Trial Outcomes & Findings for A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis (NCT NCT01680159)
NCT ID: NCT01680159
Last Updated: 2026-01-08
Results Overview
The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
51 participants
Primary outcome timeframe
Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose Period
Results posted on
2026-01-08
Participant Flow
Patients of Pustular Psoriasis and Psoriatic Erythroderma could directly receive doses of TA-650 10mg per 1kg not to go though screening period.
Participant milestones
| Measure |
TA-650
During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either "efficacy attenuated" or "efficacy maintained" at week 8 of the normal dose period).
|
|---|---|
|
Screening Period
STARTED
|
46
|
|
Screening Period
COMPLETED
|
39
|
|
Screening Period
NOT COMPLETED
|
7
|
|
Increased Dose Period
STARTED
|
51
|
|
Increased Dose Period
COMPLETED
|
43
|
|
Increased Dose Period
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
TA-650
During the normal dose period, patients received doses of TA-650 5 mg per 1 kg body weight as a slow intravenous infusion over at least 2 hours on the treatment day at week 0, and at week 8 (if patients were not assessed as being either "efficacy attenuated" or "efficacy maintained" at week 8 of the normal dose period).
|
|---|---|
|
Screening Period
Not meet criteria for dose-up period
|
7
|
|
Increased Dose Period
Adverse Event
|
6
|
|
Increased Dose Period
Withdrawal by Subject
|
2
|
Baseline Characteristics
A Clinical Study of Increased Dose of TA-650 in Patients With Psoriasis
Baseline characteristics by cohort
| Measure |
Plaque Psoriasis
n=31 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Arthritis
n=8 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Pustular Psoriasis
n=7 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Erythroderma
n=5 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Total
n=51 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
51.2 years
STANDARD_DEVIATION 13.9 • n=18 Participants
|
50.1 years
STANDARD_DEVIATION 11.9 • n=17 Participants
|
36.7 years
STANDARD_DEVIATION 9.7 • n=35 Participants
|
55.8 years
STANDARD_DEVIATION 12.5 • n=42 Participants
|
49.5 years
STANDARD_DEVIATION 13.7 • n=217 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=18 Participants
|
5 Participants
n=17 Participants
|
4 Participants
n=35 Participants
|
4 Participants
n=42 Participants
|
38 Participants
n=217 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=18 Participants
|
3 Participants
n=17 Participants
|
3 Participants
n=35 Participants
|
1 Participants
n=42 Participants
|
13 Participants
n=217 Participants
|
PRIMARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose PeriodThe investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were calculated scores of the each regions. When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PASI score assessments for each patient were performed by the same investigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator changed jobs). The number and percentage of patients achieving a 75% improvement in their PASI scores at each assessment time point.
Outcome measures
| Measure |
Overall
n=51 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Plaque Psoriasis
n=31 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Arthritis
n=8 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Pustular Psoriasis
n=7 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Erythroderma
n=5 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
|---|---|---|---|---|---|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 40 (n=43,26,7,5,5)
|
44.2 percentage of participants
|
30.8 percentage of participants
|
42.9 percentage of participants
|
80.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 0 (n=51,31,8,7,5)
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 4 (n=51,31,8,7,5)
|
13.7 percentage of participants
|
16.1 percentage of participants
|
0.0 percentage of participants
|
0.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 8 (n=50,31,8,6,5)
|
18.0 percentage of participants
|
16.1 percentage of participants
|
0.0 percentage of participants
|
33.3 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 12 (n=49,30,8,6,5)
|
36.7 percentage of participants
|
40.0 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 16 (n=48,29,8,6,5)
|
31.3 percentage of participants
|
34.5 percentage of participants
|
0.0 percentage of participants
|
50.0 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 20 (n=46,28,7,6,5)
|
50.0 percentage of participants
|
53.6 percentage of participants
|
14.3 percentage of participants
|
50.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 24 (n=45,27,7,6,5)
|
40.0 percentage of participants
|
40.7 percentage of participants
|
42.9 percentage of participants
|
33.3 percentage of participants
|
40.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 28 (n=44,26,7,6,5)
|
63.6 percentage of participants
|
69.2 percentage of participants
|
28.6 percentage of participants
|
83.3 percentage of participants
|
60.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 32 (n=44,26,7,6,5)
|
45.5 percentage of participants
|
38.5 percentage of participants
|
42.9 percentage of participants
|
50.0 percentage of participants
|
80.0 percentage of participants
|
|
Percentage of Patients Achieving 75% Improvement in the Psoriasis Area and Severity Index (PASI) Score
Week 36 (n=44,26,7,6,5)
|
47.7 percentage of participants
|
42.3 percentage of participants
|
28.6 percentage of participants
|
66.7 percentage of participants
|
80.0 percentage of participants
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose PeriodScore range is 0-72. Higher values represent a worse outcome. The investigator or the subinvestigator examined the head, trunk, and upper and lower limbs, and assessed skin findings (erythema, induration, and scaling \[scale\]) at each of the regions and the extent of area affected. Total sores were added scores of the each regions.
Outcome measures
| Measure |
Overall
n=51 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Plaque Psoriasis
n=31 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Arthritis
n=8 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Pustular Psoriasis
n=7 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Erythroderma
n=5 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
|---|---|---|---|---|---|
|
Psoriasis Area and Severity Index (PASI) Score
Week 0 (n=51,31,8,7,5)
|
14.70 units on a scale
Interval 3.0 to 44.0
|
12.80 units on a scale
Interval 4.6 to 44.0
|
13.95 units on a scale
Interval 3.0 to 29.2
|
14.70 units on a scale
Interval 3.1 to 37.2
|
22.20 units on a scale
Interval 14.7 to 35.2
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 4 (n=51,31,8,7,5)
|
7.60 units on a scale
Interval 0.6 to 30.7
|
6.20 units on a scale
Interval 1.0 to 29.4
|
8.20 units on a scale
Interval 0.6 to 28.0
|
9.90 units on a scale
Interval 3.0 to 19.3
|
9.20 units on a scale
Interval 4.2 to 30.7
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 12 (n=49,30,8,6,5)
|
4.40 units on a scale
Interval 0.7 to 39.3
|
4.40 units on a scale
Interval 0.7 to 39.3
|
6.60 units on a scale
Interval 0.8 to 24.1
|
3.70 units on a scale
Interval 1.2 to 20.9
|
3.40 units on a scale
Interval 1.6 to 25.7
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 16 (n=48,29,8,6,5)
|
6.80 units on a scale
Interval 0.4 to 39.6
|
6.60 units on a scale
Interval 0.4 to 16.2
|
6.60 units on a scale
Interval 1.3 to 24.9
|
7.40 units on a scale
Interval 0.4 to 23.0
|
9.50 units on a scale
Interval 1.5 to 39.6
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 8 (n=50,31,8,6,5)
|
7.25 units on a scale
Interval 0.8 to 46.0
|
7.50 units on a scale
Interval 1.0 to 46.0
|
8.20 units on a scale
Interval 0.8 to 27.6
|
4.20 units on a scale
Interval 1.2 to 34.8
|
14.00 units on a scale
Interval 3.5 to 34.7
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 20 (n=46,28,7,6,5)
|
3.80 units on a scale
Interval 0.0 to 22.0
|
3.95 units on a scale
Interval 0.0 to 10.9
|
3.80 units on a scale
Interval 1.2 to 22.0
|
4.80 units on a scale
Interval 2.1 to 15.8
|
3.40 units on a scale
Interval 1.2 to 14.8
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 24 (n=45,27,7,6,5)
|
4.80 units on a scale
Interval 0.4 to 27.9
|
4.70 units on a scale
Interval 0.4 to 15.1
|
4.80 units on a scale
Interval 0.4 to 18.8
|
5.80 units on a scale
Interval 2.0 to 14.0
|
5.60 units on a scale
Interval 2.4 to 27.9
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 28 (n=44,26,7,6,5)
|
3.25 units on a scale
Interval 0.0 to 20.4
|
3.25 units on a scale
Interval 0.0 to 11.9
|
4.20 units on a scale
Interval 0.0 to 20.4
|
2.75 units on a scale
Interval 0.8 to 6.3
|
5.30 units on a scale
Interval 0.9 to 11.6
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 32 (n=44,26,7,6,5)
|
4.70 units on a scale
Interval 0.0 to 25.3
|
4.50 units on a scale
Interval 0.0 to 21.6
|
4.20 units on a scale
Interval 0.4 to 16.4
|
6.05 units on a scale
Interval 1.2 to 8.8
|
4.80 units on a scale
Interval 0.9 to 25.3
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 36 (n=44,26,7,6,5)
|
3.40 units on a scale
Interval 0.0 to 29.8
|
3.40 units on a scale
Interval 0.0 to 18.3
|
1.80 units on a scale
Interval 0.0 to 29.8
|
3.15 units on a scale
Interval 2.5 to 11.7
|
3.90 units on a scale
Interval 0.9 to 24.6
|
|
Psoriasis Area and Severity Index (PASI) Score
Week 40 (n=43,26,7,5,5)
|
3.70 units on a scale
Interval 0.0 to 29.3
|
4.70 units on a scale
Interval 0.0 to 27.6
|
2.40 units on a scale
Interval 0.8 to 29.3
|
2.70 units on a scale
Interval 2.1 to 6.2
|
3.30 units on a scale
Interval 2.7 to 14.7
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose PeriodThe investigator or the subinvestigator made a global assessment of skin lesions in terms of the degree of erythema, induration, and scaling (scale), using the following 6-point scale (0 to 5). When the day of the assessment fell on a day on which study product was to be administered, the assessment was performed before the study product was administered. As a rule, the PGA for each patient were performed by the same investigator or subinvestigator throughout the study, unless there was a special reason why this was not done (e.g., the investigator or the subinvestigator changed jobs). Outcome measure data table is reported percentage of participants with Cleared and Minimal skin lesions. 0: Cleared, 1: Minimal, 2: Mild, 3: Moderate, 4: Marked, 5: Severe
Outcome measures
| Measure |
Overall
n=31 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Plaque Psoriasis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Arthritis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Pustular Psoriasis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Erythroderma
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
|---|---|---|---|---|---|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 0 (n=31)
|
0.0 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 4 (n=31)
|
32.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 8 (n=31)
|
32.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 12 (n=30)
|
43.3 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 16 (n=29)
|
41.4 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 20 (n=28)
|
57.1 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 24 (n=27)
|
40.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 28 (n=26)
|
69.2 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 32 (n=26)
|
57.7 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 36 (n=26)
|
61.5 percentage of participants
|
—
|
—
|
—
|
—
|
|
Percentage of Participants With Cleared and Minimal Skin Lesions of Physician Global Assessment (PGA) (Only for Patients With Plaque Psoriasis)
Week 40 (n=26)
|
46.2 percentage of participants
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose PeriodFrom 0 (best) to 100 (worst)
Outcome measures
| Measure |
Overall
n=8 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Plaque Psoriasis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Arthritis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Pustular Psoriasis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Erythroderma
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
|---|---|---|---|---|---|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 0 (n=8)
|
59.5 mm
Interval 10.0 to 92.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 4 (n=8)
|
19.0 mm
Interval 5.0 to 67.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 8 (n=8)
|
49.5 mm
Interval 4.0 to 98.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 12 (n=8)
|
14.0 mm
Interval 4.0 to 64.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 16 (n=8)
|
41.0 mm
Interval 5.0 to 96.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 20 (n=7)
|
27.0 mm
Interval 4.0 to 78.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 24 (n=7)
|
28.0 mm
Interval 4.0 to 72.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 28 (n=7)
|
17.0 mm
Interval 3.0 to 78.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 32 (n=7)
|
10.0 mm
Interval 6.0 to 80.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 36 (n=7)
|
8.0 mm
Interval 2.0 to 49.0
|
—
|
—
|
—
|
—
|
|
Visual Analog Scale（VAS） of Pain Assessment by Subjects (Only for Patients With Psoriatic Arthritis)
Week 40 (n=7)
|
27.0 mm
Interval 2.0 to 64.0
|
—
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Weeks 0, 4, 8, 12, 16, 20, 24, 28, 32, 36, 40 in Increased Dose PeriodFrom 0 (best) to 17 (worst)
Outcome measures
| Measure |
Overall
n=7 Participants
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Plaque Psoriasis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Arthritis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Pustular Psoriasis
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
Psoriatic Erythroderma
From week 0 to week 32, at 8-week intervals, patients received single doses of TA-650 10 mg per 1 kg body weight on each treatment day, as slow intravenous infusions administered over at least 2 hours.
|
|---|---|---|---|---|---|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 40 (n=5)
|
1.0 units on a scale
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 24 (n=6)
|
2.0 units on a scale
Interval 1.0 to 5.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 28 (n=6)
|
1.0 units on a scale
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 32 (n=6)
|
1.5 units on a scale
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 36 (n=6)
|
1.0 units on a scale
Interval 1.0 to 5.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 0 (n=7)
|
4.0 units on a scale
Interval 4.0 to 10.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 4 (n=7)
|
3.0 units on a scale
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 8 (n=6)
|
1.5 units on a scale
Interval 1.0 to 10.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 12 (n=6)
|
1.5 units on a scale
Interval 1.0 to 6.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 16 (n=6)
|
1.5 units on a scale
Interval 1.0 to 9.0
|
—
|
—
|
—
|
—
|
|
Assessment of Severity (Only for Patients With Pustular Psoriasis)
Week 20 (n=6)
|
2.0 units on a scale
Interval 1.0 to 4.0
|
—
|
—
|
—
|
—
|
Adverse Events
TA-650（Normal Dose Period）Overall
Serious events: 0 serious events
Other events: 24 other events
Deaths: 0 deaths
TA-650（Normal Dose Period）Plaque Psoriasis
Serious events: 0 serious events
Other events: 19 other events
Deaths: 0 deaths
TA-650（Normal Dose Period）Psoriatic Arthritis
Serious events: 0 serious events
Other events: 5 other events
Deaths: 0 deaths
TA-650（Dose Escalation Period）Overall
Serious events: 5 serious events
Other events: 47 other events
Deaths: 0 deaths
TA-650（Dose Escalation Period）Plaque Psoriasis
Serious events: 4 serious events
Other events: 30 other events
Deaths: 0 deaths
TA-650（Dose Escalation Period）Psoriatic Arthritis
Serious events: 0 serious events
Other events: 7 other events
Deaths: 0 deaths
TA-650（Dose Escalation Period）Pustular Psoriasis
Serious events: 1 serious events
Other events: 6 other events
Deaths: 0 deaths
TA-650（Dose Escalation Period）Psoriatic Erythroderma
Serious events: 0 serious events
Other events: 4 other events
Deaths: 0 deaths
TA-650（Entire Evaluation Period）Plaque Psoriasis
Serious events: 4 serious events
Other events: 34 other events
Deaths: 0 deaths
TA-650（Entire Evaluation Period）Psoriatic Arthritis
Serious events: 0 serious events
Other events: 9 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
TA-650（Normal Dose Period）Overall
n=46 participants at risk
Overall(Plaque Psoriasis・Psoriatic Arthritis)
|
TA-650（Normal Dose Period）Plaque Psoriasis
n=36 participants at risk
Plaque Psoriasis
|
TA-650（Normal Dose Period）Psoriatic Arthritis
n=10 participants at risk
Psoriatic Arthritis
|
TA-650（Dose Escalation Period）Overall
n=51 participants at risk
Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)
|
TA-650（Dose Escalation Period）Plaque Psoriasis
n=31 participants at risk
Plaque Psoriasis
|
TA-650（Dose Escalation Period）Psoriatic Arthritis
n=8 participants at risk
Psoriatic Arthritis
|
TA-650（Dose Escalation Period）Pustular Psoriasis
n=7 participants at risk
Pustular Psoriasis
|
TA-650（Dose Escalation Period）Psoriatic Erythroderma
n=5 participants at risk
Psoriatic Erythroderma
|
TA-650（Entire Evaluation Period）Plaque Psoriasis
n=36 participants at risk
Plaque Psoriasis
|
TA-650（Entire Evaluation Period）Psoriatic Arthritis
n=10 participants at risk
Psoriatic Arthritis
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Hepatobiliary disorders
Cholecystitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Pyelonephritis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Bacterial pneumonia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Colon cancer
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
Other adverse events
| Measure |
TA-650（Normal Dose Period）Overall
n=46 participants at risk
Overall(Plaque Psoriasis・Psoriatic Arthritis)
|
TA-650（Normal Dose Period）Plaque Psoriasis
n=36 participants at risk
Plaque Psoriasis
|
TA-650（Normal Dose Period）Psoriatic Arthritis
n=10 participants at risk
Psoriatic Arthritis
|
TA-650（Dose Escalation Period）Overall
n=51 participants at risk
Overall(Plaque Psoriasis・Psoriatic Arthritis・Pustular Psoriasis・Psoriatic Erythroderma)
|
TA-650（Dose Escalation Period）Plaque Psoriasis
n=31 participants at risk
Plaque Psoriasis
|
TA-650（Dose Escalation Period）Psoriatic Arthritis
n=8 participants at risk
Psoriatic Arthritis
|
TA-650（Dose Escalation Period）Pustular Psoriasis
n=7 participants at risk
Pustular Psoriasis
|
TA-650（Dose Escalation Period）Psoriatic Erythroderma
n=5 participants at risk
Psoriatic Erythroderma
|
TA-650（Entire Evaluation Period）Plaque Psoriasis
n=36 participants at risk
Plaque Psoriasis
|
TA-650（Entire Evaluation Period）Psoriatic Arthritis
n=10 participants at risk
Psoriatic Arthritis
|
|---|---|---|---|---|---|---|---|---|---|---|
|
Infections and infestations
Pneumonia bacterial
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Sinusitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Upper respiratory tract infection
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Infections and infestations
Urinary tract infection
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Vaginitis bacterial
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Infections and infestations
Vulvovaginal candidiasis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Vulvovaginitis trichomonal
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Gastric adenoma
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Blood and lymphatic system disorders
Iron deficiency anaemia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Decreased appetite
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Dehydration
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Diabetes mellitus
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
20.0%
1/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Metabolism and nutrition disorders
Hypoglycaemia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Psychiatric disorders
Depressive symptom
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Nervous system disorders
Headache
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
7.8%
4/51
|
6.5%
2/31
|
12.5%
1/8
|
14.3%
1/7
|
0.00%
0/5
|
5.6%
2/36
|
10.0%
1/10
|
|
Nervous system disorders
Post herpetic neuralgia
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Eye disorders
Iridocyclitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Eye disorders
Keratitis
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Deafness unilateral
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Ear and labyrinth disorders
Sudden hearing loss
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Tinnitus
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Ear and labyrinth disorders
Vertigo
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Cardiac disorders
Palpitations
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Cardiac disorders
Tachycardia
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Vascular disorders
Flushing
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Vascular disorders
Hypertension
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
5.9%
3/51
|
6.5%
2/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
5.6%
2/36
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnoea
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
5.9%
3/51
|
9.7%
3/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
8.3%
3/36
|
0.00%
0/10
|
|
Respiratory, thoracic and mediastinal disorders
Interstitial lung disease
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
2.2%
1/46
|
0.00%
0/36
|
10.0%
1/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Gastrointestinal disorders
Abdominal pain
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Abdominal pain upper
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
6.5%
2/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Chapped lips
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Dental caries
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Diarrhoea
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
6.5%
2/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Gastric ulcer
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Haemorrhoids
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Large intestine polyp
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Nausea
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
0.00%
0/31
|
12.5%
1/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Gastrointestinal disorders
Vomiting
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
5.9%
3/51
|
6.5%
2/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
Hepatobiliary disorders
Hepatitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Diffuse alopecia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Eczema
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Erythema
|
2.2%
1/46
|
0.00%
0/36
|
10.0%
1/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Psoriasis
|
4.3%
2/46
|
2.8%
1/36
|
10.0%
1/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
2.8%
1/36
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Purpura
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
7.8%
4/51
|
9.7%
3/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
8.3%
3/36
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal pain
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
3.9%
2/51
|
6.5%
2/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
8.3%
3/36
|
0.00%
0/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Trigger finger
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Renal and urinary disorders
Hypertonic bladder
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Benign prostatic hyperplasia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Dysfunctional uterine bleeding
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Reproductive system and breast disorders
Erectile dysfunction
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
General disorders
Feeling abnormal
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
General disorders
Feeling hot
|
2.2%
1/46
|
0.00%
0/36
|
10.0%
1/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
General disorders
Malaise
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
3.9%
2/51
|
6.5%
2/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
General disorders
Pyrexia
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
3.2%
1/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Investigations
Alanine aminotransferase increased
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Investigations
Aspartate aminotransferase increased
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Investigations
Blood pressure decreased
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Investigations
Blood pressure increased
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
3.9%
2/51
|
6.5%
2/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
5.6%
2/36
|
0.00%
0/10
|
|
Investigations
Blood urine present
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Investigations
Double stranded DNA antibody positive
|
34.8%
16/46
|
33.3%
12/36
|
40.0%
4/10
|
49.0%
25/51
|
58.1%
18/31
|
25.0%
2/8
|
42.9%
3/7
|
40.0%
2/5
|
69.4%
25/36
|
60.0%
6/10
|
|
Investigations
Interleukin level increased
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Investigations
Liver function test abnormal
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Investigations
Oxygen saturation decreased
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Arthropod sting
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
12.5%
1/8
|
0.00%
0/7
|
0.00%
0/5
|
0.00%
0/36
|
10.0%
1/10
|
|
Injury, poisoning and procedural complications
Contusion
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Foot fracture
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Hand fracture
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Limb crushing injury
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Nail avulsion
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Procedural pain
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Injury, poisoning and procedural complications
Wrist fracture
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Bronchitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Conjunctivitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
20.0%
1/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Infections and infestations
Enteritis infectious
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Folliculitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Infections and infestations
Furuncle
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Infections and infestations
Gastroenteritis
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Gingivitis
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
3.2%
1/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Herpes zoster
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
0.00%
0/51
|
0.00%
0/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
2.8%
1/36
|
0.00%
0/10
|
|
Infections and infestations
Infection
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
|
Infections and infestations
Influenza
|
2.2%
1/46
|
2.8%
1/36
|
0.00%
0/10
|
3.9%
2/51
|
6.5%
2/31
|
0.00%
0/8
|
0.00%
0/7
|
0.00%
0/5
|
8.3%
3/36
|
0.00%
0/10
|
|
Infections and infestations
Nasopharyngitis
|
8.7%
4/46
|
11.1%
4/36
|
0.00%
0/10
|
27.5%
14/51
|
22.6%
7/31
|
12.5%
1/8
|
42.9%
3/7
|
60.0%
3/5
|
22.2%
8/36
|
10.0%
1/10
|
|
Infections and infestations
Oral herpes
|
0.00%
0/46
|
0.00%
0/36
|
0.00%
0/10
|
2.0%
1/51
|
0.00%
0/31
|
0.00%
0/8
|
14.3%
1/7
|
0.00%
0/5
|
0.00%
0/36
|
0.00%
0/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: OTHER