Trial Outcomes & Findings for Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa (NCT NCT05635838)
NCT ID: NCT05635838
Last Updated: 2024-11-01
Results Overview
The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
COMPLETED
PHASE2
69 participants
Baseline; Week 16
2024-11-01
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 1.5% Cream BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 16 weeks.
|
Open-label Extension (OLE) Period: Ruxolitinib 1.5% Cream BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an additional 16 weeks in the OLE Period.
|
OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period.
|
|---|---|---|---|---|
|
16-Week DBVC Period
STARTED
|
34
|
35
|
0
|
0
|
|
16-Week DBVC Period
COMPLETED
|
24
|
32
|
0
|
0
|
|
16-Week DBVC Period
NOT COMPLETED
|
10
|
3
|
0
|
0
|
|
16-Week OLE Period
STARTED
|
0
|
0
|
24
|
32
|
|
16-Week OLE Period
COMPLETED
|
0
|
0
|
21
|
24
|
|
16-Week OLE Period
NOT COMPLETED
|
0
|
0
|
3
|
8
|
Reasons for withdrawal
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
Participants applied matching vehicle cream BID for 16 weeks.
|
Open-label Extension (OLE) Period: Ruxolitinib 1.5% Cream BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an additional 16 weeks in the OLE Period.
|
OLE Period: Vehicle Cream to Ruxolitinib 1.5% Cream BID
Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period.
|
|---|---|---|---|---|
|
16-Week DBVC Period
Adverse Event
|
2
|
0
|
0
|
0
|
|
16-Week DBVC Period
Lost to Follow-up
|
5
|
1
|
0
|
0
|
|
16-Week DBVC Period
Physician Decision
|
0
|
1
|
0
|
0
|
|
16-Week DBVC Period
Protocol Violation
|
1
|
0
|
0
|
0
|
|
16-Week DBVC Period
Withdrawal by Subject
|
1
|
0
|
0
|
0
|
|
16-Week DBVC Period
Presence of Disease Tunnel
|
1
|
0
|
0
|
0
|
|
16-Week DBVC Period
Developed Draining Fistula
|
0
|
1
|
0
|
0
|
|
16-Week OLE Period
Adverse Event
|
0
|
0
|
0
|
2
|
|
16-Week OLE Period
Lost to Follow-up
|
0
|
0
|
1
|
3
|
|
16-Week OLE Period
Physician Decision
|
0
|
0
|
0
|
1
|
|
16-Week OLE Period
Protocol Violation
|
0
|
0
|
1
|
1
|
|
16-Week OLE Period
Withdrawal by Subject
|
0
|
0
|
0
|
1
|
|
16-Week OLE Period
Pregnancy
|
0
|
0
|
1
|
0
|
Baseline Characteristics
Study to Evaluate of the Efficacy and Safety of Ruxolitinib Cream in Participants With Hidradenitis Suppurativa
Baseline characteristics by cohort
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=34 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=35 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
Total
n=69 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
32.0 years
STANDARD_DEVIATION 9.83 • n=93 Participants
|
31.3 years
STANDARD_DEVIATION 9.84 • n=4 Participants
|
31.7 years
STANDARD_DEVIATION 9.76 • n=27 Participants
|
|
Sex: Female, Male
Female
|
29 Participants
n=93 Participants
|
33 Participants
n=4 Participants
|
62 Participants
n=27 Participants
|
|
Sex: Female, Male
Male
|
5 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
7 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
8 Participants
n=27 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
27 Participants
n=93 Participants
|
34 Participants
n=4 Participants
|
61 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
|
19 Participants
n=93 Participants
|
12 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Black/African-American
|
11 Participants
n=93 Participants
|
18 Participants
n=4 Participants
|
29 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Asian
|
0 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Mixed Race: Black and White
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
White and American Indian/Alaska Native
|
2 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Half White, Half Asian
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
Metis, White
|
0 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
|
Race/Ethnicity, Customized
North African
|
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 treatment assignment at randomization. Only participants with available data were analyzed.
The mixed model repeated measure (MMRM) included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Abscess and Inflammatory Nodule (AN) Count at Week 16
|
-3.61 ANs
Standard Error 0.378
|
-2.42 ANs
Standard Error 0.336
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Only participants with available data were analyzed.
AN50, AN75, AN90, and AN100 were defined as at least a 50%, 75%, 90%, and 100% decrease, respectively, in AN count relative to Baseline.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16
AN50
|
79.2 percentage of participants
|
56.3 percentage of participants
|
|
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16
AN75
|
54.2 percentage of participants
|
25.0 percentage of participants
|
|
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16
AN90
|
20.8 percentage of participants
|
12.5 percentage of participants
|
|
Percentage of Participants Achieving AN50, AN75, AN90, and AN100 at Week 16
AN100
|
20.8 percentage of participants
|
12.5 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Only participants with available data were analyzed.
Pre-existing ANs at Baseline were defined as abscesses and/or inflammatory nodules present at Baseline. All new ANs identified during the study in an anatomical area that had pre-existing ANs at Baseline were counted. Any new ANs identified in an anatomical area that was initially free of ANs at Baseline were not counted. Change from Baseline was calculated as the post-Baseline value minus the Baseline value. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline to Week 16 in Total AN Count in Anatomical Areas With Pre-existing ANs at Baseline
|
-3.85 ANs
Standard Error 0.362
|
-3.17 ANs
Standard Error 0.323
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Only participants with available data were analyzed.
The Skin Pain NRS is a daily participant-reported measure (24-hour recall) of the worst level of skin pain related to Hidradenitis Suppurativa. The participants rated the pain severity of their Hidradenitis Suppurativa by selecting a number from 0 (no pain) to 10 (worst imaginable pain) that best described their worst level of pain in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=23 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=22 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Skin Pain Numeric Rating Scale (NRS) Score at Week 16
|
-1.90 scores on a scale
Standard Error 0.532
|
-2.09 scores on a scale
Standard Error 0.497
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Only participants with available data were analyzed.
The Itch NRS is a daily participant-reported measure (24-hour recall) of the worst level of itch intensity related to Hidradenitis Suppurativa. The participants rated the itch severity of their Hidradenitis Suppurativa by selecting a number from 0 (no itch) to 10 (worst imaginable itch) that best described their worst level of itching in the past 24 hours. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=23 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=22 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline in Itch NRS Score at Week 16
|
-1.45 scores on a scale
Standard Error 0.538
|
-2.39 scores on a scale
Standard Error 0.493
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Only participants with available data were analyzed.
HiSCR was defined as at least a 50% reduction in AN count with no increase in either abscess or draining fistula counts, relative to Baseline.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Percentage of Participants Who Achieve Hidradenitis Suppurativa Clinical Response (HiSCR) at Week 16
|
79.2 percentage of participants
|
50.0 percentage of participants
|
SECONDARY outcome
Timeframe: Baseline; Week 16Population: ITT Population. Only participants with available data were analyzed.
The IHS4 is a composite, dynamic score and validated tool used to determine Hidradenitis Suppurativa severity. IHS4 score was calculated by the number of inflammatory nodules (multiplied by 1) plus the number of abscesses (multiplied by 2) plus the number of draining tunnels (multiplied by 4). Scores: mild=0-3; moderate=4-10; severe ≥11. The MMRM included the fixed effects of the treatment group (ruxolitinib 1.5% and vehicle cream), stratification factor (Baseline AN count of ≥3 to 4 or ≥5 to 10), visit, and visit-by-treatment interaction. Change from Baseline was calculated as the Week 16 value minus the Baseline value.
Outcome measures
| Measure |
Double-blind, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Change From Baseline in the International Hidradenitis Suppurativa Severity Score System (IHS4) Score at Week 16
|
-3.58 scores on a scale
Standard Error 0.505
|
-2.76 scores on a scale
Standard Error 0.459
|
SECONDARY outcome
Timeframe: up to Week 16 plus 30 daysPopulation: Safety Population: all participants who applied ruxolitinib 1.5% cream or vehicle cream at least once. Treatment groups were determined according to the actual treatment the participant applied on Day 1 regardless of assigned treatment group.
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 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, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=34 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=35 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any Treatment-emergent Adverse Event (TEAE ) in the Double-blind, Vehicle-controlled (DBVC) Period
|
13 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: up to Week 16 plus 30 daysPopulation: Safety Population
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. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using Common Terminology Criteria for Adverse Events (CTCAE) v5.0 Grades 1 through 5. 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 (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=34 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=35 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any Grade 3 or Higher TEAE in the DBVC Period
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: from Week 17 up to Week 32 plus 30 daysPopulation: Open-label Extension Safety Population: all participants who applied ruxolitinib 1.5% cream BID at least once during the OLE 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 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, Vehicle-Controlled (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any TEAE in the Open-label Extension (OLE) Period
|
8 Participants
|
15 Participants
|
SECONDARY outcome
Timeframe: from Week 17 up to Week 32 plus 30 daysPopulation: Open-label Extension Safety Population
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. A TEAE was defined as any AE reported for the first time or the worsening of a pre-existing event after the first application of study drug. The severity of AEs was assessed using CTCAE v5.0 Grades 1 through 5. 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 (DBVC) Period: Ruxolitinib 1.5% Cream BID
n=24 Participants
Participants applied ruxolitinib 1.5% cream twice daily (BID) for 16 weeks.
|
DBVC Period: Vehicle Cream BID
n=32 Participants
Participants applied matching vehicle cream BID for 16 weeks.
|
|---|---|---|
|
Number of Participants With Any Grade 3 or Higher TEAE in the OLE Period
|
0 Participants
|
3 Participants
|
Adverse Events
Vehicle Cream BID
Ruxolitinib 1.5% Cream BID
Serious adverse events
| Measure |
Vehicle Cream BID
n=35 participants at risk
Participants applied matching vehicle cream twice a day (BID) for 16 weeks in the Double-blind, Vehicle-controlled Period.
|
Ruxolitinib 1.5% Cream BID
n=66 participants at risk
Participants applied ruxolitinib 1.5% cream BID during the Double-blind, Vehicle-controlled (DBVC) Period and the Open-label Extension (OLE) Period. Participants applied ruxolitinib 1.5% cream BID for 16 weeks in the DBVC Period. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an gadditional 16 weeks in the OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period.
|
|---|---|---|
|
Renal and urinary disorders
Acute kidney injury
|
0.00%
0/35 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
1.5%
1/66 • Number of events 1 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Respiratory, thoracic and mediastinal disorders
Atelectasis
|
0.00%
0/35 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
1.5%
1/66 • Number of events 1 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Gastrointestinal disorders
Crohn's disease
|
0.00%
0/35 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
1.5%
1/66 • Number of events 1 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Metabolism and nutrition disorders
Diabetic ketoacidosis
|
2.9%
1/35 • Number of events 1 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
0.00%
0/66 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
|
Musculoskeletal and connective tissue disorders
Systemic lupus erythematosus
|
0.00%
0/35 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
1.5%
1/66 • Number of events 1 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
Other adverse events
| Measure |
Vehicle Cream BID
n=35 participants at risk
Participants applied matching vehicle cream twice a day (BID) for 16 weeks in the Double-blind, Vehicle-controlled Period.
|
Ruxolitinib 1.5% Cream BID
n=66 participants at risk
Participants applied ruxolitinib 1.5% cream BID during the Double-blind, Vehicle-controlled (DBVC) Period and the Open-label Extension (OLE) Period. Participants applied ruxolitinib 1.5% cream BID for 16 weeks in the DBVC Period. Participants who completed the Week 16 assessments with no safety concerns could continue into the 16-week OLE Period. Participants who applied ruxolitinib 1.5% cream BID during the DBVC Period continued to apply ruxolitinib 1.5% cream BID for an gadditional 16 weeks in the OLE Period. Participants who applied vehicle cream BID during the DBVC Period applied ruxolitinib 1.5% cream BID for 16 weeks in the OLE Period.
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|---|---|---|
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Infections and infestations
Nasopharyngitis
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0.00%
0/35 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
7.6%
5/66 • Number of events 5 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
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Gastrointestinal disorders
Nausea
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5.7%
2/35 • Number of events 2 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
|
0.00%
0/66 • up to Week 32 plus 30 days
Treatment-emergent adverse events, defined as adverse events reported for the first time or the worsening of pre-existing events after the first application of study drug, have been reported. For safety analysis, participants who transitioned from treatment with vehicle cream BID to treatment with ruxolitinib 1.5% cream BID in the Open-label Extension Period have been counted both in the vehicle arm and the ruxolitinib arm.
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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