Trial Outcomes & Findings for Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis (NCT NCT03703102)
NCT ID: NCT03703102
Last Updated: 2024-04-26
Results Overview
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
274 participants
Primary outcome timeframe
Baseline to Week 16
Results posted on
2024-04-26
Participant Flow
The screening period began in September 2018. A total of 61 sites in four countries (Canada, Germany, Japan, and the United States) screened 351 patients and enrolled 274. The screening period closed in September 2019.
In Treatment Period A, randomized subjects received either study drug or placebo for 18 weeks. In Treatment Period B, the patients randomized to the placebo arm received study drug for 18 weeks. There was no treatment change for patients randomized to study drug arms. One subject who was randomized to the 600 mg Q4W group did not receive any study drug due to consent withdrawal before the start of the treatment. They are not included in baseline or any of the analysis sets.
Participant milestones
| Measure |
KHK4083 150 mg SC Q4W
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Overall Study
STARTED
|
54
|
53
|
55
|
54
|
57
|
|
Overall Study
Completed Treatment Period A
|
42
|
41
|
42
|
46
|
34
|
|
Overall Study
Completed Treatment Period B
|
33
|
39
|
37
|
38
|
26
|
|
Overall Study
COMPLETED
|
32
|
38
|
33
|
37
|
24
|
|
Overall Study
NOT COMPLETED
|
22
|
15
|
22
|
17
|
33
|
Reasons for withdrawal
| Measure |
KHK4083 150 mg SC Q4W
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Overall Study
Adverse Event
|
4
|
3
|
7
|
3
|
13
|
|
Overall Study
Lack of Efficacy
|
4
|
0
|
1
|
4
|
1
|
|
Overall Study
Lost to Follow-up
|
0
|
0
|
1
|
2
|
2
|
|
Overall Study
Physician Decision
|
2
|
2
|
2
|
2
|
4
|
|
Overall Study
Withdrawal by Subject
|
7
|
5
|
5
|
5
|
9
|
|
Overall Study
Ineligibility
|
0
|
0
|
1
|
0
|
0
|
|
Overall Study
Protocol Deviation
|
4
|
4
|
3
|
0
|
0
|
|
Overall Study
Non-Compliance with Study Drug
|
1
|
1
|
2
|
1
|
4
|
Baseline Characteristics
Study of an Anti-OX40 Monoclonal Antibody (KHK4083) in Subjects With Moderate to Severe Atopic Dermatitis
Baseline characteristics by cohort
| Measure |
KHK4083 150 mg SC Q4W
n=54 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=53 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=55 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
Total
n=273 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
52 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
51 Participants
n=27 Participants
|
49 Participants
n=483 Participants
|
52 Participants
n=36 Participants
|
255 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
4 Participants
n=27 Participants
|
5 Participants
n=483 Participants
|
5 Participants
n=36 Participants
|
18 Participants
n=10 Participants
|
|
Age, Continuous
|
37.4 years
n=93 Participants
|
38.9 years
n=4 Participants
|
37.5 years
n=27 Participants
|
37.3 years
n=483 Participants
|
38.7 years
n=36 Participants
|
38.0 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
17 Participants
n=93 Participants
|
22 Participants
n=4 Participants
|
24 Participants
n=27 Participants
|
24 Participants
n=483 Participants
|
26 Participants
n=36 Participants
|
113 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
37 Participants
n=93 Participants
|
31 Participants
n=4 Participants
|
31 Participants
n=27 Participants
|
30 Participants
n=483 Participants
|
31 Participants
n=36 Participants
|
160 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
2 Participants
n=93 Participants
|
2 Participants
n=4 Participants
|
1 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
1 Participants
n=36 Participants
|
7 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
51 Participants
n=93 Participants
|
51 Participants
n=4 Participants
|
54 Participants
n=27 Participants
|
53 Participants
n=483 Participants
|
54 Participants
n=36 Participants
|
263 Participants
n=10 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
2 Participants
n=36 Participants
|
3 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
36 Participants
n=93 Participants
|
32 Participants
n=4 Participants
|
37 Participants
n=27 Participants
|
33 Participants
n=483 Participants
|
37 Participants
n=36 Participants
|
175 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
3 Participants
n=93 Participants
|
1 Participants
n=4 Participants
|
2 Participants
n=27 Participants
|
1 Participants
n=483 Participants
|
6 Participants
n=36 Participants
|
13 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
14 Participants
n=93 Participants
|
20 Participants
n=4 Participants
|
16 Participants
n=27 Participants
|
20 Participants
n=483 Participants
|
14 Participants
n=36 Participants
|
84 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=93 Participants
|
0 Participants
n=4 Participants
|
0 Participants
n=27 Participants
|
0 Participants
n=483 Participants
|
0 Participants
n=36 Participants
|
1 Participants
n=10 Participants
|
|
Region of Enrollment
Canada
|
4 participants
n=93 Participants
|
5 participants
n=4 Participants
|
5 participants
n=27 Participants
|
4 participants
n=483 Participants
|
7 participants
n=36 Participants
|
25 participants
n=10 Participants
|
|
Region of Enrollment
United States
|
11 participants
n=93 Participants
|
10 participants
n=4 Participants
|
11 participants
n=27 Participants
|
11 participants
n=483 Participants
|
13 participants
n=36 Participants
|
56 participants
n=10 Participants
|
|
Region of Enrollment
Japan
|
32 participants
n=93 Participants
|
30 participants
n=4 Participants
|
33 participants
n=27 Participants
|
32 participants
n=483 Participants
|
32 participants
n=36 Participants
|
159 participants
n=10 Participants
|
|
Region of Enrollment
Germany
|
7 participants
n=93 Participants
|
8 participants
n=4 Participants
|
6 participants
n=27 Participants
|
7 participants
n=483 Participants
|
5 participants
n=36 Participants
|
33 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
|
-48.33 percentage of score change
Interval -62.62 to -34.04
|
-49.72 percentage of score change
Interval -62.47 to -35.17
|
-61.07 percentage of score change
Interval -75.19 to -46.96
|
-57.35 percentage of score change
Interval -71.27 to -43.43
|
-15.01 percentage of score change
Interval -28.6 to -1.43
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
Achieved EASI-50 at Week 16
|
30 Participants
|
31 Participants
|
36 Participants
|
35 Participants
|
17 Participants
|
|
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
achieved EASI-75 at Week 16
|
23 Participants
|
21 Participants
|
28 Participants
|
21 Participants
|
6 Participants
|
|
Achievement of 50%, 75%, or 90% Reduction From Baseline in Eczema Area and Severity Index (EASI) Score (EASI-50, EASI-75, or EASI-90) at Week 16
achieved EASI-90 at Week 16
|
10 Participants
|
6 Participants
|
19 Participants
|
10 Participants
|
2 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set. Those 6 subjects had no evaluable EASI score after the start of IP administration until Week 16.
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score
|
-22.5 score on a scale
Standard Deviation 14.7
|
-20.7 score on a scale
Standard Deviation 14.3
|
-23.3 score on a scale
Standard Deviation 9.0
|
-19.9 score on a scale
Standard Deviation 11.8
|
-9.8 score on a scale
Standard Deviation 13.0
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
|
-23.71 score on a scale
Interval -30.72 to -16.69
|
-23.86 score on a scale
Interval -30.92 to -16.81
|
-30.44 score on a scale
Interval -37.27 to -23.61
|
-27.65 score on a scale
Interval -34.39 to -20.91
|
-8.09 score on a scale
Interval -14.65 to -1.53
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score
|
-34.86 percentage of score change
Interval -45.2 to -24.51
|
-35.13 percentage of score change
Interval -45.54 to -24.72
|
-46.69 percentage of score change
Interval -56.77 to -36.61
|
-40.76 percentage of score change
Interval -50.7 to -30.81
|
-11.90 percentage of score change
Interval -21.59 to -2.22
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
In the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe).
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16
|
10 Participants
|
8 Participants
|
16 Participants
|
10 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA)
|
-22.86 percentage of total BSA involvement
Interval -30.3 to -15.42
|
-21.48 percentage of total BSA involvement
Interval -29.07 to -13.89
|
-27.92 percentage of total BSA involvement
Interval -35.3 to -20.54
|
-25.04 percentage of total BSA involvement
Interval -32.33 to -17.76
|
-7.87 percentage of total BSA involvement
Interval -14.96 to -0.77
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
|
-2.04 score on a scale
Interval -2.9 to -1.18
|
-3.02 score on a scale
Interval -3.9 to -2.15
|
-3.60 score on a scale
Interval -4.44 to -2.75
|
-2.81 score on a scale
Interval -3.64 to -1.97
|
-1.31 score on a scale
Interval -2.12 to -0.49
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score
|
-25.57 percentage of score change
Interval -39.48 to -11.66
|
-34.38 percentage of score change
Interval -48.56 to -20.21
|
-47.99 percentage of score change
Interval -61.71 to -34.26
|
-36.83 percentage of score change
Interval -50.41 to -23.25
|
-6.18 percentage of score change
Interval -6.18 to 7.01
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
|
-1.09 score on a scale
Interval -2.01 to -0.18
|
-1.93 score on a scale
Interval -2.86 to -1.0
|
-2.59 score on a scale
Interval -3.48 to -1.69
|
-2.00 score on a scale
Interval -2.9 to -1.11
|
-0.01 score on a scale
Interval -0.87 to 0.86
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score
|
-8.19 percentage of score change
Interval -44.32 to 27.95
|
-7.02 percentage of score change
Interval -44.96 to 30.93
|
-41.58 percentage of score change
Interval -78.3 to -4.86
|
-33.17 percentage of score change
Interval -69.08 to 2.74
|
-46.54 percentage of score change
Interval -100.55 to -8.89
|
SECONDARY outcome
Timeframe: Baseline to Week 16Population: Full analysis set: One subject in the 600 mg Q4W group was excluded from all analysis sets as the subject was not exposed to IP. Two subjects in the 150 mg Q4W group, 1 subject in the 600 mg Q4W group, and 3 subjects in the 300 mg Q2W group were excluded from the full analysis set.
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI)
|
-2.59 score on a scale
Interval -4.73 to -0.44
|
-4.66 score on a scale
Interval -6.89 to -2.43
|
-6.28 score on a scale
Interval -8.38 to -4.18
|
-4.93 score on a scale
Interval -7.01 to -2.84
|
0.19 score on a scale
Interval -1.88 to 2.27
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
EASI Score at Each Time Point
EASI Score at Week 15
|
10.8 score on a scale
Interval 0.0 to 59.0
|
12.6 score on a scale
Interval 0.0 to 50.0
|
9.0 score on a scale
Interval 0.0 to 48.0
|
11.6 score on a scale
Interval 0.0 to 37.0
|
20.6 score on a scale
Interval 0.0 to 72.0
|
|
EASI Score at Each Time Point
EASI Score at Week 16
|
10.8 score on a scale
Interval 0.0 to 62.0
|
11.8 score on a scale
Interval 0.0 to 48.0
|
8.0 score on a scale
Interval 0.0 to 40.0
|
11.1 score on a scale
Interval 0.0 to 41.0
|
20.4 score on a scale
Interval 0.0 to 72.0
|
|
EASI Score at Each Time Point
EASI Score at Week 56
|
4.2 score on a scale
Interval 0.0 to 22.0
|
4.7 score on a scale
Interval 0.0 to 32.0
|
2.4 score on a scale
Interval 0.0 to 18.0
|
2.8 score on a scale
Interval 0.0 to 14.0
|
3.2 score on a scale
Interval 0.0 to 11.0
|
|
EASI Score at Each Time Point
EASI Score at Baseline
|
33.2 score on a scale
Interval 16.0 to 63.0
|
32.5 score on a scale
Interval 16.0 to 69.0
|
31.6 score on a scale
Interval 16.0 to 64.0
|
31.1 score on a scale
Interval 16.0 to 60.0
|
29.2 score on a scale
Interval 16.0 to 68.0
|
|
EASI Score at Each Time Point
EASI Score at Week 1
|
33.0 score on a scale
Interval 10.0 to 65.0
|
29.5 score on a scale
Interval 6.0 to 58.0
|
28.6 score on a scale
Interval 6.0 to 69.0
|
29.4 score on a scale
Interval 2.0 to 57.0
|
28.5 score on a scale
Interval 6.0 to 62.0
|
|
EASI Score at Each Time Point
EASI Score at Week 2
|
31.7 score on a scale
Interval 5.0 to 67.0
|
27.6 score on a scale
Interval 6.0 to 60.0
|
25.6 score on a scale
Interval 2.0 to 66.0
|
27.2 score on a scale
Interval 0.0 to 58.0
|
28.1 score on a scale
Interval 5.0 to 71.0
|
|
EASI Score at Each Time Point
EASI Score at Week 4
|
27.3 score on a scale
Interval 0.0 to 71.0
|
26.3 score on a scale
Interval 5.0 to 56.0
|
22.4 score on a scale
Interval 2.0 to 49.0
|
23.4 score on a scale
Interval 1.0 to 68.0
|
28.8 score on a scale
Interval 2.0 to 71.0
|
|
EASI Score at Each Time Point
EASI Score at Week 6
|
24.7 score on a scale
Interval 0.0 to 66.0
|
21.6 score on a scale
Interval 0.0 to 57.0
|
17.6 score on a scale
Interval 0.0 to 52.0
|
19.6 score on a scale
Interval 0.0 to 52.0
|
27.9 score on a scale
Interval 2.0 to 71.0
|
|
EASI Score at Each Time Point
EASI Score at Week 8
|
20.3 score on a scale
Interval 0.0 to 63.0
|
17.6 score on a scale
Interval 0.0 to 55.0
|
15.2 score on a scale
Interval 1.0 to 50.0
|
17.3 score on a scale
Interval 0.0 to 51.0
|
25.8 score on a scale
Interval 3.0 to 67.0
|
|
EASI Score at Each Time Point
EASI Score at Week 10
|
16.5 score on a scale
Interval 0.0 to 72.0
|
15.8 score on a scale
Interval 0.0 to 65.0
|
12.9 score on a scale
Interval 0.0 to 47.0
|
16.1 score on a scale
Interval 0.0 to 46.0
|
25.5 score on a scale
Interval 2.0 to 72.0
|
|
EASI Score at Each Time Point
EASI Score at Week 12
|
14.7 score on a scale
Interval 0.0 to 72.0
|
13.9 score on a scale
Interval 0.0 to 53.0
|
10.5 score on a scale
Interval 0.0 to 47.0
|
14.9 score on a scale
Interval 1.0 to 45.0
|
23.6 score on a scale
Interval 1.0 to 72.0
|
|
EASI Score at Each Time Point
EASI Score at Week 14
|
12.6 score on a scale
Interval 0.0 to 62.0
|
12.6 score on a scale
Interval 0.0 to 55.0
|
9.8 score on a scale
Interval 0.0 to 45.0
|
12.1 score on a scale
Interval 0.0 to 44.0
|
22.7 score on a scale
Interval 1.0 to 71.0
|
|
EASI Score at Each Time Point
EASI Score at Week 18
|
10.5 score on a scale
Interval 0.0 to 60.0
|
11.0 score on a scale
Interval 0.0 to 41.0
|
8.7 score on a scale
Interval 0.0 to 39.0
|
10.6 score on a scale
Interval 0.0 to 60.0
|
22.2 score on a scale
Interval 0.0 to 72.0
|
|
EASI Score at Each Time Point
EASI Score at Week 20
|
10.0 score on a scale
Interval 0.0 to 72.0
|
9.5 score on a scale
Interval 0.0 to 39.0
|
7.2 score on a scale
Interval 0.0 to 32.0
|
8.1 score on a scale
Interval 0.0 to 38.0
|
20.8 score on a scale
Interval 0.0 to 62.0
|
|
EASI Score at Each Time Point
EASI Score at Week 22
|
8.9 score on a scale
Interval 0.0 to 72.0
|
7.5 score on a scale
Interval 0.0 to 37.0
|
6.5 score on a scale
Interval 0.0 to 38.0
|
6.0 score on a scale
Interval 0.0 to 36.0
|
16.6 score on a scale
Interval 0.0 to 60.0
|
|
EASI Score at Each Time Point
EASI Score at Week 24
|
9.4 score on a scale
Interval 0.0 to 72.0
|
7.4 score on a scale
Interval 0.0 to 37.0
|
5.0 score on a scale
Interval 0.0 to 37.0
|
6.2 score on a scale
Interval 0.0 to 46.0
|
15.9 score on a scale
Interval 0.0 to 53.0
|
|
EASI Score at Each Time Point
EASI Score at Week 26
|
8.2 score on a scale
Interval 0.0 to 72.0
|
6.8 score on a scale
Interval 0.0 to 35.0
|
4.3 score on a scale
Interval 0.0 to 36.0
|
5.8 score on a scale
Interval 0.0 to 46.0
|
10.8 score on a scale
Interval 0.0 to 48.0
|
|
EASI Score at Each Time Point
EASI Score at Week 28
|
7.7 score on a scale
Interval 0.0 to 72.0
|
6.8 score on a scale
Interval 0.0 to 29.0
|
4.7 score on a scale
Interval 0.0 to 37.0
|
4.8 score on a scale
Interval 0.0 to 28.0
|
9.8 score on a scale
Interval 0.0 to 46.0
|
|
EASI Score at Each Time Point
EASI Score at Week 30
|
6.5 score on a scale
Interval 0.0 to 51.0
|
6.1 score on a scale
Interval 0.0 to 26.0
|
4.1 score on a scale
Interval 0.0 to 50.0
|
3.8 score on a scale
Interval 0.0 to 24.0
|
8.4 score on a scale
Interval 0.0 to 38.0
|
|
EASI Score at Each Time Point
EASI Score at Week 32
|
6.4 score on a scale
Interval 0.0 to 64.0
|
5.2 score on a scale
Interval 0.0 to 25.0
|
2.9 score on a scale
Interval 0.0 to 20.0
|
3.3 score on a scale
Interval 0.0 to 18.0
|
6.3 score on a scale
Interval 0.0 to 27.0
|
|
EASI Score at Each Time Point
EASI Score at Week 34
|
5.9 score on a scale
Interval 0.0 to 67.0
|
5.8 score on a scale
Interval 0.0 to 27.0
|
2.6 score on a scale
Interval 0.0 to 19.0
|
3.4 score on a scale
Interval 0.0 to 29.0
|
5.7 score on a scale
Interval 0.0 to 30.0
|
|
EASI Score at Each Time Point
EASI Score at Week 36
|
5.6 score on a scale
Interval 0.0 to 62.0
|
4.8 score on a scale
Interval 0.0 to 26.0
|
2.1 score on a scale
Interval 0.0 to 16.0
|
3.5 score on a scale
Interval 0.0 to 17.0
|
6.3 score on a scale
Interval 0.0 to 42.0
|
|
EASI Score at Each Time Point
EASI Score at Week 40
|
4.1 score on a scale
Interval 0.0 to 25.0
|
3.8 score on a scale
Interval 0.0 to 21.0
|
2.7 score on a scale
Interval 0.0 to 30.0
|
3.1 score on a scale
Interval 0.0 to 13.0
|
5.5 score on a scale
Interval 0.0 to 30.0
|
|
EASI Score at Each Time Point
EASI Score at Week 44
|
3.5 score on a scale
Interval 0.0 to 30.0
|
5.8 score on a scale
Interval 0.0 to 72.0
|
1.5 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 12.0
|
2.8 score on a scale
Interval 0.0 to 17.0
|
|
EASI Score at Each Time Point
EASI Score at Week 48
|
6.5 score on a scale
Interval 0.0 to 33.0
|
3.0 score on a scale
Interval 0.0 to 20.0
|
1.6 score on a scale
Interval 0.0 to 7.0
|
2.5 score on a scale
Interval 0.0 to 12.0
|
3.2 score on a scale
Interval 0.0 to 19.0
|
|
EASI Score at Each Time Point
EASI Score at Week 52
|
3.1 score on a scale
Interval 0.0 to 12.0
|
2.9 score on a scale
Interval 0.0 to 20.0
|
2.2 score on a scale
Interval 0.0 to 19.0
|
2.3 score on a scale
Interval 0.0 to 10.0
|
2.6 score on a scale
Interval 0.0 to 9.0
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
In the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%). Scores calculated according to the expression "total score of 4 elements of eczema × area score of eczema" will be multiplied by 0.1 for head and neck, 0.2 for upper extremities, 0.3 for trunk, and 0.4 for lower extremities. The 4 region scores obtained will then be summed up (maximum score: 72) as EASI score.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 28
|
-78.7 percentage of score change
Interval -100.0 to 24.0
|
-77.5 percentage of score change
Interval -100.0 to -20.0
|
-84.8 percentage of score change
Interval -100.0 to 32.0
|
-83.9 percentage of score change
Interval -100.0 to -7.0
|
-70.6 percentage of score change
Interval -100.0 to 15.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 26
|
-75.3 percentage of score change
Interval -100.0 to 24.0
|
-78.2 percentage of score change
Interval -100.0 to -23.0
|
-86.3 percentage of score change
Interval -100.0 to -18.0
|
-81.0 percentage of score change
Interval -100.0 to 15.0
|
-70.1 percentage of score change
Interval -100.0 to 20.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 30
|
-80.8 percentage of score change
Interval -100.0 to -12.0
|
-81.1 percentage of score change
Interval -100.0 to -31.0
|
-87.3 percentage of score change
Interval -100.0 to 11.0
|
-86.5 percentage of score change
Interval -100.0 to -14.0
|
-74.5 percentage of score change
Interval -100.0 to -6.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 32
|
-82.5 percentage of score change
Interval -100.0 to 10.0
|
-82.7 percentage of score change
Interval -100.0 to -31.0
|
-90.5 percentage of score change
Interval -100.0 to -56.0
|
-87.9 percentage of score change
Interval -100.0 to -36.0
|
-82.4 percentage of score change
Interval -100.0 to -44.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 34
|
-83.6 percentage of score change
Interval -100.0 to 16.0
|
-80.5 percentage of score change
Interval -100.0 to -23.0
|
-91.3 percentage of score change
Interval -100.0 to -52.0
|
-87.1 percentage of score change
Interval -100.0 to 4.0
|
-81.8 percentage of score change
Interval -100.0 to -18.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 36
|
-84.5 percentage of score change
Interval -100.0 to 7.0
|
-83.5 percentage of score change
Interval -100.0 to -24.0
|
-93.0 percentage of score change
Interval -100.0 to -62.0
|
-87.2 percentage of score change
Interval -100.0 to -39.0
|
-82.2 percentage of score change
Interval -100.0 to 5.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 40
|
-88.0 percentage of score change
Interval -100.0 to -36.0
|
-86.9 percentage of score change
Interval -100.0 to -52.0
|
-91.7 percentage of score change
Interval -100.0 to -33.0
|
-88.4 percentage of score change
Interval -100.0 to -54.0
|
-82.3 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 44
|
-89.1 percentage of score change
Interval -100.0 to -14.0
|
-81.7 percentage of score change
Interval -100.0 to 106.0
|
-94.8 percentage of score change
Interval -100.0 to -82.0
|
-88.5 percentage of score change
Interval -100.0 to -41.0
|
-86.7 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 48
|
-84.5 percentage of score change
Interval -100.0 to -11.0
|
-90.8 percentage of score change
Interval -100.0 to -56.0
|
-94.3 percentage of score change
Interval -100.0 to -78.0
|
-91.6 percentage of score change
Interval -100.0 to -57.0
|
-85.0 percentage of score change
Interval -100.0 to 12.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 52
|
-90.4 percentage of score change
Interval -100.0 to -42.0
|
-92.2 percentage of score change
Interval -100.0 to -56.0
|
-93.2 percentage of score change
Interval -100.0 to -66.0
|
-92.4 percentage of score change
Interval -100.0 to -58.0
|
-90.2 percentage of score change
Interval -100.0 to -63.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 56
|
-87.4 percentage of score change
Interval -100.0 to -32.0
|
-88.3 percentage of score change
Interval -100.0 to -35.0
|
-90.3 percentage of score change
Interval -100.0 to -36.0
|
-90.4 percentage of score change
Interval -100.0 to -57.0
|
-88.3 percentage of score change
Interval -100.0 to -50.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 1
|
-2.5 percentage of score change
Interval -55.0 to 48.0
|
-9.5 percentage of score change
Interval -68.0 to 31.0
|
-8.5 percentage of score change
Interval -72.0 to 100.0
|
-7.0 percentage of score change
Interval -89.0 to 96.0
|
-2.9 percentage of score change
Interval -63.0 to 114.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 2
|
-6.7 percentage of score change
Interval -71.0 to 71.0
|
-14.3 percentage of score change
Interval -75.0 to 31.0
|
-18.4 percentage of score change
Interval -88.0 to 128.0
|
-15.6 percentage of score change
Interval -100.0 to 79.0
|
-2.6 percentage of score change
Interval -72.0 to 154.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 4
|
-19.6 percentage of score change
Interval -100.0 to 78.0
|
-19.4 percentage of score change
Interval -74.0 to 42.0
|
-26.4 percentage of score change
Interval -92.0 to 167.0
|
-24.6 percentage of score change
Interval -96.0 to 57.0
|
-8.5 percentage of score change
Interval -89.0 to 58.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 6
|
-28.8 percentage of score change
Interval -100.0 to 48.0
|
-32.5 percentage of score change
Interval -100.0 to 54.0
|
-43.4 percentage of score change
Interval -100.0 to 94.0
|
-35.8 percentage of score change
Interval -100.0 to 70.0
|
-11.1 percentage of score change
Interval -89.0 to 76.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 8
|
-40.3 percentage of score change
Interval -100.0 to 118.0
|
-45.5 percentage of score change
Interval -100.0 to 29.0
|
-52.2 percentage of score change
Interval -97.0 to 37.0
|
-42.1 percentage of score change
Interval -100.0 to 50.0
|
-19.2 percentage of score change
Interval -83.0 to 150.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 10
|
-51.5 percentage of score change
Interval -100.0 to 45.0
|
-51.9 percentage of score change
Interval -100.0 to 86.0
|
-60.4 percentage of score change
Interval -100.0 to 25.0
|
-48.2 percentage of score change
Interval -100.0 to 50.0
|
-21.1 percentage of score change
Interval -91.0 to 66.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 12
|
-56.7 percentage of score change
Interval -100.0 to 24.0
|
-58.4 percentage of score change
Interval -100.0 to 9.0
|
-68.3 percentage of score change
Interval -100.0 to 26.0
|
-50.9 percentage of score change
Interval -96.0 to 12.0
|
-29.5 percentage of score change
Interval -95.0 to 61.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 14
|
-62.5 percentage of score change
Interval -100.0 to 7.0
|
-62.1 percentage of score change
Interval -100.0 to 12.0
|
-71.1 percentage of score change
Interval -100.0 to 36.0
|
-61.5 percentage of score change
Interval -100.0 to 0.0
|
-32.1 percentage of score change
Interval -95.0 to 30.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 15
|
-67.1 percentage of score change
Interval -100.0 to 2.0
|
-62.2 percentage of score change
Interval -100.0 to 6.0
|
-74.1 percentage of score change
Interval -100.0 to -9.0
|
-62.6 percentage of score change
Interval -100.0 to 19.0
|
-35.3 percentage of score change
Interval -100.0 to 81.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 16
|
-67.0 percentage of score change
Interval -100.0 to 18.0
|
-63.2 percentage of score change
Interval -100.0 to 6.0
|
-77.2 percentage of score change
Interval -100.0 to -20.0
|
-63.6 percentage of score change
Interval -100.0 to 52.0
|
-37.4 percentage of score change
Interval -100.0 to 81.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 18
|
-67.1 percentage of score change
Interval -100.0 to 10.0
|
-66.1 percentage of score change
Interval -100.0 to -6.0
|
-75.5 percentage of score change
Interval -100.0 to -13.0
|
-63.9 percentage of score change
Interval -100.0 to 233.0
|
-32.6 percentage of score change
Interval -100.0 to 81.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 20
|
-69.7 percentage of score change
Interval -100.0 to 24.0
|
-70.6 percentage of score change
Interval -100.0 to 0.0
|
-79.0 percentage of score change
Interval -100.0 to -12.0
|
-74.4 percentage of score change
Interval -100.0 to 11.0
|
-37.9 percentage of score change
Interval -100.0 to 95.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 22
|
-74.3 percentage of score change
Interval -100.0 to 24.0
|
-75.6 percentage of score change
Interval -100.0 to -5.0
|
-80.8 percentage of score change
Interval -100.0 to -12.0
|
-79.4 percentage of score change
Interval -100.0 to 33.0
|
-49.3 percentage of score change
Interval -100.0 to 95.0
|
|
Percent Change From Baseline in EASI Score at Each Time Point
EASI Score % Change at Week 24
|
-71.7 percentage of score change
Interval -100.0 to 24.0
|
-75.5 percentage of score change
Interval -100.0 to -5.0
|
-85.3 percentage of score change
Interval -100.0 to 9.0
|
-80.4 percentage of score change
Interval -100.0 to 15.0
|
-49.7 percentage of score change
Interval -100.0 to 105.0
|
SECONDARY outcome
Timeframe: 56 WeeksIn the EASI assessment, the severity of 4 elements of eczema (erythema, induration/papulation, excoriation, and lichenification) at each of 4 body regions (head and neck, trunk, upper extremities, and lower extremities) will be assessed on a scale of 0 to 3 (0 = None , 1 = Mild, 2 = Moderate, 3 = Severe). Half scores (1.5 and 2.5) are allowed, with the exception of 0.5. Any signs must be at least 1 (mild) in severity. In addition, the extent of eczema at each of the 4 body regions will be assessed on a scale of 0 to 6 (0 = 0%, 1 = 1% to 9%, 2 = 10% to 29%, 3 = 30% to 49%, 4 = 50% to 69%, 5 = 70% to 89%, 6 = 90% to 100%).
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 20
|
33 Participants
|
32 Participants
|
36 Participants
|
39 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 22
|
32 Participants
|
34 Participants
|
36 Participants
|
41 Participants
|
19 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 24
|
32 Participants
|
34 Participants
|
39 Participants
|
40 Participants
|
19 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 26
|
31 Participants
|
31 Participants
|
35 Participants
|
39 Participants
|
21 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 28
|
30 Participants
|
33 Participants
|
34 Participants
|
38 Participants
|
21 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 30
|
30 Participants
|
35 Participants
|
36 Participants
|
39 Participants
|
21 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 1
|
1 Participants
|
2 Participants
|
7 Participants
|
3 Participants
|
1 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 2
|
5 Participants
|
7 Participants
|
11 Participants
|
8 Participants
|
3 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 4
|
10 Participants
|
9 Participants
|
14 Participants
|
11 Participants
|
2 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 6
|
12 Participants
|
17 Participants
|
22 Participants
|
20 Participants
|
5 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 8
|
18 Participants
|
21 Participants
|
29 Participants
|
24 Participants
|
10 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 10
|
26 Participants
|
29 Participants
|
32 Participants
|
26 Participants
|
10 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 12
|
28 Participants
|
31 Participants
|
34 Participants
|
27 Participants
|
13 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 14
|
31 Participants
|
31 Participants
|
33 Participants
|
34 Participants
|
12 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 15
|
30 Participants
|
30 Participants
|
33 Participants
|
31 Participants
|
15 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 16
|
30 Participants
|
31 Participants
|
36 Participants
|
35 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 18
|
32 Participants
|
32 Participants
|
34 Participants
|
36 Participants
|
16 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 32
|
30 Participants
|
35 Participants
|
37 Participants
|
38 Participants
|
21 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 34
|
31 Participants
|
36 Participants
|
35 Participants
|
35 Participants
|
20 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 36
|
31 Participants
|
34 Participants
|
36 Participants
|
36 Participants
|
23 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 40
|
24 Participants
|
34 Participants
|
29 Participants
|
30 Participants
|
20 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 44
|
23 Participants
|
31 Participants
|
29 Participants
|
29 Participants
|
18 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 48
|
19 Participants
|
32 Participants
|
28 Participants
|
26 Participants
|
16 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 52
|
17 Participants
|
33 Participants
|
23 Participants
|
24 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-50 at Week 56
|
18 Participants
|
25 Participants
|
17 Participants
|
20 Participants
|
16 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 1
|
0 Participants
|
0 Participants
|
0 Participants
|
1 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 2
|
0 Participants
|
1 Participants
|
3 Participants
|
3 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 4
|
6 Participants
|
0 Participants
|
6 Participants
|
7 Participants
|
1 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 6
|
5 Participants
|
5 Participants
|
12 Participants
|
8 Participants
|
2 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 8
|
11 Participants
|
7 Participants
|
10 Participants
|
11 Participants
|
3 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 10
|
11 Participants
|
11 Participants
|
17 Participants
|
13 Participants
|
5 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 12
|
13 Participants
|
14 Participants
|
24 Participants
|
16 Participants
|
4 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 14
|
17 Participants
|
17 Participants
|
25 Participants
|
17 Participants
|
5 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 15
|
19 Participants
|
18 Participants
|
25 Participants
|
18 Participants
|
7 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 16
|
23 Participants
|
21 Participants
|
28 Participants
|
21 Participants
|
6 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 18
|
22 Participants
|
21 Participants
|
26 Participants
|
27 Participants
|
8 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 20
|
24 Participants
|
21 Participants
|
26 Participants
|
27 Participants
|
8 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 22
|
27 Participants
|
29 Participants
|
30 Participants
|
30 Participants
|
11 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 24
|
25 Participants
|
28 Participants
|
34 Participants
|
29 Participants
|
11 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 26
|
25 Participants
|
29 Participants
|
34 Participants
|
33 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 28
|
26 Participants
|
26 Participants
|
33 Participants
|
32 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 30
|
24 Participants
|
26 Participants
|
32 Participants
|
32 Participants
|
18 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 32
|
23 Participants
|
29 Participants
|
31 Participants
|
35 Participants
|
19 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 34
|
23 Participants
|
27 Participants
|
30 Participants
|
31 Participants
|
19 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 36
|
27 Participants
|
30 Participants
|
33 Participants
|
31 Participants
|
20 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 40
|
23 Participants
|
28 Participants
|
27 Participants
|
26 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 44
|
21 Participants
|
27 Participants
|
29 Participants
|
25 Participants
|
17 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 48
|
19 Participants
|
30 Participants
|
28 Participants
|
24 Participants
|
15 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 52
|
16 Participants
|
30 Participants
|
22 Participants
|
22 Participants
|
14 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-75 at Week 56
|
15 Participants
|
24 Participants
|
16 Participants
|
17 Participants
|
14 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 2
|
0 Participants
|
0 Participants
|
0 Participants
|
2 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 4
|
2 Participants
|
0 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 6
|
2 Participants
|
1 Participants
|
3 Participants
|
2 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 8
|
4 Participants
|
3 Participants
|
7 Participants
|
4 Participants
|
0 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 10
|
7 Participants
|
3 Participants
|
8 Participants
|
5 Participants
|
1 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 12
|
9 Participants
|
4 Participants
|
10 Participants
|
5 Participants
|
26 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 14
|
6 Participants
|
6 Participants
|
16 Participants
|
8 Participants
|
2 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 15
|
11 Participants
|
6 Participants
|
17 Participants
|
8 Participants
|
3 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 16
|
10 Participants
|
6 Participants
|
19 Participants
|
10 Participants
|
2 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 18
|
9 Participants
|
11 Participants
|
15 Participants
|
13 Participants
|
3 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 20
|
14 Participants
|
14 Participants
|
17 Participants
|
14 Participants
|
3 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 22
|
16 Participants
|
15 Participants
|
20 Participants
|
17 Participants
|
5 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 24
|
14 Participants
|
14 Participants
|
26 Participants
|
16 Participants
|
6 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 26
|
14 Participants
|
16 Participants
|
26 Participants
|
20 Participants
|
6 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 28
|
15 Participants
|
14 Participants
|
25 Participants
|
17 Participants
|
5 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 30
|
14 Participants
|
18 Participants
|
25 Participants
|
24 Participants
|
8 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 32
|
16 Participants
|
17 Participants
|
27 Participants
|
25 Participants
|
11 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 34
|
19 Participants
|
15 Participants
|
27 Participants
|
24 Participants
|
11 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 36
|
18 Participants
|
19 Participants
|
28 Participants
|
21 Participants
|
13 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 40
|
15 Participants
|
19 Participants
|
23 Participants
|
18 Participants
|
13 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 44
|
14 Participants
|
24 Participants
|
24 Participants
|
20 Participants
|
12 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 48
|
14 Participants
|
21 Participants
|
22 Participants
|
18 Participants
|
11 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 52
|
12 Participants
|
24 Participants
|
17 Participants
|
19 Participants
|
11 Participants
|
|
Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point
Achievement of EASI-90 at Week 56
|
13 Participants
|
21 Participants
|
13 Participants
|
15 Participants
|
8 Participants
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 14
|
39.51 score on a scale
Interval 1.3 to 101.6
|
39.75 score on a scale
Interval 11.7 to 88.9
|
31.69 score on a scale
Interval 3.8 to 67.6
|
39.41 score on a scale
Interval 1.0 to 88.1
|
54.68 score on a scale
Interval 14.1 to 96.4
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 24
|
32.41 score on a scale
Interval 0.4 to 98.5
|
29.06 score on a scale
Interval 0.1 to 57.0
|
21.05 score on a scale
Interval 0.2 to 59.3
|
29.93 score on a scale
Interval 0.2 to 93.8
|
43.55 score on a scale
Interval 8.0 to 90.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Baseline
|
68.67 score on a scale
Interval 42.0 to 96.3
|
69.80 score on a scale
Interval 42.9 to 99.6
|
68.19 score on a scale
Interval 42.1 to 96.4
|
68.79 score on a scale
Interval 40.1 to 100.2
|
66.35 score on a scale
Interval 38.7 to 97.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 1
|
68.40 score on a scale
Interval 29.0 to 97.8
|
66.53 score on a scale
Interval 34.5 to 95.3
|
63.06 score on a scale
Interval 28.5 to 97.7
|
64.99 score on a scale
Interval 22.5 to 99.6
|
62.83 score on a scale
Interval 26.2 to 94.1
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 2
|
64.56 score on a scale
Interval 21.3 to 98.7
|
62.75 score on a scale
Interval 27.1 to 96.8
|
61.03 score on a scale
Interval 30.8 to 97.1
|
62.52 score on a scale
Interval 1.8 to 97.1
|
65.31 score on a scale
Interval 28.1 to 103.7
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 4
|
60.87 score on a scale
Interval 10.5 to 98.7
|
59.84 score on a scale
Interval 24.6 to 99.9
|
54.01 score on a scale
Interval 18.7 to 95.3
|
57.01 score on a scale
Interval 16.4 to 99.0
|
65.20 score on a scale
Interval 24.8 to 98.2
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 6
|
56.59 score on a scale
Interval 0.9 to 101.5
|
52.39 score on a scale
Interval 10.0 to 88.7
|
46.32 score on a scale
Interval 8.2 to 82.9
|
51.34 score on a scale
Interval 11.9 to 93.6
|
62.07 score on a scale
Interval 19.9 to 99.2
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 8
|
48.46 score on a scale
Interval 1.0 to 101.4
|
48.16 score on a scale
Interval 7.5 to 87.6
|
45.05 score on a scale
Interval 16.8 to 84.5
|
48.29 score on a scale
Interval 10.2 to 94.4
|
59.11 score on a scale
Interval 26.0 to 103.4
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 10
|
42.42 score on a scale
Interval 0.6 to 100.7
|
45.15 score on a scale
Interval 7.4 to 85.7
|
39.13 score on a scale
Interval 0.6 to 75.8
|
45.50 score on a scale
Interval 9.4 to 90.1
|
58.85 score on a scale
Interval 20.3 to 103.1
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 12
|
41.07 score on a scale
Interval 1.3 to 102.5
|
41.98 score on a scale
Interval 8.0 to 84.9
|
33.82 score on a scale
Interval 4.0 to 68.0
|
43.68 score on a scale
Interval 9.7 to 89.4
|
57.15 score on a scale
Interval 15.3 to 102.9
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 15
|
35.79 score on a scale
Interval 0.5 to 93.7
|
38.88 score on a scale
Interval 2.3 to 81.9
|
30.03 score on a scale
Interval 0.5 to 76.9
|
37.46 score on a scale
Interval 0.9 to 69.3
|
51.66 score on a scale
Interval 16.7 to 96.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 16
|
34.70 score on a scale
Interval 0.8 to 97.8
|
37.82 score on a scale
Interval 2.0 to 77.8
|
28.31 score on a scale
Interval 3.5 to 70.1
|
35.76 score on a scale
Interval 1.1 to 72.4
|
51.80 score on a scale
Interval 16.3 to 97.0
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 18
|
36.44 score on a scale
Interval 0.4 to 97.8
|
36.01 score on a scale
Interval 1.4 to 71.3
|
30.14 score on a scale
Interval 0.3 to 64.5
|
34.80 score on a scale
Interval 6.2 to 83.8
|
51.99 score on a scale
Interval 19.6 to 97.6
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 20
|
33.88 score on a scale
Interval 0.3 to 100.3
|
33.86 score on a scale
Interval 1.3 to 63.8
|
27.59 score on a scale
Interval 0.2 to 66.4
|
31.35 score on a scale
Interval 0.2 to 74.2
|
48.17 score on a scale
Interval 13.0 to 90.6
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 22
|
31.69 score on a scale
Interval 0.3 to 98.9
|
30.13 score on a scale
Interval 0.1 to 59.4
|
25.14 score on a scale
Interval 0.2 to 57.5
|
28.21 score on a scale
Interval 0.2 to 64.0
|
45.07 score on a scale
Interval 0.6 to 88.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 26
|
29.48 score on a scale
Interval 0.3 to 101.9
|
27.54 score on a scale
Interval 0.3 to 56.5
|
20.12 score on a scale
Interval 0.0 to 66.5
|
28.31 score on a scale
Interval 0.2 to 93.0
|
35.59 score on a scale
Interval 4.3 to 80.6
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 28
|
29.21 score on a scale
Interval 0.2 to 102.7
|
27.50 score on a scale
Interval 1.7 to 55.7
|
20.23 score on a scale
Interval 0.1 to 68.0
|
27.05 score on a scale
Interval 0.2 to 68.2
|
32.88 score on a scale
Interval 11.3 to 74.1
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 30
|
25.75 score on a scale
Interval 0.2 to 79.2
|
25.40 score on a scale
Interval 0.3 to 50.7
|
18.05 score on a scale
Interval 0.2 to 59.2
|
23.79 score on a scale
Interval 0.2 to 58.6
|
33.63 score on a scale
Interval 10.9 to 76.1
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 32
|
25.09 score on a scale
Interval 0.2 to 102.2
|
25.02 score on a scale
Interval 0.2 to 48.3
|
16.29 score on a scale
Interval 0.0 to 48.0
|
22.05 score on a scale
Interval 0.1 to 46.4
|
29.23 score on a scale
Interval 8.8 to 69.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 34
|
24.63 score on a scale
Interval 0.2 to 102.4
|
25.78 score on a scale
Interval 0.4 to 49.2
|
15.65 score on a scale
Interval 0.0 to 40.9
|
22.13 score on a scale
Interval 0.5 to 58.5
|
27.55 score on a scale
Interval 6.6 to 76.6
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 36
|
23.82 score on a scale
Interval 0.2 to 93.8
|
24.13 score on a scale
Interval 0.2 to 56.7
|
15.46 score on a scale
Interval 0.0 to 39.2
|
23.78 score on a scale
Interval 0.4 to 51.8
|
26.86 score on a scale
Interval 10.3 to 73.6
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 40
|
20.98 score on a scale
Interval 0.1 to 54.3
|
21.49 score on a scale
Interval 0.4 to 46.6
|
15.56 score on a scale
Interval 0.1 to 59.3
|
24.14 score on a scale
Interval 1.1 to 48.0
|
22.27 score on a scale
Interval 0.3 to 59.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 44
|
18.33 score on a scale
Interval 0.2 to 66.5
|
21.86 score on a scale
Interval 0.4 to 92.8
|
11.64 score on a scale
Interval 0.1 to 34.8
|
20.08 score on a scale
Interval 0.1 to 52.0
|
17.72 score on a scale
Interval 0.4 to 61.8
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 48
|
25.83 score on a scale
Interval 0.1 to 67.3
|
17.78 score on a scale
Interval 0.1 to 45.0
|
11.90 score on a scale
Interval 0.0 to 40.2
|
18.54 score on a scale
Interval 0.1 to 39.1
|
17.54 score on a scale
Interval 0.5 to 62.2
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 52
|
19.96 score on a scale
Interval 0.3 to 42.5
|
16.60 score on a scale
Interval 0.0 to 62.6
|
15.02 score on a scale
Interval 0.0 to 66.3
|
20.46 score on a scale
Interval 0.1 to 47.4
|
15.21 score on a scale
Interval 0.2 to 37.3
|
|
SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score at Week 56
|
20.65 score on a scale
Interval 0.5 to 60.3
|
18.50 score on a scale
Interval 0.2 to 76.0
|
11.92 score on a scale
Interval 0.0 to 61.1
|
19.27 score on a scale
Interval 0.1 to 43.3
|
16.91 score on a scale
Interval 0.4 to 34.3
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
In the SCORAD assessment, the extent of AD will be calculated as the sum of the percentage of each defined body area, with a maximum score of 100% (assigned as "A" in the overall SCORAD calculation). The severity of 6 specific symptoms of AD will be assessed using the following scale: 0 = none, 1 = mild, 2 = moderate, 3 = severe, with a maximum score of 18 (assigned as "B" in the overall SCORAD calculation). Itch and sleeplessness will be assessed by subjects on a visual analogue scale (VAS), where 0 is no itch (or sleeplessness) and 10 is the worst imaginable itch (or sleeplessness), with a maximum score of 20 (assigned as "C" in the overall SCORAD calculation). The SCORAD score is calculated as A/5 + 7B/2 + C. The maximum possible SCORAD score is 103; higher scores indicate poorer or more severe condition.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 28
|
-58.86 percentage of score change
Interval -99.6 to 8.7
|
-58.76 percentage of score change
Interval -97.2 to -12.0
|
-68.19 percentage of score change
Interval -99.8 to -1.3
|
-59.99 percentage of score change
Interval -99.7 to 8.9
|
-50.43 percentage of score change
Interval -81.0 to 5.9
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 30
|
-63.35 percentage of score change
Interval -99.6 to -8.1
|
-62.81 percentage of score change
Interval -99.5 to -30.2
|
-72.05 percentage of score change
Interval -99.7 to -7.8
|
-64.57 percentage of score change
Interval -99.7 to -20.2
|
-49.89 percentage of score change
Interval -76.6 to 14.6
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 32
|
-64.78 percentage of score change
Interval -99.6 to 8.1
|
-62.61 percentage of score change
Interval -99.7 to -24.5
|
-74.40 percentage of score change
Interval -100.0 to -14.9
|
-67.09 percentage of score change
Interval -99.9 to -27.5
|
-57.60 percentage of score change
Interval -87.5 to -14.6
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 34
|
-64.71 percentage of score change
Interval -99.6 to 8.4
|
-61.29 percentage of score change
Interval -99.3 to 7.5
|
-75.43 percentage of score change
Interval -100.0 to -31.5
|
-66.43 percentage of score change
Interval -99.3 to -10.7
|
-59.75 percentage of score change
Interval -92.3 to 8.7
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 36
|
-65.54 percentage of score change
Interval -99.7 to -0.7
|
-63.75 percentage of score change
Interval -99.6 to 29.5
|
-75.38 percentage of score change
Interval -100.0 to -22.5
|
-64.60 percentage of score change
Interval -99.5 to -22.9
|
-60.63 percentage of score change
Interval -87.3 to -1.8
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 40
|
-69.85 percentage of score change
Interval -99.8 to -13.5
|
-66.90 percentage of score change
Interval -99.5 to 6.4
|
-75.95 percentage of score change
Interval -99.8 to -7.6
|
-64.59 percentage of score change
Interval -98.5 to -30.0
|
-66.66 percentage of score change
Interval -99.5 to -19.4
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 44
|
-74.31 percentage of score change
Interval -99.6 to -3.5
|
-67.86 percentage of score change
Interval -99.5 to 39.3
|
-80.96 percentage of score change
Interval -99.9 to -31.2
|
-70.81 percentage of score change
Interval -99.8 to -18.2
|
-71.50 percentage of score change
Interval -99.4 to 3.2
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 48
|
-64.22 percentage of score change
Interval -99.8 to -4.5
|
-74.60 percentage of score change
Interval -99.8 to -34.0
|
-81.00 percentage of score change
Interval -100.0 to -20.6
|
-74.06 percentage of score change
Interval -99.9 to -39.9
|
-71.99 percentage of score change
Interval -99.2 to 3.8
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 52
|
-70.53 percentage of score change
Interval -99.4 to -23.1
|
-76.82 percentage of score change
Interval -100.0 to -16.8
|
-77.96 percentage of score change
Interval -100.0 to -12.0
|
-71.47 percentage of score change
Interval -99.9 to -38.1
|
-76.93 percentage of score change
Interval -99.6 to -39.9
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 56
|
-70.50 percentage of score change
Interval -99.1 to -24.8
|
-74.01 percentage of score change
Interval -99.7 to 1.1
|
-80.81 percentage of score change
Interval -100.0 to -7.3
|
-71.83 percentage of score change
Interval -99.9 to -35.2
|
-74.51 percentage of score change
Interval -99.3 to -39.3
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 1
|
-1.28 percentage of score change
Interval -35.6 to 50.0
|
-4.08 percentage of score change
Interval -42.9 to 19.7
|
-7.03 percentage of score change
Interval -58.3 to 36.1
|
-5.75 percentage of score change
Interval -50.6 to 27.7
|
-4.54 percentage of score change
Interval -38.8 to 20.3
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 2
|
-7.37 percentage of score change
Interval -52.7 to 31.7
|
-9.14 percentage of score change
Interval -61.8 to 35.2
|
-9.05 percentage of score change
Interval -53.4 to 18.2
|
-10.37 percentage of score change
Interval -95.9 to 32.8
|
-0.47 percentage of score change
Interval -34.8 to 45.0
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 4
|
-13.51 percentage of score change
Interval -76.4 to 41.0
|
-12.97 percentage of score change
Interval -54.0 to 36.2
|
-19.60 percentage of score change
Interval -72.2 to 39.5
|
-15.77 percentage of score change
Interval -79.7 to 40.0
|
-1.98 percentage of score change
Interval -42.1 to 41.9
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 6
|
-19.34 percentage of score change
Interval -98.0 to 45.0
|
-23.76 percentage of score change
Interval -86.1 to 20.3
|
-30.52 percentage of score change
Interval -73.0 to 15.5
|
-29.34 percentage of score change
Interval -85.3 to 28.5
|
-12.34 percentage of score change
Interval -53.5 to 74.8
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 8
|
-31.63 percentage of score change
Interval -97.8 to 44.9
|
-29.29 percentage of score change
Interval -89.6 to 28.1
|
-32.82 percentage of score change
Interval -73.0 to 15.5
|
-29.34 percentage of score change
Interval -85.3 to 28.5
|
-12.34 percentage of score change
Interval -53.5 to 74.8
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 10
|
-39.55 percentage of score change
Interval -98.7 to 13.7
|
-34.22 percentage of score change
Interval -89.7 to 28.1
|
-42.53 percentage of score change
Interval -99.1 to -0.5
|
-34.32 percentage of score change
Interval -86.5 to 4.6
|
-13.14 percentage of score change
Interval -63.7 to 21.3
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 12
|
-41.68 percentage of score change
Interval -97.1 to 11.0
|
-38.06 percentage of score change
Interval -88.9 to 17.1
|
-49.86 percentage of score change
Interval -95.1 to 0.9
|
-35.85 percentage of score change
Interval -86.1 to 7.0
|
-15.56 percentage of score change
Interval -72.6 to 13.8
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 14
|
-44.39 percentage of score change
Interval -97.3 to 7.9
|
-41.69 percentage of score change
Interval -83.8 to 18.2
|
-53.03 percentage of score change
Interval -95.4 to 7.4
|
-42.09 percentage of score change
Interval -98.7 to 16.3
|
-19.05 percentage of score change
Interval -74.8 to 24.7
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 15
|
-48.84 percentage of score change
Interval -98.9 to -0.8
|
-42.54 percentage of score change
Interval -96.2 to 11.5
|
-55.95 percentage of score change
Interval -99.3 to -7.4
|
-44.36 percentage of score change
Interval -98.8 to 8.5
|
-23.19 percentage of score change
Interval -70.1 to 40.4
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 16
|
-50.07 percentage of score change
Interval -98.5 to 3.5
|
-43.47 percentage of score change
Interval -96.7 to 18.9
|
-58.24 percentage of score change
Interval -95.8 to -13.9
|
-47.00 percentage of score change
Interval -98.5 to 12.1
|
-23.26 percentage of score change
Interval -71.7 to 42.9
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 18
|
-47.48 percentage of score change
Interval -99.2 to 7.1
|
-46.42 percentage of score change
Interval -97.7 to 20.8
|
-56.06 percentage of score change
Interval -99.5 to -5.0
|
-48.32 percentage of score change
Interval -91.8 to 79.0
|
-21.87 percentage of score change
Interval -80.0 to 69.0
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 20
|
-51.55 percentage of score change
Interval -99.4 to 10.0
|
-49.39 percentage of score change
Interval -97.9 to 17.8
|
-58.91 percentage of score change
Interval -99.7 to -2.8
|
-54.95 percentage of score change
Interval -99.7 to 9.6
|
-27.64 percentage of score change
Interval -85.7 to 76.6
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 22
|
-54.91 percentage of score change
Interval -99.4 to 13.3
|
-55.22 percentage of score change
Interval -99.8 to 26.9
|
-62.02 percentage of score change
Interval -99.7 to -10.4
|
-58.18 percentage of score change
Interval -99.7 to -0.9
|
-32.18 percentage of score change
Interval -99.4 to 73.1
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 24
|
-53.96 percentage of score change
Interval -99.2 to 13.6
|
-56.56 percentage of score change
Interval -99.8 to 2.3
|
-68.56 percentage of score change
Interval -99.7 to -3.4
|
-56.63 percentage of score change
Interval -99.7 to 5.7
|
-34.10 percentage of score change
Interval -86.3 to 77.0
|
|
Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point
SCORAD Score % Change at Week 26
|
-58.23 percentage of score change
Interval -99.4 to 7.8
|
-59.24 percentage of score change
Interval -99.5 to -13.5
|
-68.82 percentage of score change
Interval -100.0 to -3.5
|
-58.19 percentage of score change
Interval -99.7 to 4.8
|
-47.60 percentage of score change
Interval -92.6 to 18.8
|
SECONDARY outcome
Timeframe: 56 WeeksIn the IGA, the Investigator will evaluate the overall skin symptoms of subjects at each visit on a 5-point scale ranging from 0 (clear) to 4 (severe)
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 1
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
0 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 2
|
0 Participants
|
0 Participants
|
1 Participants
|
1 Participants
|
0 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 4
|
1 Participants
|
1 Participants
|
0 Participants
|
3 Participants
|
1 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 6
|
2 Participants
|
2 Participants
|
1 Participants
|
2 Participants
|
0 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 8
|
5 Participants
|
2 Participants
|
2 Participants
|
2 Participants
|
0 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 10
|
6 Participants
|
4 Participants
|
6 Participants
|
2 Participants
|
1 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 12
|
9 Participants
|
6 Participants
|
12 Participants
|
4 Participants
|
1 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 14
|
8 Participants
|
5 Participants
|
11 Participants
|
4 Participants
|
2 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 15
|
10 Participants
|
7 Participants
|
9 Participants
|
8 Participants
|
2 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 16
|
10 Participants
|
8 Participants
|
16 Participants
|
10 Participants
|
1 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 18
|
10 Participants
|
8 Participants
|
16 Participants
|
12 Participants
|
1 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 20
|
13 Participants
|
9 Participants
|
15 Participants
|
14 Participants
|
3 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 22
|
13 Participants
|
12 Participants
|
18 Participants
|
14 Participants
|
3 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 24
|
14 Participants
|
10 Participants
|
20 Participants
|
12 Participants
|
3 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 26
|
13 Participants
|
14 Participants
|
25 Participants
|
18 Participants
|
4 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 28
|
11 Participants
|
12 Participants
|
23 Participants
|
14 Participants
|
3 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 30
|
13 Participants
|
12 Participants
|
22 Participants
|
17 Participants
|
4 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 32
|
14 Participants
|
13 Participants
|
24 Participants
|
23 Participants
|
5 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 34
|
16 Participants
|
11 Participants
|
24 Participants
|
20 Participants
|
7 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 36
|
18 Participants
|
14 Participants
|
27 Participants
|
19 Participants
|
8 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 40
|
10 Participants
|
17 Participants
|
19 Participants
|
13 Participants
|
7 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 44
|
12 Participants
|
16 Participants
|
25 Participants
|
16 Participants
|
11 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 48
|
8 Participants
|
21 Participants
|
20 Participants
|
18 Participants
|
9 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 52
|
10 Participants
|
19 Participants
|
18 Participants
|
15 Participants
|
10 Participants
|
|
Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Each Time Point
Achievement of IGA Score at Week 56
|
12 Participants
|
18 Participants
|
13 Participants
|
14 Participants
|
9 Participants
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
The Investigator will calculate the percentage (%) of the total body surface area affected by AD.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 48
|
-46.6 percentage of total BSA involvement
Interval -87.0 to -12.0
|
-52.7 percentage of total BSA involvement
Interval -89.0 to -13.0
|
-53.9 percentage of total BSA involvement
Interval -90.0 to -18.0
|
-53.7 percentage of total BSA involvement
Interval -90.0 to -24.0
|
-46.2 percentage of total BSA involvement
Interval -90.0 to 0.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 1
|
-0.5 percentage of total BSA involvement
Interval -25.0 to 17.0
|
-1.4 percentage of total BSA involvement
Interval -25.0 to 23.0
|
-0.4 percentage of total BSA involvement
Interval -35.0 to 40.0
|
-0.1 percentage of total BSA involvement
Interval -23.0 to 23.0
|
-1.2 percentage of total BSA involvement
Interval -35.0 to 45.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 2
|
-2.6 percentage of total BSA involvement
Interval -42.0 to 20.0
|
-3.8 percentage of total BSA involvement
Interval -48.0 to 15.0
|
-6.4 percentage of total BSA involvement
Interval -45.0 to 25.0
|
-1.9 percentage of total BSA involvement
Interval -24.0 to 38.0
|
0.1 percentage of total BSA involvement
Interval -38.0 to 50.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 4
|
-6.7 percentage of total BSA involvement
Interval -60.0 to 35.0
|
-4.0 percentage of total BSA involvement
Interval -48.0 to 39.0
|
-10.7 percentage of total BSA involvement
Interval -63.0 to 25.0
|
-5.6 percentage of total BSA involvement
Interval -49.0 to 23.0
|
-2.2 percentage of total BSA involvement
Interval -27.0 to 20.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 6
|
-13.7 percentage of total BSA involvement
Interval -60.0 to 30.0
|
-11.2 percentage of total BSA involvement
Interval -63.0 to 22.0
|
-16.9 percentage of total BSA involvement
Interval -68.0 to 25.0
|
-12.1 percentage of total BSA involvement
Interval -55.0 to 42.0
|
-4.0 percentage of total BSA involvement
Interval -35.0 to 20.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 8
|
-18.6 percentage of total BSA involvement
Interval -70.0 to 32.0
|
-19.3 percentage of total BSA involvement
Interval -76.0 to 6.0
|
-21.4 percentage of total BSA involvement
Interval -73.0 to 25.0
|
-17.2 percentage of total BSA involvement
Interval -55.0 to 25.0
|
-4.4 percentage of total BSA involvement
Interval -33.0 to 40.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 10
|
-24.5 percentage of total BSA involvement
Interval -71.0 to 39.0
|
-22.6 percentage of total BSA involvement
Interval -68.0 to 3.0
|
-26.0 percentage of total BSA involvement
Interval -73.0 to 25.0
|
-20.7 percentage of total BSA involvement
Interval -65.0 to 19.0
|
-4.8 percentage of total BSA involvement
Interval -35.0 to 20.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 12
|
-27.4 percentage of total BSA involvement
Interval -75.0 to 39.0
|
-26.4 percentage of total BSA involvement
Interval -73.0 to 5.0
|
-31.1 percentage of total BSA involvement
Interval -77.0 to 25.0
|
-22.2 percentage of total BSA involvement
Interval -72.0 to 22.0
|
-4.9 percentage of total BSA involvement
Interval -35.0 to 20.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 14
|
-29.8 percentage of total BSA involvement
Interval -75.0 to 35.0
|
-29.4 percentage of total BSA involvement
Interval -88.0 to 3.0
|
-33.6 percentage of total BSA involvement
Interval -77.0 to 28.0
|
-24.4 percentage of total BSA involvement
Interval -75.0 to 22.0
|
-10.2 percentage of total BSA involvement
Interval -61.0 to 13.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 15
|
-31.9 percentage of total BSA involvement
Interval -75.0 to 24.0
|
-29.3 percentage of total BSA involvement
Interval -79.0 to 2.0
|
-35.1 percentage of total BSA involvement
Interval -81.0 to 15.0
|
-25.6 percentage of total BSA involvement
Interval -75.0 to 32.0
|
-12.2 percentage of total BSA involvement
Interval -61.0 to 20.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 16
|
-31.9 percentage of total BSA involvement
Interval -75.0 to 39.0
|
-29.6 percentage of total BSA involvement
Interval -89.0 to 25.0
|
-35.5 percentage of total BSA involvement
Interval -78.0 to 20.0
|
-28.9 percentage of total BSA involvement
Interval -80.0 to 24.0
|
-14.1 percentage of total BSA involvement
Interval -60.0 to 20.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 18
|
-34.6 percentage of total BSA involvement
Interval -80.0 to 39.0
|
-32.7 percentage of total BSA involvement
Interval -89.0 to 0.0
|
-35.5 percentage of total BSA involvement
Interval -75.0 to 5.0
|
-29.6 percentage of total BSA involvement
Interval -86.0 to 39.0
|
-13.1 percentage of total BSA involvement
Interval -60.0 to 30.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 20
|
-35.9 percentage of total BSA involvement
Interval -90.0 to 39.0
|
-34.8 percentage of total BSA involvement
Interval -84.0 to 2.0
|
-39.7 percentage of total BSA involvement
Interval -70.0 to 7.0
|
-34.6 percentage of total BSA involvement
Interval -86.0 to 19.0
|
-13.3 percentage of total BSA involvement
Interval -70.0 to 35.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 22
|
-39.3 percentage of total BSA involvement
Interval -94.0 to 39.0
|
-38.3 percentage of total BSA involvement
Interval -84.0 to 0.0
|
-40.6 percentage of total BSA involvement
Interval -77.0 to 11.0
|
-38.3 percentage of total BSA involvement
Interval -80.0 to 21.0
|
-18.5 percentage of total BSA involvement
Interval -95.0 to 35.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 24
|
-37.7 percentage of total BSA involvement
Interval -91.0 to 39.0
|
-39.0 percentage of total BSA involvement
Interval -79.0 to 0.0
|
-42.9 percentage of total BSA involvement
Interval -75.0 to 20.0
|
-40.6 percentage of total BSA involvement
Interval -80.0 to 10.0
|
-21.1 percentage of total BSA involvement
Interval -75.0 to 37.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 26
|
-38.3 percentage of total BSA involvement
Interval -85.0 to 39.0
|
-42.1 percentage of total BSA involvement
Interval -81.0 to -5.0
|
-46.4 percentage of total BSA involvement
Interval -88.0 to -10.0
|
-42.0 percentage of total BSA involvement
Interval -82.0 to 27.0
|
-26.9 percentage of total BSA involvement
Interval -80.0 to 9.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 28
|
-41.2 percentage of total BSA involvement
Interval -90.0 to 34.0
|
-43.1 percentage of total BSA involvement
Interval -83.0 to -5.0
|
-45.8 percentage of total BSA involvement
Interval -87.0 to 3.0
|
-42.8 percentage of total BSA involvement
Interval -78.0 to 37.0
|
-29.6 percentage of total BSA involvement
Interval -70.0 to 7.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 30
|
-41.4 percentage of total BSA involvement
Interval -93.0 to 19.0
|
-45.5 percentage of total BSA involvement
Interval -89.0 to -10.0
|
-46.2 percentage of total BSA involvement
Interval -87.0 to -5.0
|
-47.2 percentage of total BSA involvement
Interval -80.0 to -8.0
|
-32.1 percentage of total BSA involvement
Interval -70.0 to 6.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 32
|
-44.0 percentage of total BSA involvement
Interval -90.0 to 39.0
|
-46.5 percentage of total BSA involvement
Interval -89.0 to -7.0
|
-48.3 percentage of total BSA involvement
Interval -85.0 to -15.0
|
-48.2 percentage of total BSA involvement
Interval -84.0 to -3.0
|
-39.6 percentage of total BSA involvement
Interval -80.0 to -9.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 34
|
-44.4 percentage of total BSA involvement
Interval -92.0 to 39.0
|
-45.1 percentage of total BSA involvement
Interval -94.0 to -2.0
|
-50.7 percentage of total BSA involvement
Interval -90.0 to -18.0
|
-49.0 percentage of total BSA involvement
Interval -80.0 to -3.0
|
-41.2 percentage of total BSA involvement
Interval -85.0 to -3.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 36
|
-44.6 percentage of total BSA involvement
Interval -93.0 to 39.0
|
-48.1 percentage of total BSA involvement
Interval -89.0 to 4.0
|
-50.3 percentage of total BSA involvement
Interval -92.0 to -17.0
|
-48.0 percentage of total BSA involvement
Interval -84.0 to -3.0
|
-40.8 percentage of total BSA involvement
Interval -95.0 to 4.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 40
|
-49.0 percentage of total BSA involvement
Interval -95.0 to -5.0
|
-50.6 percentage of total BSA involvement
Interval -87.0 to -4.0
|
-51.6 percentage of total BSA involvement
Interval -92.0 to -18.0
|
-51.1 percentage of total BSA involvement
Interval -82.0 to -4.0
|
-46.6 percentage of total BSA involvement
Interval -99.0 to -1.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 44
|
-50.8 percentage of total BSA involvement
Interval -95.0 to -13.0
|
-47.9 percentage of total BSA involvement
Interval -88.0 to 5.0
|
-53.5 percentage of total BSA involvement
Interval -90.0 to -18.0
|
-50.8 percentage of total BSA involvement
Interval -90.0 to 4.0
|
-47.5 percentage of total BSA involvement
Interval -89.0 to -10.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 52
|
-49.7 percentage of total BSA involvement
Interval -87.0 to -20.0
|
-51.9 percentage of total BSA involvement
Interval -89.0 to -12.0
|
-53.7 percentage of total BSA involvement
Interval -90.0 to -18.0
|
-55.8 percentage of total BSA involvement
Interval -90.0 to -24.0
|
-48.6 percentage of total BSA involvement
Interval -90.0 to -9.0
|
|
Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point
Change in % BSA at Week 56
|
-45.6 percentage of total BSA involvement
Interval -80.0 to -10.0
|
-47.2 percentage of total BSA involvement
Interval -89.0 to 3.0
|
-53.8 percentage of total BSA involvement
Interval -90.0 to -18.0
|
-58.6 percentage of total BSA involvement
Interval -90.0 to -27.0
|
-45.9 percentage of total BSA involvement
Interval -85.0 to -6.0
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 26
|
3.7 score on a scale
Interval 0.0 to 9.0
|
3.0 score on a scale
Interval 0.0 to 10.0
|
2.0 score on a scale
Interval 0.0 to 9.0
|
3.3 score on a scale
Interval 0.0 to 9.0
|
4.1 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 28
|
3.7 score on a scale
Interval 0.0 to 10.0
|
3.1 score on a scale
Interval 0.0 to 10.0
|
1.8 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 8.0
|
3.5 score on a scale
Interval 0.0 to 8.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 30
|
3.3 score on a scale
Interval 0.0 to 9.0
|
2.5 score on a scale
Interval 0.0 to 10.0
|
2.1 score on a scale
Interval 0.0 to 9.0
|
2.9 score on a scale
Interval 0.0 to 9.0
|
3.5 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 32
|
3.2 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 10.0
|
2.0 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 7.0
|
2.9 score on a scale
Interval 0.0 to 8.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 24
|
4.0 score on a scale
Interval 0.0 to 9.0
|
3.2 score on a scale
Interval 0.0 to 10.0
|
2.2 score on a scale
Interval 0.0 to 8.0
|
3.6 score on a scale
Interval 0.0 to 9.0
|
4.3 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 34
|
3.1 score on a scale
Interval 0.0 to 9.0
|
2.8 score on a scale
Interval 0.0 to 10.0
|
1.9 score on a scale
Interval 0.0 to 7.0
|
3.0 score on a scale
Interval 0.0 to 8.0
|
2.7 score on a scale
Interval 0.0 to 8.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 36
|
3.1 score on a scale
Interval 0.0 to 8.0
|
2.5 score on a scale
Interval 0.0 to 10.0
|
1.8 score on a scale
Interval 0.0 to 8.0
|
2.8 score on a scale
Interval 0.0 to 8.0
|
2.6 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 40
|
2.8 score on a scale
Interval 0.0 to 8.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
2.1 score on a scale
Interval 0.0 to 10.0
|
2.8 score on a scale
Interval 0.0 to 8.0
|
2.4 score on a scale
Interval 0.0 to 7.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Baseline
|
7.7 score on a scale
Interval 3.0 to 10.0
|
7.7 score on a scale
Interval 2.0 to 10.0
|
7.3 score on a scale
Interval 3.0 to 10.0
|
7.6 score on a scale
Interval 1.0 to 10.0
|
7.2 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 1
|
7.3 score on a scale
Interval 2.0 to 10.0
|
7.3 score on a scale
Interval 2.0 to 10.0
|
6.8 score on a scale
Interval 1.0 to 10.0
|
6.8 score on a scale
Interval 1.0 to 10.0
|
6.9 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 2
|
6.8 score on a scale
Interval 2.0 to 10.0
|
7.0 score on a scale
Interval 2.0 to 10.0
|
6.3 score on a scale
Interval 2.0 to 10.0
|
6.8 score on a scale
Interval 1.0 to 10.0
|
7.1 score on a scale
Interval 2.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 4
|
6.4 score on a scale
Interval 1.0 to 10.0
|
6.2 score on a scale
Interval 1.0 to 10.0
|
5.7 score on a scale
Interval 0.0 to 10.0
|
6.2 score on a scale
Interval 1.0 to 10.0
|
7.1 score on a scale
Interval 3.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 6
|
6.0 score on a scale
Interval 1.0 to 10.0
|
5.4 score on a scale
Interval 0.0 to 10.0
|
4.7 score on a scale
Interval 0.0 to 10.0
|
5.5 score on a scale
Interval 0.0 to 10.0
|
6.5 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 8
|
5.4 score on a scale
Interval 1.0 to 10.0
|
5.2 score on a scale
Interval 0.0 to 10.0
|
4.4 score on a scale
Interval 0.0 to 9.0
|
5.2 score on a scale
Interval 1.0 to 10.0
|
6.0 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 10
|
4.9 score on a scale
Interval 1.0 to 9.0
|
4.7 score on a scale
Interval 0.0 to 10.0
|
4.0 score on a scale
Interval 0.0 to 9.0
|
5.1 score on a scale
Interval 1.0 to 10.0
|
5.8 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 12
|
4.8 score on a scale
Interval 0.0 to 9.0
|
4.2 score on a scale
Interval 0.0 to 10.0
|
3.6 score on a scale
Interval 0.0 to 10.0
|
4.7 score on a scale
Interval 1.0 to 10.0
|
5.8 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 14
|
4.5 score on a scale
Interval 1.0 to 9.0
|
3.7 score on a scale
Interval 0.0 to 10.0
|
3.3 score on a scale
Interval 0.0 to 9.0
|
4.6 score on a scale
Interval 1.0 to 10.0
|
5.9 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 15
|
4.4 score on a scale
Interval 1.0 to 9.0
|
3.8 score on a scale
Interval 0.0 to 10.0
|
2.9 score on a scale
Interval 0.0 to 9.0
|
4.2 score on a scale
Interval 1.0 to 9.0
|
5.3 score on a scale
Interval 1.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 16
|
4.6 score on a scale
Interval 1.0 to 9.0
|
3.6 score on a scale
Interval 0.0 to 10.0
|
2.8 score on a scale
Interval 0.0 to 9.0
|
4.1 score on a scale
Interval 0.0 to 9.0
|
5.2 score on a scale
Interval 0.0 to 10.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 18
|
4.2 score on a scale
Interval 1.0 to 9.0
|
3.7 score on a scale
Interval 0.0 to 10.0
|
3.3 score on a scale
Interval 0.0 to 8.0
|
4.2 score on a scale
Interval 0.0 to 10.0
|
5.2 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 20
|
4.0 score on a scale
Interval 1.0 to 10.0
|
3.2 score on a scale
Interval 0.0 to 10.0
|
2.9 score on a scale
Interval 0.0 to 8.0
|
3.7 score on a scale
Interval 0.0 to 10.0
|
4.8 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 22
|
4.0 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 10.0
|
2.3 score on a scale
Interval 0.0 to 7.0
|
3.5 score on a scale
Interval 0.0 to 10.0
|
4.8 score on a scale
Interval 1.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 44
|
2.9 score on a scale
Interval 0.0 to 7.0
|
2.4 score on a scale
Interval 0.0 to 10.0
|
1.6 score on a scale
Interval 0.0 to 6.0
|
2.3 score on a scale
Interval 0.0 to 8.0
|
1.6 score on a scale
Interval 0.0 to 5.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 48
|
3.2 score on a scale
Interval 0.0 to 9.0
|
2.2 score on a scale
Interval 0.0 to 10.0
|
1.7 score on a scale
Interval 0.0 to 7.0
|
2.2 score on a scale
Interval 0.0 to 6.0
|
1.8 score on a scale
Interval 0.0 to 9.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 52
|
2.8 score on a scale
Interval 0.0 to 9.0
|
2.0 score on a scale
Interval 0.0 to 10.0
|
1.9 score on a scale
Interval 0.0 to 10.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
1.4 score on a scale
Interval 0.0 to 4.0
|
|
Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score at Week 56
|
2.8 score on a scale
Interval 0.0 to 9.0
|
2.3 score on a scale
Interval 0.0 to 10.0
|
1.9 score on a scale
Interval 0.0 to 10.0
|
2.4 score on a scale
Interval 0.0 to 10.0
|
1.3 score on a scale
Interval 0.0 to 3.0
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
The worst degree of itch experienced during 24 hours before the time point will be assessed on a Numerical Rating Scale. The degree of itch will be scored on an 11-point scale, with 0 being "no itch" and 10 being the "worst itch imaginable."
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 1
|
-2.9 percentage of score change
Interval -60.0 to 167.0
|
2.5 percentage of score change
Interval -56.0 to 250.0
|
-3.4 percentage of score change
Interval -88.0 to 100.0
|
-12.2 percentage of score change
Interval -50.0 to 33.0
|
2.6 percentage of score change
Interval -67.0 to 300.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 2
|
-12.2 percentage of score change
Interval -63.0 to 67.0
|
-1.7 percentage of score change
Interval -50.0 to 200.0
|
-11.9 percentage of score change
Interval -78.0 to 50.0
|
-11.8 percentage of score change
Interval -89.0 to 43.0
|
12.9 percentage of score change
Interval -75.0 to 300.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 4
|
-16.8 percentage of score change
Interval -80.0 to 80.0
|
-8.3 percentage of score change
Interval -80.0 to 250.0
|
-18.8 percentage of score change
Interval -100.0 to 133.0
|
-17.3 percentage of score change
Interval -89.0 to 43.0
|
14.0 percentage of score change
Interval -63.0 to 350.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 6
|
-22.1 percentage of score change
Interval -90.0 to 80.0
|
-26.0 percentage of score change
Interval -100.0 to 75.0
|
-32.5 percentage of score change
Interval -100.0 to 25.0
|
-26.0 percentage of score change
Interval -100.0 to 100.0
|
5.2 percentage of score change
Interval -71.0 to 300.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 8
|
-28.1 percentage of score change
Interval -90.0 to 60.0
|
-25.5 percentage of score change
Interval -100.0 to 200.0
|
-37.3 percentage of score change
Interval -100.0 to 50.0
|
-31.0 percentage of score change
Interval -89.0 to 33.0
|
-8.8 percentage of score change
Interval -88.0 to 200.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 10
|
-37.0 percentage of score change
Interval -90.0 to 20.0
|
-36.9 percentage of score change
Interval -100.0 to 75.0
|
-43.5 percentage of score change
Interval -100.0 to 50.0
|
-32.1 percentage of score change
Interval -88.0 to 50.0
|
-14.3 percentage of score change
Interval -89.0 to 200.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 12
|
-37.9 percentage of score change
Interval -100.0 to 29.0
|
-37.9 percentage of score change
Interval -100.0 to 250.0
|
-49.0 percentage of score change
Interval -100.0 to 33.0
|
-36.0 percentage of score change
Interval -90.0 to 40.0
|
-16.0 percentage of score change
Interval -89.0 to 100.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 14
|
-43.9 percentage of score change
Interval -90.0 to 0.0
|
-45.1 percentage of score change
Interval -100.0 to 100.0
|
-52.7 percentage of score change
Interval -100.0 to 50.0
|
-36.0 percentage of score change
Interval -90.0 to 100.0
|
-13.5 percentage of score change
Interval -88.0 to 200.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 15
|
-41.7 percentage of score change
Interval -90.0 to 29.0
|
-43.6 percentage of score change
Interval -100.0 to 150.0
|
-57.8 percentage of score change
Interval -100.0 to 25.0
|
-42.6 percentage of score change
Interval -90.0 to 20.0
|
-16.3 percentage of score change
Interval -89.0 to 300.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 16
|
-39.9 percentage of score change
Interval -90.0 to 29.0
|
-44.1 percentage of score change
Interval -100.0 to 200.0
|
-57.4 percentage of score change
Interval -100.0 to 50.0
|
-45.7 percentage of score change
Interval -100.0 to 20.0
|
-20.4 percentage of score change
Interval -100.0 to 200.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 18
|
-45.8 percentage of score change
Interval -89.0 to 13.0
|
-44.5 percentage of score change
Interval -100.0 to 250.0
|
-52.1 percentage of score change
Interval -100.0 to 25.0
|
-42.9 percentage of score change
Interval -100.0 to 100.0
|
-29.3 percentage of score change
Interval -100.0 to 60.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 20
|
-46.6 percentage of score change
Interval -90.0 to 50.0
|
-49.2 percentage of score change
Interval -100.0 to 250.0
|
-56.5 percentage of score change
Interval -100.0 to 50.0
|
-49.7 percentage of score change
Interval -100.0 to 33.0
|
-25.1 percentage of score change
Interval -100.0 to 200.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 22
|
-48.0 percentage of score change
Interval -100.0 to 13.0
|
-52.1 percentage of score change
Interval -100.0 to 250.0
|
-66.2 percentage of score change
Interval -100.0 to 25.0
|
-53.6 percentage of score change
Interval -100.0 to 11.0
|
-20.9 percentage of score change
Interval -90.0 to 300.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 24
|
-48.9 percentage of score change
Interval -100.0 to 14.0
|
-53.3 percentage of score change
Interval -100.0 to 75.0
|
-66.7 percentage of score change
Interval -100.0 to 0.0
|
-51.4 percentage of score change
Interval -100.0 to 13.0
|
-33.7 percentage of score change
Interval -100.0 to 100.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 26
|
-52.4 percentage of score change
Interval -100.0 to 13.0
|
-52.2 percentage of score change
Interval -100.0 to 200.0
|
-71.2 percentage of score change
Interval -100.0 to 0.0
|
-54.0 percentage of score change
Interval -100.0 to 30.0
|
-39.3 percentage of score change
Interval -100.0 to 40.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 28
|
-50.3 percentage of score change
Interval -100.0 to 40.0
|
-56.2 percentage of score change
Interval -100.0 to 11.0
|
-73.7 percentage of score change
Interval -100.0 to 25.0
|
-57.1 percentage of score change
Interval -100.0 to 0.0
|
-45.4 percentage of score change
Interval -100.0 to 20.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 30
|
-56.1 percentage of score change
Interval -100.0 to 14.0
|
-64.3 percentage of score change
Interval -100.0 to 11.0
|
-69.4 percentage of score change
Interval -100.0 to 75.0
|
-60.0 percentage of score change
Interval -100.0 to 20.0
|
-48.4 percentage of score change
Interval -100.0 to 80.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 32
|
-58.3 percentage of score change
Interval -100.0 to 13.0
|
-61.4 percentage of score change
Interval -100.0 to 11.0
|
-70.5 percentage of score change
Interval -100.0 to 25.0
|
-60.9 percentage of score change
Interval -100.0 to 20.0
|
-63.6 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 34
|
-60.9 percentage of score change
Interval -100.0 to 13.0
|
-58.1 percentage of score change
Interval -100.0 to 50.0
|
-72.8 percentage of score change
Interval -100.0 to 25.0
|
-57.5 percentage of score change
Interval -100.0 to 40.0
|
-63.1 percentage of score change
Interval -100.0 to 40.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 36
|
-59.7 percentage of score change
Interval -100.0 to 0.0
|
-60.9 percentage of score change
Interval -100.0 to 150.0
|
-72.3 percentage of score change
Interval -100.0 to 25.0
|
-60.5 percentage of score change
Interval -100.0 to 60.0
|
-64.0 percentage of score change
Interval -100.0 to 13.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 40
|
-61.7 percentage of score change
Interval -100.0 to 0.0
|
-52.8 percentage of score change
Interval -100.0 to 250.0
|
-70.2 percentage of score change
Interval -100.0 to 25.0
|
-60.7 percentage of score change
Interval -100.0 to 0.0
|
-67.0 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 44
|
-59.2 percentage of score change
Interval -100.0 to 0.0
|
-70.6 percentage of score change
Interval -100.0 to 11.0
|
-77.1 percentage of score change
Interval -100.0 to -25.0
|
-68.4 percentage of score change
Interval -100.0 to 0.0
|
-75.2 percentage of score change
Interval -100.0 to -29.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 48
|
-56.7 percentage of score change
Interval -100.0 to -10.0
|
-69.3 percentage of score change
Interval -100.0 to 11.0
|
-74.0 percentage of score change
Interval -100.0 to 0.0
|
-68.3 percentage of score change
Interval -100.0 to 0.0
|
-69.7 percentage of score change
Interval -100.0 to 80.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 52
|
-57.1 percentage of score change
Interval -100.0 to 50.0
|
-70.1 percentage of score change
Interval -100.0 to 50.0
|
-72.9 percentage of score change
Interval -100.0 to 43.0
|
-60.3 percentage of score change
Interval -100.0 to 11.0
|
-80.3 percentage of score change
Interval -100.0 to 33.0
|
|
Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point
Pruritis NRS Score % Change at Week 56
|
-60.2 percentage of score change
Interval -100.0 to 0.0
|
-67.2 percentage of score change
Interval -100.0 to 14.0
|
-75.7 percentage of score change
Interval -100.0 to 0.0
|
-65.6 percentage of score change
Interval -100.0 to 11.0
|
-82.1 percentage of score change
Interval -100.0 to -50.0
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Baseline
|
5.9 score on a scale
Interval 0.0 to 10.0
|
5.5 score on a scale
Interval 0.0 to 10.0
|
5.0 score on a scale
Interval 0.0 to 10.0
|
5.9 score on a scale
Interval 0.0 to 10.0
|
5.0 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 1
|
6.0 score on a scale
Interval 1.0 to 10.0
|
5.4 score on a scale
Interval 0.0 to 10.0
|
5.2 score on a scale
Interval 0.0 to 10.0
|
5.1 score on a scale
Interval 0.0 to 10.0
|
5.1 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 2
|
5.3 score on a scale
Interval 1.0 to 10.0
|
5.1 score on a scale
Interval 0.0 to 10.0
|
4.7 score on a scale
Interval 0.0 to 10.0
|
5.5 score on a scale
Interval 0.0 to 10.0
|
5.6 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 4
|
5.5 score on a scale
Interval 0.0 to 10.0
|
4.7 score on a scale
Interval 0.0 to 10.0
|
4.3 score on a scale
Interval 0.0 to 10.0
|
5.0 score on a scale
Interval 0.0 to 10.0
|
5.6 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 6
|
5.3 score on a scale
Interval 0.0 to 10.0
|
3.8 score on a scale
Interval 0.0 to 10.0
|
3.2 score on a scale
Interval 0.0 to 9.0
|
4.3 score on a scale
Interval 0.0 to 9.0
|
5.0 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 8
|
4.5 score on a scale
Interval 0.0 to 10.0
|
3.5 score on a scale
Interval 0.0 to 10.0
|
3.0 score on a scale
Interval 0.0 to 9.0
|
4.2 score on a scale
Interval 0.0 to 10.0
|
4.8 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 10
|
3.9 score on a scale
Interval 0.0 to 9.0
|
3.1 score on a scale
Interval 0.0 to 10.0
|
2.5 score on a scale
Interval 0.0 to 8.0
|
3.9 score on a scale
Interval 0.0 to 9.0
|
4.6 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 12
|
3.5 score on a scale
Interval 0.0 to 10.0
|
3.2 score on a scale
Interval 0.0 to 9.0
|
2.1 score on a scale
Interval 0.0 to 9.0
|
3.6 score on a scale
Interval 0.0 to 10.0
|
4.4 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 14
|
3.8 score on a scale
Interval 0.0 to 9.0
|
2.5 score on a scale
Interval 0.0 to 9.0
|
2.5 score on a scale
Interval 0.0 to 8.0
|
3.3 score on a scale
Interval 0.0 to 10.0
|
4.7 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 15
|
3.4 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 9.0
|
1.9 score on a scale
Interval 0.0 to 8.0
|
3.0 score on a scale
Interval 0.0 to 7.0
|
4.6 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 16
|
3.5 score on a scale
Interval 0.0 to 10.0
|
2.7 score on a scale
Interval 0.0 to 8.0
|
1.8 score on a scale
Interval 0.0 to 7.0
|
2.9 score on a scale
Interval 0.0 to 8.0
|
4.2 score on a scale
Interval 0.0 to 10.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 18
|
3.6 score on a scale
Interval 0.0 to 9.0
|
2.3 score on a scale
Interval 0.0 to 9.0
|
1.6 score on a scale
Interval 0.0 to 6.0
|
3.2 score on a scale
Interval 0.0 to 10.0
|
4.2 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 20
|
3.1 score on a scale
Interval 0.0 to 10.0
|
2.1 score on a scale
Interval 0.0 to 8.0
|
1.6 score on a scale
Interval 0.0 to 7.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
4.0 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 22
|
3.1 score on a scale
Interval 0.0 to 9.0
|
2.3 score on a scale
Interval 0.0 to 9.0
|
1.3 score on a scale
Interval 0.0 to 6.0
|
2.7 score on a scale
Interval 0.0 to 10.0
|
3.8 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 24
|
2.9 score on a scale
Interval 0.0 to 9.0
|
2.1 score on a scale
Interval 0.0 to 8.0
|
1.5 score on a scale
Interval 0.0 to 9.0
|
2.7 score on a scale
Interval 0.0 to 8.0
|
3.5 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 26
|
3.1 score on a scale
Interval 0.0 to 9.0
|
1.7 score on a scale
Interval 0.0 to 7.0
|
1.2 score on a scale
Interval 0.0 to 5.0
|
2.4 score on a scale
Interval 0.0 to 8.0
|
3.2 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 28
|
3.1 score on a scale
Interval 0.0 to 10.0
|
1.6 score on a scale
Interval 0.0 to 7.0
|
1.1 score on a scale
Interval 0.0 to 7.0
|
2.3 score on a scale
Interval 0.0 to 8.0
|
2.7 score on a scale
Interval 0.0 to 8.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 30
|
2.5 score on a scale
Interval 0.0 to 9.0
|
1.4 score on a scale
Interval 0.0 to 7.0
|
1.1 score on a scale
Interval 0.0 to 6.0
|
1.9 score on a scale
Interval 0.0 to 9.0
|
2.6 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 32
|
2.3 score on a scale
Interval 0.0 to 9.0
|
1.9 score on a scale
Interval 0.0 to 8.0
|
1.2 score on a scale
Interval 0.0 to 5.0
|
1.9 score on a scale
Interval 0.0 to 8.0
|
2.4 score on a scale
Interval 0.0 to 8.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 34
|
2.3 score on a scale
Interval 0.0 to 9.0
|
1.5 score on a scale
Interval 0.0 to 8.0
|
0.9 score on a scale
Interval 0.0 to 6.0
|
2.1 score on a scale
Interval 0.0 to 7.0
|
2.1 score on a scale
Interval 0.0 to 8.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 36
|
2.0 score on a scale
Interval 0.0 to 9.0
|
1.6 score on a scale
Interval 0.0 to 8.0
|
0.9 score on a scale
Interval 0.0 to 6.0
|
2.1 score on a scale
Interval 0.0 to 8.0
|
2.0 score on a scale
Interval 0.0 to 9.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 40
|
1.5 score on a scale
Interval 0.0 to 8.0
|
1.5 score on a scale
Interval 0.0 to 7.0
|
0.8 score on a scale
Interval 0.0 to 4.0
|
1.9 score on a scale
Interval 0.0 to 7.0
|
2.0 score on a scale
Interval 0.0 to 8.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 44
|
1.9 score on a scale
Interval 0.0 to 7.0
|
1.4 score on a scale
Interval 0.0 to 8.0
|
0.6 score on a scale
Interval 0.0 to 4.0
|
1.4 score on a scale
Interval 0.0 to 8.0
|
1.1 score on a scale
Interval 0.0 to 4.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 48
|
2.1 score on a scale
Interval 0.0 to 9.0
|
1.2 score on a scale
Interval 0.0 to 8.0
|
0.6 score on a scale
Interval 0.0 to 4.0
|
1.3 score on a scale
Interval 0.0 to 5.0
|
0.9 score on a scale
Interval 0.0 to 2.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 52
|
1.6 score on a scale
Interval 0.0 to 7.0
|
0.8 score on a scale
Interval 0.0 to 8.0
|
1.3 score on a scale
Interval 0.0 to 9.0
|
1.9 score on a scale
Interval 0.0 to 6.0
|
1.2 score on a scale
Interval 0.0 to 3.0
|
|
Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score at Week 56
|
2.1 score on a scale
Interval 0.0 to 9.0
|
1.1 score on a scale
Interval 0.0 to 8.0
|
1.1 score on a scale
Interval 0.0 to 9.0
|
1.5 score on a scale
Interval 0.0 to 8.0
|
0.9 score on a scale
Interval 0.0 to 2.0
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
Daily sleep disturbance in the last 24 hours before the relevant time point will be assessed on a Numerical Rating Scale. Subjects will score the degree of their sleep disturbance on an 11-point scale ranging from 'no sleep loss' (0) to 'I cannot sleep at all' (10).
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 1
|
6.6 percentage of score change
Interval -83.0 to 300.0
|
14.2 percentage of score change
Interval -100.0 to 500.0
|
29.8 percentage of score change
Interval -100.0 to 400.0
|
-15.7 percentage of score change
Interval -100.0 to 80.0
|
51.3 percentage of score change
Interval -100.0 to 700.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 2
|
-0.7 percentage of score change
Interval -90.0 to 350.0
|
12.6 percentage of score change
Interval -100.0 to 600.0
|
12.0 percentage of score change
Interval -100.0 to 350.0
|
-6.7 percentage of score change
Interval -100.0 to 167.0
|
60.3 percentage of score change
Interval -100.0 to 700.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 4
|
4.9 percentage of score change
Interval -100.0 to 400.0
|
12.1 percentage of score change
Interval -100.0 to 500.0
|
11.9 percentage of score change
Interval -100.0 to 600.0
|
-11.2 percentage of score change
Interval -100.0 to 167.0
|
49.6 percentage of score change
Interval -100.0 to 600.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 6
|
6.2 percentage of score change
Interval -100.0 to 400.0
|
-7.1 percentage of score change
Interval -100.0 to 500.0
|
-18.3 percentage of score change
Interval -100.0 to 400.0
|
-25.5 percentage of score change
Interval -100.0 to 167.0
|
33.6 percentage of score change
Interval -100.0 to 500.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 8
|
-11.7 percentage of score change
Interval -100.0 to 300.0
|
-10.8 percentage of score change
Interval -100.0 to 400.0
|
-27.3 percentage of score change
Interval -100.0 to 400.0
|
-31.8 percentage of score change
Interval -100.0 to 43.0
|
13.5 percentage of score change
Interval -100.0 to 500.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 10
|
-29.8 percentage of score change
Interval -100.0 to 300.0
|
-31.9 percentage of score change
Interval -100.0 to 200.0
|
-41.3 percentage of score change
Interval -100.0 to 200.0
|
-36.1 percentage of score change
Interval -100.0 to 60.0
|
11.7 percentage of score change
Interval -100.0 to 500.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 12
|
-37.1 percentage of score change
Interval -100.0 to 200.0
|
-13.4 percentage of score change
Interval -100.0 to 500.0
|
-54.8 percentage of score change
Interval -100.0 to 17.0
|
-38.9 percentage of score change
Interval -100.0 to 33.0
|
4.5 percentage of score change
Interval -100.0 to 500.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 14
|
-34.5 percentage of score change
Interval -100.0 to 200.0
|
-38.4 percentage of score change
Interval -100.0 to 400.0
|
-49.6 percentage of score change
Interval -100.0 to 50.0
|
-44.0 percentage of score change
Interval -100.0 to 40.0
|
14.5 percentage of score change
Interval -100.0 to 600.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 15
|
-41.9 percentage of score change
Interval -100.0 to 100.0
|
-28.1 percentage of score change
Interval -100.0 to 300.0
|
-60.9 percentage of score change
Interval -100.0 to 100.0
|
-46.6 percentage of score change
Interval -100.0 to 25.0
|
13.7 percentage of score change
Interval -100.0 to 500.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 16
|
-38.4 percentage of score change
Interval -100.0 to 100.0
|
-10.9 percentage of score change
Interval -100.0 to 600.0
|
-63.4 percentage of score change
Interval -100.0 to 67.0
|
-48.5 percentage of score change
Interval -100.0 to 50.0
|
0.7 percentage of score change
Interval -100.0 to 600.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 18
|
-42.2 percentage of score change
Interval -100.0 to 50.0
|
-48.7 percentage of score change
Interval -100.0 to 300.0
|
-66.9 percentage of score change
Interval -100.0 to 25.0
|
-38.9 percentage of score change
Interval -100.0 to 300.0
|
8.1 percentage of score change
Interval -100.0 to 700.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 20
|
-44.4 percentage of score change
Interval -100.0 to 100.0
|
-48.4 percentage of score change
Interval -100.0 to 500.0
|
-72.3 percentage of score change
Interval -100.0 to 25.0
|
-50.0 percentage of score change
Interval -100.0 to 50.0
|
9.1 percentage of score change
Interval -100.0 to 800.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 22
|
-45.0 percentage of score change
Interval -100.0 to 200.0
|
-45.1 percentage of score change
Interval -100.0 to 500.0
|
-75.1 percentage of score change
Interval -100.0 to 25.0
|
-56.1 percentage of score change
Interval -100.0 to 29.0
|
-2.3 percentage of score change
Interval -100.0 to 700.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 24
|
-53.1 percentage of score change
Interval -100.0 to 50.0
|
-53.3 percentage of score change
Interval -100.0 to 200.0
|
-67.3 percentage of score change
Interval -100.0 to 200.0
|
-52.5 percentage of score change
Interval -100.0 to 60.0
|
-5.5 percentage of score change
Interval -100.0 to 600.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 26
|
-46.5 percentage of score change
Interval -100.0 to 100.0
|
-55.5 percentage of score change
Interval -100.0 to 300.0
|
-75.5 percentage of score change
Interval -100.0 to 0.0
|
-57.1 percentage of score change
Interval -100.0 to 60.0
|
-39.4 percentage of score change
Interval -100.0 to 80.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 28
|
-48.7 percentage of score change
Interval -100.0 to 100.0
|
-54.4 percentage of score change
Interval -100.0 to 200.0
|
-80.4 percentage of score change
Interval -100.0 to 50.0
|
-58.8 percentage of score change
Interval -100.0 to 33.0
|
-38.9 percentage of score change
Interval -100.0 to 60.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 30
|
-58.1 percentage of score change
Interval -100.0 to 29.0
|
-63.3 percentage of score change
Interval -100.0 to 300.0
|
-77.4 percentage of score change
Interval -100.0 to 67.0
|
-67.1 percentage of score change
Interval -100.0 to 40.0
|
-45.6 percentage of score change
Interval -100.0 to 80.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 32
|
-60.0 percentage of score change
Interval -100.0 to 0.0
|
-45.6 percentage of score change
Interval -100.0 to 700.0
|
-78.0 percentage of score change
Interval -100.0 to 25.0
|
-65.8 percentage of score change
Interval -100.0 to 0.0
|
-55.3 percentage of score change
Interval -100.0 to 40.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 34
|
-61.1 percentage of score change
Interval -100.0 to 0.0
|
-66.0 percentage of score change
Interval -100.0 to 100.0
|
-82.5 percentage of score change
Interval -100.0 to 0.0
|
-64.8 percentage of score change
Interval -100.0 to 20.0
|
-51.7 percentage of score change
Interval -100.0 to 33.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 36
|
-64.9 percentage of score change
Interval -100.0 to 17.0
|
-45.1 percentage of score change
Interval -100.0 to 700.0
|
-81.9 percentage of score change
Interval -100.0 to -25.0
|
-64.7 percentage of score change
Interval -100.0 to 20.0
|
-56.2 percentage of score change
Interval -100.0 to 20.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 40
|
-71.6 percentage of score change
Interval -100.0 to 0.0
|
-50.7 percentage of score change
Interval -100.0 to 400.0
|
-81.0 percentage of score change
Interval -100.0 to 0.0
|
-67.8 percentage of score change
Interval -100.0 to 0.0
|
-57.2 percentage of score change
Interval -100.0 to 60.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 44
|
-65.7 percentage of score change
Interval -100.0 to 25.0
|
-71.4 percentage of score change
Interval -100.0 to 100.0
|
-88.5 percentage of score change
Interval -100.0 to 0.0
|
-79.6 percentage of score change
Interval -100.0 to -14.0
|
-65.3 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 48
|
-60.0 percentage of score change
Interval -100.0 to 33.0
|
-70.2 percentage of score change
Interval -100.0 to 100.0
|
-84.9 percentage of score change
Interval -100.0 to 33.0
|
-78.9 percentage of score change
Interval -100.0 to -25.0
|
-74.4 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 52
|
-73.2 percentage of score change
Interval -100.0 to 17.0
|
-87.0 percentage of score change
Interval -100.0 to 14.0
|
-61.9 percentage of score change
Interval -100.0 to 200.0
|
-71.1 percentage of score change
Interval -100.0 to -14.0
|
-69.3 percentage of score change
Interval -100.0 to 0.0
|
|
Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point
Sleep Disturbance NRS Score % Change at Week 56
|
-65.9 percentage of score change
Interval -100.0 to 50.0
|
-69.7 percentage of score change
Interval -100.0 to 200.0
|
-82.2 percentage of score change
Interval -100.0 to 0.0
|
-75.9 percentage of score change
Interval -100.0 to 0.0
|
-71.3 percentage of score change
Interval -100.0 to 0.0
|
SECONDARY outcome
Timeframe: 56 WeeksPopulation: The overall number of participants analyzed is the number of subjects in the full analysis set. The number of participants analyzed per row is the number of patients who had values at the specified time points.
DLQI consists of 6 subscales (symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment), which are scored from 0 to 3 on the basis of 10 questions. The DLQI is calculated by summing the score of each question resulting in a maximum of 30 and a minimum of 0. The higher the score, the more QoL is impaired.
Outcome measures
| Measure |
KHK4083 150 mg SC Q4W
n=52 Participants
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=52 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=52 Participants
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 Participants
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 Participants
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Baseline
|
13.4 score on a scale
Interval 2.0 to 30.0
|
12.6 score on a scale
Interval 1.0 to 29.0
|
12.0 score on a scale
Interval 1.0 to 27.0
|
13.8 score on a scale
Interval 1.0 to 27.0
|
11.9 score on a scale
Interval 2.0 to 30.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 1
|
14.1 score on a scale
Interval 2.0 to 29.0
|
12.8 score on a scale
Interval 1.0 to 29.0
|
11.2 score on a scale
Interval 1.0 to 27.0
|
12.7 score on a scale
Interval 1.0 to 27.0
|
12.2 score on a scale
Interval 1.0 to 30.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 2
|
12.6 score on a scale
Interval 1.0 to 30.0
|
12.6 score on a scale
Interval 0.0 to 30.0
|
10.7 score on a scale
Interval 1.0 to 28.0
|
12.7 score on a scale
Interval 3.0 to 29.0
|
12.3 score on a scale
Interval 2.0 to 27.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 4
|
12.5 score on a scale
Interval 0.0 to 29.0
|
12.7 score on a scale
Interval 0.0 to 29.0
|
10.2 score on a scale
Interval 1.0 to 28.0
|
11.2 score on a scale
Interval 1.0 to 28.0
|
13.3 score on a scale
Interval 1.0 to 30.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 6
|
11.3 score on a scale
Interval 0.0 to 29.0
|
10.2 score on a scale
Interval 0.0 to 27.0
|
7.1 score on a scale
Interval 1.0 to 20.0
|
9.6 score on a scale
Interval 0.0 to 29.0
|
10.7 score on a scale
Interval 1.0 to 30.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 8
|
9.7 score on a scale
Interval 0.0 to 26.0
|
8.9 score on a scale
Interval 0.0 to 25.0
|
7.1 score on a scale
Interval 0.0 to 17.0
|
9.0 score on a scale
Interval 1.0 to 29.0
|
11.4 score on a scale
Interval 1.0 to 29.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 10
|
8.0 score on a scale
Interval 0.0 to 27.0
|
8.0 score on a scale
Interval 1.0 to 22.0
|
7.1 score on a scale
Interval 1.0 to 21.0
|
8.3 score on a scale
Interval 1.0 to 28.0
|
10.6 score on a scale
Interval 1.0 to 26.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 12
|
7.6 score on a scale
Interval 0.0 to 26.0
|
7.2 score on a scale
Interval 0.0 to 21.0
|
5.8 score on a scale
Interval 0.0 to 19.0
|
7.8 score on a scale
Interval 0.0 to 30.0
|
9.7 score on a scale
Interval 0.0 to 24.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 14
|
7.4 score on a scale
Interval 0.0 to 21.0
|
6.9 score on a scale
Interval 0.0 to 19.0
|
5.1 score on a scale
Interval 0.0 to 16.0
|
7.2 score on a scale
Interval 1.0 to 23.0
|
10.1 score on a scale
Interval 1.0 to 28.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 15
|
7.5 score on a scale
Interval 1.0 to 25.0
|
6.2 score on a scale
Interval 0.0 to 17.0
|
4.4 score on a scale
Interval 0.0 to 16.0
|
5.9 score on a scale
Interval 0.0 to 18.0
|
10.3 score on a scale
Interval 0.0 to 28.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 16
|
7.6 score on a scale
Interval 0.0 to 21.0
|
6.1 score on a scale
Interval 0.0 to 19.0
|
4.7 score on a scale
Interval 0.0 to 14.0
|
6.7 score on a scale
Interval 0.0 to 20.0
|
9.8 score on a scale
Interval 0.0 to 27.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 18
|
6.7 score on a scale
Interval 0.0 to 24.0
|
6.7 score on a scale
Interval 0.0 to 21.0
|
4.9 score on a scale
Interval 0.0 to 16.0
|
6.6 score on a scale
Interval 0.0 to 23.0
|
9.5 score on a scale
Interval 0.0 to 29.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 20
|
6.7 score on a scale
Interval 0.0 to 27.0
|
6.2 score on a scale
Interval 0.0 to 23.0
|
5.0 score on a scale
Interval 0.0 to 17.0
|
5.6 score on a scale
Interval 0.0 to 20.0
|
8.8 score on a scale
Interval 0.0 to 23.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 22
|
6.3 score on a scale
Interval 0.0 to 25.0
|
5.8 score on a scale
Interval 0.0 to 19.0
|
4.3 score on a scale
Interval 0.0 to 19.0
|
5.3 score on a scale
Interval 0.0 to 21.0
|
8.6 score on a scale
Interval 0.0 to 25.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 24
|
6.8 score on a scale
Interval 0.0 to 25.0
|
5.4 score on a scale
Interval 0.0 to 20.0
|
4.3 score on a scale
Interval 0.0 to 17.0
|
5.1 score on a scale
Interval 0.0 to 14.0
|
8.0 score on a scale
Interval 0.0 to 27.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 26
|
6.7 score on a scale
Interval 0.0 to 28.0
|
5.2 score on a scale
Interval 0.0 to 17.0
|
3.7 score on a scale
Interval 0.0 to 14.0
|
5.2 score on a scale
Interval 0.0 to 16.0
|
7.5 score on a scale
Interval 0.0 to 27.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 28
|
6.8 score on a scale
Interval 0.0 to 26.0
|
5.0 score on a scale
Interval 0.0 to 13.0
|
3.3 score on a scale
Interval 0.0 to 10.0
|
4.4 score on a scale
Interval 0.0 to 14.0
|
6.6 score on a scale
Interval 1.0 to 26.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 30
|
6.0 score on a scale
Interval 0.0 to 24.0
|
4.4 score on a scale
Interval 0.0 to 13.0
|
3.9 score on a scale
Interval 0.0 to 18.0
|
4.0 score on a scale
Interval 0.0 to 18.0
|
6.9 score on a scale
Interval 0.0 to 25.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 32
|
5.8 score on a scale
Interval 0.0 to 30.0
|
5.3 score on a scale
Interval 0.0 to 16.0
|
3.6 score on a scale
Interval 0.0 to 16.0
|
3.5 score on a scale
Interval 0.0 to 11.0
|
6.1 score on a scale
Interval 0.0 to 26.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 34
|
5.3 score on a scale
Interval 0.0 to 30.0
|
5.3 score on a scale
Interval 0.0 to 20.0
|
2.9 score on a scale
Interval 0.0 to 15.0
|
3.7 score on a scale
Interval 0.0 to 11.0
|
4.9 score on a scale
Interval 0.0 to 25.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 36
|
5.1 score on a scale
Interval 0.0 to 24.0
|
4.5 score on a scale
Interval 0.0 to 13.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
3.6 score on a scale
Interval 0.0 to 18.0
|
4.4 score on a scale
Interval 0.0 to 25.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 40
|
3.7 score on a scale
Interval 0.0 to 20.0
|
4.8 score on a scale
Interval 0.0 to 20.0
|
3.3 score on a scale
Interval 0.0 to 11.0
|
3.7 score on a scale
Interval 0.0 to 10.0
|
4.1 score on a scale
Interval 0.0 to 24.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 44
|
3.5 score on a scale
Interval 0.0 to 16.0
|
3.7 score on a scale
Interval 0.0 to 21.0
|
3.3 score on a scale
Interval 0.0 to 10.0
|
3.3 score on a scale
Interval 0.0 to 10.0
|
1.9 score on a scale
Interval 0.0 to 24.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 48
|
4.6 score on a scale
Interval 0.0 to 19.0
|
3.1 score on a scale
Interval 0.0 to 12.0
|
3.2 score on a scale
Interval 0.0 to 10.0
|
2.9 score on a scale
Interval 0.0 to 10.0
|
3.1 score on a scale
Interval 0.0 to 17.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 52
|
4.1 score on a scale
Interval 0.0 to 27.0
|
3.1 score on a scale
Interval 0.0 to 12.0
|
3.7 score on a scale
Interval 0.0 to 23.0
|
3.8 score on a scale
Interval 0.0 to 16.0
|
3.3 score on a scale
Interval 0.0 to 19.0
|
|
Dermatology Life Quality Index (DLQI) at Each Time Point
DLQI Score at Week 56
|
5.1 score on a scale
Interval 0.0 to 15.0
|
3.4 score on a scale
Interval 0.0 to 13.0
|
2.8 score on a scale
Interval 0.0 to 8.0
|
4.7 score on a scale
Interval 0.0 to 28.0
|
3.2 score on a scale
Interval 0.0 to 22.0
|
Adverse Events
KHK4083 150 mg SC Q4W
Serious events: 4 serious events
Other events: 47 other events
Deaths: 0 deaths
KHK4083 600 mg SC Q4W
Serious events: 1 serious events
Other events: 50 other events
Deaths: 0 deaths
KHK4083 300 mg SC Q2W
Serious events: 4 serious events
Other events: 48 other events
Deaths: 0 deaths
KHK4083 600 mg SC Q2W
Serious events: 1 serious events
Other events: 51 other events
Deaths: 0 deaths
Placebo/KHK4083 600 mg
Serious events: 2 serious events
Other events: 46 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
KHK4083 150 mg SC Q4W
n=54 participants at risk
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=53 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=55 participants at risk
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 participants at risk
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Eye disorders
Atopic cataract
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Incarcerated umbilical hernia
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Small intestine ulcer
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Pyrexia
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Anal abscess
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Cystitis
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Gastroenteritis rotavirus
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Injury, poisoning and procedural complications
Meniscus injury
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Injury, poisoning and procedural complications
Postoperative ileus
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Musculoskeletal and connective tissue disorders
Spinal stenosis
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Adenocarcinoma of colon
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Invasive ductal breast carcinoma
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Oesophageal carcinoma
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Rectosigmoid cancer
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Nervous system disorders
Presyncope
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Respiratory, thoracic and mediastinal disorders
Upper respiratory tract inflammation
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Vascular disorders
Peripheral arterial occlusive disease
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
Other adverse events
| Measure |
KHK4083 150 mg SC Q4W
n=54 participants at risk
Subjects in this arm received 150 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 600 mg SC Q4W
n=53 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 4, 8, 12, 16, 20, 24, 28, and 32.
To maintain the blind, they received placebo at Weeks 2, 6, 10, 14, 18, 22, 26, 30, and 34.
|
KHK4083 300 mg SC Q2W
n=55 participants at risk
Subjects in this arm received 300 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
KHK4083 600 mg SC Q2W
n=54 participants at risk
Subjects in this arm received 600 mg of KHK4083 at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, 16, 18, 20, 22, 24, 26, 28, 30, 32, and 34.
|
Placebo/KHK4083 600 mg
n=57 participants at risk
Subjects in this arm received placebo at Weeks 0 (Day 1), 2, 4, 6, 8, 10, 12, 14, and 16, and received KHK4083 600 mg at Weeks 18 (Day 127), 20, 22, 24, 26, 28, 30, 32, and 34.
|
|---|---|---|---|---|---|
|
Ear and labyrinth disorders
Vertigo
|
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Aphthous ulcer
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
20.8%
11/53 • Number of events 18 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.3%
4/55 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Constipation
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Diarrhoea
|
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.5%
4/53 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.6%
2/55 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Nausea
|
5.6%
3/54 • Number of events 7 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.6%
2/55 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
14.8%
8/54 • Number of events 8 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.5%
2/57 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Stomatitis
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.4%
4/54 • Number of events 10 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Gastrointestinal disorders
Vomiting
|
1.9%
1/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Chills
|
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
12.7%
7/55 • Number of events 10 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
22.2%
12/54 • Number of events 14 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Fatigue
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.5%
2/57 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Injection site pain
|
3.7%
2/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.7%
3/53 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 13 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Injection site swelling
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.8%
2/53 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.5%
3/55 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Malaise
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.8%
2/53 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
General disorders
Pyrexia
|
13.0%
7/54 • Number of events 7 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
17.0%
9/53 • Number of events 9 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
18.2%
10/55 • Number of events 11 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
20.4%
11/54 • Number of events 11 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.3%
3/57 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Influenza
|
9.3%
5/54 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Kaposi's varicelliform eruption
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.3%
3/57 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Nasopharyngitis
|
24.1%
13/54 • Number of events 21 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
20.8%
11/53 • Number of events 16 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
21.8%
12/55 • Number of events 16 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
35.2%
19/54 • Number of events 25 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
22.8%
13/57 • Number of events 18 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Oral herpes
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.8%
2/53 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.3%
4/55 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.4%
4/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.3%
3/57 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Pharyngitis
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Tinea pedis
|
3.7%
2/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Infections and infestations
Upper respiratory tract infection
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.5%
4/53 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.3%
4/55 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.3%
3/57 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.8%
2/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
9.3%
5/54 • Number of events 5 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Nervous system disorders
Headache
|
7.4%
4/54 • Number of events 12 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
11.3%
6/53 • Number of events 9 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
10.9%
6/55 • Number of events 20 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
9.3%
5/54 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
8.8%
5/57 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Renal and urinary disorders
Nephrolithiasis
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.5%
3/55 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
7.4%
4/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/53 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
7.3%
4/55 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Respiratory, thoracic and mediastinal disorders
Oropharyngeal pain
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
3.7%
2/54 • Number of events 2 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/57 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Skin and subcutaneous tissue disorders
Acne
|
1.9%
1/54 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
9.4%
5/53 • Number of events 6 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
12.7%
7/55 • Number of events 8 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 4 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.3%
3/57 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Skin and subcutaneous tissue disorders
Dermatitis atopic
|
35.2%
19/54 • Number of events 21 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
22.6%
12/53 • Number of events 12 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
32.7%
18/55 • Number of events 21 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
37.0%
20/54 • Number of events 22 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
42.1%
24/57 • Number of events 28 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Skin and subcutaneous tissue disorders
Dermatitis contact
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.9%
1/53 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/55 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.6%
3/54 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
|
Skin and subcutaneous tissue disorders
Miliaria
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
5.7%
3/53 • Number of events 3 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/55 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
0.00%
0/54 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
1.8%
1/57 • Number of events 1 • Adverse events were recorded for reporting from the subject's written consent to participate in the study through the end of the study, up to 62 weeks (potential 6 week screening period up to Week 56).
|
Additional Information
Research & Development Planning Department, Research & Development Division
Kyowa Kirin Co., Ltd.
Phone: +81-3-5205-7200
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place
Restriction type: GT60