| Primary | Percent Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of score change | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. | | OG003 | 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. | | OG004 | 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. |
| | Units | Counts |
|---|
| Participants | - OG00052
- OG00152
- OG00252
- OG003
|
| | Title | Denominators | Categories |
|---|
| | | Title | Measurements |
|---|
| - OG000-48.33(-62.62 to -34.04)
- OG001-49.72(-62.47 to -35.17)
- OG002-61.07(-75.19 to -46.96)
- OG003
|
|
| | Group IDs | Group Description | Statistical Method | Statistical Comment | P-Value | P-Value Comment | Parameter Type | Parameter Value | Dispersion Type | Dispersion Value | Confidence Interval Sides | Confidence Interval % | CI Lower Limit | CI Upper Limit | CI Lower Limit Comment | CI Upper Limit Comment | Estimate Comment | Tested Non-Inferiority | Non-Inferiority Type | Non-Inferiority Comment | Other Analysis Description |
|---|
| | ANCOVA | | < 0.001 | | | | | | | | | | | | | | Superiority | | | | | ANCOVA | | < 0.001 | | |
|
| Secondary | 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 | 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. | 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. | Posted | | Count of Participants | | Participants | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | Change From Baseline to Week 16 in Eczema Area and Severity Index (EASI) Score | 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. | 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. | Posted | | Mean | Standard Deviation | score on a scale | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. |
|
| Secondary | Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | KHK4083 600 mg SC Q4W |
|
| Secondary | Percent Change From Baseline to Week 16 in SCORing Atopic Dermatitis (SCORAD) Score | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of score change | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | KHK4083 600 mg SC Q4W |
|
| Secondary | Achievement of an Investigator's Global Assessment (IGA) Score of 0 or 1 and a Reduction From Baseline of ≥2 Points at Week 16 | 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). | 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. | Posted | | Count of Participants | | Participants | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline to Week 16 in Percent Body Surface Area of Involvement of AD (BSA) | The Investigator will calculate the percentage (%) of the total body surface area affected by AD. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of total BSA involvement | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | 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. |
|
| Secondary | Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | 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." | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | KHK4083 300 mg SC Q2W | |
|
| Secondary | Percent Change From Baseline to Week 16 in Pruritus Numerical Rating Scale (NRS) Score | 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." | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of score change | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | KHK4083 300 mg SC Q2W | |
|
| Secondary | Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | 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). | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | KHK4083 300 mg SC Q2W | |
|
| Secondary | Percent Change From Baseline to Week 16 in Sleep Disturbance Numerical Rating Scale (NRS) Score | 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). | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | percentage of score change | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | KHK4083 300 mg SC Q2W | |
|
| Secondary | Change From Baseline to Week 16 in Dermatology Life Quality Index (DLQI) | 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. | 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. | Posted | | Least Squares Mean | 95% Confidence Interval | score on a scale | | Baseline to Week 16 | | | | ID | Title | Description |
|---|
| OG000 | 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. | | OG001 | 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. | | OG002 | KHK4083 300 mg SC Q2W |
|
| Secondary | EASI Score at Each Time Point | 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. | 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. | Posted | | Mean | Full Range | score on a scale | | 56 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | KHK4083 600 mg SC Q4W |
|
| Secondary | Percent Change From Baseline in EASI Score at Each Time Point | 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. | 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. | Posted | | Mean | Full Range | percentage of score change | | 56 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 |
|
| Secondary | Achievement of EASI-50, EASI-75, or EASI-90 at Each Time Point | 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%). | | Posted | | Count of Participants | | Participants | | 56 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | KHK4083 300 mg SC Q2W |
|
| Secondary | SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | 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. | 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. | Posted | | Median | Full Range | score on a scale | | 56 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | KHK4083 600 mg SC Q4W | |
|
| Secondary | Percent Change From Baseline in SCORing Atopic Dermatitis (SCORAD) Score at Each Time Point | 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. | 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. | Posted | | Mean | Full Range | percentage of score change | | 56 Weeks | | | | ID | Title | Description |
|---|
| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | KHK4083 600 mg SC Q4W | |
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| Secondary | 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 | 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) | | Posted | | Count of Participants | | Participants | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | 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. Weeks 40-56 visits are off-treatment. | | OG003 |
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| Secondary | Change From Baseline in Percent Body Surface Area (BSA) at Each Time Point | The Investigator will calculate the percentage (%) of the total body surface area affected by AD. | 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. | Posted | | Mean | Full Range | percentage of total BSA involvement | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | 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. Weeks 40-56 visits are off-treatment. |
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| Secondary | Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | 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." | 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. | Posted | | Mean | Full Range | score on a scale | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | 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. Weeks 40-56 visits are off-treatment. |
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| Secondary | Percent Change From Baseline in Pruritus Numerical Rating Scale (NRS) Score at Each Time Point | 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." | 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. | Posted | | Mean | Full Range | percentage of score change | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | 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. Weeks 40-56 visits are off-treatment. |
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| Secondary | Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | 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). | 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. | Posted | | Mean | Full Range | score on a scale | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | 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. Weeks 40-56 visits are off-treatment. |
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| Secondary | Percent Change From Baseline in Sleep Disturbance Numerical Rating Scale (NRS) Score at Each Time Point | 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). | 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. | Posted | | Mean | Full Range | percentage of score change | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | KHK4083 300 mg SC Q2W | |
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| Secondary | Dermatology Life Quality Index (DLQI) at Each Time Point | 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. | 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. | Posted | | Mean | Full Range | score on a scale | | 56 Weeks | | | | ID | Title | Description |
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| OG000 | 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. Weeks 40-56 visits are off-treatment. | | OG001 | 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. Weeks 40-56 visits are off-treatment. | | OG002 | KHK4083 300 mg SC Q2W |
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