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.
Study Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
12
Administered SC
Nagoya City University Hospital
Nagoya, Aichi-ken, Japan
Tohoku University Hospital
Sendai, Miyagi, Japan
Kansai Medical University Hospital
Hirakata, Osaka, Japan
Teikyo University Hospital
Itabashi-ku, Tokyo, Japan
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
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
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
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
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Jikei University School of Medicine
Minato-Ku, Tokyo, Japan
Tokyo Medical University Hospital
Shinjuku-ku, Tokyo, Japan
Osaka City University Medical School Hospital
Osaka, Japan
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
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
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
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
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
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
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
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
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