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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03497975
Recruitment Status : Recruiting
First Posted : April 13, 2018
Last Update Posted : March 19, 2020
Sponsor:
Information provided by (Responsible Party):
Trevi Therapeutics

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
Prurigo Nodularis 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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 240 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.
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 : August 7, 2018
Estimated Primary Completion Date : December 2020
Estimated Study Completion Date : December 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Itching

Arm Intervention/treatment
Active Comparator: Active
162 mg nalbuphine ER tablets, BID
Drug: Nalbuphine ER Tablets
Active Nalbuphine ER Tablets
Other Name: NAL ER Tablets

Placebo Comparator: Placebo
Matching placebo tablets
Other: Matching Placebo Tablets
Matching Tablets with no active substance




Primary Outcome Measures :
  1. 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])


Secondary Outcome Measures :
  1. 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

  2. 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

  3. 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



Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Exclusion Criteria:

  • Pruritus due to localized PN (only one body part affected), or less than 10 nodules
  • Pruritic dermatoses other than PN that were active/in need of treatment in the last 6 months, such as atopic dermatitis, bullous pemphigoid or other dermatologic conditions that in the opinion of the Investigator could confound the ability to assess PN related itch.
  • 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.
    • Individuals who have previously received dupilumab or nemolizumab are excluded
  • 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.


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03497975


Contacts
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Contact: Clinical Ops Lead 2033042499 clinicalops.admin@trevitherapeutics.com
Contact: Paula Buckley +1 203 304 2499 paula.buckley@trevitherapeutics.com

Locations
Show Show 45 study locations
Sponsors and Collaborators
Trevi Therapeutics
Investigators
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Study Director: Helena Brett-Smith, MD Trevi Therapeutics
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Responsible Party: Trevi Therapeutics
ClinicalTrials.gov Identifier: NCT03497975    
Other Study ID Numbers: TR11
First Posted: April 13, 2018    Key Record Dates
Last Update Posted: March 19, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Pruritus
Prurigo
Skin Diseases
Skin Manifestations
Signs and Symptoms
Nalbuphine
Analgesics, Opioid
Narcotics
Central Nervous System Depressants
Physiological Effects of Drugs
Analgesics
Sensory System Agents
Peripheral Nervous System Agents