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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03497975
Other study ID # TR11
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date August 7, 2018
Est. completion date February 24, 2023

Study information

Verified date January 2023
Source Trevi Therapeutics
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 353
Est. completion date February 24, 2023
Est. primary completion date May 10, 2022
Accepts healthy volunteers No
Gender All
Age group 18 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
Nalbuphine ER Tablets
Active Nalbuphine ER Tablets
Other:
Matching Placebo Tablets
Matching Tablets with no active substance
Drug:
Nalbuphine ER Tablets
Open Label Extension

Locations

Country Name City State
Austria Study Site 401 Graz
Austria Study Site 402 Linz
France Study Site 501 Brest
France Study Site 502 Paris
Germany Study Site 205 Bad Bentheim
Germany Study Site 208 Berlin
Germany Study Site 209 Berlin
Germany Study Site 216 Berlin
Germany Study Site 219 Cologne
Germany Study Site 213 Dresden Sachsen
Germany Study Site 221 Düsseldorf
Germany Study Site 204 Frankfurt Hessen
Germany Study Site 215 Hamburg
Germany Study Site 222 Hamburg
Germany Study Site 212 Heidelberg
Germany Study Site 214 Kiel
Germany Study Site 201 Mainz Rheinland-Pfalz
Germany Study Site 220 Muenchen
Germany Study Site 202 Münster North Rhine-Westphal
Germany Study Site 206 Stuttgart
Poland Study Site 304 Bialystok
Poland Study Site 306 Katowice
Poland Study Site 316 Krakow
Poland Study Site 308 Kraków
Poland Study Site 309 Lódz
Poland Study Site 314 Lublin
Poland Study Site 305 Ostrowiec Swietokrzyski
Poland Study Site 313 Poznan
Poland Study Site 315 Poznan
Poland Study Site 303 Rzeszów
Poland Study Site 301 Warsaw
Poland Study Site 310 Warsaw
Poland Study Site 312 Warsaw
Poland Study Site 302 Wroclaw
United States Study Site 143 Ann Arbor Michigan
United States Study Site 137 Austin Texas
United States Study Site 138 Boca Raton Florida
United States Study Site 136 Boston Massachusetts
United States Study Site 153 Brighton Massachusetts
United States Study Site 107 Charleston South Carolina
United States Study Site 147 Charleston South Carolina
United States Study Site 140 Chattanooga Tennessee
United States Study Site 122 Cincinnati Ohio
United States Study Site 120 Cleveland Ohio
United States Study Site 121 Fremont California
United States Study Site 159 Hackensack New Jersey
United States Study Site 144 Henderson Nevada
United States Study Site 132 Hershey Pennsylvania
United States Study Site 131 Johnston Rhode Island
United States Study Site 145 Knoxville Tennessee
United States Study Site 157 Laguna Niguel California
United States Study Site 146 Las Vegas Nevada
United States Study Site 148 Morgantown West Virginia
United States Study Site 141 North Hollywood California
United States Study Site 158 Orlando Florida
United States Study Site 106 Philadelphia Pennsylvania
United States Study Site 151 Phoenix Arizona
United States Study Site 109 Portsmouth New Hampshire
United States Study Site 102 Rockville Maryland
United States Study Site 118 Saint Joseph Missouri
United States Study Site 130 San Francisco California
United States Study Site 108 South Miami Florida
United States Study Site 135 Spokane Washington
United States Study Site 134 Stony Brook New York
United States Study Site 142 Tampa Florida
United States Study Site 139 Troy Michigan
United States Study Site 128 Washington District of Columbia
United States Study Site 103 Webster Texas
United States Study Site 150 West Jordan Utah
United States Study Site 101 Wilmington North Carolina

Sponsors (1)

Lead Sponsor Collaborator
Trevi Therapeutics

Countries where clinical trial is conducted

United States,  Austria,  France,  Germany,  Poland, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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]) 14 weeks
Secondary 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 14 weeks
Secondary 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 14 weeks
Secondary 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 at week 14
See also
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Completed NCT00869089 - Safety and Efficacy of CC-10004 for Prurigo Nodularis Phase 2
Completed NCT04501666 - An Efficacy and Safety Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis Phase 3
Completed NCT06201715 - Efficacy and Safety of Tofacitinib in Patients With Prurigo Nodularis N/A
Completed NCT03181503 - Safety and Efficacy of Nemolizumab in PN Phase 2
Completed NCT03630198 - Pain Outcomes Following Intralesional Corticosteroid Injections Phase 4
Completed NCT04944862 - A Study of CDX-0159 in Patients With Prurigo Nodularis Phase 1
Active, not recruiting NCT05061693 - A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis Phase 2
Completed NCT03546816 - Study of the Efficacy, Safety and Tolerability of Serlopitant for the Treatment of Pruritus (Itch) With Prurigo Nodularis Phase 3
Completed NCT02174419 - Study of Nalbuphine HCl ER Tablets in Patients With Prurigo Nodularis Phase 2/Phase 3
Terminated NCT03540160 - Study of the Long Term Safety of Serlopitant for the Treatment of Pruritus (Itch) Phase 3
Completed NCT03816891 - Study to Assess the Efficacy, Safety, and Tolerability of Vixarelimab in Reducing Pruritus in Prurigo Nodularis Phase 2
Recruiting NCT05764161 - A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN) Phase 3
Completed NCT02196324 - A Randomized Placebo-Controlled Study of the Neurokinin-1 (NK1) Receptor Antagonist Serlopitant Prurigo Nodularis (PN) Phase 2
Recruiting NCT03576287 - Apremilast as Anti-pruritic Treatment in Patients With Prurigo Nodularis Phase 1/Phase 2
Completed NCT05052983 - A Study to Evaluate the Durability of Response and Safety of Nemolizumab for 24 Weeks in Participants With Prurigo Nodularis Phase 3
Active, not recruiting NCT04204616 - A Long-term Study of Nemolizumab (CD14152) in Participants With Prurigo Nodularis (PN) Phase 3
Not yet recruiting NCT06293053 - A Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis Phase 3
Recruiting NCT06213831 - A Study to Evaluate the Safety and Tolerability of Maximal Use Ruxolitinib Cream Phase 1
Not yet recruiting NCT04681300 - Transcriptomic Landscape of T Lymphocytes of Atopic Dermatitis, Atopic Prurigo Nodularis (of Besnier) and Non-atopic Prurigo Nodularis (of Hyde) Using Single Cell RNA-sequencing