Trial · NCT05061693
A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
NCT05061693, Phase 2, Completed, Incyte Corporation; results first posted 2024-08-27
3 sourcestrials-2026-11-12-0.5.0
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ConductScience Library. A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis. Trials, record NCT05061693. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT05061693
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Trial
As registered on ClinicalTrials.gov, in the graph's capture of the registry.
- Title
- A Study to Evaluate the Efficacy and Safety of INCB054707 in Participants With Prurigo Nodularis
- NCT number
- NCT05061693
- Status
- Completed
- Phases
- Phase 2
- Enrollment
- 146 participants, actual
- Lead sponsor
- Incyte Corporation
- Conditions
- Prurigo Nodularis
- Interventions
- INCB054707, Placebo
- First posted
- 2021-09-29
- Last updated
- 2025-07-11
- Other registries' IDs
- eudract:2021-006329-23
- Results first posted
- 2024-08-27
Source ClinicalTrials.gov
Registered outcomes7
Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.
| List | Outcome | Time frame | Description |
|---|---|---|---|
| Primary | Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 | Baseline; Week 16 | Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing. |
| Secondary | Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 | Baseline; Week 16 | The IGA for chronic prurigo considers the number of pruriginous lesions, which includes papules, nodules, plaques, umbilicated ulcers, and ulcers, and uses them as an overall severity rating on a scale of 0 to 4. 0: clear; no pruriginous lesions (0 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). The IGA-TS is defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline. |
| Secondary | Time to ≥4-point Improvement From Baseline in Itch NRS Score | up to 122 days | Each evening, the participants assessed their worst level of itch during the past 24 hours on a scale of 0 (no itch) to 10 (worst itch imaginable). The Baseline Itch NRS score was determined by averaging the 7 daily Itch NRS scores before Day 1 (i.e., Day -7 to Day -1). If ≥4 of the 7 days of the daily Itch NRS scores were missing prior to Day 1, then the Baseline Itch NRS score was set to "missing." The by-visit Itch NRS score for postbaseline visits was determined by averaging the 7 daily Itch NRS scores before the visit day. If 4 or more daily Itch NRS scores out of the 7 days before the visit day were missing, the Itch NRS score at the visit was set to missing. |
| Secondary | PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 152 days | An adverse event (AE) is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. |
| Secondary | PC Period: Number of Participants With Any ≥Grade 3 TEAE | up to 152 days | A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
| Secondary | Extension Period: Number of Participants With Any TEAE | up to 215 days | An AE is any untoward medical occurrence associated with the use of a drug in humans, whether or not it is considered drug related. An AE can therefore be any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study drug. A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. |
| Secondary | Extension Period: Number of Participants With Any ≥Grade 3 TEAE | up to 215 days | A TEAE is any AE either reported for the first time or the worsening of a pre-existing event after the first dose of study drug up to 30 days after the last dose of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and serious adverse event (SAE) reported during the study and assigned it to 1 of the following categories. Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
Source ClinicalTrials.gov
Outcomes7
Each outcome the trial posted results for, in ClinicalTrials.gov's words.
| Type | Outcome | Time frame | Population | Units | Measured as |
|---|---|---|---|---|---|
| PRIMARY | Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 | Baseline; Week 16 | Intent-to-Treat (ITT) Population: all randomized participants. Treatment groups for this population were defined according to the treatment assignment at randomization. Missing post-Baseline values and rescue therapy recipients for all subsequent visits after the initiation date of rescue therapy were imputed as nonresponders. The 95% confidence interval was based on the Clopper-Pearson exact method. | percentage of participants | NUMBER |
| SECONDARY | Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 | Baseline; Week 16 | ITT Population. Missing post-Baseline values were imputed as non-responders. The 95% confidence interval was based on the Clopper-Pearson exact method. | percentage of participants | NUMBER |
| SECONDARY | Time to ≥4-point Improvement From Baseline in Itch NRS Score | up to 122 days | ITT Population. The time to a ≥4-point improvement from Baseline in itch NRS score was estimated using the Kaplan-Meier method. The confidence interval for the median time to a ≥4-point improvement from Baseline was calculated using the method of Brookmeyer and Crowley. Only participants with available data were analyzed. | days | MEDIAN |
| SECONDARY | PC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to 152 days | Safety Population: all participants who received at least 1 dose of study drug. Treatment groups for this population were determined according to the actual treatment the participant received on Day 1. | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | PC Period: Number of Participants With Any ≥Grade 3 TEAE | up to 152 days | Safety Population | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Extension Period: Number of Participants With Any TEAE | up to 215 days | Extension Evaluable Population: all participants who received at least 1 dose of povorcitinib during the Extension Period | Participants | COUNT_OF_PARTICIPANTS |
| SECONDARY | Extension Period: Number of Participants With Any ≥Grade 3 TEAE | up to 215 days | Extension Evaluable Population | Participants | COUNT_OF_PARTICIPANTS |
Source ClinicalTrials.gov
Results by group36
Each measurement the trial posted, group by group, in the words and numbers it posted.
| Outcome | Group | Category | Value | Spread | Units |
|---|---|---|---|---|---|
| Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 | Placebo | 8.1 | 95% Confidence Interval 1.7 to 21.9 | percentage of participants | |
| Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 | Povorcitinib 15 mg | 36.1 | 95% Confidence Interval 20.8 to 53.8 | percentage of participants | |
| Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 | Povorcitinib 45 mg | 44.4 | 95% Confidence Interval 27.9 to 61.9 | percentage of participants | |
| Percentage of Participants Achieving ≥4-point Improvement in Itch Numerical Rating Scale (NRS) Score at Week 16 | Povorcitinib 75 mg | 56.8 | 95% Confidence Interval 39.5 to 72.9 | percentage of participants | |
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 | Placebo | 5.4 | 95% Confidence Interval 0.7 to 18.2 | percentage of participants | |
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 | Povorcitinib 15 mg | 13.9 | 95% Confidence Interval 4.7 to 29.5 | percentage of participants | |
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 | Povorcitinib 45 mg | 30.6 | 95% Confidence Interval 16.3 to 48.1 | percentage of participants | |
| Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) (IGA Score of 0 or 1 With a ≥2-grade Improvement From Baseline) at Week 16 | Povorcitinib 75 mg | 48.6 | 95% Confidence Interval 31.9 to 65.6 | percentage of participants | |
| Time to ≥4-point Improvement From Baseline in Itch NRS Score | Placebo | NA | 95% Confidence Interval NA to NA | days | |
| Time to ≥4-point Improvement From Baseline in Itch NRS Score | Povorcitinib 15 mg | 58.0 | 95% Confidence Interval 16.0 to NA | days |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 results by groupParticipant flow72
How many started, completed or left each group, period by period.
| Period | Milestone | Group | Participants | Units counted |
|---|---|---|---|---|
| 16-week Placebo-controlled (PC) Period | STARTED | PC Period: Placebo | 37 | |
| 16-week Placebo-controlled (PC) Period | STARTED | PC Period: Povorcitinib 15 mg | 36 | |
| 16-week Placebo-controlled (PC) Period | STARTED | PC Period: Povorcitinib 45 mg | 36 | |
| 16-week Placebo-controlled (PC) Period | STARTED | PC Period: Povorcitinib 75 mg | 37 | |
| 16-week Placebo-controlled (PC) Period | STARTED | Extension Period: Placebo to Povorcitinib 45 mg | 0 | |
| 16-week Placebo-controlled (PC) Period | STARTED | Extension Period: Povorcitinib 15 mg to 45 mg | 0 | |
| 16-week Placebo-controlled (PC) Period | STARTED | Extension Period: Povorcitinib 45 mg to 45 mg | 0 | |
| 16-week Placebo-controlled (PC) Period | STARTED | Extension Period: Povorcitinib 75 mg to 45 mg | 0 | |
| 16-week Placebo-controlled (PC) Period | STARTED | Extension Period: Placebo to Povorcitinib 75 mg | 0 | |
| 16-week Placebo-controlled (PC) Period | STARTED | Extension Period: Povorcitinib 15 mg to 75 mg | 0 |
1 to 10 of 72Source ClinicalTrials.gov
See all 72 participant flowAdverse events1,236
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 | Aspergillus test positive | Investigations | Placebo | 0 | 37 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 15 mg | 0 | 36 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 45 mg | 0 | 35 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 75 mg | 0 | 37 | 0 |
| other | Aspergillus test positive | Investigations | Placebo to Povorcitinib 45 mg | 0 | 1 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 15 mg to 45 mg | 0 | 4 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 45 mg to 45 mg | 0 | 8 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 75 mg to 45 mg | 1 | 15 | 1 |
| other | Aspergillus test positive | Investigations | Placebo to Povorcitinib 75 mg | 0 | 30 | 0 |
| other | Aspergillus test positive | Investigations | Povorcitinib 15 mg to 75 mg | 0 | 25 | 0 |
1 to 10 of 1,236Source ClinicalTrials.gov
See all 1,236 adverse eventsAdverse event totals36
The totals the trial posted for each group.
| Total | Group | Affected | At risk |
|---|---|---|---|
| Total, all-cause mortality | Placebo | 0 | 37 |
| Total, all-cause mortality | Povorcitinib 15 mg | 1 | 36 |
| Total, all-cause mortality | Povorcitinib 45 mg | 0 | 35 |
| Total, all-cause mortality | Povorcitinib 75 mg | 0 | 37 |
| Total, all-cause mortality | Placebo to Povorcitinib 45 mg | 0 | 1 |
| Total, all-cause mortality | Povorcitinib 15 mg to 45 mg | 0 | 4 |
| Total, all-cause mortality | Povorcitinib 45 mg to 45 mg | 0 | 8 |
| Total, all-cause mortality | Povorcitinib 75 mg to 45 mg | 0 | 15 |
| Total, all-cause mortality | Placebo to Povorcitinib 75 mg | 0 | 30 |
| Total, all-cause mortality | Povorcitinib 15 mg to 75 mg | 0 | 25 |
1 to 10 of 36Source ClinicalTrials.gov
See all 36 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.
For software
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