Trial Outcomes & Findings for A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA) (NCT NCT02553330)
NCT ID: NCT02553330
Last Updated: 2020-12-16
Results Overview
Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
90 participants
Primary outcome timeframe
Up to Week 24
Results posted on
2020-12-16
Participant Flow
This study was conducted at 17 study centers in the United States.
Twelve participants were enrolled at 4 sites and were evaluable in the Part A treatment period; In Part B, 78 additional participants were enrolled at 17 sites.
Participant milestones
| Measure |
Part A: Ruxolitinib Cream
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B : Placebo Cream
Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Overall Study
STARTED
|
12
|
39
|
39
|
|
Overall Study
COMPLETED
|
7
|
0
|
2
|
|
Overall Study
NOT COMPLETED
|
5
|
39
|
37
|
Reasons for withdrawal
| Measure |
Part A: Ruxolitinib Cream
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B : Placebo Cream
Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Overall Study
Study Terminated by Sponsor
|
2
|
13
|
12
|
|
Overall Study
Withdrawal by Subject
|
3
|
19
|
21
|
|
Overall Study
Other
|
0
|
1
|
0
|
|
Overall Study
Non compliance to study treatment
|
0
|
1
|
0
|
|
Overall Study
Adverse Event
|
0
|
1
|
0
|
|
Overall Study
Lost to Follow-up
|
0
|
4
|
4
|
Baseline Characteristics
A Study With Ruxolitinib Phosphate Cream Applied Topically to Subjects With Alopecia Areata (AA)
Baseline characteristics by cohort
| Measure |
Part A: Ruxolitinib Cream
n=12 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B : Placebo Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks and/or optional treatment with Ruxolitinib Phosphate Cream if eligible and follow-up is an additional 12 weeks
|
Part B : Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Age, Continuous
|
47.6 Years
STANDARD_DEVIATION 13.17 • n=5 Participants
|
44.3 Years
STANDARD_DEVIATION 15.92 • n=7 Participants
|
42.4 Years
STANDARD_DEVIATION 14.69 • n=5 Participants
|
43.4 Years
STANDARD_DEVIATION 15.25 • n=4 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
24 Participants
n=7 Participants
|
27 Participants
n=5 Participants
|
60 Participants
n=4 Participants
|
|
Sex: Female, Male
Male
|
3 Participants
n=5 Participants
|
15 Participants
n=7 Participants
|
12 Participants
n=5 Participants
|
30 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
White or Caucasian
|
11 Participants
n=5 Participants
|
33 Participants
n=7 Participants
|
29 Participants
n=5 Participants
|
73 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
0 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Asian
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
2 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Other
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
5 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Unknown
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Hispanic or Latino
|
1 Participants
n=5 Participants
|
3 Participants
n=7 Participants
|
5 Participants
n=5 Participants
|
9 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Hispanic or Latino
|
11 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
33 Participants
n=5 Participants
|
80 Participants
n=4 Participants
|
|
Race/Ethnicity, Customized
Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
PRIMARY outcome
Timeframe: Up to Week 24Population: Part A evaluable population in treatment period includes all subjects exposed to at least 1 dose of study drug in that period.
Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=12 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Week 4
|
0 Participants
|
—
|
—
|
|
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Week 8
|
0 Participants
|
—
|
—
|
|
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Week 12
|
3 Participants
|
—
|
—
|
|
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Week 18
|
4 Participants
|
—
|
—
|
|
Part A: Percentage of Participants Achieving a ≥ 50% Improvement in SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
Week 24
|
6 Participants
|
—
|
—
|
PRIMARY outcome
Timeframe: Week 24Population: Intent to Treat population in the Part B treatment period i.e all participants who are randomized
Percentage of subjects achieving a SALT 50 (defined as a ≥ 50% improvement from baseline in SALT). SALT score is on a percent scale where 0% is no hair loss and 100 % is total hair loss.
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=39 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part B : Percentage of Participants Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented)
|
5 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Up to Week 24Population: The subgroup analysis was performed on subjects exposed to at least 1 dose of study drug in that period with a baseline SALT score of 50-100%.
Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=7 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
Week 4
|
0 Participants
|
—
|
—
|
|
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
Week 8
|
0 Participants
|
—
|
—
|
|
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
Week 12
|
2 Participants
|
—
|
—
|
|
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
Week 18
|
3 Participants
|
—
|
—
|
|
Part A : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair.
Week 24
|
4 Participants
|
—
|
—
|
SECONDARY outcome
Timeframe: Week 24Population: The subgroup analysis was performed on subjects exposed to at least 1 dose of study drug in that period with a baseline SALT score of 50-100%.
Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=22 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=21 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part B : Percentage of Participants With 50% to 100% Scalp Involvement at Baseline Achieving a SALT50 Response in Terminal Hair (Pigmented and Nonpigmented).
|
2 Participants
|
4 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 18, and 24.Population: Part A evaluable population in treatment period includes all subjects exposed to at least 1 dose of study drug in that period. Intent to Treat population in the Part B treatment period i.e all participants who are randomized.
Number of participants achieving 90% or greater improvement in their SALT score (SALT90) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes.
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=12 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
Week4
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
Week 8
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
Week 12
|
0 Participants
|
0 Participants
|
1 Participants
|
|
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
Week 18
|
1 Participants
|
0 Participants
|
2 Participants
|
|
Part A and B : Percentage of Participants Achieving a SALT90 Response in Terminal Hair.
Week 24
|
2 Participants
|
0 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 24Population: Intent to Treat population in the Part B treatment period i.e all participants who are randomized. Participants dropped out of study by week 24 were excluded from analysis.
Number of subjects achieving a Physician's Global Assessment (PGA) score of 3 or above at week 24 (0, no regrowth; 1, \<25% of regrowth; 2, 25%-49% of regrowth; 3, 50%-74% of regrowth; 4, 75%-99% of re- growth; 5, 100% of regrowth).
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=33 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=33 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part B : Percentage of Subjects Whose AA Lesions Treated Since Baseline Achieved a Physician's Global Assessment of Regrowth (PGARG) Score of at Least 3
|
5 Participants
|
2 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, and 18.Population: Intent to Treat population in the Part B treatment period i.e all participants who are randomized.
Number of participants achieving 50% or greater improvement in their SALT score (SALT50) compared to Baseline. SALT score 0-100 with lower score indicating better health outcomes
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=39 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).
Week 4
|
0 Participants
|
0 Participants
|
—
|
|
Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).
Week 8
|
0 Participants
|
2 Participants
|
—
|
|
Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).
Week 12
|
1 Participants
|
3 Participants
|
—
|
|
Part B : Percentage of Participants Achieving a SALT50 in Terminal Hair (Pigmented and Nonpigmented).
Week 18
|
4 Participants
|
5 Participants
|
—
|
SECONDARY outcome
Timeframe: Weeks 4, 8, 12, 18, and 24.Population: Intent to Treat population in the Part B treatment period i.e all participants who are randomized.
Severity of Alopecia Tool Score (SALT) calculation is based on a scoring system. The scalp is divided into the following 4 areas: 1) Vertex: 40% (0.4) of scalp surface area, 2) Right profile of scalp: 18% (0.18) of scalp surface area, 3) Left profile of scalp: 18% (0.18) of scalp surface area, and 4) Posterior aspect of scalp: 24% (0.24) of scalp surface area. The percentage of hair loss in any of these areas is the percentage hair loss multiplied by percent surface area of the scalp in that area. The SALT score is the sum of percentage of hair loss in all the above-mentioned areas, so a lower number indicates a better outcome. The reported SALT score range is from a minimum of 0 (no hair loss) to a maximum of 100 (100% hair loss).
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=39 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part B: Mean Change From Baseline in SALT Score
Change from Baseline to Week 4
|
1.02 Units on a Scale
Standard Error 1.577
|
0.13 Units on a Scale
Standard Error 1.534
|
—
|
|
Part B: Mean Change From Baseline in SALT Score
Change from Baseline to Week 8
|
2.13 Units on a Scale
Standard Error 2.233
|
-1.11 Units on a Scale
Standard Error 2.160
|
—
|
|
Part B: Mean Change From Baseline in SALT Score
Change from Baseline to Week 12
|
1.23 Units on a Scale
Standard Error 2.956
|
-2.55 Units on a Scale
Standard Error 2.873
|
—
|
|
Part B: Mean Change From Baseline in SALT Score
Change from Baseline to Week 18
|
-0.01 Units on a Scale
Standard Error 3.550
|
-4.16 Units on a Scale
Standard Error 3.461
|
—
|
|
Part B: Mean Change From Baseline in SALT Score
Change from Baseline to Week 24
|
-1.68 Units on a Scale
Standard Error 3.886
|
-3.92 Units on a Scale
Standard Error 3.794
|
—
|
SECONDARY outcome
Timeframe: Up to 100 weeksPopulation: All enrolled subjects who received at least 1 dose of INCB018424 or Placebo.
Adverse events reported for the first time or worsening of a pre-existing event after first dose of study drug/treatment
Outcome measures
| Measure |
Part A: Ruxolitinib Cream
n=12 Participants
Part A: Open-label treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks
|
Part B: Ruxolitinib Cream
n=38 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
Part B : Ruxolitinib Cream
n=39 Participants
Part B: Double-blind treatment is 24 weeks, an optional open-label treatment extension is 24 weeks if eligible, and follow-up is an additional 12 weeks.
|
|---|---|---|---|
|
Part A and B : Number of Treatment-emergent Adverse Events
Treatment Period
|
9 Participants
|
28 Participants
|
23 Participants
|
|
Part A and B : Number of Treatment-emergent Adverse Events
Extension Period
|
7 Participants
|
23 Participants
|
22 Participants
|
Adverse Events
Placebo Cream
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Ruxolitinib Cream
Serious events: 4 serious events
Other events: 31 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Placebo Cream
n=38 participants at risk
Part B: Double-blind treatment for 24 weeks.
|
Ruxolitinib Cream
n=83 participants at risk
Part A: Open-label treatment for 24 weeks. Part B: Double-blind treatment for 24 weeks. Placebo group from Part B had the option to crossover after the first 24 weeks of treatment period.
Both Part A and Part B participants, if eligible, continued on to open-label extension (24 weeks) and long-term extension (48 weeks) periods.
|
|---|---|---|
|
Infections and infestations
Diverticulitis
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
1.2%
1/83 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Psychiatric disorders
Generalised anxiety disorder
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
1.2%
1/83 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Infected neoplasm
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
1.2%
1/83 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Lentigo maligna
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
1.2%
1/83 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
General disorders
Non-cardiac chest pain
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
1.2%
1/83 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Sepsis
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
1.2%
1/83 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
Other adverse events
| Measure |
Placebo Cream
n=38 participants at risk
Part B: Double-blind treatment for 24 weeks.
|
Ruxolitinib Cream
n=83 participants at risk
Part A: Open-label treatment for 24 weeks. Part B: Double-blind treatment for 24 weeks. Placebo group from Part B had the option to crossover after the first 24 weeks of treatment period.
Both Part A and Part B participants, if eligible, continued on to open-label extension (24 weeks) and long-term extension (48 weeks) periods.
|
|---|---|---|
|
Infections and infestations
Bronchitis
|
5.3%
2/38 • Number of events 2 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
2.4%
2/83 • Number of events 2 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Nasopharyngitis
|
15.8%
6/38 • Number of events 6 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
15.7%
13/83 • Number of events 16 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
7.9%
3/38 • Number of events 3 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
12.0%
10/83 • Number of events 11 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Sinusitis
|
2.6%
1/38 • Number of events 1 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
8.4%
7/83 • Number of events 7 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Skin and subcutaneous tissue disorders
Skin exfoliation
|
7.9%
3/38 • Number of events 3 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
3.6%
3/83 • Number of events 3 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/38 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
6.0%
5/83 • Number of events 5 • Up to 100 weeks
The safety population included all randomized subjects who received at least 1 dose of study drug.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee Clinical Study Agreement
- Publication restrictions are in place
Restriction type: OTHER