Lichen Sclerosus
Conditions
Keywords
Lichen Sclerosus, Skin Diseases, 18424, Ruxolitinib, topical cream, vulvar disease
Brief summary
The purpose of this study is to evaluate the efficacy and safety of Ruxolitinib cream in participants With Lichen Sclerosus. This is randomized, double-blind, vehicle-controlled (DBVC) study with a DBVC period of 12 weeks followed by an open label period (OLE) period of 12 weeks.
Interventions
DRUGRuxolitinib cream
Ruxolitinib cream is a topical formulation applied as a thin film to affected areas.
DRUGVehicle cream
Vehicle cream is matching in appearance to ruxolitinib cream and is to be applied in the same manner as ruxolitinib cream.
Sponsors
Incyte Corporation
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Caregiver, Investigator)
Intervention model description
Study will be a 12 week double-blind period followed by a 12 week open label period.
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Biopsy-proven LS in the anogenital area. * Baseline IGA score ≥ 2 for LS. * Baseline Itch NRS score ≥ 4 in anogenital area. * Willingness to avoid pregnancy.
Exclusion criteria
* Participants who do not have LS involving anogenital area. * Concurrent conditions and history of other diseases: 1. Are suspected clinically (or confirmed diagnostically) of having alternative causes of vaginal symptoms including: candidiasis, chlamydia trachomatis, trichomonas vaginalis, neisseria gonorrhoeae, bacterial vaginosis, or herpes simplex. 2. Have active genital/vulvar lesions at screening and Day 1, not related to LS 3. Chronic or acute infection requiring treatment with systemic antibiotics, antivirals, antiparasitics, antiprotozoals, or antifungals within 2 weeks before baseline. * Laboratory values outside of the protocol-defined criteria * Pregnant or lactating participants or those considering pregnancy during the period of their study participation.. * Other
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With ITCH4 at Week 12 | Baseline; Week 12 | ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Change From Baseline in the Skin Pain NRS Score at Week 12 | Baseline; Week 12 | Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours. |
| Time to Achieve ITCH4 | up to 99.0 days | ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours. |
| Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | 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 could 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 drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. |
| Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
| Number of Participants With Any TEAE During the Open-label Extension Period | from Week 12 to Week 24 plus 30 days | 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 could 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 drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. |
| Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | Baseline; Week 12 | The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible \[i.e., itch, pain, dysuria\]); signs (3 items; possibly reversible \[i.e., whitening, petechiae/ecchymosis, fissures\]); and architectural changes (6 items; irreversible \[i.e., skin fusion, perianal involvement, etc.\]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section. |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | The investigator determined if a clinical laboratory test value was clinically meaningful. |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | from Baseline to Week 12 plus 30 days | The investigator determined if a clinical laboratory test value was clinically meaningful. |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | from Week 12 to Week 24 plus 30 days | The investigator determined if a clinical laboratory test value was clinically meaningful. |
| Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | from Week 12 to Week 24 plus 30 days | The investigator determined if a clinical laboratory test value was clinically meaningful. |
| Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | from Week 12 to Week 24 plus 30 days | A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal. |
Countries
Canada, United States
Participant flow
Pre-assignment details
A total of 61 participants were randomized into the study. All randomized participants (Intent-to-Treat Population) applied study drug at least once (Safety Population), and 56 participants applied ruxolitinib 1.5% cream at least once during the Open-label Extension (OLE) Period (OLE-Evaluable Population).
Participants by arm
| Arm | Count |
|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID Participants applied ruxolitinib 1.5% cream twice daily (BID) for 12 weeks. | 31 |
| DBVC Period: Vehicle Cream BID Participants applied matching vehicle cream BID for 12 weeks. | 30 |
| Total | 61 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| 12-Week DBVC Period | Adverse Event | 1 | 0 | 0 | 0 |
| 12-Week DBVC Period | Did Not Meet Eligibility Criteria | 1 | 0 | 0 | 0 |
| 12-Week DBVC Period | Physician Decision | 0 | 1 | 0 | 0 |
| 12-Week DBVC Period | Protocol Violation | 0 | 1 | 0 | 0 |
| 12-Week DBVC Period | Withdrawal by Subject | 0 | 1 | 0 | 0 |
| 12-Week Open-Label Extension Period | Adverse Event | 0 | 0 | 1 | 1 |
| 12-Week Open-Label Extension Period | Lost to Follow-up | 0 | 0 | 1 | 1 |
| 12-Week Open-Label Extension Period | Withdrawal by Subject | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | DBVC Period: Vehicle Cream BID | Total | DBVC Period: Ruxolitinib Cream 1.5% BID |
|---|---|---|---|
| Age, Continuous | 61.9 years STANDARD_DEVIATION 12.25 | 60.9 years STANDARD_DEVIATION 11.71 | 60.0 years STANDARD_DEVIATION 11.28 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 5 Participants | 8 Participants | 3 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 25 Participants | 53 Participants | 28 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Black or African American | 5 Participants | 5 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 25 Participants | 56 Participants | 31 Participants |
| Sex: Female, Male Female | 30 Participants | 61 Participants | 31 Participants |
| Sex: Female, Male Male | 0 Participants | 0 Participants | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 58 | 0 / 30 |
| other Total, other adverse events | 10 / 58 | 6 / 30 |
| serious Total, serious adverse events | 0 / 58 | 1 / 30 |
Outcome results
Primary
Percentage of Participants With ITCH4 at Week 12
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
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 drug the participant might have taken. Only those participants with a Baseline ITCH NRS Score ≥4 were analyzed. Missing post-baseline values were imputed as Non-Responders at Week 12.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Percentage of Participants With ITCH4 at Week 12 | 35.7 percentage of participants |
| DBVC Period: Vehicle Cream BID | Percentage of Participants With ITCH4 at Week 12 | 40.0 percentage of participants |
p-value: 0.73795% CI: [0.29, 2.41]Chi-squared
95% CI: [-29.2, 20.7]
Secondary
Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12
The CLISSCO is a validated tool to assess disease severity in vulvar lichen sclerosus. The Clinical Lichen Sclerosus Score consists of 12 items divided into 3 sections: symptoms (3 items; likely reversible \[i.e., itch, pain, dysuria\]); signs (3 items; possibly reversible \[i.e., whitening, petechiae/ecchymosis, fissures\]); and architectural changes (6 items; irreversible \[i.e., skin fusion, perianal involvement, etc.\]). All symptoms, signs, and architectural changes were rated on a 4-point Likert scale: 0 (absent), 1 (mild), 2 (moderate), and 3 (severe). The investigator documented the score of each of the 12 items; the CLISSCO was calculated by summing the score of each question, with a maximum score of 36 and a minimum score of 0. The higher the score, the more severe the disease. Additionally, the total score for each of the 3 sections (symptoms, signs, and architectural changes) was summarized by summing the scores of the questions in each section.
Time frame: Baseline; Week 12
Population: ITT Population. Only participants with available data were analyzed. Mixed Model Repeated Measures (MMRM) model: response variable = treatment + visit + treatment by visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | -5.79 scores on a scale | Standard Error 0.8 |
| DBVC Period: Vehicle Cream BID | Change From Baseline in the Clinical Lichen Sclerosus Score (CLISSCO) at Week 12 | -3.03 scores on a scale | Standard Error 0.82 |
p-value: 0.018895% CI: [-5.05, -0.47]Mixed Model Repeated Measures (MMRM)
Secondary
Change From Baseline in the Skin Pain NRS Score at Week 12
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 12 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen sclerosus by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described the worst level of pain they experienced in the past 24 hours.
Time frame: Baseline; Week 12
Population: ITT Population. Only participants with available data were analyzed. No imputation was performed for missing values. MMRM model: response variable = treatment + visit + treatment by visit.
| Arm | Measure | Value (LEAST_SQUARES_MEAN) | Dispersion |
|---|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Change From Baseline in the Skin Pain NRS Score at Week 12 | -3.22 scores on a scale | Standard Error 0.5 |
| DBVC Period: Vehicle Cream BID | Change From Baseline in the Skin Pain NRS Score at Week 12 | -2.70 scores on a scale | Standard Error 0.52 |
p-value: 0.467495% CI: [-1.96, 0.91]MMRM
Secondary
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Baseline to Week 12 plus 30 days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | 0 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Double-blind, Vehicle-controlled Period | 0 Participants |
Secondary
Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Week 12 to Week 24 plus 30 days
Population: Open-label Extension Evaluable Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | 0 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Clinical Laboratory Test Results During the Open-label Extension Period | 0 Participants |
Secondary
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Baseline to Week 12 plus 30 days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | 0 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Double-blind, Vehicle-controlled Period | 0 Participants |
Secondary
Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period
The investigator determined if a clinical laboratory test value was clinically meaningful.
Time frame: from Week 12 to Week 24 plus 30 days
Population: Open-label Extension Evaluable Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | 0 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Clinically Meaningful Changes Over Time in Vital Sign Values During the Open-label Extension Period | 0 Participants |
Secondary
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (v5.0) Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Baseline to Week 12 plus 30 days
Population: Safety Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | 1 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period | 0 Participants |
Secondary
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using the CTCAE v5.0 Grades 1 through 5. The investigator made an assessment of intensity for each AE and SAE reported during the study and assigned it to 1 of the following categories: Grade 1: mild; asymptomatic or mild symptoms; clinical or diagnostic observations only; treatment not indicated. Grade 2: moderate; minimal, local, or noninvasive treatment indicated; limiting age-appropriate activities of daily living. Grade 3: severe or medically significant but not immediately life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; limiting self-care activities of daily living. Grade 4: life-threatening consequences; urgent treatment indicated. Grade 5: fatal.
Time frame: from Week 12 to Week 24 plus 30 days
Population: Open-label Extension Evaluable Population
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | 1 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period | 0 Participants |
Secondary
Number of Participants With Any TEAE During the Open-label Extension Period
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 could 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 drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Week 12 to Week 24 plus 30 days
Population: Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once during the Open-label Extension Period
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any TEAE During the Open-label Extension Period | 13 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any TEAE During the Open-label Extension Period | 11 Participants |
Secondary
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
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 could 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 drug. A TEAE was defined as an AE either reported for the first time or the worsening of a pre-existing event after the first application of study drug.
Time frame: from Baseline to Week 12 plus 30 days
Population: Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | 14 Participants |
| DBVC Period: Vehicle Cream BID | Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period | 12 Participants |
Secondary
Time to Achieve ITCH4
ITCH4 response was defined as a ≥4-point improvement from Baseline in by-visit Itch Numeric Rating Scale (NRS) score. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants rated itch severity of their lichen sclerosus by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described the worst level of itch they experienced in the past 24 hours.
Time frame: up to 99.0 days
Population: ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed.
| Arm | Measure | Value (MEDIAN) |
|---|---|---|
| DBVC Period: Ruxolitinib Cream 1.5% BID | Time to Achieve ITCH4 | 35.0 days |
| DBVC Period: Vehicle Cream BID | Time to Achieve ITCH4 | 28.0 days |
p-value: 0.907295% CI: [0.503, 1.869]Log Rank