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PRISM Study-Pruritus Relief Through Itch Scratch Modulation

Sponsor
Trevi Therapeutics (Industry)
Overall Status
Active, not recruiting
CT.gov ID
NCT03497975
Collaborator
(none)
360
Enrollment
70
Locations
2
Arms
54.7
Anticipated Duration (Months)
5.1
Patients Per Site
0.1
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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.

Condition or Disease Intervention/Treatment Phase
  • Drug: Nalbuphine ER Tablets
  • Other: Matching Placebo Tablets
 Phase 2/Phase 3

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 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.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
360 participants
Allocation:
Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
Randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment.Randomized, double-blinded, placebo-controlled, 2-arm study with an open label extension period following double-blind treatment.
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Matching Placebo
Primary Purpose:
Treatment
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)
Actual Study Start Date :
Aug 7, 2018
Actual Primary Completion Date :
May 10, 2022
Anticipated Study Completion Date :
Feb 28, 2023

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Active

162 mg nalbuphine ER tablets, BID

Drug: Nalbuphine ER Tablets
Active Nalbuphine ER Tablets
Other Names:
  • NAL ER Tablets

    		•
    Placebo Comparator: Placebo

    Matching placebo tablets

    Other: Matching Placebo Tablets
    Matching Tablets with no active substance

    Outcome Measures

    Primary Outcome Measures

    1. Comparison of percentage of responders by arm [14 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

    1. Change from baseline for itch-related quality of life: ItchyQoL total score [14 weeks]

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

    2. Change from baseline for Prurigo Nodularis skin lesions [14 weeks]

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

    3. Change from baseline for sleep disturbance [at week 14]

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

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Study Site 151 Phoenix Arizona United States 85006
    2 Study Site 121 Fremont California United States 94538
    3 Study Site 157 Laguna Niguel California United States 92677
    4 Study Site 141 North Hollywood California United States 91606
    5 Study Site 130 San Francisco California United States 94115
    6 Study Site 128 Washington District of Columbia United States 20037
    7 Study Site 138 Boca Raton Florida United States 33433
    8 Study Site 158 Orlando Florida United States 32819
    9 Study Site 108 South Miami Florida United States 33143
    10 Study Site 142 Tampa Florida United States 33615
    11 Study Site 102 Rockville Maryland United States 20850
    12 Study Site 136 Boston Massachusetts United States 02114
    13 Study Site 153 Brighton Massachusetts United States 02135
    14 Study Site 143 Ann Arbor Michigan United States 48103
    15 Study Site 139 Troy Michigan United States 48084
    16 Study Site 118 Saint Joseph Missouri United States 64506
    17 Study Site 144 Henderson Nevada United States 89052
    18 Study Site 146 Las Vegas Nevada United States 89119
    19 Study Site 109 Portsmouth New Hampshire United States 03801
    20 Study Site 159 Hackensack New Jersey United States 07601
    21 Study Site 134 Stony Brook New York United States 11794
    22 Study Site 101 Wilmington North Carolina United States 28411
    23 Study Site 122 Cincinnati Ohio United States 45219
    24 Study Site 120 Cleveland Ohio United States 44106
    25 Study Site 132 Hershey Pennsylvania United States 17033
    26 Study Site 106 Philadelphia Pennsylvania United States 19103
    27 Study Site 131 Johnston Rhode Island United States 02919
    28 Study Site 147 Charleston South Carolina United States 29407
    29 Study Site 107 Charleston South Carolina United States 29425-8908
    30 Study Site 140 Chattanooga Tennessee United States 37421
    31 Study Site 145 Knoxville Tennessee United States 37917
    32 Study Site 137 Austin Texas United States 78705
    33 Study Site 103 Webster Texas United States 77598
    34 Study Site 150 West Jordan Utah United States 84088
    35 Study Site 135 Spokane Washington United States 99202
    36 Study Site 148 Morgantown West Virginia United States 26505
    37 Study Site 401 Graz Austria 8036
    38 Study Site 402 Linz Austria 4020
    39 Study Site 501 Brest France 29609
    40 Study Site 502 Paris France 75010
    41 Study Site 204 Frankfurt Hessen Germany 60590
    42 Study Site 202 Münster North Rhine-Westphal Germany 48149
    43 Study Site 201 Mainz Rheinland-Pfalz Germany 55131
    44 Study Site 213 Dresden Sachsen Germany 01307
    45 Study Site 205 Bad Bentheim Germany 48455
    46 Study Site 216 Berlin Germany 10117
    47 Study Site 209 Berlin Germany 10247
    48 Study Site 208 Berlin Germany 10789
    49 Study Site 219 Cologne Germany 50937
    50 Study Site 221 Düsseldorf Germany 40225
    51 Study Site 215 Hamburg Germany 20246
    52 Study Site 222 Hamburg Germany 22391
    53 Study Site 212 Heidelberg Germany 69115
    54 Study Site 214 Kiel Germany 24105
    55 Study Site 220 Muenchen Germany 80802
    56 Study Site 206 Stuttgart Germany 70178
    57 Study Site 304 Białystok Poland 15-453
    58 Study Site 306 Katowice Poland 40-648
    59 Study Site 316 Krakow Poland 31-559
    60 Study Site 308 Kraków Poland 31-302
    61 Study Site 314 Lublin Poland 20-406
    62 Study Site 305 Ostrowiec Świętokrzyski Poland 27-400
    63 Study Site 313 Poznań Poland 60-529
    64 Study Site 315 Poznań Poland 60-848
    65 Study Site 303 Rzeszów Poland 35055
    66 Study Site 310 Warsaw Poland 01-142
    67 Study Site 301 Warsaw Poland 01-817
    68 Study Site 312 Warsaw Poland 02-962
    69 Study Site 302 Wrocław Poland 50566
    70 Study Site 309 Łódź Poland 90-265

    Sponsors and Collaborators

    • Trevi Therapeutics

    Investigators

    • Study Director: William Forbes, PharmD, Trevi Therapeutics

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Trevi Therapeutics
    ClinicalTrials.gov Identifier:
    NCT03497975
    Other Study ID Numbers:
    • TR11
    First Posted:
    Apr 13, 2018
    Last Update Posted:
    Aug 5, 2022
    Last Verified:
    Aug 1, 2022
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    Yes
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Pruritus
    Prurigo
    Nalbuphine

    Study Results

    No Results Posted as of Aug 5, 2022