Trial Outcomes & Findings for A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus (NCT NCT05593432)
NCT ID: NCT05593432
Last Updated: 2024-10-24
Results Overview
The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.
COMPLETED
PHASE2
64 participants
Baseline; Week 16
2024-10-24
Participant Flow
This study was conducted at 19 study centers in Canada and the United States.
Participant milestones
| Measure |
Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 16 weeks.
|
Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.
|
Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.
|
|---|---|---|---|---|
|
16-Week DBVC Period
STARTED
|
32
|
32
|
0
|
0
|
|
16-Week DBVC Period
COMPLETED
|
30
|
29
|
0
|
0
|
|
16-Week DBVC Period
NOT COMPLETED
|
2
|
3
|
0
|
0
|
|
16-Week OLE Period
STARTED
|
0
|
0
|
30
|
29
|
|
16-Week OLE Period
COMPLETED
|
0
|
0
|
29
|
23
|
|
16-Week OLE Period
NOT COMPLETED
|
0
|
0
|
1
|
6
|
Reasons for withdrawal
| Measure |
Double-Blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib Cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 16 weeks.
|
Open-Label Extension (OLE) Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-blind, Vehicle-controlled Period continued to apply ruxolitinib cream 1.5% BID for an additional 16 weeks in the Open-label Extension Period.
|
Open-Label Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week Open-label Extension Period. Participants who applied vehicle cream BID during the Double-blind, Vehicle-controlled Period applied ruxolitinib cream 1.5% BID for 16 weeks in the Open-label Extension Period.
|
|---|---|---|---|---|
|
16-Week DBVC Period
Withdrawal by Subject
|
2
|
3
|
0
|
0
|
|
16-Week OLE Period
Lack of Efficacy
|
0
|
0
|
0
|
1
|
|
16-Week OLE Period
Lost to Follow-up
|
0
|
0
|
1
|
2
|
|
16-Week OLE Period
Withdrawal by Subject
|
0
|
0
|
0
|
3
|
Baseline Characteristics
A Study to Evaluate the Efficacy and Safety of Ruxolitinib Cream in Participants With Cutaneous Lichen Planus
Baseline characteristics by cohort
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=32 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
Total
n=64 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Sex: Female, Male
Male
|
10 Participants
n=93 Participants
|
8 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Age, Continuous
|
56.3 years
STANDARD_DEVIATION 14.35 • n=93 Participants
|
58.2 years
STANDARD_DEVIATION 10.86 • n=4 Participants
|
57.3 years
STANDARD_DEVIATION 12.66 • n=27 Participants
|
|
Sex: Female, Male
Female
|
22 Participants
n=93 Participants
|
24 Participants
n=4 Participants
|
46 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
31 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
21 Participants
n=93 Participants
|
19 Participants
n=4 Participants
|
40 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
9 Participants
n=93 Participants
|
9 Participants
n=4 Participants
|
18 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Biracial
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Mixed Race
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
PRIMARY outcome
Timeframe: Baseline; Week 16Population: 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 during their participation in the Double-blind; vehicle-controlled (DBVC) period. Missing post-Baseline values were imputed as nonresponders. Only participants with available data were analyzed.
The Investigator's Global Assessment (IGA) is a modified global assessment tool to assess the severity of lesions. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at Week 16.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=32 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving Investigator's Global Assessment-Treatment Success (IGA-TS) at Week 16
|
50.0 percentage of participants
Interval 31.9 to 68.1
|
21.9 percentage of participants
Interval 9.3 to 40.0
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, 12, and 16Population: ITT Population. Only participants with available data were analyzed.
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=31 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 2
|
9.7 percentage of participants
Interval 2.0 to 25.8
|
6.5 percentage of participants
Interval 0.8 to 21.4
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 4
|
25.8 percentage of participants
Interval 11.9 to 44.6
|
13.3 percentage of participants
Interval 3.8 to 30.7
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 8
|
51.6 percentage of participants
Interval 33.1 to 69.8
|
12.9 percentage of participants
Interval 3.6 to 29.8
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 12
|
53.3 percentage of participants
Interval 34.3 to 71.7
|
24.1 percentage of participants
Interval 10.3 to 43.5
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 16
|
53.3 percentage of participants
Interval 34.3 to 71.7
|
24.1 percentage of participants
Interval 10.3 to 43.5
|
SECONDARY outcome
Timeframe: Baseline; Weeks 18, 20, 24, 28, and 32Population: ITT Population. Only participants with available data were analyzed.
The IGA is a global assessment tool to assess the severity of lesions. The IGA includes items such as depigmentation/hypopigmentation, lichenification (fine wrinkling/cigarette paper skin), excoriations, petechiae/ecchymosis, telangiectasias, erosions, fissures, or ulcers. Grading was based on 0 (clear), 1 (almost clear), 2 (mild), 3 (moderate), and 4 (severe). IGA-TS response was defined as an IGA score of 0 or 1 with a ≥2-grade improvement from Baseline at each scheduled post-Baseline visit. Participants with a score of 0 have a morphology of: no inflammatory signs (no erythema, no induration/papulation). Postinflammatory hyperpigmentation and/or hypopigmentation may be present. Participants with a score of 1 have a morphology of: barely perceptible erythema, barely perceptible induration/papulation/elevation, and/or minimal scale. Features include palpable, slightly erythematous papules.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=30 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=28 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 18
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
25.0 percentage of participants
Interval 10.7 to 44.9
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 20
|
62.1 percentage of participants
Interval 42.3 to 79.3
|
33.3 percentage of participants
Interval 16.5 to 54.0
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 24
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
44.0 percentage of participants
Interval 24.4 to 65.1
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 28
|
58.6 percentage of participants
Interval 38.9 to 76.5
|
45.8 percentage of participants
Interval 25.6 to 67.2
|
|
Percentage of Participants Achieving IGA-TS at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 32
|
60.0 percentage of participants
Interval 40.6 to 77.3
|
60.9 percentage of participants
Interval 38.5 to 80.3
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, 12, and 16Population: ITT Population. Only participants with available data were analyzed.
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus 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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=29 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=30 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 2
|
21.4 percentage of participants
Interval 8.3 to 41.0
|
3.3 percentage of participants
Interval 0.1 to 17.2
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 4
|
44.8 percentage of participants
Interval 26.4 to 64.3
|
7.1 percentage of participants
Interval 0.9 to 23.5
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 8
|
53.8 percentage of participants
Interval 33.4 to 73.4
|
7.4 percentage of participants
Interval 0.9 to 24.3
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 12
|
52.0 percentage of participants
Interval 31.3 to 72.2
|
12.0 percentage of participants
Interval 2.5 to 31.2
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 16
|
57.7 percentage of participants
Interval 36.9 to 76.6
|
19.2 percentage of participants
Interval 6.6 to 39.4
|
SECONDARY outcome
Timeframe: Baseline; Weeks 18, 20, 24, 28, and 32Population: ITT Population. Only participants with available data were analyzed.
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus 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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=25 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 18
|
72.7 percentage of participants
Interval 49.8 to 89.3
|
48.0 percentage of participants
Interval 27.8 to 68.7
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 20
|
73.9 percentage of participants
Interval 51.6 to 89.8
|
63.6 percentage of participants
Interval 40.7 to 82.8
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 24
|
79.2 percentage of participants
Interval 57.8 to 92.9
|
76.2 percentage of participants
Interval 52.8 to 91.8
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 28
|
86.4 percentage of participants
Interval 65.1 to 97.1
|
76.5 percentage of participants
Interval 50.1 to 93.2
|
|
Percentage of Participants With ITCH4 at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 32
|
84.2 percentage of participants
Interval 60.4 to 96.6
|
73.3 percentage of participants
Interval 44.9 to 92.2
|
SECONDARY outcome
Timeframe: up to Week 16Population: ITT Population. Only those participants achieving a ≥4-point improvement in daily Itch NRS score from Baseline were analyzed.
ITCH4 response was defined as a ≥4-point improvement in the Itch Numeric Rating Scale (NRS) score from Baseline at each scheduled post-Baseline visit, up to and including Week 32. The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity. Participants were instructed to complete and record their Itch NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated itch severity of their lichen planus 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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=32 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=31 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Time to Achieve ITCH4 in the Double-blind, Vehicle-controlled Period
|
17.0 days
Interval 7.0 to 27.0
|
97.0 days
Interval 31.0 to
The upper limit of the confidence interval was not estimable because there were too few events of ITCH4 response.
|
SECONDARY outcome
Timeframe: Baseline; Weeks 2, 4, 8, 12, and 16Population: ITT Population. No imputation was performed for missing values. Only participants with available data were analyzed.
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus 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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=31 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Baseline
|
4.86 scores on a scale
Standard Deviation 2.303
|
4.51 scores on a scale
Standard Deviation 2.618
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 2
|
-1.69 scores on a scale
Standard Deviation 2.047
|
-0.55 scores on a scale
Standard Deviation 0.975
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 4
|
-2.64 scores on a scale
Standard Deviation 2.307
|
-0.69 scores on a scale
Standard Deviation 1.261
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 8
|
-2.96 scores on a scale
Standard Deviation 2.622
|
-0.95 scores on a scale
Standard Deviation 1.385
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 12
|
-3.01 scores on a scale
Standard Deviation 2.823
|
-0.84 scores on a scale
Standard Deviation 1.613
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Double-Blind, Vehicle-Controlled Period
Week 16
|
-3.02 scores on a scale
Standard Deviation 2.656
|
-1.25 scores on a scale
Standard Deviation 2.263
|
SECONDARY outcome
Timeframe: Baseline; Weeks 18, 20, 24, 28, and 32Population: ITT Population. Only participants with available data were analyzed.
Participants were instructed to complete and record the Skin Pain NRS in a diary each evening beginning on the day of screening through Week 32 or treatment discontinuation. Participants rated their pain, which included all types of pain (e.g., burning, tearing, pulling, stabbing, etc.) severity of lichen planus 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. Change from Baseline was calculated as the post-Baseline value minus the Baseline value.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=31 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Baseline
|
4.86 scores on a scale
Standard Deviation 2.303
|
4.51 scores on a scale
Standard Deviation 2.618
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 18
|
-3.65 scores on a scale
Standard Deviation 2.086
|
-2.46 scores on a scale
Standard Deviation 2.253
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 20
|
-3.81 scores on a scale
Standard Deviation 2.079
|
-2.96 scores on a scale
Standard Deviation 2.584
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 24
|
-3.82 scores on a scale
Standard Deviation 2.385
|
-3.13 scores on a scale
Standard Deviation 2.868
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 28
|
-3.99 scores on a scale
Standard Deviation 2.272
|
-3.54 scores on a scale
Standard Deviation 3.145
|
|
Change From Baseline in the Skin Pain NRS Score at Each Scheduled Post-Baseline Visit in the Open-label Extension Period
Week 32
|
-4.25 scores on a scale
Standard Deviation 2.276
|
-3.51 scores on a scale
Standard Deviation 3.470
|
SECONDARY outcome
Timeframe: from Baseline to Week 16 plus 30 daysPopulation: Safety Population: all participants who applied ruxolitinib 1.5% cream BID or vehicle cream BID at least once. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1 regardless of assigned study drug treatment.
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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE) During the Double-blind, Vehicle-controlled Period
|
15 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: from Baseline to Week 16 plus 30 daysPopulation: Safety Population
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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=31 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE During the Double-blind, Vehicle-controlled Period
|
0 Participants
|
0 Participants
|
SECONDARY outcome
Timeframe: from Week 17 to Week 32 plus 30 daysPopulation: Open-label Extension Evaluable Population: all participants who applied ruxolitinib 1.5% cream at least once 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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=30 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=29 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any TEAE During the Open-label Extension Period
|
8 Participants
|
11 Participants
|
SECONDARY outcome
Timeframe: from Week 17 to Week 32 plus 30 daysPopulation: Open-label Extension Evaluable Population
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.
Outcome measures
| Measure |
Double-Blind, Vehicle-Controlled Period: Ruxolitinib Cream 1.5% BID
n=30 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
Double-Blind, Vehicle-Controlled Period: Vehicle Cream BID
n=29 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any ≥Grade 3 TEAE During the Open-label Extension Period
|
0 Participants
|
1 Participants
|
Adverse Events
Vehicle Cream BID
Ruxolitinib Cream 1.5% BID
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Vehicle Cream BID
n=32 participants at risk
Participants applied matching vehicle cream BID for 16 weeks in the Double-Blind, Vehicle-Controlled Period.
|
Ruxolitinib Cream 1.5% BID
n=60 participants at risk
Participants who applied ruxolitinib cream 1.5% BID for 16 weeks during the Double-Blind, Vehicle-Controlled Period plus participants who completed the Week 16 assessments with no safety concerns, continued into the Open-label Extension Period, and applied ruxolitinib cream 1.5% BID for an additional 16 weeks
|
|---|---|---|
|
Infections and infestations
COVID-19
|
3.1%
1/32 • Number of events 1 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
5.0%
3/60 • Number of events 3 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Endocrine disorders
Hypothyroidism
|
6.2%
2/32 • Number of events 2 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
0.00%
0/60 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Nasopharyngitis
|
3.1%
1/32 • Number of events 1 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
8.3%
5/60 • Number of events 5 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Sinusitis
|
3.1%
1/32 • Number of events 1 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
5.0%
3/60 • Number of events 3 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/32 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
5.0%
3/60 • Number of events 3 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Infections and infestations
Urinary tract infection
|
3.1%
1/32 • Number of events 1 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
5.0%
3/60 • Number of events 3 • from Baseline to Week 32 plus 30 days
For safety analysis, participants who switched from treatment with vehicle to treatment with ruxolitinib cream 1.5% BID in the Open-Label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Following the first publication, the Institution and/or Principal Investigator may publish data or results from the Study, provided, however, that the Institution and/or Principal Investigator submits the proposed publication to the Sponsor for review at least sixty (60) days prior to the date of the proposed publication. Sponsor may remove from the proposed publication any information that is considered confidential and/or proprietary other than Study data and results.
- Publication restrictions are in place
Restriction type: OTHER