study Site 118
City
Saint Joseph
State/Province
Missouri
ZIP/Postal Code
64506
Country
United States
Facility Name
Study Site 144
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89052
Country
United States
Facility Name
Study Site 146
City
Las Vegas
State/Province
Nevada
ZIP/Postal Code
89119
Country
United States
Facility Name
Study Site 109
City
Portsmouth
State/Province
New Hampshire
ZIP/Postal Code
03801
Country
United States
Facility Name
Study Site 159
City
Hackensack
State/Province
New Jersey
ZIP/Postal Code
07601
Country
United States
Facility Name
Study Site 134
City
Stony Brook
State/Province
New York
ZIP/Postal Code
11794
Country
United States
Facility Name
Study Site 101
City
Wilmington
State/Province
North Carolina
ZIP/Postal Code
28411
Country
United States
Facility Name
Study Site 122
City
Cincinnati
State/Province
Ohio
ZIP/Postal Code
45219
Country
United States
Facility Name
Study Site 120
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
Study Site 132
City
Hershey
State/Province
Pennsylvania
ZIP/Postal Code
17033
Country
United States
Facility Name
Study Site 106
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19103
Country
United States
Facility Name
Study Site 131
City
Johnston
State/Province
Rhode Island
ZIP/Postal Code
02919
Country
United States
Facility Name
Study Site 147
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29407
Country
United States
Facility Name
Study Site 107
City
Charleston
State/Province
South Carolina
ZIP/Postal Code
29425-8908
Country
United States
Facility Name
Study Site 140
City
Chattanooga
State/Province
Tennessee
ZIP/Postal Code
37421
Country
United States
Facility Name
Study Site 145
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37917
Country
United States
Facility Name
Study Site 137
City
Austin
State/Province
Texas
ZIP/Postal Code
78705
Country
United States
Facility Name
Study Site 103
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
Study Site 150
City
West Jordan
State/Province
Utah
ZIP/Postal Code
84088
Country
United States
Facility Name
Study Site 135
City
Spokane
State/Province
Washington
ZIP/Postal Code
99202
Country
United States
Facility Name
Study Site 148
City
Morgantown
State/Province
West Virginia
ZIP/Postal Code
26505
Country
United States
Facility Name
Study Site 401
City
Graz
ZIP/Postal Code
8036
Country
Austria
Facility Name
Study Site 402
City
Linz
ZIP/Postal Code
4020
Country
Austria
Facility Name
Study Site 501
City
Brest
ZIP/Postal Code
29609
Country
France
Facility Name
Study Site 502
City
Paris
ZIP/Postal Code
75010
Country
France
Facility Name
Study Site 204
City
Frankfurt
State/Province
Hessen
ZIP/Postal Code
60590
Country
Germany
Facility Name
Study Site 202
City
Münster
State/Province
North Rhine-Westphal
ZIP/Postal Code
48149
Country
Germany
Facility Name
Study Site 201
City
Mainz
State/Province
Rheinland-Pfalz
ZIP/Postal Code
55131
Country
Germany
Facility Name
Study Site 213
City
Dresden
State/Province
Sachsen
ZIP/Postal Code
01307
Country
Germany
Facility Name
Study Site 205
City
Bad Bentheim
ZIP/Postal Code
48455
Country
Germany
Facility Name
Study Site 216
City
Berlin
ZIP/Postal Code
10117
Country
Germany
Facility Name
Study Site 209
City
Berlin
ZIP/Postal Code
10247
Country
Germany
Facility Name
Study Site 208
City
Berlin
ZIP/Postal Code
10789
Country
Germany
Facility Name
Study Site 219
City
Cologne
ZIP/Postal Code
50937
Country
Germany
Facility Name
Study Site 221
City
Düsseldorf
ZIP/Postal Code
40225
Country
Germany
Facility Name
Study Site 215
City
Hamburg
ZIP/Postal Code
20246
Country
Germany
Facility Name
Study Site 222
City
Hamburg
ZIP/Postal Code
22391
Country
Germany
Facility Name
Study Site 212
City
Heidelberg
ZIP/Postal Code
69115
Country
Germany
Facility Name
Study Site 214
City
Kiel
ZIP/Postal Code
24105
Country
Germany
Facility Name
Study Site 220
City
Muenchen
ZIP/Postal Code
80802
Country
Germany
Facility Name
Study Site 206
City
Stuttgart
ZIP/Postal Code
70178
Country
Germany
Facility Name
Study Site 304
City
Białystok
ZIP/Postal Code
15-453
Country
Poland
Facility Name
Study Site 306
City
Katowice
ZIP/Postal Code
40-648
Country
Poland
Facility Name
Study Site 316
City
Krakow
ZIP/Postal Code
31-559
Country
Poland
Facility Name
Study Site 308
City
Kraków
ZIP/Postal Code
31-302
Country
Poland
Facility Name
Study Site 314
City
Lublin
ZIP/Postal Code
20-406
Country
Poland
Facility Name
Study Site 305
City
Ostrowiec Świętokrzyski
ZIP/Postal Code
27-400
Country
Poland
Facility Name
Study Site 313
City
Poznań
ZIP/Postal Code
60-529
Country
Poland
Facility Name
Study Site 315
City
Poznań
ZIP/Postal Code
60-848
Country
Poland
Facility Name
Study Site 303
City
Rzeszów
ZIP/Postal Code
35055
Country
Poland
Facility Name
Study Site 310
City
Warsaw
ZIP/Postal Code
01-142
Country
Poland
Facility Name
Study Site 301
City
Warsaw
ZIP/Postal Code
01-817
Country
Poland
Facility Name
Study Site 312
City
Warsaw
ZIP/Postal Code
02-962
Country
Poland
Facility Name
Study Site 302
City
Wrocław
ZIP/Postal Code
50566
Country
Poland
Facility Name
Study Site 309
City
Łódź
ZIP/Postal Code
90-265
Country
Poland

12. IPD Sharing Statement

Plan to Share IPD
No

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PRISM Study-Pruritus Relief Through Itch Scratch Modulation

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