Trial Outcomes & Findings for A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis (NCT NCT02852967)
NCT ID: NCT02852967
Last Updated: 2022-03-16
Results Overview
The percentage of subjects who exhibited a 75% decrease or greater in the Psoriasis Area and Severity Index Score (PASI 75) whether they completed 16 weeks of treatment or not (last observation carried forward \[LOCF\]) and those who did complete 16 weeks of treatment (observed). \[PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
110 participants
Primary outcome timeframe
16 weeks
Results posted on
2022-03-16
Participant Flow
Participant milestones
| Measure |
Belumosudil 200 mg QD + Placebo
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
23
|
22
|
21
|
26
|
18
|
|
Overall Study
Completed Period 1: Double-blind
|
14
|
15
|
17
|
16
|
10
|
|
Overall Study
Completed Period 2: Open-label
|
11
|
8
|
13
|
11
|
14
|
|
Overall Study
COMPLETED
|
9
|
6
|
9
|
4
|
2
|
|
Overall Study
NOT COMPLETED
|
14
|
16
|
12
|
22
|
16
|
Reasons for withdrawal
| Measure |
Belumosudil 200 mg QD + Placebo
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
3
|
1
|
0
|
1
|
0
|
|
Overall Study
Death
|
1
|
0
|
0
|
0
|
0
|
|
Overall Study
Lost to Follow-up
|
1
|
2
|
3
|
4
|
4
|
|
Overall Study
Withdrawal by Subject
|
6
|
12
|
7
|
10
|
10
|
|
Overall Study
SAE
|
0
|
0
|
0
|
3
|
0
|
|
Overall Study
Elevated Liver Enzymes
|
2
|
0
|
0
|
2
|
2
|
|
Overall Study
Physician Decision
|
0
|
0
|
0
|
1
|
0
|
|
Overall Study
Lack of Efficacy
|
0
|
1
|
0
|
0
|
0
|
|
Overall Study
Non-compliance
|
0
|
0
|
1
|
1
|
0
|
|
Overall Study
Dispensing Drug Violation
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Inclusion/Exclusion Violation
|
1
|
0
|
0
|
0
|
0
|
Baseline Characteristics
A Phase 2, Double-blind, Placebo-controlled Study of the Efficacy and Safety of Belumosudil in Subjects With Moderate/Severe Chronic Plaque Psoriasis
Baseline characteristics by cohort
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
Total
n=110 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Continuous
|
49.3 Years
STANDARD_DEVIATION 8.9 • n=5 Participants
|
46.2 Years
STANDARD_DEVIATION 9.6 • n=7 Participants
|
43.0 Years
STANDARD_DEVIATION 11.4 • n=5 Participants
|
43.5 Years
STANDARD_DEVIATION 11.5 • n=4 Participants
|
45.7 Years
STANDARD_DEVIATION 14.2 • n=21 Participants
|
45.5 Years
STANDARD_DEVIATION 11.2 • n=10 Participants
|
|
Sex: Female, Male
Female
|
16 Participants
n=5 Participants
|
13 Participants
n=7 Participants
|
14 Participants
n=5 Participants
|
15 Participants
n=4 Participants
|
11 Participants
n=21 Participants
|
69 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
7 Participants
n=5 Participants
|
9 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
11 Participants
n=4 Participants
|
7 Participants
n=21 Participants
|
41 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
4 Participants
n=7 Participants
|
4 Participants
n=5 Participants
|
8 Participants
n=4 Participants
|
2 Participants
n=21 Participants
|
23 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
18 Participants
n=5 Participants
|
18 Participants
n=7 Participants
|
16 Participants
n=5 Participants
|
18 Participants
n=4 Participants
|
15 Participants
n=21 Participants
|
85 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
1 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
1 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
1 Participants
n=4 Participants
|
3 Participants
n=21 Participants
|
8 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=5 Participants
|
19 Participants
n=7 Participants
|
17 Participants
n=5 Participants
|
24 Participants
n=4 Participants
|
14 Participants
n=21 Participants
|
94 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=21 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
0 Participants
n=4 Participants
|
1 Participants
n=21 Participants
|
2 Participants
n=10 Participants
|
|
BMI (Mean)
|
33.8 kg/m^2
STANDARD_DEVIATION 9.9 • n=5 Participants
|
30.7 kg/m^2
STANDARD_DEVIATION 7.0 • n=7 Participants
|
29.9 kg/m^2
STANDARD_DEVIATION 7.4 • n=5 Participants
|
33.1 kg/m^2
STANDARD_DEVIATION 10.7 • n=4 Participants
|
32 kg/m^2
STANDARD_DEVIATION 6.7 • n=21 Participants
|
32.0 kg/m^2
STANDARD_DEVIATION 8.7 • n=10 Participants
|
PRIMARY outcome
Timeframe: 16 weeksPopulation: PASI 75 determined by Last Observation Carried Forward (LOCF) and Observed at the end of Double-blind Period: 16 weeks
The percentage of subjects who exhibited a 75% decrease or greater in the Psoriasis Area and Severity Index Score (PASI 75) whether they completed 16 weeks of treatment or not (last observation carried forward \[LOCF\]) and those who did complete 16 weeks of treatment (observed). \[PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed
LOCF (%)
|
8.7 Percentage of participants
Interval 1.1 to 28.0
|
9.1 Percentage of participants
Interval 1.1 to 29.2
|
19.0 Percentage of participants
Interval 5.4 to 41.9
|
7.7 Percentage of participants
Interval 0.9 to 25.1
|
16.7 Percentage of participants
Interval 3.6 to 41.4
|
10.9 Percentage of participants
Interval 5.3 to 19.1
|
|
Efficacy: Percentage of Subjects With a ≥ 75% Decrease in PASI (PASI 75) at Week 16 (Double-blind Period)--LOCF and Observed
Observed (%)
|
7.1 Percentage of participants
Interval 0.2 to 33.9
|
13.3 Percentage of participants
Interval 1.7 to 40.5
|
23.5 Percentage of participants
Interval 6.8 to 49.9
|
12.5 Percentage of participants
Interval 1.6 to 38.3
|
30.0 Percentage of participants
Interval 6.7 to 65.2
|
14.5 Percentage of participants
Interval 6.9 to 25.8
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Not all subjects had PASI performed
The mean change in the raw Psoriasis Area and Severity Index (PASI) score from baseline score to Week 16 and to Week 48 whether the subject completed 16 and 48 weeks, respectively (last observation carried forward \[LOCF\]), or for only those subjects who completed 16 and 48 weeks (observed), respectively. Negative values represent favorable results; positive values represent unfavorable results. \[The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
Change at Week 16--LOCF
|
-5.69 Score on a scale
Standard Deviation 8.59
|
-4.49 Score on a scale
Standard Deviation 7.44
|
-5.0 Score on a scale
Standard Deviation 8.31
|
-4.63 Score on a scale
Standard Deviation 8.04
|
-5.68 Score on a scale
Standard Deviation 12.31
|
-4.96 Score on a scale
Standard Deviation 7.98
|
|
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
Baseline
|
18.93 Score on a scale
Standard Deviation 8.31
|
20.60 Score on a scale
Standard Deviation 8.27
|
18.82 Score on a scale
Standard Deviation 6.08
|
19.80 Score on a scale
Standard Deviation 9.03
|
20.72 Score on a scale
Standard Deviation 8.08
|
19.55 Score on a scale
Standard Deviation 7.97
|
|
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
Change at Week 16--Observed
|
-3.75 Score on a scale
Standard Deviation 8.62
|
-6.29 Score on a scale
Standard Deviation 6.45
|
-4.96 Score on a scale
Standard Deviation 8.72
|
-3.81 Score on a scale
Standard Deviation 5.37
|
-8.44 Score on a scale
Standard Deviation 15.36
|
-4.71 Score on a scale
Standard Deviation 7.31
|
|
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
Change at Week 48--LOCF
|
-3.85 Score on a scale
Standard Deviation 10.53
|
-6.38 Score on a scale
Standard Deviation 5.16
|
-9.01 Score on a scale
Standard Deviation 7.63
|
-0.83 Score on a scale
Standard Deviation 7.73
|
-9.56 Score on a scale
Standard Deviation 18.98
|
-5.11 Score on a scale
Standard Deviation 8.45
|
|
Efficacy: Mean Change of Raw PASI Score From Baseline to Week 16 and Week 48--LOCF and Observed
Change at Week 48--Observed
|
-5.93 Score on a scale
Standard Deviation 11.26
|
-5.30 Score on a scale
Standard Deviation 5.88
|
-12.99 Score on a scale
Standard Deviation 6.71
|
-4.27 Score on a scale
Standard Deviation 2.16
|
9.45 Score on a scale
Standard Deviation 21.00
|
-7.98 Score on a scale
Standard Deviation 8.76
|
SECONDARY outcome
Timeframe: 48 weeksPopulation: Not all subjects had PASI performed
The percentage (%) change in the mean Psoriasis Area and Severity Index (PASI) score from baseline ore to Week 16 and to Week 48 whether the subject completed 16 and 48 weeks, respectively (last observation carried forward \[LOCF\]) or for only those subjects who completed 16 and 48 weeks (observed), respectively. \[The PASI is a composite score based on the degree of effect on body surface area of psoriasis and the extension of erythema (reddening), induration (thickness), desquamation (scaling) of the lesions and area affected as observed on the day of examination. The severity of each sign is assessed using a 5-point scale, where 0=no symptoms, 1=slight, 2=moderate, 3=marked, 4=very marked. The PASI score ranges from 0 to 72, where 0 indicates no psoriasis and 72 indicates very severe psoriasis.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed
Change (%) at Week 16--LOCF
|
-27.17 Percentage Change in PASI Score
Standard Deviation 37.60
|
-19.61 Percentage Change in PASI Score
Standard Deviation 35.60
|
-24.31 Percentage Change in PASI Score
Standard Deviation 42.74
|
-20.07 Percentage Change in PASI Score
Standard Deviation 31.20
|
-18.23 Percentage Change in PASI Score
Standard Deviation 43.93
|
-22.78 Percentage Change in PASI Score
Standard Deviation 36.27
|
|
Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed
Change (%) at Week 16--Observed
|
-15.21 Percentage Change in PASI Score
Standard Deviation 36.90
|
-29.70 Percentage Change in PASI Score
Standard Deviation 30.72
|
-24.17 Percentage Change in PASI Score
Standard Deviation 44.61
|
-20.22 Percentage Change in PASI Score
Standard Deviation 30.16
|
-25.09 Percentage Change in PASI Score
Standard Deviation 54.31
|
-22.46 Percentage Change in PASI Score
Standard Deviation 35.77
|
|
Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed
Change (%) at Week 48--LOCF
|
-12.82 Percentage Change in PASI Score
Standard Deviation 40.33
|
-30.75 Percentage Change in PASI Score
Standard Deviation 24.51
|
-46.97 Percentage Change in PASI Score
Standard Deviation 39.90
|
-9.31 Percentage Change in PASI Score
Standard Deviation 41.28
|
-19.89 Percentage Change in PASI Score
Standard Deviation 90.61
|
-25.54 Percentage Change in PASI Score
Standard Deviation 39.87
|
|
Efficacy: Percentage Change in Mean PASI Score From Baseline to Week 16 and to Week 48--LOCF and Observed
Change (%) at Week 48--Observed
|
-21.81 Percentage Change in PASI Score
Standard Deviation 38.75
|
-30.02 Percentage Change in PASI Score
Standard Deviation 34.39
|
-63.04 Percentage Change in PASI Score
Standard Deviation 29.04
|
-33.16 Percentage Change in PASI Score
Standard Deviation 15.48
|
84.98 Percentage Change in PASI Score
Standard Deviation 166.19
|
-38.33 Percentage Change in PASI Score
Standard Deviation 36.22
|
SECONDARY outcome
Timeframe: 16 weeksThe number of subjects who had a "Clear" or "Almost Clear" assessment, using the Physician Global Assessment Scale (PGA), at Week 16 of all subjects whether they completed 16 weeks or not (last observation carried forward \[LOCF\]) \[The PGA documents the physician's assessment of the subject's psoriasis and was assessed relative to baseline conditions. The PGA rating is from 1-6, where 1 = 100% clearing of psoriasis (clear), 5 = 0 to 24% clearing (little or no change), and 6 = worse.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Number of Subjects With Clear or Almost Clear PGA at Week 16--LOCF
|
1 Participants
|
0 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
4 Participants
|
SECONDARY outcome
Timeframe: 16 weeksPopulation: Not all subjects had a response to treatment
The percentage (%) of subjects who had a "Clear" or "Almost Clear" assessment using the Physician Global Assessment Scale at Week 16 of belumosudil vs. placebo for all subjects whether they completed 16 weeks or not (last observation carried forward \[LOCF\]). \[The PGA documents the physician's assessment of the subject's psoriasis and was assessed relative to baseline conditions. The PGA rating is from 1-6, where 1 = 100% clearing of psoriasis (clear), 5 = 0 to 24% clearing (little or no change), and 6 = worse.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=92 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Percentage of Subjects With Clear or Almost Clear PGA Comparing Belumosudil to Placebo at Week 16--LOCF
|
-6.8 Percentage (%) of subjects
Interval -23.5 to 10.0
|
-11.1 Percentage (%) of subjects
Interval -25.6 to 3.4
|
-1.6 Percentage (%) of subjects
Interval -20.8 to 17.6
|
-7.3 Percentage (%) of subjects
Interval -23.6 to 9.0
|
-6.8 Percentage (%) of subjects
Interval -21.9 to 8.3
|
—
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Not all subjects could be evaluated at all visits.
Changes in mean Dermatology Life Quality Index (DLQI) score from baseline at Week 16 (End of Double-blind Period) and at Week 48 (End of Study Treatment). \[The DLQI is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. DLQI scoring as measured on subject's life: 0-1 = no effect; 2-5 = small effect; 6-10 = moderate effect; 11 to 20 = very large effect; 21 to 30 = extremely large effect. Change \< 0% is improvement; \> 0% is worsening. The total rating ranges from 0 (no effect on a subject's life) to 30 (extremely large effect on a subject's life.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48
Baseline
|
10.6 Score on a scale
Standard Deviation 6.3
|
16.5 Score on a scale
Standard Deviation 9.4
|
12.2 Score on a scale
Standard Deviation 6.5
|
11.0 Score on a scale
Standard Deviation 7.1
|
10.3 Score on a scale
Standard Deviation 6.4
|
12.5 Score on a scale
Standard Deviation 7.7
|
|
Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48
Change at Week 16
|
-2.2 Score on a scale
Standard Deviation 5.6
|
-3.4 Score on a scale
Standard Deviation 4.0
|
-2.5 Score on a scale
Standard Deviation 6.0
|
-2.3 Score on a scale
Standard Deviation 7.0
|
-4.0 Score on a scale
Standard Deviation 6.7
|
-2.6 Score on a scale
Standard Deviation 5.7
|
|
Efficacy: Change in Mean DLQI Raw Score at Week 16 and at Week 48
Change at Week 48
|
-6.5 Score on a scale
Standard Deviation 5.1
|
-1.0 Score on a scale
Standard Deviation 8.6
|
-5.2 Score on a scale
Standard Deviation 6.9
|
-3.7 Score on a scale
Standard Deviation 3.2
|
-3.0 Score on a scale
Standard Deviation 2.8
|
-4.7 Score on a scale
Standard Deviation 6.3
|
SECONDARY outcome
Timeframe: Up to 48 weeksPopulation: Not all subjects could be evaluated at all visits. Mean decrease in mean DLQI score is favorable; mean increase is not favorable
Mean percentage changes in Dermatology Life Quality Index (DLQI) from baseline at Week 16 (End of Double-blind Period) and at Week 48 (End of Study Treatment). \[The DLQI is a skin disease-specific instrument designed to assess the impact of the disease on a subject's quality of life. The rating ranges from 0 (no effect on a subject's life) to 30 (extremely large effect on a subject's life.\]
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48
Percentage Change at Week 16
|
-5.73 Percentage change of DLQI score
Standard Deviation 60.75
|
-14.8 Percentage change of DLQI score
Standard Deviation 28.78
|
-22.22 Percentage change of DLQI score
Standard Deviation 48.60
|
-6.4 Percentage change of DLQI score
Standard Deviation 79.95
|
-40.30 Percentage change of DLQI score
Standard Deviation 47.83
|
-12.55 Percentage change of DLQI score
Standard Deviation 56.58
|
|
Efficacy: Percentage Change of Mean DLQI Score From Baseline to Week 16 and Week 48
Percentage Change at Week 48
|
-32.41 Percentage change of DLQI score
Standard Deviation 86.97
|
3.54 Percentage change of DLQI score
Standard Deviation 54.32
|
-45.60 Percentage change of DLQI score
Standard Deviation 45.84
|
-53.73 Percentage change of DLQI score
Standard Deviation 45.24
|
-54.17 Percentage change of DLQI score
Standard Deviation 41.25
|
-33.11 Percentage change of DLQI score
Standard Deviation 65.64
|
SECONDARY outcome
Timeframe: Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-upThe number of subjects who had treatment-emergent adverse events (TEAEs), severity of TEAEs, relationship of TEAEs to study medication, serious TEAEs (SAEs), dose interruption, discontinuations, and deaths. Treatment-emergent adverse events (TEAEs) are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP. Severity: Grade 1 = mild; Grade 2 = moderate; Grade 3 = severe; Grade 4 = life-threatening; Grade 5 = Death. Related to study medication is defined as possible related, probable related, and related
Outcome measures
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 Participants
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 Participants
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 Participants
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=18 Participants
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 Participants
All subjects in the Belumosudil 200 mg QD, 200 mg BID, 400 mg QD, and 600 mg/day cohorts
|
|---|---|---|---|---|---|---|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
At least 1 TEAE
|
14 Participants
|
13 Participants
|
14 Participants
|
16 Participants
|
11 Participants
|
57 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Grade 3 or Greater TEAE
|
2 Participants
|
3 Participants
|
0 Participants
|
5 Participants
|
2 Participants
|
10 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Related TEAE
|
8 Participants
|
6 Participants
|
5 Participants
|
9 Participants
|
6 Participants
|
28 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Related Grade 3 or Greater TEAE
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
5 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Leading to Dose Interruption
|
1 Participants
|
1 Participants
|
1 Participants
|
4 Participants
|
0 Participants
|
7 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
SAE
|
1 Participants
|
0 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
4 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Related SAE
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Leading to Discontinuation
|
6 Participants
|
1 Participants
|
1 Participants
|
7 Participants
|
3 Participants
|
15 Participants
|
|
Safety: Number of Subjects With TEAEs, SAEs, and Deaths Throughout the Study
Deaths
|
1 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Belumosudil 200 mg QD + Placebo
Serious events: 1 serious events
Other events: 14 other events
Deaths: 1 deaths
Belumosudil 200 mg BID (Twice Daily) + Placebo
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Belumosudil 400 mg QD + Placebo
Serious events: 0 serious events
Other events: 14 other events
Deaths: 0 deaths
Belumosudil 600 mg/Day
Serious events: 3 serious events
Other events: 16 other events
Deaths: 0 deaths
Placebo
Serious events: 1 serious events
Other events: 11 other events
Deaths: 0 deaths
All Belumosudil
Serious events: 1 serious events
Other events: 57 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 participants at risk
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 participants at risk
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 participants at risk
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 participants at risk
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=92 participants at risk；n=18 participants at risk
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 participants at risk
All subjects from all cohorts who received belumosudil
|
|---|---|---|---|---|---|---|
|
Respiratory, thoracic and mediastinal disorders
Chronic obstructive pulmonary disease (COPD)
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/18 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Pneumonia
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/18 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Nervous system disorders
Thalamic infarction
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/18 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Metabolism and nutrition disorders
Hypercholesterolemia
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.6%
1/18 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
General disorders
Natural death
|
4.3%
1/23 • Number of events 1 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/18 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
Other adverse events
| Measure |
Belumosudil 200 mg QD + Placebo
n=23 participants at risk
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 200 mg BID (Twice Daily) + Placebo
n=22 participants at risk
One belumosudil 200 mg tablet and 1 matching placebo tablet in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 400 mg QD + Placebo
n=21 participants at risk
Two belumosudil 200 mg tablets in the morning and 1 matching placebo tablet in the evening
Belumosudil: Belumosudil tablets
Placebo: Placebo tablets matching belumosudil
|
Belumosudil 600 mg/Day
n=26 participants at risk
Two belumosudil 200 mg tablets in the morning and 1 belumosudil 200 mg tablet in the evening
Belumosudil: Belumosudil tablets
|
Placebo
n=92 participants at risk；n=18 participants at risk
Two matching placebo tablets in the morning and 1 matching placebo tablet in the evening
Placebo: Placebo tablets matching belumosudil
|
All Belumosudil
n=92 participants at risk
All subjects from all cohorts who received belumosudil
|
|---|---|---|---|---|---|---|
|
Investigations
Alanine aminotransaminase (ALT) increased
|
8.7%
2/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
7.7%
2/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.4%
5/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Investigations
Hepatic enzyme increased
|
8.7%
2/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
7.7%
2/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.4%
5/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Investigations
Aspartate aminotransferase increased
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
7.7%
2/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
5.4%
5/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Investigations
Blood creatinine phosphokinase increased
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Viral upper respiratory tract infection
|
8.7%
2/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
13.6%
3/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
6.5%
6/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Influenza
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
14.3%
3/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.3%
4/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Upper respiratory tract infection
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.3%
3/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
9.5%
2/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.3%
3/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Bronchitis
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Infections and infestations
Tooth infection
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
18.2%
4/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
6.5%
6/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Gastrointestinal disorders
Diarrhea
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.3%
4/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
7.7%
2/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.3%
3/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Gastrointestinal disorders
Dyspepsia
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
9.1%
2/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Gastrointestinal disorders
Gastroesophageal reflux disease
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
9.1%
2/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Injury, poisoning and procedural complications
Ligament pain
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Injury, poisoning and procedural complications
Meniscus injry
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Injury, poisoning and procedural complications
Tooth fracture
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Nervous system disorders
Headache
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
9.1%
2/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
9.5%
2/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
7.7%
2/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
6.5%
6/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Nervous system disorders
Dizziness
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Psychiatric disorders
Depression
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Psychiatric disorders
Insomnia
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
9.5%
2/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
1.1%
1/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.3%
4/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.3%
3/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
General disorders
Fatigue
|
0.00%
0/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.8%
1/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
2.2%
2/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
|
Vascular disorders
Hypertension
|
4.3%
1/23 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.5%
1/22 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
4.8%
1/21 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/26 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
0.00%
0/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
3.3%
3/92 • Approximately 52 weeks: up to 48 weeks of treatment and 30-day follow-up
Adverse events were categorized as treatment-emergent adverse events (TEAEs). TEAEs are AEs that are not present before the first dose of IMP or that are present before the first dose of IMP but worsen in intensity during exposure to IMP.
|
Additional Information
Olivier Schueller, Senior Vice President, CMC & Clinical Pharmacology
Kadmon Corporation, LLC
Phone: 724-778-6170
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee The only disclosure restriction on the PI is that the sponsor can review results communications prior to public release and can embargo communications regarding results. The sponsor cannot require changes to the study results in the communication except to remove sponsor's confidential information. Sponsor cannot unilaterally extend the embargo.
- Publication restrictions are in place
Restriction type: OTHER