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A Study in Japanese Participants With Moderate-to-Severe Psoriasis (UNCOVER-J)

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: NCT01624233
Recruitment Status : Completed
First Posted : June 20, 2012
Results First Posted : September 30, 2016
Last Update Posted : November 15, 2018
Sponsor:
Information provided by (Responsible Party):
Eli Lilly and Company

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Psoriasis
Intervention Drug: 80 mg ixekizumab
Enrollment 91
Recruitment Details Period 2-Induction Dosing Period (Weeks 0 up to 12), Period 3-Maintenance Dosing Period (Weeks 12 up to 52), Period 4-Drug Free Period (Weeks 52 up to 100), Period 5-Retreatment Period (up to 192 additional weeks) and Period 6-Post-Treatment Follow-Up Period up to 12 weeks after the last visit.
Pre-assignment Details  
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description

Ixekizumab:

Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).

Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks.

Period Title: Period 2 - Induction
Started 91
Received at Least 1 Dose of Study Drug 91
Erythrodermic Psoriasis (Ps) 8
Pustular Ps 5
Plaque Ps 78
Completed 90
Not Completed 1
Reason Not Completed
Adverse Event             1
Period Title: Period 3 - Maintenance
Started 90
Received at Least 1 Dose of Study Drug 90
Completed 83
Not Completed 7
Reason Not Completed
Adverse Event             2
Lack of Efficacy             1
Physician Decision             2
Withdrawal by Subject             2
Period Title: Period 4 - Drug Free Period
Started 70 [1]
Adverse Event 1 [2]
Physician Decision 1 [3]
Completed 9
Not Completed 61
Reason Not Completed
Relapsed             61
[1]
Only responders in participants with plaque Ps moved to the Drug Free Period 4.
[2]
1 participant who discontinued due to adverse event is included in the participants who relapsed.
[3]
1 participant who discontinued due to physician decision is included in the participants relapsed.
Period Title: Period 5 - Retreatment Period
Started 80 [1]
Completed 70
Not Completed 10
Reason Not Completed
Adverse Event             5
Lack of Efficacy             1
Physician Decision             1
Withdrawal by Subject             3
[1]
Period 5 included (participants with erythrodermic Ps or pustular Ps) or Period 4 completers.
Period Title: Period 6: Follow-up
Started 88 [1]
Completed 79
Not Completed 9
Reason Not Completed
Adverse Event             3
Lack of Efficacy             2
Physician Decision             1
Withdrawal by Subject             3
[1]
Period 6 included participants received a dose of drug and exhibited the required neutrophil count.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Baseline Participants 91
Hide Baseline Analysis Population Description
All enrolled participants.
Age, Continuous  
Mean (Standard Deviation)
Unit of measure:  Years
Number Analyzed 91 participants
46.2  (11.89)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants
Female
21
  23.1%
Male
70
  76.9%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants
Hispanic or Latino
0
   0.0%
Not Hispanic or Latino
91
 100.0%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 91 participants
American Indian or Alaska Native
0
   0.0%
Asian
91
 100.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
0
   0.0%
White
0
   0.0%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Japan Number Analyzed 91 participants
91
Psoriasis Area and Severity Index (PASI) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants
27.24  (10.545)
[1]
Measure Description: The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0(no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Static Physician Global Assessment (sPGA) Score   [1] 
Measure Type: Number
Unit of measure:  Participants
0: Clear Number Analyzed 91 participants
0
1: Minimal Number Analyzed 91 participants
0
2: Mild Number Analyzed 91 participants
1
3: Moderate Number Analyzed 91 participants
26
4: Severe Number Analyzed 91 participants
53
5: Very Severe Number Analyzed 91 participants
11
[1]
Measure 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. Participants Ps were assessed as clear (0), minimal (1), mild (2), moderate (3), severe (4), or very severe (5).
Percentage (%) of Body Surface Area (BSA)   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants
45.5  (23.22)
[1]
Measure Description: BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), where 1% corresponds to the size of the participant's hand (includes the palm, fingers and thumb). Total BSA is the sum of handprints from the affected areas.
Nail Psoriasis Severity Index (NAPSI) Total Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 56 participants
31.1  (22.16)
[1]
Measure Description: The NAPSI scale evaluates Ps severity in the fingernail bed and fingernail matrix with each divided into quadrants. Scores range from 0 (none) to 4 (Ps in all 4 quadrants), depending on the presence (score of 1) or absence (score of 0) of Ps in each quadrant of the fingernail bed or matrix. NAPSI score of a fingernail is the sum of scores from each quadrant of the fingernail bed and fingernail matrix (maximum of 8). The total NAPSI score equals the sum of all fingernails and ranges from 0 to 80. Higher scores indicate more severe Ps.
[2]
Measure Analysis Population Description: Only participants with non-missing data were included.
Psoriasis Scalp Severity Index (PSSI) Total Score   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 87 participants
27.0  (15.99)
[1]
Measure Description: The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total score ranging from 0 (less severity) to 72 (more severity).
[2]
Measure Analysis Population Description: Only participants with non-missing data were included.
Quick Inventory of Depressive Symptomatology-Self Reported 16 Items(QIDS-SR16) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants
4.6  (4.14)
[1]
Measure Description: QIDS-SR16 is a participant-administered, 16-item instrument assesses the existence and severity of symptoms of depression. A participant is asked a statement relating to the way they have felt for the past 7 days and rate on a 4-point scale: 0 (best) to 3 (worst). The sum of the domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance, decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.
Itch Numeric Rating Scale (NRS) Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants
6.1  (2.53)
[1]
Measure Description: The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Quick Inventory of Depressive Symptomatology-Self Reported (DLQI) Total Score   [1] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 91 participants
10.8  (6.50)
[1]
Measure Description: DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered ("not relevant") responses were scored as "0." Total scores range from 0 to 30, with higher score indicating greater quality of life impairment.
Joint Pain Visual Analog Scale (VAS)   [1] [2] 
Mean (Standard Deviation)
Unit of measure:  Units on a scale
Number Analyzed 11 participants
62.4  (23.79)
[1]
Measure Description: The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).
[2]
Measure Analysis Population Description: Only participants with non-missing data were included.
1.Primary Outcome
Title Percentage of Participants Achieving ≥75% Improvement in Psoriasis Area and Severity Index (PASI) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis. Measure: PASI)
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Week (Wk) 12
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least one dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to specified time points were defined as non-responders for Non-Responder Imputation (NRI) analysis.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
98.7
2.Secondary Outcome
Title Percentage of Participants Achieving ≥75% Improvement in PASI
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region, the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Wks 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 measurement of PASI after study treatment. Non-responders and participants who discontinued at any time prior to Wk 52 were defined as non-responders for NRI analysis.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
Wk 24 95.9
Wk 52 92.3
3.Secondary Outcome
Title Pharmacokinetics (PK): Ctrough at Steady State (Ctrough ss) of Ixekizumab
Hide Description PK samples were from 1 or 2 sampling cohorts. Ctrough is the minimum observed concentration of ixekizumab at steady state. Steady-state ixekizumab trough concentrations were summarized for the induction dosing period at week 12, the time of the primary efficacy assessment. Steady-state ixekizumab trough concentrations were summarized for the maintenance dosing period at week 24.
Time Frame Pre-dose at Wks 12 (Day 84) and Wks24 (Day 168)
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who had at least 1 dose of study drug and evaluable Ctrough data at the specified time points.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 43
Geometric Mean (Geometric Coefficient of Variation)
Unit of Measure: micrograms/milliliter (µg/mL)
Wk 12 (80 mg Q2W) Cohort 2 Number Analyzed 22 participants
9.63
(43.6%)
Wk 24 (80 mg Q4W) Cohort 1 Number Analyzed 21 participants
3.48
(65.4%)
4.Secondary Outcome
Title Number of Participants With Anti-Ixekizumab Antibodies
Hide Description Treatment-emergent immunogenicity is defined as any occurrence of a 4-fold or 2-dilution increase in titer over the pretreatment baseline titer. In the case of a negative result at baseline, treatment-emergent immunogenicity is defined as an increase in titer to ≥1:10.
Time Frame Baseline through Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps, Pustular Ps or Erythrodermic Ps who received at least 1 dose of study drug.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 91
Measure Type: Number
Unit of Measure: participants
Plaque Ps Number Analyzed 78 participants
10
Erythrodermic Ps Number Analyzed 8 participants
0
Pustular Ps Number Analyzed 5 participants
0
5.Secondary Outcome
Title Percent of Participants Achieving PASI 90% and 100% Improvement
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated from 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Wks 12, 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 12 and 52.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
Wk 12 (80 mg Q2W) PASI 90% 83.3
Wk 12 (80 mg Q2W) PASI 100% 32.1
Wk 24 (80 mg Q4W) PASI 90% 90.5
Wk 24 (80 mg Q4W) PASI 100% 48.6
Wk 52 (80 mg Q4W) PASI 90% 80.8
Wk 52 (80 mg Q4W) PASI 100% 48.7
6.Secondary Outcome
Title Percentage of Participants With Static Physician Global Assessment (sPGA) (0 or 1) or sPGA (0) (Efficacy of Ixekizumab in Participants With Moderate to Severe Plaque Psoriasis Measure: sPGA)
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. Participants Ps were assessed as 0 (clear) or 1 (minimal).
Time Frame Wks 12, 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of sPGA after study treatment. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI analysis for Wks 12 and 52.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Measure Type: Number
Unit of Measure: percentage of participants
Wk 12 (80 mg Q2W) sPGA (0 or 1) 89.7
Wk 24 (80 mg Q4W) sPGA (0 or 1) 89.2
Wk 52 (80 mg Q4W) sPGA (0 or 1) 83.3
Wk 12 (80 mg Q2W) sPGA (0) 35.9
Wk 24 (80 mg Q4W) sPGA (0) 51.4
Wk 52 (80 mg Q4W) sPGA (0) 52.6
7.Secondary Outcome
Title Change From Baseline in Percent of Body Surface Area (BSA) Involvement
Hide Description BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).
Time Frame Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps with a baseline and at least 1 post-dose result. Participants with missing BSA at Wks 12 and 52 were imputed by last observation carried forward (LOCF).
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
Wk 12 (80 mg Q2W) -38.3  (19.26)
Wk 24 (80 mg Q4W) -41.2  (20.23)
Wk 52 (80 mg Q4W) -40.8  (19.73)
8.Secondary Outcome
Title Change From Baseline in Nail Psoriasis Severity Index (NAPSI)
Hide Description The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all fingernails equals the total NAPSI score with a range from range 0 to 80. Higher scores indicated more severe psoriasis.
Time Frame Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants Plaque Ps with NAPSI at baseline and at least 1 post dose result. Participants with missing NAPSI at Wks 12 and 52 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 44
Mean (Standard Deviation)
Unit of Measure: units on a scale
Wk 12 (80 mg Q2W) -7.7  (14.65)
Wk 24 (80 mg Q4W) -20.5  (19.42)
Wk 52 (80 mg Q4W) -23.4  (23.67)
9.Secondary Outcome
Title Change From Baseline in Psoriasis Scalp Severity Index (PSSI)
Hide Description The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.
Time Frame Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps with a PSSI baseline and at least 1 post-dose result. Participants with missing PSSI at Wks 12 and 52 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 76
Mean (Standard Deviation)
Unit of Measure: units on a scale
Wk 12 (80 mg Q2W) -24.8  (15.12)
Wk 24 (80 mg Q4W) -24.9  (15.11)
Wk 52 (80 mg Q4W) -23.3  (16.48)
10.Secondary Outcome
Title Change From Baseline in Quick Inventory of Depressive Symptomatology-Self Reported 16 Items (QIDS-SR16) Score [Quality of Life and Outcome Assessments. Measures: Patient Reported Outcomes (PRO)]
Hide Description QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst). The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] to give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.
Time Frame Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Plaque Ps who had QIDS-SR16 at baseline and at least 1 post-dose result. Participants with missing QIDS-SR16 at Wks 12 and 52 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Wk 12 (80 mg Q2W) -1.1  (3.65)
Wk 24 (80 mg Q4W) -1.6  (3.80)
Wk 52 (80 mg Q4W) -1.4  (3.57)
11.Secondary Outcome
Title Change From Baseline in Itch Numeric Rating Scale (NRS) Score
Hide Description The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10 (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time Frame Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Plaque Ps who had Itch NRS at baseline and at least 1 post-dose result. Participants with missing Itch NRS at Wks 12 and 52 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Wk 12 (80 mg Q2W) -4.7  (2.68)
Wk 24 (80 mg Q4W) -4.8  (2.90)
Wk 52 (80 mg Q4W) -4.8  (2.83)
12.Secondary Outcome
Title Change From Baseline in Dermatology Life Quality Index (DLQI) Score
Hide Description DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher score indicating greater quality of life is impairment. A 5-point increase in total score from baseline is considered clinically relevant.
Time Frame Baseline, Wk 12; Baseline, Wk 24; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with Plaques Ps who had DLQI at baseline and at least 1 post-dose result. Participants with missing DLQI at Wks 12 and 52 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 78
Mean (Standard Deviation)
Unit of Measure: units on a scale
Wk 12 (80 mg Q2W) -9.2  (5.75)
Wk 24 (80 mg Q4W) -9.2  (6.57)
Wk 52 (80 mg Q4W) -9.6  (6.24)
13.Secondary Outcome
Title Number of Participants Achieving American College of Rheumatology 20% (ACR20) Improvement [Efficacy of Ixekizumab in Participants With Psoriatic Arthritis (PsA) as Measured by ACR20]
Hide Description ACR20 response is defined as a ≥20% improvement from baseline for tender joint count (TJC) and swollen joint count (SJC) and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain visual analog scale (VAS), Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the Health Assessment Questionnaire Disability Index (HAQ-DI), or C-reactive protein (CRP) or the erythrocyte sedimentation rate (ESR).
Time Frame Wks 12, 24 and 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 5
Measure Type: Number
Unit of Measure: participants
Wk 12 (80 mg Q2W) 4
Wk 24 (80 mg Q4W) 4
Wk 52 (80 mg Q4W) 5
14.Secondary Outcome
Title Change From Baseline in Participants Assessment of Joint Pain Visual Analog Scale (VAS) (Efficacy of Ixekizumab in Participants With PsA Pain VAS)
Hide Description The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0 mm (no pain) to 100 mm (pain as severe as you can imagine).
Time Frame Baseline, Wk 12; Baseline, Wk 52
Hide Outcome Measure Data
Hide Analysis Population Description
Participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 5
Mean (Standard Deviation)
Unit of Measure: mm
Wk 12 (80 mg Q2W) -47.3  (22.05)
Wk 52 (80 mg Q4W) -51.0  (19.05)
15.Secondary Outcome
Title Percent of Participants Achieving PASI 75%, 90% and/or 100% Improvement
Hide Description The PASI combines the extent of body surface involvement in 4 anatomical regions (head, trunk, arms, and legs). For each region the percent area of skin involved was estimated: 0 (0%) to 6 (90%-100%) and severity was estimated by clinical signs of erythema, induration and scaling, with a scores range from 0 (no involvement) to 4 (severe involvement). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI=sum of severity parameters for each region * area score * weighing factor [head (0.1), upper limbs (0.2), trunk (0.3), lower limbs (0.4)]. Overall scores range from 0 (no Ps) to 72 (the most severe disease).
Time Frame Wk 100 and Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-milligram (mg) subcutaneous (SC) injections at Week 0, followed by 80 mg given as 1 SC injection every 2 weeks (Q2W) (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection every 4 weeks (Q4W) (Week 12 up to Week 52).

Period 4 - No ixekizumab administered (drug-free). Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80-mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants
Wk 100, PASI 75 7.5
Wk 100, PASI 90 3.0
Wk 100, PASI 100 0
Wk 192, PASI 75 0
Wk 192, PASI 90 0
Wk 192, PASI 100 0
16.Secondary Outcome
Title Percentage of Participants With sPGA (0 or 1) and 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. Participants Ps were assessed as 0 (clear) or 1 (minimal).
Time Frame Wk 100 and Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 67
Measure Type: Number
Unit of Measure: percentage of participants
Wk 100, sPGA(0, 1) 4.5
Wk 100, sPGA(0) 0
Wk 192, sPGA(0, 1) 0
Wk 192, sPGA(0) 0
17.Secondary Outcome
Title Change From Baseline in Percent of BSA Involvement
Hide Description BSA is a physician rating of the percentage of involvement of Ps for each participant. BSA is assessed on a continuous scale from 0% (no involvement) to 100% (full involvement), in which 1% corresponds to the size of the participants hand (includes the palm, fingers and thumb).
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing BSA at Wks 100 and 192 were imputed by last observation carried forward (LOCF).
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: percentage of BSA
Baseline, Wk 100 -24.7  (17.32)
Baseline, Wk 192 -40.2  (21.18)
18.Secondary Outcome
Title Change From Baseline in NAPSI
Hide Description The NAPSI is a numeric, reproducible, objective tool for evaluation of fingernail Ps. This scale is used to evaluate the severity of fingernail bed Ps and fingernail matrix Ps by area of involvement in the fingernail unit. The fingernail is divided with imaginary horizontal and longitudinal lines into quadrants. Each fingernail is given a score for fingernail bed Ps 0 (none) to 4 (Ps in 4 quadrants of the fingernail) and fingernail matrix Ps 0 (none) to 4 (Ps in 4 quadrants in matrix), depending on the presence (score of 1) or absence (score of 0) of any of the features of fingernail bed or matrix Ps in each quadrant. The NAPSI score of a fingernail is the sum of scores in fingernail bed and fingernail matrix from each quadrant (maximum of 8). Each fingernail is evaluated, then the sum of all the fingernails equals the total NAPSI score with a range 0 to 80. Higher scores indicate more severe psoriasis.
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing NAPSI at Wks 100 and 192 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 36
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, Wk 100 -16.8  (19.87)
Baseline, Wk 192 -21.4  (26.31)
19.Secondary Outcome
Title Change From Baseline in PSSI
Hide Description The PSSI is a physician assessment of erythema, induration and desquamation and percent of scalp that is covered with a scores range from 0 (none) to 4 (very severe). The composite score is derived from the sum of scores for erythema, induration, and desquamation multiplied by the score recorded for the extent of the scalp area involved, 1 (<10%) to 6 (90%-100%) with a total scores range from 0 to 72, with lower scores indicating less severity.
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing PSSI at Wks 100 and 192 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 64
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, Wk 100 -8.5  (16.16)
Baseline, Wk 192 -23.2  (15.17)
20.Secondary Outcome
Title Change From Baseline in QIDS-SR16 Score
Hide Description QIDS-SR16 is a participant-administered, 16-item instrument intended to assess the existence and severity of symptoms of depression. A participant is asked to consider each statement as it relates to the way they have felt for the past 7 days and rate each on a 4-point scale: 0 (best) to 3 (worst) scale. The sum of the 16 items corresponding to 9 depression domains [sad mood, concentration, self-criticism, suicidal ideation, interest, energy/fatigue, sleep disturbance (initial, middle and late insomnia or hypersomnia), decrease/increase in appetite/weight, and psychomotor agitation/retardation] give a single total scores range from 0 to 27, with higher scores indicating greater symptom severity.
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing QIDS-SR16 at Wks 100 and 192 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 46
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, Wk 100 -0.5  (4.02)
Baseline, Wk 192 -1.8  (3.87)
21.Secondary Outcome
Title Change From Baseline in Itch NRS Score
Hide Description The Itch NRS is a participant-administered, 11-point horizontal scale anchored at 0 (no itch) and 10, (worst itch imaginable). Overall severity of a participant's itching from Ps is indicated by circling the number that best describes the worst level of itching in the past 24 hours.
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Itch NRS at Wks 100 and 192 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, Wk 100 -1.1  (2.62)
Baseline, Wk 192 -4.9  (2.59)
22.Secondary Outcome
Title Change From Baseline in DLQI Score
Hide Description DLQI is a participant-administered, 10-question, validated, quality-of-life questionnaire that covers 6 domains, including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. Response categories include 0 (not at all), 1 (a little), 2 (a lot), and 3 (very much) and unanswered (“not relevant”) responses were scored as “0.” Total scores range from 0 to 30, with higher scores indicating greater quality of life impairment. A 5-point increase in total score from baseline is considered clinically relevant.
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing DLQI at Wks 100 and 192 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 67
Mean (Standard Deviation)
Unit of Measure: units on a scale
Baseline, Wk 100 -2.3  (4.83)
Baseline, Wk 192 -8.9  (5.70)
23.Secondary Outcome
Title Change From Baseline in Participants Assessment of Joint Pain VAS
Hide Description The pain VAS is a participant-administered single-item scale designed to measure current joint pain from PsA using a 100-mm horizontal VAS. Overall severity of participant's joint pain from PsA is indicated by placing a single mark on the horizontal 100-mm scale from 0mm (no pain) to 100 mm (pain as severe as you can imagine).
Time Frame Baseline, Wk 100; Baseline, Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants with missing Joint Pain VAS at Wks 100 and 192 were imputed by LOCF.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 10
Mean (Standard Deviation)
Unit of Measure: mm
Baseline, Wk 100 -12.8  (39.59)
Baseline, Wk 192 -43.8  (25.66)
24.Secondary Outcome
Title Number of Participants Achieving ACR20
Hide Description

ACR20 response is defined as ≥20% improvement from baseline for TJC and SJC and in at least 3 of the following 5 criteria: participant's assessment of Joint Pain VAS, Patient’s Global Assessment of Disease Activity VAS, Physician's Global Assessment of the Disease Activity VAS, participant's assessment of physical function using the HAQ-DI, or CRP or the ESR.

Analysis population included participants with PsA who had 3 or more tender joints and 3 or more swollen joints at screening and baseline.

Time Frame Wk 100 and Wk Retreatment Wk 192
Hide Outcome Measure Data
Hide Analysis Population Description
All participants with Plaque Ps who received at least 1 dose of study drug and had at least 1 post-dose measurement of PASI after study treatment and entered Period 5. Participants who discontinued treatment at any time prior to the specified time points were defined as non-responders for NRI at Wks 100 and 192.
Arm/Group Title 80 mg Ixekizumab (LY2439821)
Hide Arm/Group Description:

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Overall Number of Participants Analyzed 10
Measure Type: Count of Participants
Unit of Measure: Participants
Wk 100 0
Wk 192 0
Time Frame [Not Specified]
Adverse Event Reporting Description All enrolled participants.
 
Arm/Group Title LY2439821 80mg-Combined Induction and Maintenance Periods LY2439821 80mg-Drug-Free Period LY2439821 80mg-Retreatment Period LY2439821 80mg-Post-Treatment Follow-Up Period
Hide Arm/Group Description

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

Ixekizumab:

Period 2 - Participants were administered two 80-mg SC injections at Week 0, followed by 80-mg given as 1 SC injection Q2W (Weeks 2, 4, 6, 8, and 10).

Period 3 - Participants were administered 80-mg as 1 SC injection Q4W (Week 12 up to Week 52) Period 4 - No ixekizumab administered (drug-free), (Week 52 up to Week 100) Period 5 - Participants who had a Ps relapse during the drug-free period (Period 4) or who completed Period 4 were administered 80 mg as 1 SC injection Q4W for up to 192 weeks.

All-Cause Mortality
LY2439821 80mg-Combined Induction and Maintenance Periods LY2439821 80mg-Drug-Free Period LY2439821 80mg-Retreatment Period LY2439821 80mg-Post-Treatment Follow-Up Period
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--      --/--      --/--      --/--    
Show Serious Adverse Events Hide Serious Adverse Events
LY2439821 80mg-Combined Induction and Maintenance Periods LY2439821 80mg-Drug-Free Period LY2439821 80mg-Retreatment Period LY2439821 80mg-Post-Treatment Follow-Up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   4/91 (4.40%)      3/70 (4.29%)      9/80 (11.25%)      0/88 (0.00%)    
Gastrointestinal disorders         
Diverticulum intestinal haemorrhagic  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Large intestine polyp  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Hepatobiliary disorders         
Cholelithiasis  1  1/91 (1.10%)  1 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Hyperplastic cholecystopathy  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Infections and infestations         
Cytomegalovirus infection  1  0/91 (0.00%)  0 1/70 (1.43%)  1 0/80 (0.00%)  0 0/88 (0.00%)  0
Pharyngotonsillitis  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Pneumonia  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Injury, poisoning and procedural complications         
Ankle fracture  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Hand fracture  1  0/91 (0.00%)  0 1/70 (1.43%)  1 1/80 (1.25%)  1 0/88 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Intervertebral disc protrusion  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Spondylolisthesis  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)         
Colon cancer  1  1/91 (1.10%)  1 0/70 (0.00%)  0 0/80 (0.00%)  0 0/88 (0.00%)  0
Gastric cancer  1  0/91 (0.00%)  0 1/70 (1.43%)  1 0/80 (0.00%)  0 0/88 (0.00%)  0
Haemangioma  1  0/91 (0.00%)  0 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Pulmonary embolism  1  1/91 (1.10%)  1 0/70 (0.00%)  0 0/80 (0.00%)  0 0/88 (0.00%)  0
Sleep apnoea syndrome  1  1/91 (1.10%)  1 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Vascular disorders         
Deep vein thrombosis  1  1/91 (1.10%)  1 0/70 (0.00%)  0 0/80 (0.00%)  0 0/88 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
LY2439821 80mg-Combined Induction and Maintenance Periods LY2439821 80mg-Drug-Free Period LY2439821 80mg-Retreatment Period LY2439821 80mg-Post-Treatment Follow-Up Period
Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events Affected / at Risk (%) # Events
Total   61/91 (67.03%)      18/70 (25.71%)      52/80 (65.00%)      2/88 (2.27%)    
Gastrointestinal disorders         
Diarrhoea  1  5/91 (5.49%)  10 1/70 (1.43%)  1 1/80 (1.25%)  1 0/88 (0.00%)  0
General disorders         
Injection site reaction  1  8/91 (8.79%)  45 0/70 (0.00%)  0 2/80 (2.50%)  7 0/88 (0.00%)  0
Pyrexia  1  2/91 (2.20%)  8 0/70 (0.00%)  0 5/80 (6.25%)  9 0/88 (0.00%)  0
Hepatobiliary disorders         
Hepatic function abnormal  1  0/91 (0.00%)  0 1/70 (1.43%)  1 7/80 (8.75%)  8 0/88 (0.00%)  0
Hepatic steatosis  1  2/91 (2.20%)  2 1/70 (1.43%)  1 5/80 (6.25%)  5 0/88 (0.00%)  0
Immune system disorders         
Seasonal allergy  1  6/91 (6.59%)  6 0/70 (0.00%)  0 3/80 (3.75%)  3 0/88 (0.00%)  0
Infections and infestations         
Folliculitis  1  3/91 (3.30%)  3 2/70 (2.86%)  4 7/80 (8.75%)  7 0/88 (0.00%)  0
Influenza  1  2/91 (2.20%)  2 3/70 (4.29%)  3 9/80 (11.25%)  12 0/88 (0.00%)  0
Viral upper respiratory tract infection  1  36/91 (39.56%)  48 6/70 (8.57%)  8 16/80 (20.00%)  28 0/88 (0.00%)  0
Investigations         
Alanine aminotransferase increased  1  5/91 (5.49%)  5 2/70 (2.86%)  2 0/80 (0.00%)  0 0/88 (0.00%)  0
Musculoskeletal and connective tissue disorders         
Arthralgia  1  7/91 (7.69%)  7 2/70 (2.86%)  2 5/80 (6.25%)  5 0/88 (0.00%)  0
Back pain  1  4/91 (4.40%)  5 2/70 (2.86%)  2 6/80 (7.50%)  6 2/88 (2.27%)  2
Nervous system disorders         
Headache  1  5/91 (5.49%)  5 2/70 (2.86%)  2 3/80 (3.75%)  3 0/88 (0.00%)  0
Respiratory, thoracic and mediastinal disorders         
Oropharyngeal pain  1  6/91 (6.59%)  6 1/70 (1.43%)  1 2/80 (2.50%)  2 0/88 (0.00%)  0
Skin and subcutaneous tissue disorders         
Dermatitis contact  1  6/91 (6.59%)  9 0/70 (0.00%)  0 5/80 (6.25%)  5 0/88 (0.00%)  0
Eczema  1  11/91 (12.09%)  13 1/70 (1.43%)  1 10/80 (12.50%)  11 0/88 (0.00%)  0
Eczema asteatotic  1  3/91 (3.30%)  3 0/70 (0.00%)  0 9/80 (11.25%)  9 0/88 (0.00%)  0
Pruritus  1  6/91 (6.59%)  6 0/70 (0.00%)  0 5/80 (6.25%)  5 0/88 (0.00%)  0
Seborrhoeic dermatitis  1  8/91 (8.79%)  9 0/70 (0.00%)  0 1/80 (1.25%)  1 0/88 (0.00%)  0
Urticaria  1  8/91 (8.79%)  8 3/70 (4.29%)  3 3/80 (3.75%)  4 0/88 (0.00%)  0
Vascular disorders         
Hypertension  1  1/91 (1.10%)  1 0/70 (0.00%)  0 7/80 (8.75%)  7 0/88 (0.00%)  0
Indicates events were collected by systematic assessment
1
Term from vocabulary, MedDRA 20.0
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: NCT01624233     History of Changes
Other Study ID Numbers: 13976
I1F-JE-RHAT ( Other Identifier: Eli Lilly and Company )
First Submitted: June 18, 2012
First Posted: June 20, 2012
Results First Submitted: April 20, 2016
Results First Posted: September 30, 2016
Last Update Posted: November 15, 2018