Trial Outcomes & Findings for A Study to Evaluate the Mechanism of Action of Ruxolitinib Cream in Subjects With Vitiligo (TRuE-V MOA) (NCT NCT04896385)
NCT ID: NCT04896385
Last Updated: 2025-08-05
Results Overview
Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value)\*100.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
60 participants
Primary outcome timeframe
Baseline; Week 4, Week 12, and Week 24
Results posted on
2025-08-05
Participant Flow
This study was conducted at a total of 11 sites in Canada, France, and the United States.
Participant milestones
| Measure |
Double-Blind Period: Ruxolitinib Cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
24-Week Double-Blind Period
STARTED
|
41
|
19
|
0
|
0
|
|
24-Week Double-Blind Period
COMPLETED
|
37
|
14
|
0
|
0
|
|
24-Week Double-Blind Period
NOT COMPLETED
|
4
|
5
|
0
|
0
|
|
28-Week Treatment-Extension Period
STARTED
|
0
|
0
|
37
|
14
|
|
28-Week Treatment-Extension Period
COMPLETED
|
0
|
0
|
27
|
9
|
|
28-Week Treatment-Extension Period
NOT COMPLETED
|
0
|
0
|
10
|
5
|
Reasons for withdrawal
| Measure |
Double-Blind Period: Ruxolitinib Cream 1.5% BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
24-Week Double-Blind Period
Lost to Follow-up
|
2
|
3
|
0
|
0
|
|
24-Week Double-Blind Period
Withdrawal by Subject
|
2
|
2
|
0
|
0
|
|
28-Week Treatment-Extension Period
Lost to Follow-up
|
0
|
0
|
5
|
2
|
|
28-Week Treatment-Extension Period
Withdrawal by Subject
|
0
|
0
|
1
|
1
|
|
28-Week Treatment-Extension Period
Participant Refused Safety Follow-up
|
0
|
0
|
3
|
2
|
|
28-Week Treatment-Extension Period
Pregnancy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Only participants with available data were analyzed.
Baseline characteristics by cohort
| Measure |
Double-Blind Period: Ruxolitinib Cream 1.5% BID
n=41 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=19 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Total
n=60 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
45.1 years
STANDARD_DEVIATION 12.73 • n=41 Participants
|
43.7 years
STANDARD_DEVIATION 13.16 • n=19 Participants
|
44.7 years
STANDARD_DEVIATION 12.77 • n=60 Participants
|
|
Sex: Female, Male
Female
|
18 Participants
n=41 Participants
|
8 Participants
n=19 Participants
|
26 Participants
n=60 Participants
|
|
Sex: Female, Male
Male
|
23 Participants
n=41 Participants
|
11 Participants
n=19 Participants
|
34 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
8 Participants
n=41 Participants
|
4 Participants
n=19 Participants
|
12 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
30 Participants
n=41 Participants
|
14 Participants
n=19 Participants
|
44 Participants
n=60 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
3 Participants
n=41 Participants
|
1 Participants
n=19 Participants
|
4 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
White/Caucasian
|
25 Participants
n=41 Participants
|
13 Participants
n=19 Participants
|
38 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
4 Participants
n=41 Participants
|
2 Participants
n=19 Participants
|
6 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Asian
|
5 Participants
n=41 Participants
|
3 Participants
n=19 Participants
|
8 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Native Hawaiian/Pacific Islander
|
1 Participants
n=41 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
5 Participants
n=41 Participants
|
0 Participants
n=19 Participants
|
5 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
South Asian
|
1 Participants
n=41 Participants
|
0 Participants
n=19 Participants
|
1 Participants
n=60 Participants
|
|
Race/Ethnicity, Customized
Middle Eastern
|
0 Participants
n=41 Participants
|
1 Participants
n=19 Participants
|
1 Participants
n=60 Participants
|
|
Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an immune biomarker
|
600.066 nanograms per Liter (ng/L)
STANDARD_DEVIATION 959.3097 • n=40 Participants • Only participants with available data were analyzed.
|
415.471 nanograms per Liter (ng/L)
STANDARD_DEVIATION 177.4902 • n=18 Participants • Only participants with available data were analyzed.
|
542.778 nanograms per Liter (ng/L)
STANDARD_DEVIATION 804.0389 • n=58 Participants • Only participants with available data were analyzed.
|
PRIMARY outcome
Timeframe: Baseline; Week 4, Week 12, and Week 24Population: Safety Population: all participants who applied at least 1 dose of study drug. Treatment groups for this population were to be determined according to the actual treatment the participant received on Day 1. Only participants with available data were analyzed.
Baseline was defined as the last non-missing measurement obtained on or before the first application of study drug. Percentage change from Baseline was calculated as the (\[post-Baseline value minus the Baseline value\] / Baseline value)\*100.
Outcome measures
| Measure |
Double-Blind Period: Ruxolitinib Cream 1.5% BID
n=39 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=16 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
Week 4
|
-20.93 percent change
Standard Deviation 36.216
|
8.13 percent change
Standard Deviation 52.491
|
—
|
—
|
|
Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
Week 12
|
-18.33 percent change
Standard Deviation 40.035
|
21.13 percent change
Standard Deviation 70.690
|
—
|
—
|
|
Percentage Change From Baseline in Chemokine (C-X-C Motif) Ligand 10 (CXCL10), an Immune Biomarker, at Week 4, Week 12, and Week 24
Week 24
|
-12.92 percent change
Standard Deviation 46.146
|
22.17 percent change
Standard Deviation 68.893
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline, Week 12, and Week 24Population: Safety Population. Repeated measures correlation (Crm) takes into account that measures were taken from the same individual across multiple timepoints. Included in the analysis were only those participants with values at each of 3 timepoints: Baseline, Week 12, and Week 24.
Clinical scores (facial Vitiligo Area Scoring Index \[F-VASI\] and total body Vitiligo Area Scoring Index \[T-VASI\]) were evaluated for correlation with skin CXCL10 levels.
Outcome measures
| Measure |
Double-Blind Period: Ruxolitinib Cream 1.5% BID
n=38 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=17 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts
F-VASI
|
-0.34 correlation coefficient
|
0.15 correlation coefficient
|
—
|
—
|
|
Correlation of Key Skin Inflammatory Biomarkers of Vitiligo in Target Lesions to Efficacy Readouts
T-VASI
|
-0.43 correlation coefficient
|
0.02 correlation coefficient
|
—
|
—
|
SECONDARY outcome
Timeframe: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)Population: Double-Blind Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once during the Double-Blind Period. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.
An adverse event (AE) was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could 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 any AE 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 Period: Ruxolitinib Cream 1.5% BID
n=41 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=19 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
Number of Participants With Treatment-emergent Adverse Events (TEAEs) During the Double-Blind Period
|
19 Participants
|
7 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 daysPopulation: Treatment-Extension Evaluable Population: all participants who applied ruxolitinib cream at least once during the Treatment-Extension Period
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. An AE could 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 any AE 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 Period: Ruxolitinib Cream 1.5% BID
n=37 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=14 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
Number of Participants With TEAEs During the Treatment-Extension Period
|
12 Participants
|
3 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from the time of Informed Consent Form signing until the start of the Treatment-Extension Period or 30 days after the last application of study drug during the Double-Blind Period (up to Week 24 + 30 days)Population: Double-Blind Safety Population. Treatment groups for this population were determined according to the actual treatment the participant applied on Day 1.
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. 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. AE severity was assessed per the Common Terminology Criteria for Adverse Events (CTCAE), version 5.0: 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 Period: Ruxolitinib Cream 1.5% BID
n=41 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=19 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
Number of Participants With a Grade 3 or Higher TEAE During the Double-Blind Period
|
1 Participants
|
0 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: from the completion of the Week 24 assessments until at least 30 days after the last application of study drug at Week 52 + 30 daysPopulation: Treatment-Extension Evaluable Population
An AE was defined as any untoward medical occurrence associated with the use of a drug in humans, whether or not considered drug-related. 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. AE severity was assessed per the CTCAE, version 5.0: 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 Period: Ruxolitinib Cream 1.5% BID
n=37 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 24 weeks.
|
Double-Blind Period: Vehicle Cream BID
n=14 Participants
Participants applied matching vehicle cream BID for 24 weeks.
|
Treatment-Extension Period: Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period.
|
Treatment-Extension Period: Vehicle Cream to Ruxolitinib Cream 1.5% BID
Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
|---|---|---|---|---|
|
Number of Participants With a Grade 3 or Higher TEAE During the Treatment-Extension Period
|
0 Participants
|
1 Participants
|
—
|
—
|
Adverse Events
Ruxolitinib Cream 1.5% BID
Serious events: 1 serious events
Other events: 10 other events
Deaths: 0 deaths
Vehicle Cream BID
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Ruxolitinib Cream 1.5% BID
n=55 participants at risk
Participants applied ruxolitinib cream during the Double-Blind Treatment Period and the Treatment-Extension Period. Participants applied ruxolitinib 1.5% cream BID for 24 weeks. Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
Vehicle Cream BID
n=19 participants at risk
Participants applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period.
|
|---|---|---|
|
Cardiac disorders
Acute coronary syndrome
|
1.8%
1/55 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
0.00%
0/19 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
Other adverse events
| Measure |
Ruxolitinib Cream 1.5% BID
n=55 participants at risk
Participants applied ruxolitinib cream during the Double-Blind Treatment Period and the Treatment-Extension Period. Participants applied ruxolitinib 1.5% cream BID for 24 weeks. Participants who completed the Week 24 assessments with no safety concerns could continue into the 28-week Treatment-Extension Period. Participants who applied ruxolitinib cream 1.5% BID during the Double-Blind Period continued to apply ruxolitinib cream 1.5% BID for an additional 28 weeks in the Treatment-Extension Period. Participants who applied vehicle cream BID during the Double-Blind Period applied ruxolitinib cream 1.5% BID for 28 weeks in the Treatment-Extension Period.
|
Vehicle Cream BID
n=19 participants at risk
Participants applied matching vehicle cream twice a day (BID) for 24 weeks in the Double-Blind Period.
|
|---|---|---|
|
General disorders
Application site exfoliation
|
1.8%
1/55 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
5.3%
1/19 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
|
Infections and infestations
COVID-19
|
16.4%
9/55 • Number of events 9 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
10.5%
2/19 • Number of events 2 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/55 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
5.3%
1/19 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
|
Infections and infestations
Gastroenteritis
|
0.00%
0/55 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
5.3%
1/19 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
|
Congenital, familial and genetic disorders
Hydrocele
|
0.00%
0/55 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
5.3%
1/19 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Seborrhoeic keratosis
|
0.00%
0/55 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
5.3%
1/19 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/55 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
5.3%
1/19 • Number of events 1 • from the time of Informed Consent Form signing until at least 30 days after the last application of study drug (up to Week 52 + 30 days)
Treatment-emergent adverse events (TEAEs): AEs reported for the first time or the worsening of a pre-existing event after the first application of study drug. For the Double-Blind Period, TEAEs are reported for members of the Safety Population: all participants who applied ruxolitinib cream or vehicle cream at least once. For the Treatment-Extension (TE) Period, TEAEs are reported for the TE Evaluable Population: all participants who applied ruxolitinib cream at least once in the TE Period.
|
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