A Phase 2/3 interventional study of nalbuphine HCl ER tablets 90 mg BID and nalbuphine HCl ER tablets 180 mg BID in Prurigo Nodularis, Nodularis Prurigo and Prurigo, sponsored by Trevi Therapeutics. Completed at 4 sites in 3 countries. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Trevi Therapeutics · Phase 2/3, Interventional, and Treatment
Among 23 studies in Prurigo with a site in United States — 4 open to participants now, 8 under way, 4 of them phase 3. Prurigo · United States.
Among the 23 studies in Prurigo with a site in United States, this one is the 13th largest by enrollment of the 21 interventional ones that give a count, is the only one that started in 2015, is one of 2 in phase 2/3, and was the 3rd registered.
38 studies on the registry are indexed under Prurigo; 10 are open to participants now.
Browse Prurigo studies →4 of the 23 studies in Prurigo with a site in United States are open now. Recruiting first, the newest first:
Beijing InnoCare Pharma Tech Co., Ltd. · Sites in United States, China, France and 2 more countries
Galderma R&D · Sites in United States, Germany
Sanofi · Sites in United States
University of Maryland, Baltimore · Sites in United States
A study can be open while its sites in United States have not opened yet or have stopped. Only those recruiting at a site in United States →
Of the 7 Prurigo studies recruiting now, 4 (57%) set no upper age limit and 2 (29%) stop at 75 or younger; 2 take children under 18; 0 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →This tab as a report to print or save as PDF → With an account.
23 studies; the count open now beside each. This study's row is marked.
A study in two phases is counted once above. Listed by phase, each with its combined phases: Phase 1 2 · Phase 2 7 · Phase 3 12 · Phase 4 1
First in 2008; this study’s year is marked. 1 started in 2015.
This study's enrollment of 62 is below the median of 135 across 31 interventional studies indexed under Prurigo.
Median enrollment 140 across the 21 interventional studies, 355 across the 2 observational. Of the 14 that completed or were terminated, 9 (64%) have results posted.
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19 of 23 have an industry lead sponsor. The 10 most frequent:
Trevi Therapeutics is the lead sponsor of 17 studies on the registry; 3 are open to participants now.
Of its 9 completed or terminated interventional studies of FDA-regulated products, 6 (67%) have results posted.
Trevi Therapeutics has 3 studies filed under Prurigo — fewer than ten, so there is no comparison to draw.
3 of the studies in Prurigo with a site in United States that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT06293053Phase 3SanofiA Study to Investigate the Pharmacokinetics and Safety of Dupilumab in Participants ≥6 Months to <18 Years of Age With Prurigo Nodularis | 2027-10-28 |
| NCT07236099Beijing InnoCare Pharma Tech Co., Ltd.Study of the Efficacy and Safety of ICP-332 in Participants With Prurigo Nodularis | 2027-03 |
| NCT06988618Galderma R&DReal-world Experience on Using Nemolizumab in the Treatment of Moderate-to- Severe Prurigo Nodularis in Adults | 2027-11-30 |
Among the 23 studies in Prurigo with a site in United States, from their registry updates:
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The primary objectives of the study are to evaluate the effects of two doses of nalbuphine HCl ER tablets on the change from baseline in the worst itch Numerical Rating Scale (NRS) in patients with prurigo nodularis and to evaluate the safety and tolerability in the study population.
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Exclusion Criteria:
nalbuphine HCl ER tablets 90 mg BID
Drug: nalbuphine HCl ER tablets 90 mg BID
nalbuphine HCl ER tablets 180 mg BID
Drug: nalbuphine HCl ER tablets 180 mg BID
Placebo tablets BID
Drug: Placebo tablets BID
nalbuphine HCl ER tablets 90 mg BID administered for 8 weeks
Also known as: nalbuphine ER
nalbuphine HCl ER tablets 180 mg BID administered for 8 weeks
Also known as: nalbuphine ER
Placebo tablets BID administered for 10 weeks
Also known as: sugar pill
Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale
The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,
Time frame: Baseline, Week 10
Change From Baseline to the Evaluation Visit (Week 10) in the Mean Itch on the 0-10 Numerical Rating Scale
Time frame: Baseline, Week 10
Change From Baseline to the Evaluation Visit (Week 10) in the Verbal Rating Scale
Time frame: Baseline, Week 10
| Milestone | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill |
|---|---|---|---|
| Started | 22 | 18 | 22 |
| Completed | 18 | 12 | 20 |
| Not completed | 4 | 6 | 2 |
The number of subjects who reported at least a 30% reduction from baseline to Week 10, expressed as a percentage of subjects in the particular arm/group who were evaluated,
| percentage of subjects | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill |
|---|---|---|---|
| Change From Baseline to the Evaluation Visit (Week 10) in Itch on the 0-10 Numerical Rating Scale | 27.3 | 44.4 | 36.4 |
Results for this outcome have not been posted.
Results for this outcome have not been posted.
Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Nalbuphine HCl ER 90mg | — | 1/22 (4.5%) | 0/22 (0%) |
| Nalbuphine HCl ER 180 mg | — | 0/18 (0%) | 0/18 (0%) |
| Sugar Pill | — | 1/22 (4.5%) | 0/22 (0%) |
| Event | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill |
|---|---|---|---|
| Road traffic accidentInjury, poisoning and procedural complications | 1/22 | 0/18 | 0/22 |
| Thoracic vertebral fractureInjury, poisoning and procedural complications | 1/22 | 0/18 | 0/22 |
| LeukocytosisBlood and lymphatic system disorders | 0/22 | 0/18 | 1/22 |
| Age, Continuous(years) | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill | Total |
|---|---|---|---|---|
| Mean | 55.0 ± 8.6 | 49.1 ± 16.3 | 53.3 ± 16.7 | 52.7 ± 14.2 |
| Sex: Female, Male(Participants) | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill | Total |
|---|---|---|---|---|
| Female | 12 | 10 | 12 | 34 |
| Male | 10 | 8 | 10 | 28 |
| Ethnicity (NIH/OMB)(Participants) | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill | Total |
|---|---|---|---|---|
| Hispanic or Latino | 0 | 0 | 0 | 0 |
| Not Hispanic or Latino | 22 | 18 | 22 | 62 |
| Unknown or Not Reported | 0 | 0 | 0 | 0 |
| Race (NIH/OMB)(Participants) | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill | Total |
|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | 0 | 0 |
| Asian | 0 | 1 | 0 | 1 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | 0 | 0 |
| Black or African American | 2 | 2 | 2 | 6 |
| White | 20 | 15 | 19 | 54 |
| More than one race | 0 | 0 | 0 | 0 |
| Unknown or Not Reported | 0 | 0 | 1 | 1 |
| Region of Enrollment(participants) | Nalbuphine HCl ER 90mg | Nalbuphine HCl ER 180 mg | Sugar Pill | Total |
|---|---|---|---|---|
| United States | 5 | 4 | 6 | 15 |
| Europe | 17 | 14 | 16 | 47 |
The record gives a start of Mar 2015, a primary completion of Aug 2016 and a completion of Aug 2016. It does not say whether these dates are actual or estimated.
Results were first posted in Aug 2020, 4 years after primary completion. A results delay was requested in May 2017.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Nalbuphine