ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 28 of 29 for:    LY2439821

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01777191
Recruitment Status : Completed
First Posted : January 28, 2013
Results First Posted : May 26, 2016
Last Update Posted : October 24, 2016
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Plaque Psoriasis
Interventions Drug: Ixekizumab Auto-Injector
Drug: Ixekizumab Prefilled Syringe
Enrollment 204
Recruitment Details  
Pre-assignment Details  
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description 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). 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.
Period Title: Treatment Period (Per) (Week 0-Week 12)
Started 102 102
Completed 96 94
Not Completed 6 8
Reason Not Completed
Adverse Event             2             1
Entry Criteria Not Met             1             1
Protocol Violation             1             2
Withdrawal by Subject             0             3
Lack of Efficacy             1             1
Lost to Follow-up             1             0
Period Title: Safety Extension Per (Week 12-Week 48)
Started 94 [1] 91 [1]
Completed 85 78
Not Completed 9 13
Reason Not Completed
Adverse Event             3             3
Death             0             1
Withdrawal by Subject             4             4
Lack of Efficacy             1             2
Lost to Follow-up             1             3
[1]
Participation in the safety extension period was optional.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector Total
Hide Arm/Group Description 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. 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 of all reporting groups
Overall Number of Baseline Participants 102 102 204
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 102 participants 102 participants 204 participants
46.3  (14.53) 46.8  (13.09) 46.5  (13.80)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
Female
31
  30.4%
31
  30.4%
62
  30.4%
Male
71
  69.6%
71
  69.6%
142
  69.6%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
Hispanic or Latino
33
  32.4%
29
  28.4%
62
  30.4%
Not Hispanic or Latino
69
  67.6%
73
  71.6%
142
  69.6%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
American Indian or Alaska Native
1
   1.0%
0
   0.0%
1
   0.5%
Asian
4
   3.9%
2
   2.0%
6
   2.9%
Native Hawaiian or Other Pacific Islander
0
   0.0%
0
   0.0%
0
   0.0%
Black or African American
13
  12.7%
5
   4.9%
18
   8.8%
White
82
  80.4%
95
  93.1%
177
  86.8%
More than one race
2
   2.0%
0
   0.0%
2
   1.0%
Unknown or Not Reported
0
   0.0%
0
   0.0%
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
Puerto Rico 19 20 39
United States 83 82 165
Baseline in Psoriasis Area and Severity Index (PASI)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 102 participants 204 participants
21.05  (9.379) 17.76  (6.141) 19.40  (8.078)
[1]
Measure Description: The 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.
Baseline in Static Physician Global Assessment (sPGA) Score   [1] 
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 102 participants 102 participants 204 participants
sPGA=3 55 53 108
sPGA=4, 5 47 49 96
[1]
Measure Description: The sPGA is the physician’s determination of the participant’s Ps lesions overall at a given time point. The sPGA is recommended as an endpoint to use to assess efficacy in the treatment of Ps (EMEA 2004). Overall lesions are categorized by descriptions for induration, erythema, and scaling. For the analysis of responses, the participant's Ps is assessed at a given time point on a 6-point scale in which 0 = cleared, 1 = minimal, 2 = mild, 3 = moderate; 4 = severe, 5 = very severe.
Baseline in Subcutaneous Administration Assessment Questionnaire (SQAAQ)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 102 participants 102 participants 204 participants
Easy for me to learn how to use (n=99,101) 6.4  (1.08) 6.7  (0.91) 6.6  (1.01)
Easy for me to unlock (n=93,101) 6.4  (0.94) 6.7  (1.01) 6.6  (0.98)
Easy to hold in hand when I inject dose (n=99,101) 6.3  (1.27) 6.6  (0.97) 6.4  (1.14)
Easy to inject my dose (n=99,101) 6.2  (1.32) 6.6  (1.00) 6.4  (1.18)
Easy to know that my dose is complete (n=99,101) 6.4  (1.20) 6.7  (0.93) 6.6  (1.07)
Easy to store device in refrigerator (n=94, 97) 6.5  (0.88) 6.6  (1.00) 6.5  (0.94)
Easy to remove needle shield/cover (n=99, 100) 6.6  (0.67) 6.6  (1.09) 6.6  (0.91)
Easy to pick up (n=99, 100) 6.7  (0.67) 6.7  (0.94) 6.7  (0.81)
Overall, easy to use (n=99,101) 6.4  (1.10) 6.6  (0.99) 6.5  (1.05)
Device is stable during injection (n=99, 101) 6.3  (1.18) 6.6  (1.06) 6.5  (1.12)
Confident in ability to use the device (n=99, 101) 6.4  (1.16) 6.7  (1.06) 6.5  (1.12)
I am confident my dose is complete (n=98,101) 6.6  (1.09) 6.7  (0.89) 6.6  (0.99)
[1]
Measure Description: 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" and 7 represents "Strongly Agree".
1.Primary Outcome
Title Pharmacokinetics (PK): Maximum Serum Concentration (Cmax) by Drug Delivery Device
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 94 98
Geometric Mean (90% Confidence Interval)
Unit of Measure: micrograms/milliliter (µg/mL)
15.0
(13.9 to 16.1)
14.8
(13.8 to 15.9)
2.Primary Outcome
Title PK: Area Under the Concentration Time Curve From Time Zero to Last Measured Concentration Value (AUC 0-[Tlast]) by Drug Delivery Device
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 94 98
Geometric Mean (90% Confidence Interval)
Unit of Measure: micrograms*day/milliliter (µg*day/mL)
157
(147 to 168)
154
(144 to 165)
3.Secondary Outcome
Title PK: Cmax of Ixekizumab by Site of Injection (Arm, Thigh or Abdomen)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 92 98
Geometric Mean (90% Confidence Interval)
Unit of Measure: µg/ml
Arm (n=30, 29)
14.4
(12.4 to 16.8)
11.5
(10.1 to 13.0)
Abdomen (n=34, 32)
12.7
(11.3 to 14.2)
15.4
(13.5 to 17.5)
Thigh (n=28, 37)
18.5
(17.0 to 20.1)
17.6
(16.0 to 19.4)
4.Secondary Outcome
Title PK: AUC 0-tlast by Site of Injection (Arm, Thigh or Abdomen)
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 92 98
Geometric Mean (90% Confidence Interval)
Unit of Measure: µg*day/mL
Arm (n=30, 29)
151
(131 to 173)
124
(109 to 142)
Abdomen (n=34, 32)
135
(122 to 150)
159
(140 to 180)
Thigh (n=28, 37)
190
(176 to 206)
178
(163 to 194)
5.Secondary Outcome
Title PK: Cmax by Body Weight
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data for Cmax.
Arm/Group Title 80 mg Ixekizumab
Hide Arm/Group Description:
Ixekizumab administered via prefilled syringe and auto-injector 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.
Overall Number of Participants Analyzed 192
Geometric Mean (95% Confidence Interval)
Unit of Measure: µg/mL
Low <80 kg (n=68)
18.2
(16.9 to 19.5)
Medium 80-100 kg (n=64)
15.1
(13.8 to 16.5)
High >100 kg (n=60)
11.7
(10.8 to 12.7)
6.Secondary Outcome
Title PK: AUC 0-tlast by Body Weight
Hide Description 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)
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received at least 1 dose of study drug and had evaluable PK data for AUC.
Arm/Group Title 80 mg Ixekizumab
Hide Arm/Group Description:
Ixekizumab administered via prefilled syringe and auto-injector 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.
Overall Number of Participants Analyzed 192
Geometric Mean (90% Confidence Interval)
Unit of Measure: µg*day/mL
Low <80 kilograms (kg) (n=68)
193
(181 to 205)
Medium 80-100 kg (n=64)
155
(143 to 168)
High >100 kg (n=60)
122
(113 to 132)
7.Secondary Outcome
Title 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)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 102 102
Measure Type: Number
Unit of Measure: percentage of participants
PASI 75 88.2 78.4
PASI 90 76.5 62.7
PASI 100 48.0 42.2
8.Secondary Outcome
Title 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)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 102 102
Measure Type: Number
Unit of Measure: percentage of participants
80.4 73.5
9.Secondary Outcome
Title Percentage of Participants With a Static Physician Global Assessment (sPGA) (0)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
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/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 102 102
Measure Type: Number
Unit of Measure: percentage of participants
51.0 43.1
10.Secondary Outcome
Title Percentage of Device Operation Failures
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 102 102
Overall Number of Units Analyzed
Type of Units Analyzed: Injections
680 674
Measure Type: Number
Unit of Measure: percentage of incomplete injections
0 0.3
Show Statistical Analysis 1 Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection 80 mg Ixekizumab Prefilled Syringe, 80 mg Ixekizumab Auto-Injector
Comments [Not Specified]
Type of Statistical Test Superiority or Other
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.248
Comments [Not Specified]
Method Fisher Exact
Comments [Not Specified]
11.Secondary Outcome
Title Percentage of Participants With Anti-Ixekizumab Antibodies
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants who received a least 1 dose of study drug during the Treatment Period and had evaluable data.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 102 99
Measure Type: Number
Unit of Measure: percentage of participants
11.8 8.1
12.Secondary Outcome
Title SQAAQ Item Scores: Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)
Hide Description 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
Show Outcome Measure DataHide Outcome Measure Data
Hide Analysis Population Description
All randomized participants.
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe 80 mg Ixekizumab Auto-Injector
Hide Arm/Group Description:
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.
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.
Overall Number of Participants Analyzed 102 102
Mean (Standard Deviation)
Unit of Measure: units on a scale
Easy for me to learn how to use, Week 4 (n=94, 90) 6.6  (0.67) 6.7  (0.86)
Easy for me to unlock, Week 4 (n=86, 90) 6.6  (0.81) 6.8  (0.74)
Easy to hold in hand, Week 4 (n=94, 90) 6.6  (0.70) 6.6  (0.91)
Easy to inject my dose, Week 4 (n=94, 90) 6.6  (0.76) 6.7  (0.83)
Easy to know dose is complete, Week 4 (n=94, 90) 6.7  (0.53) 6.7  (0.79)
Easy to store in refrigerator, Week 4 (n=91, 88) 6.7  (0.54) 6.7  (0.77)
Easy to remove needle shield, Week 4 (n=94, 90) 6.6  (0.79) 6.6  (0.95)
Easy to pick up, Week 4 (n=94, 90) 6.8  (0.56) 6.7  (0.80)
Overall, easy to use, Week 4 (n=94, 90) 6.6  (0.70) 6.7  (0.82)
Device is stable against skin, Week 4 (n=93, 90) 6.6  (0.81) 6.6  (1.05)
Confident in ability to use, Week 4 (n=94, 90) 6.7  (0.62) 6.7  (0.83)
Confident my dose is complete, Week 4 (n=94, 90) 6.8  (0.44) 6.8  (0.71)
Easy for me to learn how to use, Week 8 (n=89, 92) 6.7  (0.63) 6.8  (0.69)
Easy for me to unlock, Week 8 (n=87, 92) 6.6  (0.67) 6.8  (0.69)
Easy to hold when I inject dose, Week 8 (n=89, 92) 6.6  (0.67) 6.7  (0.94)
Easy to inject my dose, Week 8 (n=89, 92) 6.5  (0.80) 6.8  (0.82)
Easy to know dose is complete, Week 8 (n=89, 92) 6.7  (0.52) 6.8  (0.70)
Easy to store in refrigerator, Week 8 (n=89, 92) 6.7  (0.62) 6.8  (0.72)
Easy to remove needle shield, Week 8 (n=89, 92) 6.6  (0.75) 6.7  (0.89)
Easy to pick up, Week 8 (n=89, 92) 6.7  (0.63) 6.8  (0.68)
Overall, easy to use, Week 8 (n=89, 92) 6.6  (0.76) 6.8  (0.74)
Device is stable against skin, Week 8 (n=88, 92) 6.6  (0.81) 6.6  (1.10)
Confident in ability to use, Week 8 (n=89, 92) 6.7  (0.77) 6.8  (0.71)
Confident my dose is complete, Week 8 (n=89, 92) 6.7  (0.47) 6.8  (0.70)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title 80 mg Ixekizumab Prefilled Syringe Treatment Period 80 mg Ixekizumab Auto-Injector Treatment Period 80 mg Ixe Prefilled Syringe Optional Safety Extension Follow Up Period
Hide Arm/Group Description 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. 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. One 80 mg Ixekizumab administered as an SC injection Q4W. All participants who received at least 1 dose of Ixekizumab entered the follow-up period.
All-Cause Mortality
80 mg Ixekizumab Prefilled Syringe Treatment Period 80 mg Ixekizumab Auto-Injector Treatment Period 80 mg Ixe Prefilled Syringe Optional Safety Extension Follow Up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
80 mg Ixekizumab Prefilled Syringe Treatment Period 80 mg Ixekizumab Auto-Injector Treatment Period 80 mg Ixe Prefilled Syringe Optional Safety Extension Follow Up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   3/102 (2.94%)      4/102 (3.92%)      9/185 (4.86%)      1/176 (0.57%)    
Cardiac disorders         
Acute myocardial infarction  1  0/102 (0.00%)  0 1/102 (0.98%)  1 0/185 (0.00%)  0 0/176 (0.00%)  0
Cardio-respiratory arrest  1  0/102 (0.00%)  0 0/102 (0.00%)  0 1/185 (0.54%)  1 0/176 (0.00%)  0
Supraventricular tachycardia  1  0/102 (0.00%)  0 0/102 (0.00%)  0 1/185 (0.54%)  2 0/176 (0.00%)  0
Gastrointestinal disorders         
Colitis  1  0/102 (0.00%)  0 0/102 (0.00%)  0 1/185 (0.54%)  1 0/176 (0.00%)  0
Gastric ulcer haemorrhage  1  0/102 (0.00%)  0 0/102 (0.00%)  0 1/185 (0.54%)  1 0/176 (0.00%)  0
Hepatobiliary disorders         
Cholecystitis  1  0/102 (0.00%)  0 0/102 (0.00%)  0 1/185 (0.54%)  1 0/176 (0.00%)  0
Immune system disorders         
Anaphylactic reaction  1  0/102 (0.00%)  0 1/102 (0.98%)  1 0/185 (0.00%)  0 0/176 (0.00%)  0
Infections and infestations         
Cellulitis  1  0/102 (0.00%)  0 0/102 (0.00%)  0 1/185 (0.54%)  1 1/176 (0.57%)  1
Diverticulitis  1  1/102 (0.98%)  1 0/102 (0.00%)  0 1/185 (0.54%)  1 0/176 (0.00%)  0
Tooth abscess  1  0/102 (0.00%)  0 1/102 (0.98%)  1 0/185 (0.00%)  0 0/176 (0.00%)  0
Urinary tract infection  1  1/102 (0.98%)  1 0/102 (0.00%)  0 0/185 (0.00%)  0 0/176 (0.00%)  0
Injury, poisoning and procedural complications         
Hip fracture  1  0/102 (0.00%)  0 1/102 (0.98%)  1 0/185 (0.00%)  0 0/176 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Squamous cell carcinoma of skin  1  1/102 (0.98%)  1 0/102 (0.00%)  0 0/185 (0.00%)  0 0/176 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Chronic obstructive pulmonary disease  1  0/102 (0.00%)  0 0/102 (0.00%)  0 2/185 (1.08%)  3 0/176 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
80 mg Ixekizumab Prefilled Syringe Treatment Period 80 mg Ixekizumab Auto-Injector Treatment Period 80 mg Ixe Prefilled Syringe Optional Safety Extension Follow Up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   12/102 (11.76%)      10/102 (9.80%)      24/185 (12.97%)      0/176 (0.00%)    
General disorders         
Injection site reaction  1  8/102 (7.84%)  12 5/102 (4.90%)  8 8/185 (4.32%)  8 0/176 (0.00%)  0
Infections and infestations         
Upper respiratory tract infection  1  4/102 (3.92%)  4 5/102 (4.90%)  5 16/185 (8.65%)  19 0/176 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 18.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Chief Medical Officer
Organization: Eli Lilly and Company
Phone: 800-545-5979
Responsible Party: Eli Lilly and Company
ClinicalTrials.gov Identifier: NCT01777191     History of Changes
Other Study ID Numbers: 14728
I1F-MC-RHBL ( Other Identifier: Eli Lilly and Company )
First Submitted: January 24, 2013
First Posted: January 28, 2013
Results First Submitted: April 20, 2016
Results First Posted: May 26, 2016
Last Update Posted: October 24, 2016