A Phase 3 interventional study of Ruxolitinib Cream and Vehicle Cream in Prurigo, sponsored by Incyte Corporation. Completed at 71 sites in 11 countries. Open to participants aged 18 Years to 99 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Incyte Corporation · Phase 3, Interventional, and Treatment
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
The study comprises of a 12 week double-blind, vehicle-controlled (DBVC) treatment period, followed by a 40 week open label extension period, and 30 day safety follow-up period During the double blind period, all PN-affected areas identified at baseline will be treated, and during the open label period, only active PN-affected areas will be treated.
38 studies on the registry are indexed under Prurigo; 10 are open to participants now.
This study's enrollment of 204 is above the median of 135 across 31 interventional studies indexed under Prurigo.
Browse Prurigo studies →Incyte Corporation is the lead sponsor of 288 studies on the registry; 34 are open to participants now.
Of its 149 completed or terminated interventional studies of FDA-regulated products, 95 (64%) have results posted.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
The following participants are excluded in France:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants apply ruxolitinib matching vehicle cream topically to the affected areas as a thin film twice daily (BID) for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream topically during the open label extension (OLE) period for up to 40 weeks.
Drug: Vehicle Cream
Participants apply ruxolitinib 1.5% cream topically to the affected areas as a thin film BID for 12 weeks during the DBVC period. Participants who have completed the treatment during DBVC period will apply ruxolitinib 1.5% cream the open label extension (OLE) period for up to 40 weeks.
Drug: Ruxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the vehicle controlled (DBVC)and open label treatment period (OLE).
Also known as: INCB018424 phosphate cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle controlled period (DBVC).
WI-NRS4 Response at 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.
Time frame: Baseline; Week 12
WI-NRS4 Response at 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.
Time frame: Baseline; Week 4
Percentage of Participants With Overall-Treatment Success at 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 \[over 100 lesions\]).
Time frame: Baseline; Week 12
Percentage of Participants With IGA-CPG-S-TS at 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 \[over 100 lesions\]).
Time frame: Baseline; Week 12
WI-NRS4 Response on 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.
Time frame: Baseline; Day 7
DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
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.
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit
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.
Time frame: Baseline; up to Week 52
WI-NRS4 Response at Each Post-baseline Visit
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.
Time frame: Baseline; up to Week 52
Time to ≥2-point Improvement From Baseline in WI-NRS Score
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.
Time frame: Baseline; up to Week 52
Time to ≥4-point Improvement From Baseline in WI-NRS Score
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.
Time frame: Baseline; up to Week 52
DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.
Time frame: Baseline; up to Week 12
OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline; up to Week 52
Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit
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 nodularis 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 \[over 100 lesions\]). 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.
Time frame: Baseline; up to Week 52
Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit
The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts \[up to approximately 10% of all pruriginous lesions\]); 2, mild (minority of pruriginous lesions have excoriations or crusts \[approximately 11%-25% of all pruriginous lesions\]); 3, moderate (many pruriginous lesions have excoriations or crusts \[approximately 26%-75% of all pruriginous lesions\]); 4, severe (majority of pruriginous lesions have excoriations or crusts \[approximately 76%-100% of all pruriginous lesions\]).
Time frame: Baseline; up to Week 52
DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit
The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.
Time frame: Baseline; up to Week 12
OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit
The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit
The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit
The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in European Quality of Life 5 Dimensions 5 Level Version (EQ-5D-5L) Visual Analog Scale (VAS) Score at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline; up to Week 52
DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline; up to Week 12
OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
Time frame: Baseline; up to Week 52
DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE)
An adverse event (AE) was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: up to Week 12
DBVC Period: Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.
Time frame: up to Week 12
OLE Period: Number of Participants With Any TEAE
An AE was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from beginning of Week 13 up to Week 56
OLE Period: Number of Participants With Any ≥Grade 3 TEAE
An AE was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.
Time frame: from beginning of Week 13 up to Week 56
| Milestone | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Started | 103 | 101 |
| Completed | 84 | 90 |
| Not completed | 19 | 11 |
| Withdrew: Adverse event | 4 | 1 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Protocol violation | 4 | 2 |
| Withdrew: Withdrawal by subject | 9 | 7 |
| Withdrew: Sponsor decision | 1 | 0 |
| Milestone | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Started | 84 | 90 |
| Completed | 68 | 66 |
| Not completed | 16 | 24 |
| Withdrew: Adverse event | 0 | 2 |
| Withdrew: Lack of efficacy | 1 | 2 |
| Withdrew: Lost to follow-up | 2 | 3 |
| Withdrew: Physician decision | 1 | 2 |
| Withdrew: Protocol violation | 1 | 1 |
| Withdrew: Withdrawal by subject | 8 | 12 |
| Withdrew: Sponsor decision | 3 | 0 |
| Withdrew: Did not complete safety follow-up period | 0 | 2 |
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.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| WI-NRS4 Response at Week 12 | 20.6 (13.2 to 29.7) | 44.6 (34.7 to 54.8) |
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.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| WI-NRS4 Response at Week 4 | 12.7 (7.0 to 20.8) | 29.7 (21.0 to 39.6) |
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 \[over 100 lesions\]).
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Percentage of Participants With Overall-Treatment Success at Week 12 | 2.9 (0.6 to 8.3) | 11.9 (6.3 to 19.8) |
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 \[over 100 lesions\]).
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Percentage of Participants With IGA-CPG-S-TS at Week 12 | 3.9 (1.1 to 9.6) | 15.8 (9.3 to 24.4) |
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.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| WI-NRS4 Response on Day 7 | 8.9 (3.9 to 16.8) | 23.3 (15.1 to 33.4) |
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.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 2 | -1.08 ± 0.196 | -2.07 ± 0.199 |
| Change from Baseline at Week 4 | -1.52 ± 0.247 | -2.94 ± 0.250 |
| Change from Baseline at Week 8 | -1.89 ± 0.267 | -3.58 ± 0.267 |
| Change from Baseline at Week 12 | -2.13 ± 0.273 | -3.80 ± 0.272 |
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.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 14 | -3.11 ± 2.526 | -4.36 ± 2.698 |
| Change from Baseline at Week 16 | -3.53 ± 2.640 | -4.35 ± 2.736 |
| Change from Baseline at Week 20 | -4.17 ± 2.518 | -4.55 ± 2.744 |
| Change from Baseline at Week 24 | -4.14 ± 2.628 | -4.64 ± 2.566 |
| Change from Baseline at Week 28 | -4.02 ± 2.601 | -4.71 ± 2.606 |
| Change from Baseline at Week 32 | -4.26 ± 2.647 | -4.90 ± 2.554 |
| Change from Baseline at Week 36 | -4.59 ± 2.596 | -4.99 ± 2.680 |
| Change from Baseline at Week 40 | -4.38 ± 2.634 | -4.89 ± 2.598 |
| Change from Baseline at Week 44 | -4.91 ± 2.620 | -5.23 ± 2.338 |
| Change from Baseline at Week 48 | -4.68 ± 2.838 | -5.35 ± 2.287 |
| Change from Baseline at Week 52 | -4.90 ± 2.775 | -5.24 ± 2.298 |
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.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 2 | 5.2 (1.7 to 11.7) | 22.2 (14.1 to 32.2) |
| Week 4 | 13.8 (7.6 to 22.5) | 34.5 (24.6 to 45.4) |
| Week 8 | 22.1 (13.4 to 33.0) | 48.8 (37.7 to 60.0) |
| Week 12 | 25.9 (16.8 to 36.9) | 52.3 (41.3 to 63.2) |
| Week 14 | 33.8 (23.2 to 45.7) | 55.4 (44.1 to 66.3) |
| Week 16 | 42.7 (31.3 to 54.6) | 55.8 (44.1 to 67.2) |
| Week 20 | 54.1 (42.1 to 65.7) | 57.5 (45.4 to 69.0) |
| Week 24 | 54.8 (42.7 to 66.5) | 60.5 (48.6 to 71.6) |
| Week 28 | 53.6 (41.2 to 65.7) | 64.4 (52.3 to 75.3) |
| Week 32 | 57.6 (44.8 to 69.7) | 67.6 (55.2 to 78.5) |
| Week 36 | 67.2 (54.6 to 78.2) | 72.5 (60.4 to 82.5) |
| Week 40 | 61.2 (48.5 to 72.9) | 67.2 (54.3 to 78.4) |
| Week 44 | 70.5 (57.4 to 81.5) | 75.0 (63.0 to 84.7) |
| Week 48 | 60.0 (47.1 to 72.0) | 76.5 (64.6 to 85.9) |
| Week 52 | 64.5 (51.3 to 76.3) | 74.2 (61.5 to 84.5) |
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.
| days | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Time to ≥2-point Improvement From Baseline in WI-NRS Score | 13.0 (7.0 to 24.0) | 5.0 (4.0 to 8.0) |
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.
| days | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Time to ≥4-point Improvement From Baseline in WI-NRS Score | NA (60.0 to NA) | 26.0 (18.0 to 39.0) |
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 2 | 20.2 (12.4 to 30.1) | 36.1 (25.9 to 47.4) |
| Week 4 | 30.7 (21.3 to 41.4) | 56.3 (44.7 to 67.3) |
| Week 8 | 33.8 (23.0 to 46.0) | 64.9 (53.2 to 75.5) |
| Week 12 | 45.3 (33.8 to 57.3) | 65.8 (54.3 to 76.1) |
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 14 | 57.1 (44.7 to 68.9) | 76.6 (65.6 to 85.5) |
| Week 16 | 68.6 (56.4 to 79.1) | 78.6 (67.1 to 87.5) |
| Week 20 | 79.4 (67.9 to 88.3) | 77.6 (65.8 to 86.9) |
| Week 24 | 77.9 (66.2 to 87.1) | 80.0 (68.7 to 88.6) |
| Week 28 | 75.0 (62.6 to 85.0) | 82.4 (71.2 to 90.5) |
| Week 32 | 78.7 (66.3 to 88.1) | 81.0 (69.1 to 89.8) |
| Week 36 | 79.0 (66.8 to 88.3) | 82.8 (71.3 to 91.1) |
| Week 40 | 82.3 (70.5 to 90.8) | 83.1 (71.0 to 91.6) |
| Week 44 | 87.7 (76.3 to 94.9) | 84.1 (72.7 to 92.1) |
| Week 48 | 81.7 (69.6 to 90.5) | 85.7 (74.6 to 93.3) |
| Week 52 | 86.0 (74.2 to 93.7) | 86.0 (74.2 to 93.7) |
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 2 | -1.02 ± 0.187 | -1.70 ± 0.187 |
| Change from Baseline at Week 4 | -1.44 ± 0.242 | -2.58 ± 0.242 |
| Change from Baseline at Week 8 | -1.84 ± 0.265 | -2.94 ± 0.261 |
| Change from Baseline at Week 12 | -2.05 ± 0.276 | -3.19 ± 0.271 |
Participants assessed their worst level of prurigo nodularis-related skin pain during the past 24 hours on a scale of 0 ("no pain") to 10 ("worse imaginable pain"). The Skin Pain NRS score for baseline was determined by averaging the 7 daily NRS scores before Day 1 (i.e., Days -7 to -1) for all by-visit summaries. The by-visit Skin Pain NRS score for post-baseline visits was determined by averaging the 7 daily NRS scores before the visit day. Change from baseline was calculated as the post-baseline value minus the baseline value.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 14 | -2.88 ± 2.540 | -3.72 ± 2.726 |
| Change from Baseline at Week 16 | -3.20 ± 2.496 | -3.68 ± 2.691 |
| Change from Baseline at Week 20 | -3.76 ± 2.486 | -3.88 ± 2.792 |
| Change from Baseline at Week 24 | -3.84 ± 2.770 | -3.95 ± 2.839 |
| Change from Baseline at Week 28 | -3.81 ± 2.691 | -4.04 ± 2.705 |
| Change from Baseline at Week 32 | -3.95 ± 2.860 | -4.29 ± 2.785 |
| Change from Baseline at Week 36 | -4.28 ± 2.815 | -4.39 ± 2.760 |
| Change from Baseline at Week 40 | -4.29 ± 2.928 | -4.31 ± 2.693 |
| Change from Baseline at Week 44 | -4.72 ± 2.612 | -4.77 ± 2.705 |
| Change from Baseline at Week 48 | -4.51 ± 2.664 | -4.84 ± 2.632 |
| Change from Baseline at Week 52 | -4.72 ± 2.551 | -4.73 ± 2.617 |
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 nodularis 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 \[over 100 lesions\]). 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 | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 2 | 1.0 (0.0 to 5.6) | 2.1 (0.3 to 7.3) |
| Week 4 | 3.2 (0.7 to 9.0) | 8.4 (3.7 to 15.9) |
| Week 8 | 5.8 (1.9 to 13.0) | 15.6 (8.8 to 24.7) |
| Week 12 | 4.8 (1.3 to 11.7) | 17.8 (10.5 to 27.3) |
| Week 14 | 7.6 (2.8 to 15.8) | 22.5 (14.3 to 32.6) |
| Week 16 | 17.5 (9.9 to 27.6) | 29.9 (20.5 to 40.6) |
| Week 20 | 24.1 (15.1 to 35.0) | 29.4 (20.0 to 40.3) |
| Week 24 | 21.5 (13.1 to 32.2) | 32.5 (22.6 to 43.7) |
| Week 28 | 25.0 (15.8 to 36.3) | 33.3 (23.2 to 44.7) |
| Week 32 | 36.6 (25.5 to 48.9) | 37.7 (26.9 to 49.4) |
| Week 36 | 35.7 (24.6 to 48.1) | 38.2 (27.2 to 50.0) |
| Week 40 | 31.4 (20.9 to 43.6) | 36.1 (25.1 to 48.3) |
| Week 44 | 40.6 (28.9 to 53.1) | 39.2 (28.0 to 51.2) |
| Week 48 | 37.7 (26.3 to 50.2) | 35.6 (24.7 to 47.7) |
| Week 52 | 42.0 (30.2 to 54.5) | 46.5 (34.5 to 58.7) |
The Investigator Global Assessment for Activity of Chronic Prurigo (IGA-CPG-A) is an overall severity rating of chronic prurigo nodularis on a scale of 0 to 4: 0, clear (no pruriginous lesions have excoriations or crusts); 1, almost clear (very small proportion of pruriginous lesions have excoriations or crusts \[up to approximately 10% of all pruriginous lesions\]); 2, mild (minority of pruriginous lesions have excoriations or crusts \[approximately 11%-25% of all pruriginous lesions\]); 3, moderate (many pruriginous lesions have excoriations or crusts \[approximately 26%-75% of all pruriginous lesions\]); 4, severe (majority of pruriginous lesions have excoriations or crusts \[approximately 76%-100% of all pruriginous lesions\]).
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 2 | 1.0 (0.0 to 5.6) | 5.2 (1.7 to 11.6) |
| Week 4 | 5.3 (1.7 to 12.0) | 11.6 (5.9 to 19.8) |
| Week 8 | 14.0 (7.4 to 23.1) | 24.4 (16.0 to 34.6) |
| Week 12 | 10.7 (5.0 to 19.4) | 23.3 (15.1 to 33.4) |
| Week 14 | 17.7 (10.0 to 27.9) | 24.7 (16.2 to 35.0) |
| Week 16 | 31.3 (21.3 to 42.6) | 34.5 (24.6 to 45.4) |
| Week 20 | 27.8 (18.3 to 39.1) | 35.3 (25.2 to 46.4) |
| Week 24 | 39.2 (28.4 to 50.9) | 38.6 (28.1 to 49.9) |
| Week 28 | 39.5 (28.4 to 51.4) | 40.7 (29.9 to 52.2) |
| Week 32 | 40.8 (29.3 to 53.2) | 41.6 (30.4 to 53.4) |
| Week 36 | 41.4 (29.8 to 53.8) | 42.1 (30.9 to 54.0) |
| Week 40 | 41.4 (29.8 to 53.8) | 36.1 (25.1 to 48.3) |
| Week 44 | 44.9 (32.9 to 57.4) | 44.6 (33.0 to 56.6) |
| Week 48 | 46.4 (34.3 to 58.8) | 46.6 (34.8 to 58.6) |
| Week 52 | 50.7 (38.4 to 63.0) | 50.7 (38.6 to 62.8) |
The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 2 | 10.3 (5.1 to 18.1) | 14.4 (8.1 to 23.0) |
| Week 4 | 21.3 (13.5 to 30.9) | 26.3 (17.8 to 36.4) |
| Week 8 | 23.3 (14.8 to 33.6) | 32.2 (22.8 to 42.9) |
| Week 12 | 22.6 (14.2 to 33.0) | 32.2 (22.8 to 42.9) |
The extent and severity of prurigo nodularis was assessed via the PAS (version 1.2). The first 3 items are descriptive of the type, predominant type, distribution, and quantity of pruriginous lesions. The remaining 2 items of the PAS assess disease activity in terms of percentage (i.e., 0%, 1%-25%, 26%-50%, 51%-75%, and 76%-100%) of pruriginous lesions with excoriations/crusts on top (to reflect active scratching) and the percentage (i.e., 100%, 76%-99%, 51%-75%, 26%-50%, and 0%-25%) of healed pruriginous lesions in order to quantify change of prurigo nodularis skin lesions.
| percentage of participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Week 14 | 36.7 (26.1 to 48.3) | 37.1 (27.1 to 48.0) |
| Week 16 | 40.0 (29.2 to 51.6) | 44.8 (34.1 to 55.9) |
| Week 20 | 46.8 (35.5 to 58.4) | 45.9 (35.0 to 57.0) |
| Week 24 | 58.2 (46.6 to 69.2) | 49.4 (38.2 to 60.6) |
| Week 28 | 61.8 (50.0 to 72.8) | 48.1 (36.9 to 59.5) |
| Week 32 | 62.0 (49.7 to 73.2) | 51.9 (40.3 to 63.5) |
| Week 36 | 62.9 (50.5 to 74.1) | 57.9 (46.0 to 69.1) |
| Week 40 | 64.3 (51.9 to 75.4) | 62.5 (50.3 to 73.6) |
| Week 44 | 66.7 (54.3 to 77.6) | 68.9 (57.1 to 79.2) |
| Week 48 | 66.7 (54.3 to 77.6) | 67.1 (55.1 to 77.7) |
| Week 52 | 69.6 (57.3 to 80.1) | 66.2 (54.0 to 77.0) |
The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 2 | -4.47 ± 0.591 | -4.67 ± 0.576 |
| Change from Baseline at Week 4 | -5.37 ± 0.661 | -5.71 ± 0.650 |
| Change from Baseline at Week 8 | -5.17 ± 0.677 | -6.25 ± 0.661 |
| Change from Baseline at Week 12 | -4.65 ± 0.696 | -6.04 ± 0.675 |
The DLQI is a simple, 10-question, validated questionnaire to measure how much the skin problem has affected the participant over the previous 7 days. Each question was scored as: 3 (very much), 2 (a lot), 1 (a little), 0 (not at all or not relevant). The DLQI total score was calculated by summing the score of each question, resulting in a maximum of 30 and a minimum of 0. The higher the score, the more the quality of life was impaired. Total DLQI scores were categorized as follows: 0 to 1 (no effect), 2 to 5 (small effect), 6 to 10 (moderate effect), 11 to 20 (very large effect), and 21 to 30 (extremely large effect). Change from Baseline was calculated as the post-baseline visit minus the baseline visit.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 14 | -7.22 ± 6.179 | -6.91 ± 6.051 |
| Change from Baseline at Week 16 | -7.27 ± 6.210 | -7.47 ± 6.054 |
| Change from Baseline at Week 20 | -7.30 ± 6.406 | -6.94 ± 6.029 |
| Change from Baseline at Week 24 | -7.30 ± 5.801 | -7.27 ± 6.149 |
| Change from Baseline at Week 28 | -7.79 ± 6.198 | -7.58 ± 5.859 |
| Change from Baseline at Week 32 | -8.25 ± 5.769 | -8.00 ± 6.368 |
| Change from Baseline at Week 36 | -7.85 ± 5.863 | -8.19 ± 6.668 |
| Change from Baseline at Week 40 | -8.54 ± 6.561 | -7.76 ± 6.695 |
| Change from Baseline at Week 44 | -8.26 ± 6.417 | -7.99 ± 6.617 |
| Change from Baseline at Week 48 | -8.19 ± 6.790 | -8.10 ± 6.091 |
| Change from Baseline at Week 52 | -8.09 ± 6.401 | -8.09 ± 6.453 |
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 2 | 3.00 ± 1.948 | 7.90 ± 1.896 |
| Change from Baseline at Week 4 | 5.59 ± 1.940 | 8.90 ± 1.914 |
| Change from Baseline at Week 8 | 2.52 ± 2.189 | 9.83 ± 2.133 |
| Change from Baseline at Week 12 | 5.35 ± 2.235 | 11.26 ± 2.171 |
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 14 | 7.54 ± 19.216 | 10.31 ± 19.293 |
| Change from Baseline at Week 16 | 6.06 ± 20.263 | 11.96 ± 18.199 |
| Change from Baseline at Week 20 | 8.87 ± 18.598 | 12.35 ± 20.565 |
| Change from Baseline at Week 24 | 10.62 ± 17.560 | 11.83 ± 20.360 |
| Change from Baseline at Week 28 | 10.68 ± 17.102 | 13.28 ± 19.800 |
| Change from Baseline at Week 32 | 11.45 ± 16.056 | 13.01 ± 21.124 |
| Change from Baseline at Week 36 | 10.34 ± 16.395 | 13.40 ± 20.482 |
| Change from Baseline at Week 40 | 10.34 ± 17.984 | 14.79 ± 20.261 |
| Change from Baseline at Week 44 | 9.55 ± 17.923 | 14.94 ± 19.640 |
| Change from Baseline at Week 48 | 12.28 ± 17.664 | 13.58 ± 18.755 |
| Change from Baseline at Week 52 | 11.18 ± 16.621 | 12.51 ± 19.233 |
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 2, Mobility | -0.18 ± 0.912 | -0.07 ± 0.606 |
| Change from Baseline at Week 4, Mobility | -0.21 ± 0.742 | -0.08 ± 0.810 |
| Change from Baseline at Week 8, Mobility | -0.19 ± 0.813 | -0.08 ± 0.690 |
| Change from Baseline at Week 12, Mobility | -0.13 ± 0.973 | -0.14 ± 0.714 |
| Change from Baseline at Week 2, Self-care | -0.01 ± 0.533 | -0.05 ± 0.533 |
| Change from Baseline at Week 4, Self-care | -0.06 ± 0.505 | -0.07 ± 0.493 |
| Change from Baseline at Week 8, Self-care | -0.06 ± 0.581 | -0.06 ± 0.581 |
| Change from Baseline at Week 12, Self-care | 0.03 ± 0.636 | -0.06 ± 0.488 |
| Change from Baseline at Week 2, Usual activities | -0.19 ± 0.782 | -0.25 ± 0.714 |
| Change from Baseline at Week 4, Usual activities | -0.11 ± 0.785 | -0.21 ± 0.727 |
| Change from Baseline at Week 8, Usual activities | -0.23 ± 0.811 | -0.22 ± 0.726 |
| Change from Baseline at Week 12, Usual activities | -0.05 ± 0.727 | -0.27 ± 0.723 |
| Change from Baseline at Week 2, Pain/discomfort | -0.42 ± 1.136 | -0.56 ± 0.953 |
| Change from Baseline at Week 4, Pain/discomfort | -0.67 ± 1.132 | -0.67 ± 1.039 |
| Change from Baseline at Week 8, Pain/discomfort | -0.56 ± 1.112 | -0.66 ± 1.080 |
| Change from Baseline at Week 12, Pain/discomfort | -0.54 ± 1.078 | -0.70 ± 1.074 |
| Change from Baseline at Week 2, Anxiety/depression | -0.20 ± 1.013 | -0.24 ± 0.919 |
| Change from Baseline at Week 4, Anxiety/depression | -0.28 ± 1.102 | -0.34 ± 0.996 |
| Change from Baseline at Week 8, Anxiety/depression | -0.19 ± 1.045 | -0.37 ± 0.934 |
| Change from Baseline at Week 12, Anxiety/depression | -0.24 ± 1.105 | -0.32 ± 0.941 |
The EQ-5D-5L is a standardized instrument for use as a measure of health outcome. The EQ-5D-5L consists of 2 sections: the EQ-5D descriptive system and the EQ VAS. The descriptive system comprises 5 dimensions: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 response levels, which are coded by single-digit numbers: 1 = no problems, 2 = slight problems, 3 = moderate problems, 4 = severe problems, 5 = unable to/extreme problems. The EQ VAS records the participant's self-rated health on a vertical VAS (0-100), on which the endpoints are labeled "the best health you can imagine" (100 score) and "the worst health you can imagine" (0 score). Change from Baseline was calculated as the post-baseline value minus the baseline value.
| scores on a scale | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| Change from Baseline at Week 14, Mobility | -0.05 ± 0.728 | -0.10 ± 0.872 |
| Change from Baseline at Week 16, Mobility | -0.17 ± 0.657 | -0.11 ± 0.772 |
| Change from Baseline at Week 20, Mobility | -0.21 ± 0.789 | -0.17 ± 0.746 |
| Change from Baseline at Week 24, Mobility | -0.28 ± 0.873 | -0.10 ± 0.695 |
| Change from Baseline at Week 28, Mobility | -0.14 ± 0.918 | -0.14 ± 0.833 |
| Change from Baseline at Week 32, Mobility | -0.15 ± 0.957 | -0.20 ± 0.860 |
| Change from Baseline at Week 36, Mobility | -0.19 ± 0.941 | -0.14 ± 0.787 |
| Change from Baseline at Week 40, Mobility | -0.27 ± 0.863 | -0.13 ± 0.815 |
| Change from Baseline at Week 44, Mobility | -0.11 ± 0.994 | -0.11 ± 0.815 |
| Change from Baseline at Week 48, Mobility | -0.24 ± 0.889 | -0.11 ± 0.881 |
| Change from Baseline at Week 52, Mobility | -0.26 ± 0.900 | -0.06 ± 0.899 |
| Change from Baseline at Week 14, Self-care | 0.04 ± 0.552 | 0.02 ± 0.606 |
| Change from Baseline at Week 16, Self-care | 0.00 ± 0.562 | -0.11 ± 0.512 |
| Change from Baseline at Week 20, Self-care | 0.03 ± 0.565 | -0.06 ± 0.478 |
| Change from Baseline at Week 24, Self-care | -0.07 ± 0.499 | 0.01 ± 0.470 |
| Change from Baseline at Week 28, Self-care | -0.08 ± 0.493 | -0.09 ± 0.432 |
| Change from Baseline at Week 32, Self-care | -0.10 ± 0.431 | -0.08 ± 0.517 |
| Change from Baseline at Week 36, Self-care | -0.10 ± 0.465 | -0.07 ± 0.536 |
| Change from Baseline at Week 40, Self-care | -0.15 ± 0.469 | -0.06 ± 0.535 |
| Change from Baseline at Week 44, Self-care | -0.09 ± 0.420 | -0.06 ± 0.471 |
| Change from Baseline at Week 48, Self-care | -0.10 ± 0.465 | -0.08 ± 0.496 |
| Change from Baseline at Week 52, Self-care | -0.11 ± 0.434 | -0.07 ± 0.491 |
| Change from Baseline at Week 14, Usual activities | -0.13 ± 0.838 | -0.23 ± 0.769 |
| Change from Baseline at Week 16, Usual activities | -0.21 ± 0.800 | -0.27 ± 0.730 |
| Change from Baseline at Week 20, Usual activities | -0.26 ± 0.806 | -0.30 ± 0.777 |
| Change from Baseline at Week 24, Usual activities | -0.25 ± 0.802 | -0.19 ± 0.685 |
| Change from Baseline at Week 28, Usual activities | -0.26 ± 0.834 | -0.32 ± 0.845 |
| Change from Baseline at Week 32, Usual activities | -0.36 ± 0.792 | -0.32 ± 0.846 |
| Change from Baseline at Week 36, Usual activities | -0.21 ± 0.789 | -0.33 ± 0.647 |
| Change from Baseline at Week 40, Usual activities | -0.33 ± 0.746 | -0.23 ± 0.783 |
| Change from Baseline at Week 44, Usual activities | -0.36 ± 0.671 | -0.26 ± 0.750 |
| Change from Baseline at Week 48, Usual activities | -0.28 ± 0.755 | -0.31 ± 0.781 |
| Change from Baseline at Week 52, Usual activities | -0.32 ± 0.807 | -0.24 ± 0.806 |
| Change from Baseline at Week 14, Pain/discomfort | -0.78 ± 1.040 | -0.68 ± 1.056 |
| Change from Baseline at Week 16, Pain/discomfort | -0.86 ± 0.969 | -0.73 ± 1.084 |
| Change from Baseline at Week 20, Pain/discomfort | -0.80 ± 0.924 | -0.71 ± 1.215 |
| Change from Baseline at Week 24, Pain/discomfort | -0.92 ± 0.906 | -0.83 ± 1.098 |
| Change from Baseline at Week 28, Pain/discomfort | -0.95 ± 0.956 | -0.90 ± 0.988 |
| Change from Baseline at Week 32, Pain/discomfort | -0.97 ± 0.953 | -0.99 ± 1.116 |
| Change from Baseline at Week 36, Pain/discomfort | -0.99 ± 1.022 | -0.96 ± 1.098 |
| Change from Baseline at Week 40, Pain/discomfort | -1.00 ± 1.015 | -1.03 ± 1.063 |
| Change from Baseline at Week 44, Pain/discomfort | -0.98 ± 1.015 | -0.97 ± 0.978 |
| Change from Baseline at Week 48, Pain/discomfort | -1.04 ± 0.960 | -0.99 ± 1.094 |
| Change from Baseline at Week 52, Pain/discomfort | -1.06 ± 0.990 | -0.86 ± 1.158 |
| Change from Baseline at Week 14, Anxiety/depression | -0.25 ± 1.179 | -0.36 ± 1.030 |
| Change from Baseline at Week 16, Anxiety/depression | -0.35 ± 1.167 | -0.46 ± 0.970 |
| Change from Baseline at Week 20, Anxiety/depression | -0.33 ± 0.971 | -0.36 ± 0.932 |
| Change from Baseline at Week 24, Anxiety/depression | -0.34 ± 0.960 | -0.31 ± 0.902 |
| Change from Baseline at Week 28, Anxiety/depression | -0.33 ± 0.958 | -0.33 ± 0.892 |
| Change from Baseline at Week 32, Anxiety/depression | -0.39 ± 0.887 | -0.42 ± 0.951 |
| Change from Baseline at Week 36, Anxiety/depression | -0.39 ± 1.029 | -0.52 ± 1.015 |
| Change from Baseline at Week 40, Anxiety/depression | -0.43 ± 0.891 | -0.50 ± 0.959 |
| Change from Baseline at Week 44, Anxiety/depression | -0.33 ± 1.028 | -0.43 ± 0.901 |
| Change from Baseline at Week 48, Anxiety/depression | -0.39 ± 0.937 | -0.39 ± 0.881 |
| Change from Baseline at Week 52, Anxiety/depression | -0.39 ± 0.892 | -0.41 ± 0.893 |
An adverse event (AE) was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
| Participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 37 | 31 |
An AE was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.
| Participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| DBVC Period: Number of Participants With Any ≥Grade 3 TEAE | 5 | 4 |
An AE was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug.
| Participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| OLE Period: Number of Participants With Any TEAE | 44 | 56 |
An AE was defined as 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 have been any unfavorable or unintended sign (including an abnormal laboratory finding), symptom, or disease (new or exacerbated) temporally associated with the use of study cream. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of TEAEs was assessed using CTCAE version 5.0 Grades 1 through 5. The investigator made an assessment of intensity for each TEAE and assigned it to one of the following categories: Grade 1, mild; Grade 2, moderate; Grade 3, severe or medically significant but not immediately life threatening; Grade 4, life-threatening consequences; Grade 5, fatal.
| Participants | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|
| OLE Period: Number of Participants With Any ≥Grade 3 TEAE | 5 | 6 |
Collected over up to Week 56. Non-serious events are listed at a 5% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Vehicle BID | 0/103 (0%) | 5/103 (4.9%) | 6/103 (5.8%) |
| INCB018424 1.5% BID | 0/184 (0%) | 14/184 (7.6%) | 33/184 (17.9%) |
| Event | Vehicle BID | INCB018424 1.5% BID |
|---|---|---|
| PneumoniaInfections and infestations | 1/103 | 2/184 |
| COVID-19Infections and infestations | 1/103 | 0/184 |
| Cerebrovascular accidentNervous system disorders | 1/103 | 0/184 |
| NephrolithiasisRenal and urinary disorders | 1/103 | 1/184 |
| NeurodermatitisSkin and subcutaneous tissue disorders | 1/103 | 1/184 |
| Urinary tract infectionInfections and infestations | 1/103 | 0/184 |
| Abscess neckInfections and infestations | 0/103 | 1/184 |
| AnaemiaBlood and lymphatic system disorders | 0/103 | 1/184 |
| Atrial flutterCardiac disorders | 0/103 | 1/184 |
| Borderline personality disorderPsychiatric disorders | 0/103 | 1/184 |
| Event | Vehicle BID | INCB018424 1.5% BID |
|---|---|---|
| NasopharyngitisInfections and infestations | 2/103 | 23/184 |
| COVID-19Infections and infestations | 4/103 | 11/184 |
| Age, Continuous(years) | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Total |
|---|---|---|---|
| Mean | 61.0 ± 13.85 | 59.1 ± 13.78 | 60.1 ± 13.81 |
| Sex: Female, Male(Participants) | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Total |
|---|---|---|---|
| Female | 65 | 64 | 129 |
| Male | 38 | 37 | 75 |
| Race/Ethnicity, Customized(Participants) | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Total |
|---|---|---|---|
| White/Caucasian | 84 | 87 | 171 |
| Black or African American | 9 | 7 | 16 |
| Asian and Others | 9 | 5 | 14 |
| Missing | 1 | 2 | 3 |
| Race/Ethnicity, Customized(Participants) | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Total |
|---|---|---|---|
| Hispanic or Latino | 14 | 18 | 32 |
| Not Hispanic or Latino | 88 | 80 | 168 |
| Unknown | 0 | 1 | 1 |
| Missing | 1 | 2 | 3 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: Yes — Incyte shares data with qualified external researchers after a research proposal is submitted. These requests are reviewed and approved by a review panel on the basis of scientific merit. All data provided is anonymized to respect the privacy of patients who have participated in the trial in line with applicable laws and regulations. The trial data availability is according to the criteria and process described on https://www.incyte.com/our-company/compliance-and-transparency
Supporting information: Study protocol, Statistical analysis plan
Time frame: Data will be shared after the primary publication or 2 years after the study has ended for market authorized products and indications.
Access criteria: Data from eligible studies will be shared with qualified researchers according to the criteria and process described in the Data Sharing section of the www.incyteclinicaltrials.com website. For approved requests, the researchers will be granted access to anonymized data under the terms of a data sharing agreement.
Data sharing details ↗ · www.incyte.com
This study is completed, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: Ruxolitinib