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

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ClinicalTrials.gov Identifier: NCT03497975
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : June 3, 2021
Sponsor:
Information provided by (Responsible Party):
Trevi Therapeutics

Tracking Information
First Submitted Date  ICMJE March 22, 2018
First Posted Date  ICMJE April 13, 2018
Last Update Posted Date June 3, 2021
Actual Study Start Date  ICMJE August 7, 2018
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
Comparison of percentage of responders by arm [ Time Frame: 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])
Original Primary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
A 4 point reduction in the Worst Itch Numerical Rating Scale (WINRS) at Week 14. (Responder = at least an improvement of 4 in WINRS score) [ Time Frame: 14 weeks ]
Comparison of percentage responders by arm;
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: July 15, 2019)
  • Change from baseline for itch-related quality of life: ItchyQoL total score [ Time Frame: 14 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 Prurigo Nodularis skin lesions [ Time Frame: 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
  • Change from baseline for sleep disturbance [ Time Frame: at week 14 ]
    To evaluate the effect of NAL ER on sleep as assessed by the PROMIS Sleep Disturbance Short Form 8a
Original Secondary Outcome Measures  ICMJE
 (submitted: April 10, 2018)
  • The change from baseline up to week 14 for WINRS up to Week 14 [ Time Frame: 14 weeks ]
    assessment of improvement from baseline
  • The change from baseline up to week 14 for itchyQOL up to Week 14 [ Time Frame: 14 weeks ]
    assessment of improvement from baseline
  • PBI-P, a simple analysis of covariance (ANCOVA) will be used to assess the change from baseline at Week 14. [ Time Frame: 14 weeks ]
    assessment of a subject's perception of their disease before and after treatment
  • PAS: 1-category improvement from baseline in lesions with excoriations. [ Time Frame: at week 14 and at week 52 ]
    Assessment of number of subjects with 1-category improvement from baseline in lesions with excoriations.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE PRISM Study-Pruritus Relief Through Itch Scratch Modulation
Official Title  ICMJE 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)
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.
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 Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Phase 3
Study Design  ICMJE 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.
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Masking Description:
Matching Placebo
Primary Purpose: Treatment
Condition  ICMJE Prurigo Nodularis
Intervention  ICMJE
  • Drug: Nalbuphine ER Tablets
    Active Nalbuphine ER Tablets
    Other Name: NAL ER Tablets
  • Other: Matching Placebo Tablets
    Matching Tablets with no active substance
Study Arms  ICMJE
  • Active Comparator: Active
    162 mg nalbuphine ER tablets, BID
    Intervention: Drug: Nalbuphine ER Tablets
  • Placebo Comparator: Placebo
    Matching placebo tablets
    Intervention: Other: Matching Placebo Tablets
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: September 17, 2020)
360
Original Estimated Enrollment  ICMJE
 (submitted: April 10, 2018)
240
Estimated Study Completion Date  ICMJE December 2022
Estimated Primary Completion Date December 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.

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 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 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 substance abuse in the last 3 years. Individuals using sedating antidepressants. Individuals using non-sedating antidepressants must be on a stable dose for a minimum of 8 weeks prior to entering the study.
  • 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:

    • Within 14 days prior to screening: opiates, gabapentin, pregabalin, calcineurin inhibitors, cannabinoid agonists, capsaicin, cryosurgery, topical doxepin, thalidomide or methotrexate, antihistamines (systemic or topical), and topical corticosteroids, cryotherapy.
    • 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.

Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Clinical Ops Lead 2033042499 clinicalops.admin@trevitherapeutics.com
Contact: Paula Buckley +1 203 304 2499 paula.buckley@trevitherapeutics.com
Listed Location Countries  ICMJE Austria,   France,   Germany,   Poland,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03497975
Other Study ID Numbers  ICMJE TR11
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Trevi Therapeutics
Study Sponsor  ICMJE Trevi Therapeutics
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Director: Helena Brett-Smith, MD Trevi Therapeutics
PRS Account Trevi Therapeutics
Verification Date January 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP