Fremont, California 94538

  • Prurigo Nodularis

Purpose:

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.


Study summary:

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.


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 - 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.


NCT ID:

NCT03497975


Primary Contact:

Study Director
Helena Brett-Smith, MD
Trevi Therapeutics

Clinical Ops Lead
Phone: 2033042499
Email: clinicalops.admin@trevitherapeutics.com


Backup Contact:

Email: paula.buckley@trevitherapeutics.com
Paula Buckley
Phone: +1 203 304 2499


Location Contact:

Fremont, California 94538
United States



There is no listed contact information for this specific location.

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: September 23, 2021

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