Trial · NCT05755438
A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
NCT05755438, Phase 3, Completed, Incyte Corporation; results first posted 2025-11-14
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN). Trials, record NCT05755438. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05755438
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Safety and Efficacy of Ruxolitinib Cream in Participants With Prurigo Nodularis (PN)
- NCT number
- NCT05755438
- Status
- Completed
- Phases
- Phase 3
- Enrollment
- 204 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Prurigo
- Interventions
- Ruxolitinib Cream, Vehicle Cream
- First posted
- 2023-03-06
- Last updated
- 2026-08-12
- Results first posted
- 2025-11-14
Source ClinicalTrials.gov
Registered outcomes28
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | WI-NRS4 Response at Week 12 | Baseline; Week 12 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in Worst-Itch Numeric Rating Scale (WI-NRS) score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders. |
| Secondary | WI-NRS4 Response at Week 4 | Baseline; Week 4 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | Percentage of Participants With Overall-Treatment Success at Week 12 | Baseline; Week 12 | Overall-Treatment Success was defined as both a WI-NRS4 response and Investigator's Global Assessment for Stage of Chronic Prurigo Treatment Success (IGA-CPG-S-TS). IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no pruriginous lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]). |
| Secondary | Percentage of Participants With IGA-CPG-S-TS at Week 12 | Baseline; Week 12 | IGA-CPG-S-TS was defined as an IGA-CPG-S score of 0 or 1 with a ≥2 grade improvement from baseline. The IGA-CPG-S is an overall severity rating of chronic prurigo on a scale of 0 to 4: 0, clear (no lesions); 1, almost clear (rare palpable pruriginous lesions \[approximately 1-5 lesions\]); 2, mild (few palpable pruriginous lesions \[approximately 6-19 lesions\]); 3, moderate (many palpable pruriginous lesions \[approximately 20-100 lesions\]); 4, severe (abundant palpable pruriginous lesions \[over 100 lesions\]). |
| Secondary | WI-NRS4 Response on Day 7 | Baseline; Day 7 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Baseline; up to Week 12 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Baseline; up to Week 52 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | WI-NRS4 Response at Each Post-baseline Visit | Baseline; up to Week 52 | WI-NRS4 was defined as the percentage of participants achieving a ≥4-point improvement (reduction) in WI-NRS score from baseline. The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | Time to ≥2-point Improvement From Baseline in WI-NRS Score | Baseline; up to Week 52 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
| Secondary | Time to ≥4-point Improvement From Baseline in WI-NRS Score | Baseline; up to Week 52 | The WI-NRS is a patient-reported outcome comprised of a single item rated on a scale from 0 ("no itch") to 10 ("worst imaginable itch"). Participants assessed their worst level of prurigo nodularis-related itch during the past 24 hours on a scale of 0 to 10. The WI-NRS score for baseline was determined by averaging the 7 daily WI-NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit WI-NRS score for post-baseline visits was determined by averaging the 7 daily WI-NRS scores before the visit day. |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 registered outcomesOutcomes28
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | WI-NRS4 Response at Week 12 | Baseline; Week 12 | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups were defined according to the treatment assignment at the time of randomization regardless of the actual study cream the participant might have applied during their participation in the double-blind, vehicle-controlled period. Participants with a baseline ITCH Score ≥4 were analyzed. | percentage of participants | NUMBER |
| SECONDARY | WI-NRS4 Response at Week 4 | Baseline; Week 4 | ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Participants with missing Week 4 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With Overall-Treatment Success at Week 12 | Baseline; Week 12 | ITT Population. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants With IGA-CPG-S-TS at Week 12 | Baseline; Week 12 | ITT Population. Participants with missing Week 12 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | WI-NRS4 Response on Day 7 | Baseline; Day 7 | ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Participants with missing Day 7 data for any reason, including treatment discontinuation (due to development of atopic dermatitis lesions or any other cause), were defined as nonresponders. | percentage of participants | NUMBER |
| SECONDARY | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Baseline; up to Week 12 | ITT Population. Only participants with available data were analyzed. | scores on a scale | LEAST_SQUARES_MEAN |
| SECONDARY | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Baseline; up to Week 52 | Open-label Extension Population: all participants who applied ruxolitinib 1.5% cream at least once during the OLE Period. Only participants with available data were analyzed. | scores on a scale | MEAN |
| SECONDARY | WI-NRS4 Response at Each Post-baseline Visit | Baseline; up to Week 52 | ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed. | percentage of participants | NUMBER |
| SECONDARY | Time to ≥2-point Improvement From Baseline in WI-NRS Score | Baseline; up to Week 52 | ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis. | days | MEDIAN |
| SECONDARY | Time to ≥4-point Improvement From Baseline in WI-NRS Score | Baseline; up to Week 52 | ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis. | days | MEDIAN |
1 to 10 of 28Source ClinicalTrials.gov
See all 28 outcomesResults by group442
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| WI-NRS4 Response at Week 12 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 20.6 | 95% Confidence Interval 13.2 to 29.7 | percentage of participants | |
| WI-NRS4 Response at Week 12 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 44.6 | 95% Confidence Interval 34.7 to 54.8 | percentage of participants | |
| WI-NRS4 Response at Week 4 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 12.7 | 95% Confidence Interval 7.0 to 20.8 | percentage of participants | |
| WI-NRS4 Response at Week 4 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 29.7 | 95% Confidence Interval 21.0 to 39.6 | percentage of participants | |
| Percentage of Participants With Overall-Treatment Success at Week 12 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 2.9 | 95% Confidence Interval 0.6 to 8.3 | percentage of participants | |
| Percentage of Participants With Overall-Treatment Success at Week 12 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 11.9 | 95% Confidence Interval 6.3 to 19.8 | percentage of participants | |
| Percentage of Participants With IGA-CPG-S-TS at Week 12 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 3.9 | 95% Confidence Interval 1.1 to 9.6 | percentage of participants | |
| Percentage of Participants With IGA-CPG-S-TS at Week 12 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 15.8 | 95% Confidence Interval 9.3 to 24.4 | percentage of participants | |
| WI-NRS4 Response on Day 7 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 8.9 | 95% Confidence Interval 3.9 to 16.8 | percentage of participants | |
| WI-NRS4 Response on Day 7 | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 23.3 | 95% Confidence Interval 15.1 to 33.4 | percentage of participants |
1 to 10 of 442Source ClinicalTrials.gov
See all 442 results by groupParticipant flow12
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 12-week DBVC Period | STARTED | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 103 | |
| 12-week DBVC Period | STARTED | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 101 | |
| 12-week DBVC Period | COMPLETED | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 84 | |
| 12-week DBVC Period | COMPLETED | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 90 | |
| 12-week DBVC Period | NOT COMPLETED | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 19 | |
| 12-week DBVC Period | NOT COMPLETED | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 11 | |
| 40-week OLE Period | STARTED | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 84 | |
| 40-week OLE Period | STARTED | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 90 | |
| 40-week OLE Period | COMPLETED | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 25 | |
| 40-week OLE Period | COMPLETED | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 20 |
1 to 10 of 12Source ClinicalTrials.gov
See all 12 participant flowAdverse events46
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 | COVID-19 | Infections and infestations | Vehicle Cream BID | 4 | 103 | 4 |
| other | COVID-19 | Infections and infestations | Ruxolitinib 1.5% Cream BID | 10 | 184 | 10 |
| other | Nasopharyngitis | Infections and infestations | Vehicle Cream BID | 2 | 103 | 2 |
| other | Nasopharyngitis | Infections and infestations | Ruxolitinib 1.5% Cream BID | 17 | 184 | 21 |
| serious | Abscess neck | Infections and infestations | Vehicle Cream BID | 0 | 103 | 0 |
| serious | Abscess neck | Infections and infestations | Ruxolitinib 1.5% Cream BID | 1 | 184 | 1 |
| serious | Atrial flutter | Cardiac disorders | Vehicle Cream BID | 0 | 103 | 0 |
| serious | Atrial flutter | Cardiac disorders | Ruxolitinib 1.5% Cream BID | 1 | 184 | 1 |
| serious | Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Vehicle Cream BID | 0 | 103 | 0 |
| serious | Bowen's disease | Neoplasms benign, malignant and unspecified (incl cysts and polyps) | Ruxolitinib 1.5% Cream BID | 1 | 184 | 1 |
1 to 10 of 46Source ClinicalTrials.gov
See all 46 adverse eventsAdverse event totals6
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Vehicle Cream BID | 0 | 103 |
| Total, all-cause mortality | Ruxolitinib 1.5% Cream BID | 0 | 184 |
| Total, other adverse events | Vehicle Cream BID | 6 | 103 |
| Total, other adverse events | Ruxolitinib 1.5% Cream BID | 27 | 184 |
| Total, serious adverse events | Vehicle Cream BID | 5 | 103 |
| Total, serious adverse events | Ruxolitinib 1.5% Cream BID | 13 | 184 |
Source ClinicalTrials.gov
Papers0
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 comparisons6
Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.
| Comparison | Source |
|---|---|
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID to Ruxolitinib 1.5% Cream BID: OLE Period: Number of Participants With Any ≥Grade 3 TEAE | Trial comparisons |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID to Ruxolitinib 1.5% Cream BID: OLE Period: Number of Participants With Any TEAE | Trial comparisons |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID to Ruxolitinib 1.5% Cream BID: DBVC Period: Number of Participants With Any ≥Grade 3 TEAE | Trial comparisons |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID to Ruxolitinib 1.5% Cream BID: DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | Trial comparisons |
| Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID: deaths from any cause | Trial comparisons |
| Ruxolitinib 1.5% Cream BID vs Vehicle Cream BID: serious adverse events | Trial comparisons |
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.
For software
Read this trial from software.
The record and each of its lists are JSON, twenty rows a page. No key.
GET https://conductscience.org/api/trials/v1/NCT05755438
GET https://conductscience.org/api/trials/v1/NCT05755438/registered?page=2