Trial · NCT03497975
PRISM Study-Pruritus Relief Through Itch Scratch Modulation
NCT03497975, Phase 2, Phase 3, Completed, Trevi Therapeutics; results first posted 2025-06-24
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. PRISM Study-Pruritus Relief Through Itch Scratch Modulation. Trials, record NCT03497975. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT03497975
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- PRISM Study-Pruritus Relief Through Itch Scratch Modulation
- NCT number
- NCT03497975
- Status
- Completed
- Phases
- Phase 2, Phase 3
- Enrollment
- 353 participants, actual
- Lead sponsor
- Trevi Therapeutics
- Conditions
- Prurigo Nodularis
- Interventions
- Nalbuphine ER Tablets, Placebo Tablets
- First posted
- 2018-04-13
- Last updated
- 2025-06-24
- Other registries' IDs
- eudract:2018-001219-53
- Results first posted
- 2025-06-24
Source ClinicalTrials.gov
Registered outcomes12
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants With ≥ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14 | Baseline up to Week 14 | The NRS is a patient related outcome (PRO) instrument, designed to quantify the intensity of worst itching experienced during a 24-hour period, and can be applied and validated either with reference to the average itch or to the absolute worst itch (WI-NRS) over that 24-hour period. WI-NRS is a set of boxes, one for each number, from 0 (no itching) to 10 (worst possible itching). Higher scores indicate worst itching experience. Responder was defined as a participant with a ≥4-point decrease in the 7-day average WI-NRS from baseline to Week 14. |
| Secondary | Change From Baseline in Itch-related Quality of Life (ItchyQoL) Total Score at Week 14 | Baseline, Week 14 | The ItchyQoL consists of 22 pruritus-specific items measuring how pruritus affects participant's QoL in the area of symptoms related to the itch condition (6 questions), functional limitations (7 questions), and emotions (9 questions). The participant scored each question never = 1, rarely = 2, sometimes = 3, often = 4, all the time = 5. The ItchyQoL total score were obtained as the sum of the 22 items ranging from 22 to 110, with higher score indicating worsening of pruritus. A negative change from baseline indicated improvement in the pruritus-related difficulties. |
| Secondary | Change From Baseline in Prurigo Activity Score (PAS) Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Pruriginous Lesions With Excoriations/Crusts (Item 5a) at Week 14 | Baseline, Week 14 | PAS consists of 5 quantitative/qualitative measurements related to examination of skin: Type; number;distribution;quantitative number of lesions in a body part;activity. Prurigo lesion activity is recorded as a stage (0 to 4), based on percentage of overall lesions with relevant characteristic. Three types of PAS responders defined one for each of the following items: Pruriginous lesions with excoriations/crusts (item 5a);Healed lesions (item 5b);Number of lesions (item 2). Pruriginous lesions with excoriations/crusts (item 5a) was recorded from 0 to 4;where 0 = 0-25%1 = 26-50%,2 = 51-75%,3 = 76-90%,4 = 91-100%. Higher score=a greater number of pruriginous lesions with excoriations/crusts. A responder was defined as a participant who has at least 1-category improvement in the relevant item from baseline to Week 14. Baseline is defined as the last non-missing evaluation (including repeated and unscheduled assessments) taken prior to or on the date of first dose of study medication. |
| Secondary | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a at Week 14 | Baseline, Week 14 | PROMIS Sleep Disturbance Short Form 8a questionnaire is a tool for assessing sleep. It has 8 questions which measures sleep in the past 7 days.There is 1 broad sleep quality question with options:"very poor","poor","fair","good",and "very good".Remaining 7 questions are answered with:"not at all","a little bit","somewhat","quite a bit",and "very much".Lowest possible raw score=8; highest possible raw score=40. The T-score rescales raw score into a standardized score with a mean of 50 and an standard deviation of 10 derived from general population.Lowest possible T-score=28.9;highest possible T-score=76.6.Higher T-score shows more of the concept measured,higher the T-Score worse the sleep disturbance.Scores \<55=normal limits, 55-60=mild, 61-70=moderate,and \>70=severe sleep disturbance.Baseline=last non-missing evaluation (including repeated and unscheduled assessments) taken prior to or on the date of first dose of study medication.Negative change from baseline indicated better sleep. |
| Secondary | Change From Baseline in 7-Day Average WI-NRS to Week 14 | Baseline, Week 14 | The NRS is a PRO instrument, designed to quantify the intensity of worst itching experienced during a 24-hour period, and can be applied and validated either with reference to the average itch or to the absolute worst itch (WI-NRS) over that 24-hour period. WI-NRS is a set of boxes, one for each number, from 0 (no itching) to 10 (worst possible itching). Higher scores indicate worst itching experience. Baseline WI-NRS value was calculated as the arithmetic mean of the WI-NRS values (minimum of 5 required) taken for eligibility review by site at the time of randomization. A negative change from baseline indicates improvement in symptoms. |
| Secondary | Change From Baseline in PAS Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Healed Lesions (Item 5b) at Week 14 | Baseline, Week 14 | PAS consists of 5 quantitative/qualitative measurements related to skin-Type; number; distribution; quantitative number of lesions in body part; activity. Prurigo lesion activity is recorded as stage (0 to 4), based on percentage of overall lesions with relevant characteristic. Three types of PAS responders are defined: Pruriginous lesions with excoriations/crusts (item 5a); Healed lesions (item 5b); Number of lesions (item 2). Prurigo lesions (item 5b), where 0 = 100%,1 = 75-99%,2 = 50-74%,3 = 25-49%,4 = 0-24% healed pruriginous lesions. Lower score=more number of healed pruriginous lesions. A responder was defined as a participant who has at least 1-category improvement in the relevant item from baseline to Week 14. Baseline was defined as the last non-missing evaluation (including repeated and unscheduled assessments) taken prior to or on the date of first dose of treatment. A negative change from baseline would indicate higher number of healed lesions. |
| Secondary | Change From Baseline in PAS Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Lesions (Item 2) at Week 14 | Baseline, Week 14 | PAS consists of 5 quantitative/qualitative measurements of skin- Type; number; distribution; quantitative number of lesions in body part; activity. Prurigo lesion activity is recorded as stage (0 to 4) based on percentage of overall lesions with relevant characteristic. Three types of PAS responders are defined: Pruriginous lesions with excoriations/crusts (item 5a); Healed lesions (item 5b); Number of lesions (item 2). Prurigo lesion activity is recorded as a stage (0 to 4), based on the percentage of overall lesions with the relevant characteristic. A lower score indicates less number of pruriginous lesions. A responder was defined as a participant who has at least 1-category improvement in the relevant item from baseline to Week 14. Baseline was defined as the last non-missing evaluation (including repeated and unscheduled assessments) taken prior to or on the date of first dose of study medication. A negative change from baseline would indicate lower number of lesions. |
| Secondary | Change From Baseline in Investigator Global Assessment-Prurigo Nodularis (IGA-PN) Assessed by the Percentage of Participants With 1-Category Improvement in Activity at Week 14 | Baseline, Week 14 | The IGA-PN collects an investigator global assessment of status of PN skin lesions. The IGA-PN uses a 5-category scale (scoring 0 to 4) to describe the status of 2 aspects of disease: The Activity (amount of excoriation and crusting associated with the prurigo lesions), and the Stage (the quantitative presence and proportion of flattening of the lesions). The excoriation/crusting activity on the surface (PN-Activity) where it considers number of PN lesion with excoriations and crusts on the top, 0=clear (No nodules), 1 =small number, 2=minority of nodules, 3=most nodules, 4=severe (vast majority of nodules). A higher number indicates severe status of PN skin lesions. An IGA-PN responder for activity was defined as participants who has at a least 1-category improvement in the respective score from baseline to Week 14. Baseline was defined as the last non-missing evaluation (including repeated and unscheduled assessments) taken prior to or on the date of first dose of study medication. |
| Secondary | Change From Baseline in IGA-PN Assessed by the Percentage of Participants With 1-Category Improvement in Stage at Week 14 | Baseline, Week 14 | The IGA-PN collects an investigator global assessment of status of PN skin lesions. The IGA-PN uses a 5-category scale(scoring 0 to 4) to describe 2 aspects of disease. The Activity(amount of excoriation and crusting of prurigo lesions) and the Stage(the quantitative presence and proportion of flattening of lesions),where 0=clear(No nodules),1=Rare, flattened lesions, with no more than single dome-shaped palpable nodules(1-5 nodules), 2=Few,mostly flattened lesions, with small number of dome-shaped palpable nodules(6-19 nodules,3=Many lesions, partially flattened and dome-shaped palpable nodules (20-100 nodules),4=Abundant lesions, majority are dome-shaped palpable nodules (over 100 nodules).Higher number= presence of abundant lesions.Responder as defined as participants who has at a least 1-category improvement from baseline to Week 14.Baseline was defined as the last non-missing evaluation(repeated and unscheduled assessments)taken prior to or on the date of first dose of treatment. |
| Secondary | Percentage of Participants Having a Patient Benefit Index, Pruritus Version (PBI-P) Score of ≥1 at Week 14 | At Week 14 | PBI-P is an instrument that measures participant-defined treatment objectives and benefits acquired during the course of treatment.During and after therapy, the participant completes a matched "on-treatment" Treatment Benefits questionnaire and rates the extent to which the treatment objectives have been achieved.It consists of 27 multiple choice questions that can be answered "not at all","somewhat","moderately","quite","very".PBI-P global score is computed according to the score obtained for patient needs questionnaire (PNQ) and patient benefit questionnaire (PBQ).Score may only be computed if the participant has provided valid data on importance (PNQ) and benefit (PBQ) for at least 75% of the respective treatment goals,i.e., for at least 21 of the 27 items. Total score ranges from 0-135. Higher scores=more benefit received from the study to the participant.Responses "does/did not apply","question answered" are considered valid values when counting number of non-missing responses. |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 registered outcomesOutcomes12
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants With ≥ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14 | Baseline up to Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Itch-related Quality of Life (ItchyQoL) Total Score at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in Prurigo Activity Score (PAS) Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Pruriginous Lesions With Excoriations/Crusts (Item 5a) at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | T-score | MEAN |
| SECONDARY | Change From Baseline in 7-Day Average WI-NRS to Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | score on a scale | MEAN |
| SECONDARY | Change From Baseline in PAS Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Healed Lesions (Item 5b) at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in PAS Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Lesions (Item 2) at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in Investigator Global Assessment-Prurigo Nodularis (IGA-PN) Assessed by the Percentage of Participants With 1-Category Improvement in Activity at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Change From Baseline in IGA-PN Assessed by the Percentage of Participants With 1-Category Improvement in Stage at Week 14 | Baseline, Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Having a Patient Benefit Index, Pruritus Version (PBI-P) Score of ≥1 at Week 14 | At Week 14 | The mITT population included all randomized participants who received at least a single dose of IP. Overall number of participants analyzed indicates number of participants who were evaluable for this outcome measure. | percentage of participants | NUMBER |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 outcomesResults by group32
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants With ≥ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14 | NAL ER | 24.24 | percentage of participants | ||
| Percentage of Participants With ≥ 4- Point Decrease in 7-day Average Worst Itch - Numerical Rating Scale (WI-NRS) up to Week 14 | Placebo | 14.50 | percentage of participants | ||
| Change From Baseline in Itch-related Quality of Life (ItchyQoL) Total Score at Week 14 | NAL ER | -17.4 | Standard Deviation 18.01 | score on a scale | |
| Change From Baseline in Itch-related Quality of Life (ItchyQoL) Total Score at Week 14 | Placebo | -8.8 | Standard Deviation 17.15 | score on a scale | |
Change From Baseline in Prurigo Activity Score (PAS) Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Pruriginous Lesions With Excoriations/Crusts (Item 5a) at Week 14 | NAL ER | 54.5 | percentage of participants | ||
Change From Baseline in Prurigo Activity Score (PAS) Assessed by the Percentage of Participants With 1-Category Improvement in the Percentage of Pruriginous Lesions With Excoriations/Crusts (Item 5a) at Week 14 | Placebo | 41.1 | percentage of participants | ||
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a at Week 14 | NAL ER | -9.5 | Standard Deviation 10.01 | T-score | |
| Change From Baseline in Patient-Reported Outcomes Measurement Information System (PROMIS) Sleep Disturbance Short Form 8a at Week 14 | Placebo | -4.5 | Standard Deviation 8.44 | T-score | |
| Change From Baseline in 7-Day Average WI-NRS to Week 14 | NAL ER | -2.5 | Standard Deviation 2.36 | score on a scale | |
| Change From Baseline in 7-Day Average WI-NRS to Week 14 | Placebo | -1.6 | Standard Deviation 2.14 | score on a scale |
1 to 10 of 32Source ClinicalTrials.gov
See all 32 results by groupParticipant flow10
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| Overall Study | STARTED | NAL ER | 173 | |
| Overall Study | STARTED | Placebo | 180 | |
| Overall Study | Modified Intent-to-treat (mITT) Analysis Set | NAL ER | 168 | |
| Overall Study | Modified Intent-to-treat (mITT) Analysis Set | Placebo | 176 | |
| Overall Study | Participants Who Entered the OLE Period | NAL ER | 107 | |
| Overall Study | Participants Who Entered the OLE Period | Placebo | 144 | |
| Overall Study | COMPLETED | NAL ER | 71 | |
| Overall Study | COMPLETED | Placebo | 80 | |
| Overall Study | NOT COMPLETED | NAL ER | 102 | |
| Overall Study | NOT COMPLETED | Placebo | 100 |
Source ClinicalTrials.gov
Adverse events208
Each adverse event the trial posted, group by group: the participants affected out of those at risk.
| Type | Event | Organ system | Group | Affected | At risk | Events |
|---|---|---|---|---|---|---|
| other | Nausea | Gastrointestinal disorders | NAL ER (DB Period) | 52 | 168 | |
| other | Nausea | Gastrointestinal disorders | Placebo (DB Period) | 16 | 176 | |
| other | Nausea | Gastrointestinal disorders | Prior NAL ER (OLE Period) | 13 | 107 | |
| other | Nausea | Gastrointestinal disorders | Prior Placebo (OLE Period) | 44 | 144 | |
| other | Constipation | Gastrointestinal disorders | NAL ER (DB Period) | 26 | 168 | |
| other | Constipation | Gastrointestinal disorders | Placebo (DB Period) | 7 | 176 | |
| other | Constipation | Gastrointestinal disorders | Prior NAL ER (OLE Period) | 4 | 107 | |
| other | Constipation | Gastrointestinal disorders | Prior Placebo (OLE Period) | 11 | 144 | |
| other | Vomiting | Gastrointestinal disorders | NAL ER (DB Period) | 19 | 168 | |
| other | Vomiting | Gastrointestinal disorders | Placebo (DB Period) | 6 | 176 |
1 to 10 of 208Source ClinicalTrials.gov
See all 208 adverse eventsAdverse event totals12
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | NAL ER (DB Period) | 0 | 168 |
| Total, all-cause mortality | Placebo (DB Period) | 0 | 176 |
| Total, all-cause mortality | Prior NAL ER (OLE Period) | 0 | 107 |
| Total, all-cause mortality | Prior Placebo (OLE Period) | 0 | 144 |
| Total, other adverse events | NAL ER (DB Period) | 112 | 168 |
| Total, other adverse events | Placebo (DB Period) | 58 | 176 |
| Total, other adverse events | Prior NAL ER (OLE Period) | 49 | 107 |
| Total, other adverse events | Prior Placebo (OLE Period) | 95 | 144 |
| Total, serious adverse events | NAL ER (DB Period) | 9 | 168 |
| Total, serious adverse events | Placebo (DB Period) | 8 | 176 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 adverse event totalsPapers0
The papers the trial lists on ClinicalTrials.gov.
None in this release.
Grants0
The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.
None in this release.
Trial comparisons0
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
None in this release.
Tests0
The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.
None in this release.
Data dates
The day each source was copied for this release.
Sources 3
- ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
- ClinicalTrials.govNo license stated
- NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
- ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
- ClinicalTrials.govnone stated
- NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)
ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.
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