Erythrodermic Psoriasis, Generalized Pustular Psoriasis
Conditions
Keywords
Generalized Pustular Psoriasis (GPP), Erythrodermic Psoriasis (EP), Japan
Brief summary
The reason for this study is to see if the study drug ixekizumab is safe and effective in participants with generalized pustular psoriasis and erythrodermic psoriasis.
Interventions
DRUGIxekizumab
Administered SC
Sponsors
Eli Lilly and Company
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
20 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present with GPP or EP based on an investigator-confirmed diagnosis and meet the associated criteria * GPP: Meet the criteria for GPP set by Ministry of Health, Labour and Welfare (MHLW) at screening and baseline regardless of IL-36 mutation status. * EP: Diagnosed to have BSA ≥80% involvement (with inflammatory erythema) at screening and baseline. * Candidates for phototherapy and/or systemic therapy * Men must agree to use a reliable method of birth control during the study * Women must agree to use birth control or remain abstinent during the study and for at least 12 weeks after stopping treatment
Exclusion criteria
* History of drug-induced psoriasis * Concurrent or recent use of any biologic agent * Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to enrollment and during the study * Have previously received ixekizumab * Serious disorder or illness other than psoriasis * Serious infection within the last 12 weeks * Breastfeeding or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS | Week 12 through Week 20 | GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved | Week 20 | GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline. |
| Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged | Week 20 | GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline. |
| Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened | Week 20 | GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline. |
| Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1) | Week 20 | The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of psoriasis. |
| Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) | Week 20 | PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease). |
| Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved | Week 20 | GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline. |
| Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis | Baseline, Week 20 | Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb). |
| Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | Baseline, Week 20 | The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a little,a lot, and very much, with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (the higher the score, the more quality of life is impaired) and a 5-point change from baseline is considered clinically relevant (Basra et al. 2008). |
| Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA) | Week 20 | Number of participants who developed treatment-emergent anti-ixekizumab antibodies (TE-ADA) was summarized by treatment group. |
| Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb) | Week 20 | Number of participants who developed neutralizing Anti-Ixekizumab antibody (NAb) was summarized by treatment group. |
| Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index | Baseline, Week 20 | GPP Severity Index was evaluated only for participants with pustular psoriasis at screening and at baseline. This is a composite score derived from the sum of scores for assessment of dermal symptoms, systemic symptoms, and laboratory findings (range, 0 to 17, with 17 representing severe symptoms). Skin symptoms were assessed by the score with the area of erythema (on a 0 to 3 scale), area of confluent pustules (on a 0 to 3 scale), and are of skin edema (on a 0 to 3 scale). The total score will be assessed (range, 0 to 9, with 9 representing severe symptoms). Systemic symptoms and laboratory findings were assessed by the score with fever (on a 0 to 2 scale), white blood cell (on a 0 to -2 scale), C-reactive protein (on a 0 to 2 scale) and Albumin (on a 0 to 2 scale). The total score will be assessed (range, 0 to 8, with 8 representing severe symptoms). |
| Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline | Baseline, Week 20 | The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent 1. = Slight 2. = Moderate 3. = Severe 4. = Severest Possible Percent of Scalp Involved: 1. = \<10% 2. = 10% - 29% 3. = 30% - 49% 4. = 50% - 69% 5. = 70% - 89% 6. = 90% - 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease). |
Countries
Japan
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) Induction Dosing Period:
Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.
Maintenance Dosing Period:
Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.
Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1. | 7 |
| Ixekizumab - Erythrodermic Psoriasis (EP) Induction Dosing Period:
Participants received 160 mg ixekizumab SC as 2 injections at Week 0 followed by 80 mg ixekizumab SC as 1 injection at Week 2, 4, 6, 8 and 10.
Maintenance Dosing Period:
Participants with Global Improvement Score (GIS) = 1 at Week 12 are responders who will complete the study.
Participants who are inadequate responders (GIS ≥2 at Week 12 and based on the investigators' discretion) will be administered 80 mg ixekizumab SC as 1 injection at Week 12, 14, 16, and 18 or until they achieve a GIS score of 1. | 5 |
| Total | 12 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Induction Dosing Period (12 Weeks) | Adverse Event | 0 | 1 |
| Induction Dosing Period (12 Weeks) | Lack of Efficacy | 1 | 0 |
Baseline characteristics
| Characteristic | Ixekizumab - Generalized Pustular Psoriasis (GPP) | Total | Ixekizumab - Erythrodermic Psoriasis (EP) |
|---|---|---|---|
| Age, Continuous | 45.0 years STANDARD_DEVIATION 19.1 | 43.8 years STANDARD_DEVIATION 16.63 | 42.2 years STANDARD_DEVIATION 14.39 |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 7 Participants | 12 Participants | 5 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) White | 0 Participants | 0 Participants | 0 Participants |
| Region of Enrollment Japan | 7 Participants | 12 Participants | 5 Participants |
| Sex: Female, Male Female | 4 Participants | 6 Participants | 2 Participants |
| Sex: Female, Male Male | 3 Participants | 6 Participants | 3 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 7 | 0 / 5 | 0 / 2 | 0 / 4 |
| other Total, other adverse events | 4 / 7 | 2 / 5 | 1 / 2 | 3 / 4 |
| serious Total, serious adverse events | 0 / 7 | 1 / 5 | 0 / 2 | 0 / 4 |
Outcome results
Primary
Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS
GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.
Time frame: Week 12 through Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS | 1 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants Who Improved Global Improvement Score (GIS) at Least 1 Point From Week 12 Through Week 20 and With ≤2 of GIS | 0 Participants |
Secondary
Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index
GPP Severity Index was evaluated only for participants with pustular psoriasis at screening and at baseline. This is a composite score derived from the sum of scores for assessment of dermal symptoms, systemic symptoms, and laboratory findings (range, 0 to 17, with 17 representing severe symptoms). Skin symptoms were assessed by the score with the area of erythema (on a 0 to 3 scale), area of confluent pustules (on a 0 to 3 scale), and are of skin edema (on a 0 to 3 scale). The total score will be assessed (range, 0 to 9, with 9 representing severe symptoms). Systemic symptoms and laboratory findings were assessed by the score with fever (on a 0 to 2 scale), white blood cell (on a 0 to -2 scale), C-reactive protein (on a 0 to 2 scale) and Albumin (on a 0 to 2 scale). The total score will be assessed (range, 0 to 8, with 8 representing severe symptoms).
Time frame: Baseline, Week 20
Population: Maintenance Dosing Period: All participants who received at least one dose of study drug in GPP arm.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Generalized Pustular Psoriasis (GPP) Only: Change From Baseline on Generalized Pustular Psoriasis Severity Index | -2.5 units on a scale |
Secondary
Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score
The DLQI is a simple, patient-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include not at all, a little,a lot, and very much, with corresponding scores of 0, 1, 2, and 3, respectively, and unanswered (not relevant) responses scored as 0. Totals range from 0 to 30 (the higher the score, the more quality of life is impaired) and a 5-point change from baseline is considered clinically relevant (Basra et al. 2008).
Time frame: Baseline, Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | -4.0 score on a scale |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Change From Baseline in Dermatology Life Quality Index (DLQI) Total Score | -6.5 score on a scale |
Secondary
Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis
Percentage involvement of psoriasis on each participants body surface area was assessed by the investigator on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participant's hand (including palm, fingers and thumb).
Time frame: Baseline, Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis | -44.5 units on a scale |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Change From Baseline in Percent of Body Surface Area (BSA) Involvement of Psoriasis Body Surface Area (BSA) Involvement of Psoriasis | -61.3 units on a scale |
Secondary
Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline
The scalp was assessed for erythema (redness), induration (hardness), and desquamation (shedding of skin) and percentage of area affected as follows: Erythema, Induration and Desquamation: 0 = Absent 1. = Slight 2. = Moderate 3. = Severe 4. = Severest Possible Percent of Scalp Involved: 1. = \<10% 2. = 10% - 29% 3. = 30% - 49% 4. = 50% - 69% 5. = 70% - 89% 6. = 90% - 100% The PSSI score is a composite score derived from the sum of the scores for erythema, induration and desquamation multiplied by the score for the extent of scalp area involved (percent of scalp involved). The range is 0 (no psoriasis) to 72 (Most severe Disease).
Time frame: Baseline, Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug who had Scalp Involvement at Baseline.
| Arm | Measure | Value (MEAN) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline | -9.0 units on a scale |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Change From Baseline in Psoriasis Scalp Severity Index (PSSI) in Participants With Scalp Involvement at Baseline | -25.5 units on a scale |
Secondary
Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75)
PASI combines assessments of the extent of body surface involvement in 4 regions (head & neck(h), trunk(t), arms(u), legs(l)) & severity of scaling (S), redness (R), & plaque induration/infiltration (thickness, T) in each region. Severity is rated for each index (R, S, T) on a 0-4 scale (0 for no involvement up to 4 for severe involvement): 0 = none, 1 = slight, 2 = mild, 3 = moderate, 4 = severe Fraction of total body surface area (BSA) affected is graded on a 0-6 scale (0 for no involvement to 6 for 90% - 100% involvement): 0 = 0% (clear), 1 = \>0% to \<10%, 2 = 10% to \<30%, 3 = 30% to \<50%, 4 = 50% to \<70%, 5 = 70% to 90%, 6 = 90% to 100%. Overall score ranges from 0 (no psoriasis) to 72 (most severe disease).
Time frame: Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) | 2 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants Who Achieved at Least a 75% Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) Improvement From Baseline in Psoriasis Area and Severity Index (PASI) Score (PASI 75) | 3 Participants |
Secondary
Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1)
The sPGA is a physician's determination of the participant's psoriasis lesions overall at a given time point categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's psoriasis is assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5). An sPGA assessed as either 0 or 1 represents a clinically meaningful response of minimal plaque severity or complete resolution of psoriasis.
Time frame: Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1) | 2 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants Who Achieved Static Physician Global Assessment (sPGA) of (0, 1) | 1 Participants |
Secondary
Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb)
Number of participants who developed neutralizing Anti-Ixekizumab antibody (NAb) was summarized by treatment group.
Time frame: Week 20
Population: Maintenance Dosing Period: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb) | 0 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants Who Developed Neutralizing Anti-Ixekizumab Antibody (NAb) | 0 Participants |
Secondary
Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA)
Number of participants who developed treatment-emergent anti-ixekizumab antibodies (TE-ADA) was summarized by treatment group.
Time frame: Week 20
Population: Maintenance Dosing Period: All participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA) | 0 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants Who Developed Treatment-Emergent Anti-Ixekizumab Antibodies (TE-ADA) | 0 Participants |
Secondary
Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved
GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.
Time frame: Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved | 1 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants With GIS Grade 1: Resolved | 0 Participants |
Secondary
Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved
GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.
Time frame: Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved | 1 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants With GIS Grade 2: Improved | 4 Participants |
Secondary
Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged
GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.
Time frame: Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged | 0 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants With GIS Grade 3: Unchanged | 0 Participants |
Secondary
Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened
GIS was assessed in the 4 grades by comparing the psoriatic findings: (1) resolved, (2) improved, (3) unchanged, or (4) worsened. The global improvement score was assessed based on the comparison of the psoriatic findings, Static Physician Global Assessment (sPGA), Psoriasis Area and Severity Index (PASI) score, and other evaluations with those at the baseline.
Time frame: Week 20
Population: Maintenance Dosing Period: All randomized participants who received at least one dose of study drug.
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Ixekizumab - Generalized Pustular Psoriasis (GPP) | Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened | 0 Participants |
| Ixekizumab - Erythrodermic Psoriasis (EP) | Maintenance Dosing Period: Number of Participants With GIS Grade 4: Worsened | 0 Participants |