Prurigo Nodularis
Conditions
Keywords
PN, INCB18424-320, INCB18424, Prurigo, Prurigo Nodularis, Skin Diseases, Dermatitis, ruxolitinib
Brief summary
The purpose of this study is to evaluate the safety and tolerability of Ruxolitinib cream in participants with Prurigo Nodularis (PN).
Detailed description
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.
Interventions
DRUGRuxolitinib Cream
Ruxolitinib cream 1.5% twice daily (BID) during the continuous and open label treatment period.
DRUGVehicle Cream
Ruxolitinib matching vehicle cream 1.5% twice daily (BID) during the vehicle-controlled period.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 99 Years
Healthy volunteers
No
Inclusion criteria
* Clinical diagnosis of PN ≥ 3 months before screening. * ≥ 6 pruriginous lesions on ≥ 2 different body areas (such as right and left leg) at screening and baseline having a treatment area \<20% BSA. * IGA-CPG-S score of ≥ 2 at screening and baseline. * Baseline PN-related WI-NRS score ≥ 7. * Willingness to avoid pregnancy or fathering children.
Exclusion criteria
* Chronic pruritus due to a condition other than PN * Total estimated BSA treatment area (excluding the scalp) \> 20%. * Neuropathic and psychogenic pruritus * Active atopic dermatitis lesions within 3 months of screening and baseline. * Uncontrolled thyroid function * Concurrent skin or other serious or unstable medical conditions which may interfere with the evaluation of PN such as immunocompromised status, acute/chronic infections, active malignancy, history of TB, history of DVT/VTE, etc Protocol defined abnormal laboratory results. * Use of any protocol-defined prohibited medication unless a washout is completed or use of medication known to cause itching. * Psoralen and ultraviolet A or ultraviolet B therapy within 4 weeks before baseline or Ultraviolet light therapy or prolonged exposure to natural or artificial sources of ultraviolet radiation (within 2 weeks before baseline * Pregnant or lactating, or considering pregnancy. * History of alcoholism or drug addiction within 1 year * Known allergy or reaction to any of the components of the study drug. * Committed to a mental health institution by virtue of an order issued either by the judicial or the administrative authorities. * Employees of the sponsor or investigator or otherwise dependents of them. * The following participants are excluded in France: 1. Vulnerable populations according to article L.1121-6 of the French Public Health Code. 2. Adults under legal protection or who are unable to express their consent per article L.1121-8 of the French Public Health Code. 3. Individuals not affiliated with the social security system.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 \[over 100 lesions\]). |
| 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 \[over 100 lesions\]). |
| WI-NRS4 Response at 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| 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. |
| DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Baseline; up to Week 12 | 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. |
| OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Baseline; up to Week 52 | 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. |
| DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Baseline; up to Week 12 | 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. |
| OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Baseline; up to Week 52 | OLE Period: Change from baseline in Skin Pain NRS score at each post-baseline visit |
| Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Baseline; up to Week 52 | 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. |
| 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. |
| DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Baseline; up to Week 12 | 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. |
| OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Baseline; up to Week 52 | 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. |
| DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Baseline; up to Week 12 | 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. |
| OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Baseline; up to Week 52 | 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. |
| 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 | Baseline; up to Week 12 | 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. |
| OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Baseline; up to Week 52 | 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. |
| DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Baseline; up to Week 12 | 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. |
| OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Baseline; up to Week 52 | 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. |
| DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | up to Week 12 | 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. |
| DBVC Period: Number of Participants With Any ≥Grade 3 TEAE | up to Week 12 | 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. |
| OLE Period: Number of Participants With Any TEAE | from beginning of Week 13 up to Week 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. |
| OLE Period: Number of Participants With Any ≥Grade 3 TEAE | from beginning of Week 13 up to Week 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. |
| Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Baseline; up to Week 52 | 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 \[approximately 76%-100% of all pruriginous lesions\]). |
Countries
Australia, Austria, Bulgaria, Canada, Denmark, France, Germany, Italy, Poland, South Korea, Spain, Switzerland, United States
Participant flow
Pre-assignment details
Data collected through a cut off date of 30 December 2024 have been included in this summary. Participants were enrolled at 190 sites in Australia, Austria, Bulgaria, Canada, France, Germany, Italy, South Korea, Poland, Spain, Switzerland, and the United States.
Participants by arm
| Arm | Count |
|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID Participants applied vehicle cream twice daily (BID) through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 centimeter (cm) area surrounding each lesion in the Double-blind, Vehicle-controlled (DBVC) Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (Investigator Global Assessment for Stage of Chronic Prurigo \[IGA-CPG-S\] score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week Open-label Extension (OLE) Period. Participants randomized to vehicle cream at baseline switched to ruxolitinib 1.5% cream BID and received treatment through Week 52. During the OLE period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching. | 94 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID Participants applied ruxolitinib 1.5% cream BID through Week 12 to all pruriginous lesions identified at baseline plus an approximate 1 cm area surrounding each lesion in the DBVC Period. At Week 12, the investigator assessed whether the participant required continuation of therapy (IGA-CPG-S score ≥1 and/or the presence of prurigo nodularis-related itching). Those participants who completed 12 weeks of treatment with no safety concerns were eligible to enter the 40-week OLE Period. Participants randomized to ruxolitinib 1.5% cream at baseline remained on ruxolitinib 1.5% cream BID through Week 52. During the OLE Period, participants applied ruxolitinib 1.5% cream BID to prurigo nodularis-affected areas plus an approximate 1 cm area surrounding each pruriginous lesion and/or areas of prurigo nodularis-related itching. | 96 |
| Total | 190 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| 12-week DBVC Period | Lack of Efficacy | 2 | 1 |
| 12-week DBVC Period | Lost to Follow-up | 0 | 2 |
| 12-week DBVC Period | Protocol Violation | 2 | 4 |
| 12-week DBVC Period | Withdrawal by Subject | 7 | 6 |
| 40-week OLE Period | Extended Travel | 0 | 1 |
| 40-week OLE Period | Lack of Efficacy | 0 | 1 |
| 40-week OLE Period | Lost to Follow-up | 1 | 4 |
| 40-week OLE Period | Ongoing | 66 | 59 |
| 40-week OLE Period | Withdrawal by Subject | 2 | 7 |
Baseline characteristics
| Characteristic | Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Total | Vehicle Cream BID to Ruxolitinib 1.5% Cream BID |
|---|---|---|---|
| Age, Continuous | 56.2 years STANDARD_DEVIATION 14.83 | 56.6 years STANDARD_DEVIATION 15.08 | 57.1 years STANDARD_DEVIATION 15.39 |
| Race/Ethnicity, Customized American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized Asian | 13 Participants | 21 Participants | 8 Participants |
| Race/Ethnicity, Customized Black or African American | 2 Participants | 6 Participants | 4 Participants |
| Race/Ethnicity, Customized Hispanic or Latino | 4 Participants | 13 Participants | 9 Participants |
| Race/Ethnicity, Customized Missing | 1 Participants | 6 Participants | 0 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 90 Participants | 175 Participants | 85 Participants |
| Race/Ethnicity, Customized Unknown or Not Reported | 1 Participants | 1 Participants | 0 Participants |
| Race/Ethnicity, Customized White/Caucasian | 75 Participants | 156 Participants | 81 Participants |
| Sex: Female, Male Female | 55 Participants | 106 Participants | 51 Participants |
| Sex: Female, Male Male | 41 Participants | 84 Participants | 43 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 94 | 0 / 178 |
| other Total, other adverse events | 4 / 94 | 19 / 178 |
| serious Total, serious adverse events | 0 / 94 | 4 / 178 |
Outcome results
Primary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Week 12 | 36.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Week 12 | 40.0 percentage of participants |
p-value: 0.585995% CI: [0.651, 2.143]Cochran-Mantel-Haenszel
95% CI: [-9.84, 17.46]
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Mobility | -0.15 scores on a scale | Standard Deviation 0.736 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Mobility | -0.24 scores on a scale | Standard Deviation 0.547 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Mobility | -0.16 scores on a scale | Standard Deviation 0.648 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Mobility | -0.16 scores on a scale | Standard Deviation 0.689 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Self-care | -0.06 scores on a scale | Standard Deviation 0.793 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Self-care | -0.20 scores on a scale | Standard Deviation 0.628 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Self-care | -0.17 scores on a scale | Standard Deviation 0.739 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Self-care | -0.17 scores on a scale | Standard Deviation 0.601 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Usual activities | -0.25 scores on a scale | Standard Deviation 0.962 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Usual activities | -0.30 scores on a scale | Standard Deviation 0.833 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Usual activities | -0.19 scores on a scale | Standard Deviation 0.819 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Usual activities | -0.24 scores on a scale | Standard Deviation 0.759 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Pain/discomfort | -0.50 scores on a scale | Standard Deviation 0.871 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Pain/discomfort | -0.66 scores on a scale | Standard Deviation 0.815 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Pain/discomfort | -0.80 scores on a scale | Standard Deviation 1.125 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Pain/discomfort | -0.77 scores on a scale | Standard Deviation 1.108 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Anxiety/depression | -0.35 scores on a scale | Standard Deviation 0.872 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Anxiety/depression | -0.44 scores on a scale | Standard Deviation 0.895 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Anxiety/depression | -0.45 scores on a scale | Standard Deviation 0.863 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Anxiety/depression | -0.45 scores on a scale | Standard Deviation 0.859 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Anxiety/depression | -0.44 scores on a scale | Standard Deviation 0.742 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Mobility | -0.02 scores on a scale | Standard Deviation 0.621 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Usual activities | -0.12 scores on a scale | Standard Deviation 0.697 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Mobility | -0.02 scores on a scale | Standard Deviation 0.431 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Pain/discomfort | -1.04 scores on a scale | Standard Deviation 1.101 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Mobility | -0.07 scores on a scale | Standard Deviation 0.431 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Usual activities | -0.19 scores on a scale | Standard Deviation 0.792 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Mobility | 0.04 scores on a scale | Standard Deviation 0.697 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Anxiety/depression | -0.46 scores on a scale | Standard Deviation 0.791 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Self-care | -0.02 scores on a scale | Standard Deviation 0.426 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Pain/discomfort | -0.72 scores on a scale | Standard Deviation 0.988 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Self-care | -0.07 scores on a scale | Standard Deviation 0.334 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Anxiety/depression | -0.43 scores on a scale | Standard Deviation 0.796 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Self-care | 0.01 scores on a scale | Standard Deviation 0.5 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Pain/discomfort | -0.89 scores on a scale | Standard Deviation 0.982 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 12, Self-care | 0.01 scores on a scale | Standard Deviation 0.536 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Anxiety/depression | -0.41 scores on a scale | Standard Deviation 0.849 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 2, Usual activities | -0.10 scores on a scale | Standard Deviation 0.784 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 8, Pain/discomfort | -0.94 scores on a scale | Standard Deviation 1.039 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 4, Usual activities | -0.23 scores on a scale | Standard Deviation 0.773 |
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 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 | Change from Baseline at Week 2 | 4.43 scores on a scale | Standard Error 1.791 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 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 | Change from Baseline at Week 4 | 6.52 scores on a scale | Standard Error 1.738 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 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 | hange from Baseline at Week 8 | 6.02 scores on a scale | Standard Error 1.681 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | 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 | Change from Baseline at Week 12 | 7.07 scores on a scale | Standard Error 1.816 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 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 | Change from Baseline at Week 12 | 8.48 scores on a scale | Standard Error 1.814 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 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 | Change from Baseline at Week 2 | 7.02 scores on a scale | Standard Error 1.776 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 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 | hange from Baseline at Week 8 | 8.84 scores on a scale | Standard Error 1.672 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | 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 | Change from Baseline at Week 4 | 8.64 scores on a scale | Standard Error 1.727 |
Comparison: Week 2p-value: 0.305395% CI: [-2.38, 7.57]Mixed Model for Repeated Measures
Comparison: Week 4p-value: 0.389395% CI: [-2.72, 6.95]Mixed Model for Repeated Measures
Comparison: Week 8p-value: 0.235795% CI: [-1.86, 7.5]Mixed Model for Repeated Measures
Comparison: Week 12p-value: 0.583995% CI: [-3.66, 6.47]Mixed Model for Repeated Measures
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 2 | -1.06 scores on a scale | Standard Error 0.177 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 4 | -1.80 scores on a scale | Standard Error 0.229 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 8 | -2.39 scores on a scale | Standard Error 0.262 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 12 | -2.97 scores on a scale | Standard Error 0.286 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 12 | -3.57 scores on a scale | Standard Error 0.284 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 2 | -1.86 scores on a scale | Standard Error 0.176 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 8 | -3.26 scores on a scale | Standard Error 0.26 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 4 | -2.68 scores on a scale | Standard Error 0.225 |
Comparison: Week 2p-value: 0.001695% CI: [-1.29, -0.31]Mixed Model for Repeated Measures
Comparison: Week 4p-value: 0.007195% CI: [-1.51, -0.24]Mixed Model for Repeated Measures
Comparison: Week 8p-value: 0.019895% CI: [-1.6, -0.14]Mixed Model for Repeated Measures
Comparison: Week 12p-value: 0.138495% CI: [-1.4, 0.2]Mixed Model for Repeated Measures
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 2 | -3.81 scores on a scale | Standard Error 0.528 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 4 | -4.75 scores on a scale | Standard Error 0.573 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 8 | -5.43 scores on a scale | Standard Error 0.638 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 12 | -5.72 scores on a scale | Standard Error 0.668 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 12 | -6.38 scores on a scale | Standard Error 0.665 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 2 | -5.14 scores on a scale | Standard Error 0.524 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 8 | -6.29 scores on a scale | Standard Error 0.634 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in the Dermatology Life Quality Index (DLQI) Total Score at Each Post-baseline Visit | Change from Baseline at Week 4 | -5.93 scores on a scale | Standard Error 0.57 |
Comparison: Week 2p-value: 0.075995% CI: [-2.8, 0.14]Mixed Model for Repeated Measures
Comparison: Week 4p-value: 0.144795% CI: [-2.78, 0.41]Mixed Model for Repeated Measures
Comparison: Week 8p-value: 0.339595% CI: [-2.64, 0.91]Mixed Model for Repeated Measures
Comparison: Week 12p-value: 0.479495% CI: [-2.53, 1.19]Mixed Model for Repeated Measures
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 2 | -1.14 scores on a scale | Standard Error 0.174 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 4 | -1.86 scores on a scale | Standard Error 0.216 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 8 | -2.60 scores on a scale | Standard Error 0.261 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 12 | -3.06 scores on a scale | Standard Error 0.282 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 12 | -3.94 scores on a scale | Standard Error 0.278 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 2 | -2.01 scores on a scale | Standard Error 0.172 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 8 | -3.68 scores on a scale | Standard Error 0.257 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 4 | -2.90 scores on a scale | Standard Error 0.212 |
Comparison: Week 12p-value: 0.028795% CI: [-1.65, -0.09]Mixed Model for Repeated Measures
Comparison: Week 2p-value: 0.000595% CI: [-1.35, -0.39]Mixed Model for Repeated Measures (MMRM)
Comparison: Week 4p-value: 0.000795% CI: [-1.64, -0.45]Mixed Model for Repeated Measures
Comparison: Week 8p-value: 0.003695% CI: [-1.81, -0.36]Mixed Model for Repeated Measures
Secondary
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
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Number of Participants With Any ≥Grade 3 TEAE | 1 Participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Number of Participants With Any ≥Grade 3 TEAE | 1 Participants |
Secondary
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
Population: Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 22 Participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Number of Participants With Any Treatment-emergent Adverse Event (TEAE) | 27 Participants |
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 2 | 9.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 4 | 16.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 8 | 20.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 12 | 31.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 12 | 42.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 2 | 12.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 8 | 39.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With >75% Healed Lesions From Prurigo Activity Score (PAS) at Each Postbaseline Visit | Week 4 | 21.5 percentage of participants |
Secondary
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
Population: ITT Population. Participants with a baseline Skin Pain NRS score ≥2 and available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 2 | 22.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 4 | 34.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 8 | 48.1 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 12 | 60.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 12 | 73.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 2 | 40.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 8 | 65.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | DBVC Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 4 | 58.6 percentage of participants |
Secondary
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
Population: Open-label Extension Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Mobility | -0.17 scores on a scale | Standard Deviation 0.578 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Mobility | -0.12 scores on a scale | Standard Deviation 0.682 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Mobility | -0.17 scores on a scale | Standard Deviation 0.557 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Mobility | -0.15 scores on a scale | Standard Deviation 0.46 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Mobility | -0.15 scores on a scale | Standard Deviation 0.51 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Mobility | -0.17 scores on a scale | Standard Deviation 0.537 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Mobility | -0.06 scores on a scale | Standard Deviation 0.359 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Mobility | -0.17 scores on a scale | Standard Deviation 0.576 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Mobility | -0.19 scores on a scale | Standard Deviation 0.68 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Mobility | -0.28 scores on a scale | Standard Deviation 0.669 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Mobility | -0.29 scores on a scale | Standard Deviation 0.47 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Self-care | -0.20 scores on a scale | Standard Deviation 0.637 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Self-care | -0.19 scores on a scale | Standard Deviation 0.612 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Self-care | -0.10 scores on a scale | Standard Deviation 0.775 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Self-care | -0.12 scores on a scale | Standard Deviation 0.615 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Self-care | -0.11 scores on a scale | Standard Deviation 0.477 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Self-care | -0.12 scores on a scale | Standard Deviation 0.67 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Self-care | 0.06 scores on a scale | Standard Deviation 0.68 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Self-care | -0.04 scores on a scale | Standard Deviation 0.367 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Self-care | -0.05 scores on a scale | Standard Deviation 0.384 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Self-care | 0.00 scores on a scale | Standard Deviation 0.485 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Self-care | 0.00 scores on a scale | Standard Deviation 0.354 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Usual activities | -0.28 scores on a scale | Standard Deviation 0.727 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Usual activities | -0.31 scores on a scale | Standard Deviation 0.739 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Usual activities | -0.25 scores on a scale | Standard Deviation 0.968 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Usual activities | -0.19 scores on a scale | Standard Deviation 0.841 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Usual activities | -0.11 scores on a scale | Standard Deviation 0.84 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Usual activities | -0.26 scores on a scale | Standard Deviation 0.767 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Usual activities | -0.03 scores on a scale | Standard Deviation 0.948 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Usual activities | -0.13 scores on a scale | Standard Deviation 1.14 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Usual activities | -0.14 scores on a scale | Standard Deviation 0.91 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Usual activities | -0.28 scores on a scale | Standard Deviation 0.958 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Usual activities | -0.06 scores on a scale | Standard Deviation 1.029 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Pain/discomfort | -1.00 scores on a scale | Standard Deviation 1.078 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Pain/discomfort | -1.07 scores on a scale | Standard Deviation 1.102 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Pain/discomfort | -1.15 scores on a scale | Standard Deviation 1.102 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Pain/discomfort | -1.15 scores on a scale | Standard Deviation 0.998 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Pain/discomfort | -1.21 scores on a scale | Standard Deviation 1.041 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Pain/discomfort | -1.02 scores on a scale | Standard Deviation 1 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Pain/discomfort | -0.94 scores on a scale | Standard Deviation 1.124 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Pain/discomfort | -1.17 scores on a scale | Standard Deviation 1.154 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Pain/discomfort | -1.05 scores on a scale | Standard Deviation 1.284 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Pain/discomfort | -1.11 scores on a scale | Standard Deviation 1.451 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Pain/discomfort | -1.18 scores on a scale | Standard Deviation 1.334 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Anxiety/depression | -0.51 scores on a scale | Standard Deviation 0.921 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Anxiety/depression | -0.49 scores on a scale | Standard Deviation 0.91 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Anxiety/depression | -0.48 scores on a scale | Standard Deviation 0.93 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Anxiety/depression | -0.54 scores on a scale | Standard Deviation 0.999 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Anxiety/depression | -0.51 scores on a scale | Standard Deviation 0.882 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Anxiety/depression | -0.57 scores on a scale | Standard Deviation 0.859 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Anxiety/depression | -0.48 scores on a scale | Standard Deviation 0.811 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Anxiety/depression | -0.57 scores on a scale | Standard Deviation 0.945 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Anxiety/depression | -0.71 scores on a scale | Standard Deviation 1.102 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Anxiety/depression | -0.83 scores on a scale | Standard Deviation 0.985 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Anxiety/depression | -0.94 scores on a scale | Standard Deviation 0.966 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Usual activities | -0.15 scores on a scale | Standard Deviation 0.63 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Mobility | -0.01 scores on a scale | Standard Deviation 0.686 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Pain/discomfort | -1.12 scores on a scale | Standard Deviation 0.781 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Mobility | -0.03 scores on a scale | Standard Deviation 0.718 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Usual activities | -0.14 scores on a scale | Standard Deviation 0.591 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Mobility | -0.07 scores on a scale | Standard Deviation 0.525 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Anxiety/depression | -0.38 scores on a scale | Standard Deviation 0.768 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Mobility | -0.08 scores on a scale | Standard Deviation 0.549 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Usual activities | 0.12 scores on a scale | Standard Deviation 0.485 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Mobility | -0.06 scores on a scale | Standard Deviation 0.485 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Pain/discomfort | -1.47 scores on a scale | Standard Deviation 0.915 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Mobility | -0.03 scores on a scale | Standard Deviation 0.28 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Usual activities | 0.06 scores on a scale | Standard Deviation 0.429 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Mobility | -0.04 scores on a scale | Standard Deviation 0.331 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Anxiety/depression | -0.67 scores on a scale | Standard Deviation 0.816 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Mobility | -0.06 scores on a scale | Standard Deviation 0.429 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Usual activities | 0.07 scores on a scale | Standard Deviation 0.458 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Mobility | 0.00 scores on a scale | Standard Deviation 0.354 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Pain/discomfort | -1.15 scores on a scale | Standard Deviation 0.899 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Mobility | 0.00 scores on a scale | Standard Deviation 0.378 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Usual activities | 0.00 scores on a scale | Standard Deviation 0.408 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Mobility | -0.08 scores on a scale | Standard Deviation 0.277 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Anxiety/depression | -0.33 scores on a scale | Standard Deviation 0.955 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Self-care | -0.03 scores on a scale | Standard Deviation 0.413 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Pain/discomfort | -1.20 scores on a scale | Standard Deviation 1.009 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Self-care | -0.08 scores on a scale | Standard Deviation 0.414 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Anxiety/depression | -0.44 scores on a scale | Standard Deviation 0.806 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Self-care | 0.05 scores on a scale | Standard Deviation 0.711 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Pain/discomfort | -1.13 scores on a scale | Standard Deviation 1.055 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Self-care | -0.08 scores on a scale | Standard Deviation 0.385 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Anxiety/depression | -0.71 scores on a scale | Standard Deviation 0.92 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Self-care | -0.09 scores on a scale | Standard Deviation 0.408 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Pain/discomfort | -1.17 scores on a scale | Standard Deviation 1.094 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Self-care | -0.15 scores on a scale | Standard Deviation 0.432 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Anxiety/depression | -0.46 scores on a scale | Standard Deviation 0.895 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Self-care | -0.11 scores on a scale | Standard Deviation 0.315 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Pain/discomfort | -1.15 scores on a scale | Standard Deviation 1.045 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Self-care | -0.06 scores on a scale | Standard Deviation 0.243 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Anxiety/depression | -0.29 scores on a scale | Standard Deviation 0.713 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 44, Self-care | 0.00 scores on a scale | Standard Deviation 0 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Pain/discomfort | -1.21 scores on a scale | Standard Deviation 1.062 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 48, Self-care | -0.07 scores on a scale | Standard Deviation 0.258 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Anxiety/depression | -0.43 scores on a scale | Standard Deviation 0.819 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Self-care | -0.08 scores on a scale | Standard Deviation 0.277 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 32, Pain/discomfort | -1.23 scores on a scale | Standard Deviation 1.111 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 14, Usual activities | -0.21 scores on a scale | Standard Deviation 0.893 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 52, Anxiety/depression | -0.54 scores on a scale | Standard Deviation 0.877 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 16, Usual activities | -0.21 scores on a scale | Standard Deviation 0.744 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 36, Pain/discomfort | -1.32 scores on a scale | Standard Deviation 1.02 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 20, Usual activities | -0.17 scores on a scale | Standard Deviation 0.958 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Anxiety/depression | -0.40 scores on a scale | Standard Deviation 0.743 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 24, Usual activities | -0.23 scores on a scale | Standard Deviation 0.697 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Pain/discomfort | -1.00 scores on a scale | Standard Deviation 0.791 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 28, Usual activities | -0.21 scores on a scale | Standard Deviation 0.623 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L Dimension Scores at Each Postbaseline Visit | Change from Baseline at Week 40, Anxiety/depression | -0.65 scores on a scale | Standard Deviation 0.862 |
Secondary
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
Population: Open-label Extension Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 24 | 10.87 scores on a scale | Standard Deviation 20.519 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 36 | 12.00 scores on a scale | Standard Deviation 24.181 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 20 | 12.33 scores on a scale | Standard Deviation 18.678 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 40 | 7.61 scores on a scale | Standard Deviation 25.748 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 28 | 10.66 scores on a scale | Standard Deviation 20.595 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 44 | 8.48 scores on a scale | Standard Deviation 26.776 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 16 | 10.11 scores on a scale | Standard Deviation 18.437 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 48 | 10.00 scores on a scale | Standard Deviation 29.412 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 32 | 10.21 scores on a scale | Standard Deviation 21.577 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 52 | 11.76 scores on a scale | Standard Deviation 29.098 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 14 | 10.51 scores on a scale | Standard Deviation 17.081 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 52 | 12.00 scores on a scale | Standard Deviation 12.916 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 14 | 10.15 scores on a scale | Standard Deviation 15.211 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 16 | 11.25 scores on a scale | Standard Deviation 14.9 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 20 | 6.60 scores on a scale | Standard Deviation 17.273 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 24 | 8.42 scores on a scale | Standard Deviation 18.392 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 28 | 8.77 scores on a scale | Standard Deviation 19.863 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 32 | 9.44 scores on a scale | Standard Deviation 20.883 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 36 | 11.86 scores on a scale | Standard Deviation 19.669 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 40 | 9.82 scores on a scale | Standard Deviation 18.112 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 44 | 8.76 scores on a scale | Standard Deviation 18.219 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in EQ-5D-5L VAS Score at Each Postbaseline Visit | Change from Baseline at Week 48 | 11.47 scores on a scale | Standard Deviation 16.604 |
Secondary
OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit
OLE Period: Change from baseline in Skin Pain NRS score at each post-baseline visit
Time frame: Baseline; up to Week 52
Population: Open-label Extension Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 24 | -5.16 scores on a scale | Standard Deviation 2.818 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 36 | -5.03 scores on a scale | Standard Deviation 2.869 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 20 | -4.95 scores on a scale | Standard Deviation 2.864 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 40 | -4.55 scores on a scale | Standard Deviation 3.365 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 28 | -5.46 scores on a scale | Standard Deviation 2.754 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 44 | -4.53 scores on a scale | Standard Deviation 3.229 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 16 | -4.57 scores on a scale | Standard Deviation 2.69 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 48 | -4.09 scores on a scale | Standard Deviation 3.42 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 32 | -5.40 scores on a scale | Standard Deviation 2.641 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 52 | -3.85 scores on a scale | Standard Deviation 3.168 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 14 | -3.81 scores on a scale | Standard Deviation 2.599 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 52 | -5.46 scores on a scale | Standard Deviation 2.074 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 14 | -3.93 scores on a scale | Standard Deviation 2.436 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 16 | -4.17 scores on a scale | Standard Deviation 2.34 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 20 | -4.38 scores on a scale | Standard Deviation 2.449 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 24 | -4.58 scores on a scale | Standard Deviation 2.582 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 28 | -4.63 scores on a scale | Standard Deviation 2.63 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 32 | -4.80 scores on a scale | Standard Deviation 2.409 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 36 | -5.18 scores on a scale | Standard Deviation 2.369 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 40 | -4.24 scores on a scale | Standard Deviation 2.341 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 44 | -4.46 scores on a scale | Standard Deviation 2.497 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in Skin Pain NRS Score at Each Post-baseline Visit | Week 48 | -5.17 scores on a scale | Standard Deviation 2.175 |
Secondary
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
Population: Open-label Extension Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 24 | -7.54 scores on a scale | Standard Deviation 5.952 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 36 | -8.10 scores on a scale | Standard Deviation 8.332 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 20 | -7.63 scores on a scale | Standard Deviation 6.365 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 40 | -7.17 scores on a scale | Standard Deviation 7.315 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 28 | -8.23 scores on a scale | Standard Deviation 6.502 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 44 | -7.29 scores on a scale | Standard Deviation 7.491 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 16 | -7.07 scores on a scale | Standard Deviation 6.327 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 48 | -7.83 scores on a scale | Standard Deviation 8.319 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 32 | -8.33 scores on a scale | Standard Deviation 6.888 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 52 | -7.47 scores on a scale | Standard Deviation 8.776 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 14 | -6.88 scores on a scale | Standard Deviation 5.733 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 52 | -9.23 scores on a scale | Standard Deviation 4.764 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 14 | -7.14 scores on a scale | Standard Deviation 5.834 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 16 | -7.22 scores on a scale | Standard Deviation 5.774 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 20 | -7.09 scores on a scale | Standard Deviation 6.062 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 24 | -7.70 scores on a scale | Standard Deviation 5.944 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 28 | -7.72 scores on a scale | Standard Deviation 6.678 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 32 | -8.15 scores on a scale | Standard Deviation 5.475 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 36 | -8.93 scores on a scale | Standard Deviation 5.875 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 40 | -7.76 scores on a scale | Standard Deviation 4.161 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 44 | -8.47 scores on a scale | Standard Deviation 4.346 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in the DLQI Total Score at Each Post-baseline Visit | Change from Baseline at Week 48 | -8.60 scores on a scale | Standard Deviation 4.239 |
Secondary
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
Population: 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.
| Arm | Measure | Group | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 24 | -5.42 scores on a scale | Standard Error 2.357 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 36 | -5.73 scores on a scale | Standard Error 2.122 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 20 | -5.30 scores on a scale | Standard Error 2.552 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 40 | -5.62 scores on a scale | Standard Error 2.709 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 28 | -5.83 scores on a scale | Standard Error 2.181 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 44 | -5.54 scores on a scale | Standard Error 2.603 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 16 | -4.82 scores on a scale | Standard Error 2.408 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 48 | -5.39 scores on a scale | Standard Error 2.756 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 32 | -5.83 scores on a scale | Standard Error 2.002 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 52 | -5.17 scores on a scale | Standard Error 2.677 |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 14 | -4.07 scores on a scale | Standard Error 2.434 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 52 | -6.06 scores on a scale | Standard Error 2.037 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 14 | -4.20 scores on a scale | Standard Error 2.44 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 16 | -4.40 scores on a scale | Standard Error 2.336 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 20 | -4.67 scores on a scale | Standard Error 2.399 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 24 | -5.00 scores on a scale | Standard Error 2.393 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 28 | -5.17 scores on a scale | Standard Error 2.647 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 32 | -5.15 scores on a scale | Standard Error 2.329 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 36 | -5.56 scores on a scale | Standard Error 2.176 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 40 | -4.72 scores on a scale | Standard Error 2.328 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 44 | -5.27 scores on a scale | Standard Error 2.449 |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Change From Baseline in WI-NRS Score at Each Post-baseline Visit | Change from Baseline at Week 48 | -6.02 scores on a scale | Standard Error 1.862 |
Secondary
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
Population: Open-label Extension Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Number of Participants With Any ≥Grade 3 TEAE | 2 Participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Number of Participants With Any ≥Grade 3 TEAE | 4 Participants |
Secondary
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
Population: Open-label Extension Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Number of Participants With Any TEAE | 36 Participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Number of Participants With Any TEAE | 36 Participants |
Secondary
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
Population: Open-label Extension Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 32 | 46.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 16 | 41.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 36 | 48.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 24 | 40.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 40 | 69.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 14 | 36.8 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 44 | 52.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 28 | 50.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 48 | 50.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 52 | 52.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 20 | 44.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 52 | 61.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 14 | 47.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 16 | 48.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 20 | 52.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 24 | 56.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 28 | 55.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 32 | 51.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 36 | 53.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 40 | 64.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 44 | 64.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With >75% Healed Lesions From PAS at Each Postbaseline Visit | Week 48 | 60.0 percentage of participants |
Secondary
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
Population: ITT Population. Participants with a baseline Skin Pain NRS score ≥2 and available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 24 | 85.1 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 36 | 84.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 20 | 85.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 40 | 78.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 28 | 90.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 44 | 83.3 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 16 | 77.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 48 | 80.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 32 | 87.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 52 | 78.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 14 | 72.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 52 | 100.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 14 | 79.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 16 | 88.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 20 | 84.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 24 | 89.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 28 | 84.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 32 | 90.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 36 | 95.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 40 | 86.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 44 | 93.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | OLE Period: Percentage of Participants With a ≥2-point Improvement (Reduction) in Skin Pain NRS Score From Baseline | Week 48 | 100.0 percentage of participants |
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 14 | 31.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 28 | 58.3 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 4 | 9.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 32 | 53.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 16 | 43.2 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 36 | 61.3 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 12 | 16.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 40 | 47.8 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 20 | 52.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 44 | 47.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 8 | 17.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 48 | 44.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 24 | 53.8 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 52 | 52.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 2 | 4.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 52 | 53.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 2 | 9.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 4 | 16.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 8 | 26.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 12 | 32.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 14 | 41.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 16 | 45.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 20 | 49.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 24 | 54.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 28 | 63.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 32 | 64.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 36 | 67.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 40 | 47.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 44 | 47.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With a IGA-CPG-A Score of 0 or 1 With ≥2-grade Improvement (Reduction) at Each Post-baseline Visit | Week 48 | 40.0 percentage of participants |
Secondary
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
Population: ITT Population. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 12 | 12.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 52 | 47.1 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 2 | 4.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 4 | 5.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 8 | 10.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 14 | 23.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 16 | 28.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 20 | 29.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 24 | 30.8 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 28 | 39.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 32 | 34.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 36 | 38.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 40 | 43.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 44 | 47.6 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 48 | 44.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 52 | 61.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 24 | 32.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 40 | 47.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 2 | 3.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 28 | 42.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 4 | 11.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 48 | 46.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 8 | 23.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 12 | 27.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 32 | 43.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 14 | 31.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 44 | 47.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 16 | 29.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 36 | 46.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Each Postbaseline Visit | Week 20 | 27.1 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Week 12 | 10.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With IGA-CPG-S-TS at Week 12 | 24.0 percentage of participants |
p-value: 0.014295% CI: [1.193, 6.033]Cochran-Mantel-Haenszel
95% CI: [2.9, 24.01]
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With Overall-Treatment Success at Week 12 | 6.4 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Percentage of Participants With Overall-Treatment Success at Week 12 | 12.5 percentage of participants |
p-value: 0.149395% CI: [0.75, 5.74]Cochran-Mantel-Haenszel
95% CI: [-2.18, 14.51]
Secondary
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
Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Time to ≥2-point Improvement From Baseline in WI-NRS Score | 15.0 days |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Time to ≥2-point Improvement From Baseline in WI-NRS Score | 5.0 days |
p-value: 0.000595% CI: [1.288, 2.468]Log Rank
Secondary
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
Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Censored participants were included in the analysis.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | Time to ≥4-point Improvement From Baseline in WI-NRS Score | 63.0 days |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | Time to ≥4-point Improvement From Baseline in WI-NRS Score | 21.0 days |
p-value: 0.039995% CI: [1.015, 2.15]Log Rank
Secondary
WI-NRS4 Response at 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
Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Day 7 | 5.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Day 7 | 15.6 percentage of participants |
p-value: 0.038795% CI: [1.06, 8.897]Cochran-Mantel-Haenszel
95% CI: [0.98, 18]
Secondary
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
Population: ITT Population. Participants with a baseline ITCH Score ≥4 were analyzed. Only participants with available data were analyzed.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 32 | 83.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 2 | 4.5 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 4 | 21.2 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 8 | 31.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 12 | 43.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 14 | 54.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 16 | 69.9 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 20 | 72.4 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 24 | 74.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 28 | 83.0 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 36 | 79.3 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 40 | 72.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 44 | 66.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 48 | 66.7 percentage of participants |
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 52 | 70.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 40 | 68.8 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 24 | 67.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 2 | 15.9 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 48 | 85.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 4 | 32.2 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 28 | 71.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 8 | 45.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 32 | 68.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 12 | 47.5 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 44 | 75.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 14 | 49.3 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 36 | 76.0 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 16 | 58.7 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 52 | 84.6 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Each Post-baseline Visit | Week 20 | 61.0 percentage of participants |
Secondary
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
Population: 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.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Vehicle Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Week 4 | 19.1 percentage of participants |
| Ruxolitinib 1.5% Cream BID to Ruxolitinib 1.5% Cream BID | WI-NRS4 Response at Week 4 | 30.5 percentage of participants |
p-value: 0.074195% CI: [0.938, 3.683]Cochran-Mantel-Haenszel
95% CI: [-0.93, 23.23]