Plaque Psoriasis
Conditions
Brief summary
The purpose of this study is to evaluate the serum concentration of ixekizumab after administration using either prefilled syringe or auto-injector in participants with moderate to severe plaque psoriasis. Treatment period is followed by 40 weeks optional safety extension.
Interventions
Administered SC by auto-injector
Administered SC by prefilled syringe
Sponsors
Eli Lilly and Company
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Present with chronic plaque psoriasis based on a confirmed diagnosis of chronic psoriasis vulgaris for at least 6 months prior to randomization * At least 10% Body Surface Area (BSA) of Psoriasis at screening and at randomization * Static Physician Global Assessment (sPGA) score of at least 3 AND Psoriasis Area and Severity Index (PASI) score of at least 12 at screening and at randomization * Candidate 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
* Pustular, erythrodermic, and/or guttate forms of psoriasis * History of drug-induced psoriasis * Clinically significant flare of psoriasis during the 12 weeks prior to randomization * Concurrent or recent use of any biologic agent * Received systemic psoriasis therapy \[such as psoralen and ultraviolet A (PUVA) light therapy\] or phototherapy within the previous 4 weeks; or had topical psoriasis treatment within the previous 2 weeks prior to randomization * Cannot avoid excessive sun exposure or use of tanning booths for at least 4 weeks prior to randomization and during the study * Have participated in any study with interleukin-17 (IL-17) antagonists, including Ixekizumab * Serious disorder or illness other than plaque psoriasis * Serious infection within the last 3 months * Breastfeeding or nursing (lactating) women
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device | Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. |
| PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device | Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| PK: Cmax by Body Weight | Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: \<80 kilogram (kg), Medium: 80-100 kg, or High: \>100 kg). |
| PK: AUC 0-tlast by Body Weight | Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: \<80 kg, Medium: 80-100 kg, or High: \>100 kg). |
| Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | Week 12 | PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline. |
| Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA) | Week 12 | The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline. |
| PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. |
| Percentage of Device Operation Failures | Baseline through Week 12 | Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use. |
| Percentage of Participants With Anti-Ixekizumab Antibodies | Baseline to Week 12 | The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%. |
| SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Baseline, Week 4 and Week 8 | The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree). 1 represents Strongly Disagree while 7 represents Strongly Agree. The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit. |
| Percentage of Participants With a Static Physician Global Assessment (sPGA) (0) | Week 12 | The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). |
| PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration) | AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. |
Countries
Puerto Rico, United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 80 mg Ixekizumab Prefilled Syringe Ixekizumab administered via prefilled syringe as two 80 mg SC injections at Week 0, then one 80 mg SC injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W. | 102 |
| 80 mg Ixekizumab Auto-Injector Ixekizumab administered via auto-injector as two 80 mg SC injections at Week 0, then one 80 mg SC once injection Q2W at week 2, 4, 6, 8 and 10, and were then followed in the optional safety extension period from week 12 to week 48 using the prefilled syringe 80 mg dose Q4W. | 102 |
| Total | 204 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 |
|---|---|---|---|
| Safety Extension Per (Week 12-Week 48) | Adverse Event | 3 | 3 |
| Safety Extension Per (Week 12-Week 48) | Death | 0 | 1 |
| Safety Extension Per (Week 12-Week 48) | Lack of Efficacy | 1 | 2 |
| Safety Extension Per (Week 12-Week 48) | Lost to Follow-up | 1 | 3 |
| Safety Extension Per (Week 12-Week 48) | Withdrawal by Subject | 4 | 4 |
| Treatment Period (Per) (Week 0-Week 12) | Adverse Event | 2 | 1 |
| Treatment Period (Per) (Week 0-Week 12) | Entry Criteria Not Met | 1 | 1 |
| Treatment Period (Per) (Week 0-Week 12) | Lack of Efficacy | 1 | 1 |
| Treatment Period (Per) (Week 0-Week 12) | Lost to Follow-up | 1 | 0 |
| Treatment Period (Per) (Week 0-Week 12) | Protocol Violation | 1 | 2 |
| Treatment Period (Per) (Week 0-Week 12) | Withdrawal by Subject | 0 | 3 |
Baseline characteristics
| Characteristic | Total | 80 mg Ixekizumab Prefilled Syringe | 80 mg Ixekizumab Auto-Injector |
|---|---|---|---|
| Age, Continuous | 46.5 years STANDARD_DEVIATION 13.8 | 46.3 years STANDARD_DEVIATION 14.53 | 46.8 years STANDARD_DEVIATION 13.09 |
| Baseline in Psoriasis Area and Severity Index (PASI) | 19.40 units on a scale STANDARD_DEVIATION 8.078 | 21.05 units on a scale STANDARD_DEVIATION 9.379 | 17.76 units on a scale STANDARD_DEVIATION 6.141 |
| Baseline in Static Physician Global Assessment (sPGA) Score sPGA=3 | 108 participants | 55 participants | 53 participants |
| Baseline in Static Physician Global Assessment (sPGA) Score sPGA=4, 5 | 96 participants | 47 participants | 49 participants |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Confident in ability to use the device (n=99, 101) | 6.5 units on a scale STANDARD_DEVIATION 1.12 | 6.4 units on a scale STANDARD_DEVIATION 1.16 | 6.7 units on a scale STANDARD_DEVIATION 1.06 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Device is stable during injection (n=99, 101) | 6.5 units on a scale STANDARD_DEVIATION 1.12 | 6.3 units on a scale STANDARD_DEVIATION 1.18 | 6.6 units on a scale STANDARD_DEVIATION 1.06 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy for me to learn how to use (n=99,101) | 6.6 units on a scale STANDARD_DEVIATION 1.01 | 6.4 units on a scale STANDARD_DEVIATION 1.08 | 6.7 units on a scale STANDARD_DEVIATION 0.91 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy for me to unlock (n=93,101) | 6.6 units on a scale STANDARD_DEVIATION 0.98 | 6.4 units on a scale STANDARD_DEVIATION 0.94 | 6.7 units on a scale STANDARD_DEVIATION 1.01 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to hold in hand when I inject dose (n=99,101) | 6.4 units on a scale STANDARD_DEVIATION 1.14 | 6.3 units on a scale STANDARD_DEVIATION 1.27 | 6.6 units on a scale STANDARD_DEVIATION 0.97 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to inject my dose (n=99,101) | 6.4 units on a scale STANDARD_DEVIATION 1.18 | 6.2 units on a scale STANDARD_DEVIATION 1.32 | 6.6 units on a scale STANDARD_DEVIATION 1 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to know that my dose is complete (n=99,101) | 6.6 units on a scale STANDARD_DEVIATION 1.07 | 6.4 units on a scale STANDARD_DEVIATION 1.2 | 6.7 units on a scale STANDARD_DEVIATION 0.93 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to pick up (n=99, 100) | 6.7 units on a scale STANDARD_DEVIATION 0.81 | 6.7 units on a scale STANDARD_DEVIATION 0.67 | 6.7 units on a scale STANDARD_DEVIATION 0.94 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to remove needle shield/cover (n=99, 100) | 6.6 units on a scale STANDARD_DEVIATION 0.91 | 6.6 units on a scale STANDARD_DEVIATION 0.67 | 6.6 units on a scale STANDARD_DEVIATION 1.09 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to store device in refrigerator (n=94, 97) | 6.5 units on a scale STANDARD_DEVIATION 0.94 | 6.5 units on a scale STANDARD_DEVIATION 0.88 | 6.6 units on a scale STANDARD_DEVIATION 1 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) I am confident my dose is complete (n=98,101) | 6.6 units on a scale STANDARD_DEVIATION 0.99 | 6.6 units on a scale STANDARD_DEVIATION 1.09 | 6.7 units on a scale STANDARD_DEVIATION 0.89 |
| Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Overall, easy to use (n=99,101) | 6.5 units on a scale STANDARD_DEVIATION 1.05 | 6.4 units on a scale STANDARD_DEVIATION 1.1 | 6.6 units on a scale STANDARD_DEVIATION 0.99 |
| Ethnicity (NIH/OMB) Hispanic or Latino | 62 Participants | 33 Participants | 29 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 142 Participants | 69 Participants | 73 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants | 0 Participants | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 1 Participants | 1 Participants | 0 Participants |
| Race (NIH/OMB) Asian | 6 Participants | 4 Participants | 2 Participants |
| Race (NIH/OMB) Black or African American | 18 Participants | 13 Participants | 5 Participants |
| Race (NIH/OMB) More than one race | 2 Participants | 2 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 | 177 Participants | 82 Participants | 95 Participants |
| Region of Enrollment Puerto Rico | 39 participants | 19 participants | 20 participants |
| Region of Enrollment United States | 165 participants | 83 participants | 82 participants |
| Sex: Female, Male Female | 62 Participants | 31 Participants | 31 Participants |
| Sex: Female, Male Male | 142 Participants | 71 Participants | 71 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 | — / — | — / — | — / — | — / — |
| other Total, other adverse events | 12 / 102 | 10 / 102 | 24 / 185 | 0 / 176 |
| serious Total, serious adverse events | 3 / 102 | 4 / 102 | 9 / 185 | 1 / 176 |
Outcome results
Primary
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device
Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.
Time frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device | 15.0 micrograms/milliliter (µg/mL) |
| 80 mg Ixekizumab Auto-Injector | Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device | 14.8 micrograms/milliliter (µg/mL) |
Primary
PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device
AUC 0-tlast by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.
Time frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.
| Arm | Measure | Value (GEOMETRIC_MEAN) |
|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device | 157 micrograms*day/milliliter (µg*day/mL) |
| 80 mg Ixekizumab Auto-Injector | PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device | 154 micrograms*day/milliliter (µg*day/mL) |
Secondary
Percentage of Device Operation Failures
Device operation failure (that is, incomplete dose administration) was defined as an event during the treatment period (week 0 to week 12) when the participant indicated that a complete dose of ixekizumab was not delivered and/or the drug delivery device did not perform as expected per the directions for use.
Time frame: Baseline through Week 12
Population: All randomized participants.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Device Operation Failures | 0 percentage of incomplete injections |
| 80 mg Ixekizumab Auto-Injector | Percentage of Device Operation Failures | 0.3 percentage of incomplete injections |
p-value: 0.248Fisher Exact
Secondary
Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI)
PASI combines assessments of the extent of body-surface involvement in 4 anatomical regions (head, trunk, arms, and legs) and the severity of desquamation, erythema, and plaque induration/infiltration (thickness) in each region, yielding an overall score of 0 or no Ps to 72 for the most severe disease. Participants achieving PASI 75, 90, or 100 are defined as having an improvement of at least 75%, 90%, or of 100%, respectively, in the PASI scores compared to baseline.
Time frame: Week 12
Population: All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for Non-Responder Imputation (NRI) analysis.
| Arm | Measure | Group | Value (NUMBER) |
|---|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | PASI 75 | 88.2 percentage of participants |
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | PASI 90 | 76.5 percentage of participants |
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | PASI 100 | 48.0 percentage of participants |
| 80 mg Ixekizumab Auto-Injector | Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | PASI 75 | 78.4 percentage of participants |
| 80 mg Ixekizumab Auto-Injector | Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | PASI 90 | 62.7 percentage of participants |
| 80 mg Ixekizumab Auto-Injector | Percentage of Participants Achieving a ≥75%, ≥ 90% and 100% Improvement in Psoriasis Area and Severity Index (PASI): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Psoriasis Area and Severity Index (PASI) | PASI 100 | 42.2 percentage of participants |
Secondary
Percentage of Participants With Anti-Ixekizumab Antibodies
The percentage of participants with treatment-emergent positive anti-ixekizumab antibodies at anytime post-baseline were summarized by drug delivery device group. Percentage was calculated based on the number of evaluable participants and was calculated by number of participants with treatment-emergent positive anti-ixekizumab antibodies / number of evaluable participants \* 100%.
Time frame: Baseline to Week 12
Population: All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Participants With Anti-Ixekizumab Antibodies | 11.8 percentage of participants |
| 80 mg Ixekizumab Auto-Injector | Percentage of Participants With Anti-Ixekizumab Antibodies | 8.1 percentage of participants |
Secondary
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)
The sPGA is the physician's determination of the participant's Ps lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe).
Time frame: Week 12
Population: All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Participants With a Static Physician Global Assessment (sPGA) (0) | 51.0 percentage of participants |
| 80 mg Ixekizumab Auto-Injector | Percentage of Participants With a Static Physician Global Assessment (sPGA) (0) | 43.1 percentage of participants |
Secondary
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA)
The sPGA is the physician's determination of the participant's Psoriasis (Ps) lesions overall at a given time point. Lesions were categorized by descriptions for induration, erythema, and scaling. Participant's Ps was assessed as 0 (clear), 1 (minimal), 2 (mild), 3 (moderate), 4 (severe), or 5 (very severe). An sPGA responder was defined as having a post-baseline sPGA score of 0 or 1 with at least a 2-point improvement from baseline.
Time frame: Week 12
Population: All randomized participants. Participants who did not meet the clinical response criteria or had missing data at Week 12 were considered non-responders for NRI analysis.
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA) | 80.4 percentage of participants |
| 80 mg Ixekizumab Auto-Injector | Percentage of Participants With a Static Physician Global Assessment (sPGA) (0,1): Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: Static Physician Global Assessment (sPGA) | 73.5 percentage of participants |
Secondary
PK: AUC 0-tlast by Body Weight
AUC 0-tlast by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours. Body weight is defined by (Low: \<80 kg, Medium: 80-100 kg, or High: \>100 kg).
Time frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | PK: AUC 0-tlast by Body Weight | Low <80 kilograms (kg) (n=68) | 193 µg*day/mL |
| 80 mg Ixekizumab Prefilled Syringe | PK: AUC 0-tlast by Body Weight | Medium 80-100 kg (n=64) | 155 µg*day/mL |
| 80 mg Ixekizumab Prefilled Syringe | PK: AUC 0-tlast by Body Weight | High >100 kg (n=60) | 122 µg*day/mL |
Secondary
PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)
AUC 0-tlast by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0. AUC 0-tlast is equal to AUC 0-14 days where the last time point was 14 days ± 24 hours.
Time frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Arm (n=30, 29) | 151 µg*day/mL |
| 80 mg Ixekizumab Prefilled Syringe | PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Abdomen (n=34, 32) | 135 µg*day/mL |
| 80 mg Ixekizumab Prefilled Syringe | PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Thigh (n=28, 37) | 190 µg*day/mL |
| 80 mg Ixekizumab Auto-Injector | PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Arm (n=30, 29) | 124 µg*day/mL |
| 80 mg Ixekizumab Auto-Injector | PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Abdomen (n=34, 32) | 159 µg*day/mL |
| 80 mg Ixekizumab Auto-Injector | PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) | Thigh (n=28, 37) | 178 µg*day/mL |
Secondary
PK: Cmax by Body Weight
Cmax by body weight of Ixekizumab, after the 160 mg starting dose was administered on Day 0. Body weight is defined by (Low: \<80 kilogram (kg), Medium: 80-100 kg, or High: \>100 kg).
Time frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | PK: Cmax by Body Weight | Low <80 kg (n=68) | 18.2 µg/mL |
| 80 mg Ixekizumab Prefilled Syringe | PK: Cmax by Body Weight | Medium 80-100 kg (n=64) | 15.1 µg/mL |
| 80 mg Ixekizumab Prefilled Syringe | PK: Cmax by Body Weight | High >100 kg (n=60) | 11.7 µg/mL |
Secondary
PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)
Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.
Time frame: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
Population: All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.
| Arm | Measure | Group | Value (GEOMETRIC_MEAN) |
|---|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Arm (n=30, 29) | 14.4 µg/ml |
| 80 mg Ixekizumab Prefilled Syringe | PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Abdomen (n=34, 32) | 12.7 µg/ml |
| 80 mg Ixekizumab Prefilled Syringe | PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Thigh (n=28, 37) | 18.5 µg/ml |
| 80 mg Ixekizumab Auto-Injector | PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Thigh (n=28, 37) | 17.6 µg/ml |
| 80 mg Ixekizumab Auto-Injector | PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Arm (n=30, 29) | 11.5 µg/ml |
| 80 mg Ixekizumab Auto-Injector | PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) | Abdomen (n=34, 32) | 15.4 µg/ml |
Secondary
SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
The SQAAQ is a self-administered questionnaire which provides an assessment of ease of use and confidence with using a device to administer a subcutaneous injection of drug. Participants and injection assistants responded to questionnaire items using a 7-point Likert scale (from Strongly Disagree to Strongly Agree). 1 represents Strongly Disagree while 7 represents Strongly Agree. The ease of use and confidence of ixekizumab subcutaneous administrations across drug delivery device groups were evaluated by SQAAQ item scores at each post baseline visit.
Time frame: Baseline, Week 4 and Week 8
Population: All randomized participants.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to remove needle shield, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.79 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to unlock, Week 4 (n=86, 90) | 6.6 units on a scale | Standard Deviation 0.81 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to hold in hand, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.7 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to inject my dose, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.76 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to know dose is complete, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.53 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to store in refrigerator, Week 4 (n=91, 88) | 6.7 units on a scale | Standard Deviation 0.54 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to learn how to use, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.67 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to pick up, Week 4 (n=94, 90) | 6.8 units on a scale | Standard Deviation 0.56 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Overall, easy to use, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.7 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Device is stable against skin, Week 4 (n=93, 90) | 6.6 units on a scale | Standard Deviation 0.81 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident in ability to use, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.62 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident my dose is complete, Week 4 (n=94, 90) | 6.8 units on a scale | Standard Deviation 0.44 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to learn how to use, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.63 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to unlock, Week 8 (n=87, 92) | 6.6 units on a scale | Standard Deviation 0.67 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to hold when I inject dose, Week 8 (n=89, 92) | 6.6 units on a scale | Standard Deviation 0.67 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to inject my dose, Week 8 (n=89, 92) | 6.5 units on a scale | Standard Deviation 0.8 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to know dose is complete, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.52 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to store in refrigerator, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.62 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to remove needle shield, Week 8 (n=89, 92) | 6.6 units on a scale | Standard Deviation 0.75 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to pick up, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.63 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Overall, easy to use, Week 8 (n=89, 92) | 6.6 units on a scale | Standard Deviation 0.76 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Device is stable against skin, Week 8 (n=88, 92) | 6.6 units on a scale | Standard Deviation 0.81 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident in ability to use, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.77 |
| 80 mg Ixekizumab Prefilled Syringe | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident my dose is complete, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.47 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident in ability to use, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.71 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to learn how to use, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.86 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to learn how to use, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.69 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to unlock, Week 4 (n=86, 90) | 6.8 units on a scale | Standard Deviation 0.74 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to remove needle shield, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.89 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to hold in hand, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.91 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy for me to unlock, Week 8 (n=87, 92) | 6.8 units on a scale | Standard Deviation 0.69 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to inject my dose, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.83 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Device is stable against skin, Week 8 (n=88, 92) | 6.6 units on a scale | Standard Deviation 1.1 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to know dose is complete, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.79 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to hold when I inject dose, Week 8 (n=89, 92) | 6.7 units on a scale | Standard Deviation 0.94 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to store in refrigerator, Week 4 (n=91, 88) | 6.7 units on a scale | Standard Deviation 0.77 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to pick up, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.68 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to remove needle shield, Week 4 (n=94, 90) | 6.6 units on a scale | Standard Deviation 0.95 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to inject my dose, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.82 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to pick up, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.8 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident my dose is complete, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.7 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Overall, easy to use, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.82 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to know dose is complete, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.7 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Device is stable against skin, Week 4 (n=93, 90) | 6.6 units on a scale | Standard Deviation 1.05 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Overall, easy to use, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.74 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident in ability to use, Week 4 (n=94, 90) | 6.7 units on a scale | Standard Deviation 0.83 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Easy to store in refrigerator, Week 8 (n=89, 92) | 6.8 units on a scale | Standard Deviation 0.72 |
| 80 mg Ixekizumab Auto-Injector | SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO) | Confident my dose is complete, Week 4 (n=94, 90) | 6.8 units on a scale | Standard Deviation 0.71 |