Trial Outcomes & Findings for Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis (NCT NCT02174432)

NCT ID: NCT02174432

Last Updated: 2025-05-21

Results Overview

Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern.

• Recruitment status: COMPLETED
• Study phase: PHASE2/PHASE3
• Target enrollment: 36 participants
• Primary outcome timeframe: 50 weeks
• Results posted on: 2025-05-21

Participant Flow

Participant milestones

Measure	Nalbuphine HCl ER nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Overall Study STARTED	36
Overall Study COMPLETED	16
Overall Study NOT COMPLETED	20

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Open Label Extension Study of Nalbuphine HCl ER in Patients With Prurigo Nodularis

Baseline characteristics by cohort

Measure	Nalbuphine HCl ER n=36 Participants nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Age, Continuous	52.4 years STANDARD_DEVIATION 13.2 • n=5 Participants
Sex: Female, Male Female	16 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	36 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	2 Participants n=5 Participants
Race (NIH/OMB) White	33 Participants n=5 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Region of Enrollment United States	5 participants n=5 Participants
Region of Enrollment Europe	31 participants n=5 Participants
Height	172.33 cm STANDARD_DEVIATION 8.15 • n=5 Participants
Weight	79.68 kg STANDARD_DEVIATION 16.64 • n=5 Participants

PRIMARY outcome

Timeframe: 50 weeks

Incidence of adverse events is calculated based on events observed on or after the date of first dose, where incidence is defined as the number of subjects who reported one or more events of a particular adverse event divided by the number of subjects who received at least one dose of investigational product. Overall incidence is the proportion of subjects who had one or more adverse events of any type and nature pertains to the incidence of individual events coded by MedDRA nomenclature. An additional consideration was to evaluate incidence of adverse events by dose achieved but this was not done as subjects achieved a maximum dose during the study that varied and, per protocol, dosing could be modified per the investigator, during the course of this extension to TR03. In addition, TR03EXT involved a dose titration whereas events could have been reported well before a subject achieved some partciular dose level. Consequently, such a presentation would have been impossible to discern.

Outcome measures

Measure	Nalbuphine HCl ER n=36 Participants nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Overall Incidence and Nature of Treatment Emergent Adverse Events (TEAEs)	34 Participants

Adverse Events

Nalbuphine HCl ER

Serious events: 2 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	Nalbuphine HCl ER n=36 participants at risk nalbuphine HCl ER nalbuphine HCl ER: nalbuphine HCl ER BID for up to 50 weeks
Cardiac disorders Bradycardia	2.8% 1/36 • Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.
Injury, poisoning and procedural complications Joint injury	2.8% 1/36 • Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.
Musculoskeletal and connective tissue disorders Tenosynovitis stenosans	2.8% 1/36 • Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.
Musculoskeletal and connective tissue disorders Ulnocarpal abutment syndrome	2.8% 1/36 • Adverse events collected beginning with the first date and time of dosing through up to 50 weeks of dosing.

Other adverse events

Adverse event data not reported

Additional Information

Thomas Sciascia, MD

Trevi Therapeutics

Phone: 203-304-2499

Email: thomas.sciascia@trevitherapeutics.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place