Trial Outcomes & Findings for Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis (NCT NCT01777191)

NCT ID: NCT01777191

Last Updated: 2019-09-30

Results Overview

Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

• Recruitment status: COMPLETED
• Study phase: PHASE3
• Target enrollment: 204 participants
• Primary outcome timeframe: Day 2, Day 4, Day 7, Day 10 and Day 14 (prior to Ixekizumab administration)
• Results posted on: 2019-09-30

Participant Flow

Participant milestones

Measure	80 mg Ixekizumab Prefilled Syringe Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (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 every 4 weeks (Q4W).	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.
Treatment Period (Per) (Week 0-Week 12) STARTED	102	102
Treatment Period (Per) (Week 0-Week 12) COMPLETED	96	94
Treatment Period (Per) (Week 0-Week 12) NOT COMPLETED	6	8
Safety Extension Per (Week 12-Week 48) STARTED	94	91
Safety Extension Per (Week 12-Week 48) COMPLETED	85	78
Safety Extension Per (Week 12-Week 48) NOT COMPLETED	9	13

Reasons for withdrawal

Measure	80 mg Ixekizumab Prefilled Syringe Ixekizumab administered via prefilled syringe as two 80 milligrams (mg) subcutaneous (SC) injections at Week 0, then one 80 mg SC injection every two weeks (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 every 4 weeks (Q4W).	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.
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) Protocol Violation	1	2
Treatment Period (Per) (Week 0-Week 12) Withdrawal by Subject	0	3
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
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) Withdrawal by Subject	4	4
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

Baseline Characteristics

Evaluation of Ixekizumab Using Auto-Injector or Prefilled Syringe in Participants With Moderate to Severe Plaque Psoriasis

Baseline characteristics by cohort

Measure	80 mg Ixekizumab Prefilled Syringe n=102 Participants 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.	80 mg Ixekizumab Auto-Injector n=102 Participants 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.	Total n=204 Participants Total of all reporting groups
Age, Continuous	46.3 years STANDARD_DEVIATION 14.53 • n=5 Participants	46.8 years STANDARD_DEVIATION 13.09 • n=7 Participants	46.5 years STANDARD_DEVIATION 13.80 • n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants	31 Participants n=7 Participants	62 Participants n=5 Participants
Sex: Female, Male Male	71 Participants n=5 Participants	71 Participants n=7 Participants	142 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	33 Participants n=5 Participants	29 Participants n=7 Participants	62 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	69 Participants n=5 Participants	73 Participants n=7 Participants	142 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	1 Participants n=5 Participants	0 Participants n=7 Participants	1 Participants n=5 Participants
Race (NIH/OMB) Asian	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Race (NIH/OMB) Black or African American	13 Participants n=5 Participants	5 Participants n=7 Participants	18 Participants n=5 Participants
Race (NIH/OMB) White	82 Participants n=5 Participants	95 Participants n=7 Participants	177 Participants n=5 Participants
Race (NIH/OMB) More than one race	2 Participants n=5 Participants	0 Participants n=7 Participants	2 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants
Region of Enrollment Puerto Rico	19 participants n=5 Participants	20 participants n=7 Participants	39 participants n=5 Participants
Region of Enrollment United States	83 participants n=5 Participants	82 participants n=7 Participants	165 participants n=5 Participants
Baseline in Psoriasis Area and Severity Index (PASI)	21.05 units on a scale STANDARD_DEVIATION 9.379 • n=5 Participants	17.76 units on a scale STANDARD_DEVIATION 6.141 • n=7 Participants	19.40 units on a scale STANDARD_DEVIATION 8.078 • n=5 Participants
Baseline in Static Physician Global Assessment (sPGA) Score sPGA=3	55 participants n=5 Participants	53 participants n=7 Participants	108 participants n=5 Participants
Baseline in Static Physician Global Assessment (sPGA) Score sPGA=4, 5	47 participants n=5 Participants	49 participants n=7 Participants	96 participants n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy for me to learn how to use (n=99,101)	6.4 units on a scale STANDARD_DEVIATION 1.08 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 0.91 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 1.01 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy for me to unlock (n=93,101)	6.4 units on a scale STANDARD_DEVIATION 0.94 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 1.01 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 0.98 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to hold in hand when I inject dose (n=99,101)	6.3 units on a scale STANDARD_DEVIATION 1.27 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 0.97 • n=7 Participants	6.4 units on a scale STANDARD_DEVIATION 1.14 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to inject my dose (n=99,101)	6.2 units on a scale STANDARD_DEVIATION 1.32 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 1.00 • n=7 Participants	6.4 units on a scale STANDARD_DEVIATION 1.18 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to know that my dose is complete (n=99,101)	6.4 units on a scale STANDARD_DEVIATION 1.20 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 0.93 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 1.07 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to store device in refrigerator (n=94, 97)	6.5 units on a scale STANDARD_DEVIATION 0.88 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 1.00 • n=7 Participants	6.5 units on a scale STANDARD_DEVIATION 0.94 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to remove needle shield/cover (n=99, 100)	6.6 units on a scale STANDARD_DEVIATION 0.67 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 1.09 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 0.91 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Easy to pick up (n=99, 100)	6.7 units on a scale STANDARD_DEVIATION 0.67 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 0.94 • n=7 Participants	6.7 units on a scale STANDARD_DEVIATION 0.81 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Overall, easy to use (n=99,101)	6.4 units on a scale STANDARD_DEVIATION 1.10 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 0.99 • n=7 Participants	6.5 units on a scale STANDARD_DEVIATION 1.05 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Device is stable during injection (n=99, 101)	6.3 units on a scale STANDARD_DEVIATION 1.18 • n=5 Participants	6.6 units on a scale STANDARD_DEVIATION 1.06 • n=7 Participants	6.5 units on a scale STANDARD_DEVIATION 1.12 • n=5 Participants
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ) Confident in ability to use the device (n=99, 101)	6.4 units on a scale STANDARD_DEVIATION 1.16 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 1.06 • n=7 Participants	6.5 units on a scale STANDARD_DEVIATION 1.12 • n=5 Participants
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 1.09 • n=5 Participants	6.7 units on a scale STANDARD_DEVIATION 0.89 • n=7 Participants	6.6 units on a scale STANDARD_DEVIATION 0.99 • n=5 Participants

PRIMARY outcome

Timeframe: 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.

Cmax by drug delivery device (prefilled syringe or auto-injector) of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=94 Participants 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.	80 mg Ixekizumab Auto-Injector n=98 Participants 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.
Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device	15.0 micrograms/milliliter (µg/mL) Interval 13.9 to 16.1	14.8 micrograms/milliliter (µg/mL) Interval 13.8 to 15.9

PRIMARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=94 Participants 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.	80 mg Ixekizumab Auto-Injector n=98 Participants 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.
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) Interval 147.0 to 168.0	154 micrograms*day/milliliter (µg*day/mL) Interval 144.0 to 165.0

SECONDARY outcome

Timeframe: 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.

Cmax by site of injection of Ixekizumab, after the 160 mg starting dose was administered on Day 0.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=92 Participants 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.	80 mg Ixekizumab Auto-Injector n=98 Participants 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.
PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) Thigh (n=28, 37)	18.5 µg/ml Interval 17.0 to 20.1	17.6 µg/ml Interval 16.0 to 19.4
PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) Arm (n=30, 29)	14.4 µg/ml Interval 12.4 to 16.8	11.5 µg/ml Interval 10.1 to 13.0
PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen) Abdomen (n=34, 32)	12.7 µg/ml Interval 11.3 to 14.2	15.4 µg/ml Interval 13.5 to 17.5

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=92 Participants 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.	80 mg Ixekizumab Auto-Injector n=98 Participants 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.
PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) Arm (n=30, 29)	151 µg*day/mL Interval 131.0 to 173.0	124 µg*day/mL Interval 109.0 to 142.0
PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) Abdomen (n=34, 32)	135 µg*day/mL Interval 122.0 to 150.0	159 µg*day/mL Interval 140.0 to 180.0
PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen) Thigh (n=28, 37)	190 µg*day/mL Interval 176.0 to 206.0	178 µg*day/mL Interval 163.0 to 194.0

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=192 Participants 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.	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.
PK: Cmax by Body Weight Low <80 kg (n=68)	18.2 µg/mL Interval 16.9 to 19.5	—
PK: Cmax by Body Weight Medium 80-100 kg (n=64)	15.1 µg/mL Interval 13.8 to 16.5	—
PK: Cmax by Body Weight High >100 kg (n=60)	11.7 µg/mL Interval 10.8 to 12.7	—

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=192 Participants 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.	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.
PK: AUC 0-tlast by Body Weight High >100 kg (n=60)	122 µg*day/mL Interval 113.0 to 132.0	—
PK: AUC 0-tlast by Body Weight Low <80 kilograms (kg) (n=68)	193 µg*day/mL Interval 181.0 to 205.0	—
PK: AUC 0-tlast by Body Weight Medium 80-100 kg (n=64)	155 µg*day/mL Interval 143.0 to 168.0	—

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=102 Participants 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.	80 mg Ixekizumab Auto-Injector n=102 Participants 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.
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	78.4 percentage of participants
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	62.7 percentage of participants
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	42.2 percentage of participants

SECONDARY outcome

Timeframe: 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.

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.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=102 Participants 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.	80 mg Ixekizumab Auto-Injector n=102 Participants 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.
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	73.5 percentage of participants

SECONDARY outcome

Timeframe: 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.

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).

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=102 Participants 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.	80 mg Ixekizumab Auto-Injector n=102 Participants 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.
Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)	51.0 percentage of participants	43.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline through Week 12

Population: All randomized participants.

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.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=680 Injections 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.	80 mg Ixekizumab Auto-Injector n=674 Injections 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.
Percentage of Device Operation Failures	0 percentage of incomplete injections	0.3 percentage of incomplete injections

SECONDARY outcome

Timeframe: 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.

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%.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=102 Participants 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.	80 mg Ixekizumab Auto-Injector n=99 Participants 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.
Percentage of Participants With Anti-Ixekizumab Antibodies	11.8 percentage of participants	8.1 percentage of participants

SECONDARY outcome

Timeframe: Baseline, Week 4 and Week 8

Population: All randomized participants.

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.

Outcome measures

Measure	80 mg Ixekizumab Prefilled Syringe n=102 Participants 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.	80 mg Ixekizumab Auto-Injector n=102 Participants 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.
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	6.7 units on a scale Standard Deviation 0.80
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 0.70	6.7 units on a scale Standard Deviation 0.82
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	6.6 units on a scale Standard Deviation 1.05
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	6.7 units on a scale Standard Deviation 0.83
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	6.8 units on a scale Standard Deviation 0.71
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	6.8 units on a scale Standard Deviation 0.69
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	6.8 units on a scale Standard Deviation 0.69
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	6.7 units on a scale Standard Deviation 0.94
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 0.80	6.8 units on a scale Standard Deviation 0.82
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	6.8 units on a scale Standard Deviation 0.70
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	6.8 units on a scale Standard Deviation 0.72
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	6.7 units on a scale Standard Deviation 0.89
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	6.8 units on a scale Standard Deviation 0.68
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	6.8 units on a scale Standard Deviation 0.74
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	6.6 units on a scale Standard Deviation 1.10
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	6.7 units on a scale Standard Deviation 0.86
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	6.8 units on a scale Standard Deviation 0.74
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 0.70	6.6 units on a scale Standard Deviation 0.91
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	6.7 units on a scale Standard Deviation 0.83
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	6.7 units on a scale Standard Deviation 0.79
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	6.7 units on a scale Standard Deviation 0.77
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	6.6 units on a scale Standard Deviation 0.95
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	6.8 units on a scale Standard Deviation 0.71
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	6.8 units on a scale Standard Deviation 0.70

Adverse Events

80 mg Ixekizumab Prefilled Syringe Treatment Period

Serious events: 3 serious events

Other events: 12 other events

Deaths: 0 deaths

80 mg Ixekizumab Auto-Injector Treatment Period

Serious events: 4 serious events

Other events: 10 other events

Deaths: 0 deaths

80 mg Ixe Prefilled Syringe Optional Safety Extension

Serious events: 9 serious events

Other events: 24 other events

Deaths: 0 deaths

Follow Up Period

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Measure	80 mg Ixekizumab Prefilled Syringe Treatment Period n=102 participants at risk 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.	80 mg Ixekizumab Auto-Injector Treatment Period n=102 participants at risk 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.	80 mg Ixe Prefilled Syringe Optional Safety Extension n=185 participants at risk One 80 mg Ixekizumab administered as an SC injection Q4W.	Follow Up Period n=176 participants at risk All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
Cardiac disorders Acute myocardial infarction	0.00% 0/102	0.98% 1/102 • Number of events 1	0.00% 0/185	0.00% 0/176
Cardiac disorders Cardio-respiratory arrest	0.00% 0/102	0.00% 0/102	0.54% 1/185 • Number of events 1	0.00% 0/176
Cardiac disorders Supraventricular tachycardia	0.00% 0/102	0.00% 0/102	0.54% 1/185 • Number of events 2	0.00% 0/176
Gastrointestinal disorders Colitis	0.00% 0/102	0.00% 0/102	0.54% 1/185 • Number of events 1	0.00% 0/176
Gastrointestinal disorders Gastric ulcer haemorrhage	0.00% 0/102	0.00% 0/102	0.54% 1/185 • Number of events 1	0.00% 0/176
Hepatobiliary disorders Cholecystitis	0.00% 0/102	0.00% 0/102	0.54% 1/185 • Number of events 1	0.00% 0/176
Immune system disorders Anaphylactic reaction	0.00% 0/102	0.98% 1/102 • Number of events 1	0.00% 0/185	0.00% 0/176
Infections and infestations Cellulitis	0.00% 0/102	0.00% 0/102	0.54% 1/185 • Number of events 1	0.57% 1/176 • Number of events 1
Infections and infestations Diverticulitis	0.98% 1/102 • Number of events 1	0.00% 0/102	0.54% 1/185 • Number of events 1	0.00% 0/176
Infections and infestations Tooth abscess	0.00% 0/102	0.98% 1/102 • Number of events 1	0.00% 0/185	0.00% 0/176
Infections and infestations Urinary tract infection	0.98% 1/102 • Number of events 1	0.00% 0/102	0.00% 0/185	0.00% 0/176
Injury, poisoning and procedural complications Hip fracture	0.00% 0/102	0.98% 1/102 • Number of events 1	0.00% 0/185	0.00% 0/176
Neoplasms benign, malignant and unspecified (incl cysts and polyps) Squamous cell carcinoma of skin	0.98% 1/102 • Number of events 1	0.00% 0/102	0.00% 0/185	0.00% 0/176
Respiratory, thoracic and mediastinal disorders Chronic obstructive pulmonary disease	0.00% 0/102	0.00% 0/102	1.1% 2/185 • Number of events 3	0.00% 0/176

Other adverse events

Measure	80 mg Ixekizumab Prefilled Syringe Treatment Period n=102 participants at risk 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.	80 mg Ixekizumab Auto-Injector Treatment Period n=102 participants at risk 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.	80 mg Ixe Prefilled Syringe Optional Safety Extension n=185 participants at risk One 80 mg Ixekizumab administered as an SC injection Q4W.	Follow Up Period n=176 participants at risk All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
General disorders Injection site reaction	7.8% 8/102 • Number of events 12	4.9% 5/102 • Number of events 8	4.3% 8/185 • Number of events 8	0.00% 0/176
Infections and infestations Upper respiratory tract infection	3.9% 4/102 • Number of events 4	4.9% 5/102 • Number of events 5	8.6% 16/185 • Number of events 19	0.00% 0/176

Additional Information

Chief Medical Officer

Eli Lilly and Company

Phone: 800-545-5979

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60