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Clinical Trial Results:
A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis

Summary
EudraCT number	2010-018948-14
Trial protocol	DK
Global end of trial date	02 Aug 2016

Results information
Results version number	v1(current)
This version publication date	18 Aug 2017
First version publication date	18 Aug 2017
Other versions

Trial Information
Subject Disposition
Baseline Characteristics
End Points
Adverse Events
More Information

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Trial information

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Sponsor protocol code

I1F-MC-RHAJ

ISRCTN number

US NCT number

NCT01107457

WHO universal trial number (UTN)

Other trial identifiers

Trial Number: 12060

Sponsor organisation name

Eli Lilly and Company

Sponsor organisation address

Lilly Corporate Center, Indianapolis, IN, United States, 46285

Public contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐CTLilly,

Scientific contact

Available Mon ‐ Fri 9 AM ‐ 5 PM EST, Eli Lilly and Company, 1 877‐285‐4559,

Is trial part of an agreed paediatric investigation plan (PIP)

Does article 45 of REGULATION (EC) No 1901/2006 apply to this trial?

Does article 46 of REGULATION (EC) No 1901/2006 apply to this trial?

Analysis stage

Final

Date of interim/final analysis

02 Aug 2016

Is this the analysis of the primary completion data?

Global end of trial reached?

Yes

Global end of trial date

02 Aug 2016

Was the trial ended prematurely?

Main objective of the trial

The primary purpose for this study is to help answer the following research questions •The safety of ixekizumab (LY2439821) and any side effects that might be associated with it. •Whether ixekizumab can help participants with Psoriasis. •How much ixekizumab should be given to participants.

Protection of trial subjects

This study was conducted in accordance with International Conference on Harmonization (ICH) Good Clinical Practice, and the principles of the Declaration of Helsinki, in addition to following the laws and regulations of the country or countries in which a study is conducted.

Background therapy

Evidence for comparator

Actual start date of recruitment

19 Apr 2010

Long term follow-up planned

Yes

Long term follow-up rationale

Safety, Efficacy

Long term follow-up duration

5 Years

Independent data monitoring committee (IDMC) involvement?

Number of subjects enrolled per country

Country: Number of subjects enrolled

Denmark: 3

Country: Number of subjects enrolled

United States: 139

Worldwide total number of subjects

142

EEA total number of subjects

Number of subjects enrolled per age group

In utero

Preterm newborn - gestational age < 37 wk

Newborns (0-27 days)

Infants and toddlers (28 days-23 months)

Children (2-11 years)

Adolescents (12-17 years)

Adults (18-64 years)

134

From 65 to 84 years

85 years and over

Subject disposition

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Recruitment details

This study has 3 parts:Part A is a randomized, double-blind, placebo-controlled, parallel-group, dose ranging design (approximately 20-40 weeks [wks]).Treatment durability (sustained efficacy off treatment) from Week 20 up to Week 32 was evaluated during Part A.

Screening details

Part B is an optional extension period with an open-label design (approximately 240 weeks). Part C is an additional optional extension period with an open-label design(up to approximately 104 weeks).

Period 1 title

Part A

Is this the baseline period?

Yes

Allocation method

Randomised - controlled

Blinding used

Double blind

Roles blinded

Subject, Investigator, Carer, Assessor

Are arms mutually exclusive

Yes

Placebo

Arm description

Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Arm type

Placebo

Investigational medicinal product name

Placebo

Investigational medicinal product code

Other name

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

10 mg ixekizumab

Arm description

Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Arm type

Experimental

Investigational medicinal product name

ixekizumab

Investigational medicinal product code

Other name

LY2439821,Taltz

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

25 mg ixekizumab

Arm description

Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

Other name

LY2439821,Taltz

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

75 mg ixekizumab

Arm description

Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

Other name

LY2439821,Taltz

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

150 mg ixekizumab

Arm description

Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

Other name

LY2439821,Taltz

Pharmaceutical forms

Powder for solution for injection

Routes of administration

Subcutaneous use

Dosage and administration details

150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Number of subjects in period 1	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Started	27	28	30	29	28
Received at Least 1 Dose of Study Drug	27	28	30	29	28
Completed	22	21	29	26	27
Not completed	5	7	1	3	1
Consent withdrawn by subject	3	3	-	3	1
Adverse event, non-fatal	1	2	1	-	-
Lost to follow-up	-	1	-	-	-
Lack of efficacy	1	-	-	-	-
Protocol deviation	-	1	-	-	-

Period 2 title

Part B and C

Is this the baseline period?

Allocation method

Non-randomised - controlled

Blinding used

Not blinded

120 mg/80 mg Total Ixekizumab

Arm description

Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344. Part C was stopped once ixekizumab became available through marketing authorization. Only participants with neutropenia entered the post treatment safety visits. No participants completed the study as Part C was stopped.

Arm type

Experimental

Investigational medicinal product name

Ixekizumab

Investigational medicinal product code

Other name

LY2439821,Taltz

Pharmaceutical forms

Solution for injection in pre-filled syringe

Routes of administration

Subcutaneous use

Dosage and administration details

Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236. Part C: (optional) 80 mg ixekizumab given SC Q4W through week 344. Note: The pharmaceutical form of drug in the first part of Part B was powder for solution for injection.

Number of subjects in period 2 ^[1]	120 mg/80 mg Total Ixekizumab
Started	120
Completed Part B (Week 240)	74
Completed Part C	0
Post Treatment Safety Visits	6
Completed	0
Not completed	120
Inclusion/Exclusion Criteria Not Met	1
Physician decision	3
Consent withdrawn by subject	16
Clinical Relapse	4
Adverse event, non-fatal	12
Sponsor Decision	66
Lost to follow-up	10
Lack of efficacy	7
Protocol deviation	1

Notes
[1] - The number of subjects starting the period is not consistent with the number completing the preceding period. It is expected the number of subjects starting the subsequent period will be the same as the number completing the preceding period.
Justification: 80 and 120 mg ixekizumab were only administered during Part B and C. Not all participants that participated in Part A moved to Part B and C.

Baseline characteristics

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Reporting group title

Placebo

Reporting group description

Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

10 mg ixekizumab

Reporting group description

Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

25 mg ixekizumab

Reporting group description

Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

75 mg ixekizumab

Reporting group description

Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

150 mg ixekizumab

Reporting group description

Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab	Total
Number of subjects	27	28	30	29	28	142
Age categorical
Units: Subjects
In utero						0
Preterm newborn infants (gestational age < 37 wks)						0
Newborns (0-27 days)						0
Infants and toddlers (28 days-23 months)						0
Children (2-11 years)						0
Adolescents (12-17 years)						0
Adults (18-64 years)						0
From 65-84 years						0
85 years and over						0
Age Continuous
Units: years
arithmetic mean (standard deviation)	45 ( 12.76 )	47.65 ( 11.2 )	45.93 ( 14.53 )	46.37 ( 12.5 )	45.97 ( 13 )	-
Gender, Male/Female
Units: Participants
Female	13	12	12	10	14	61
Male	14	16	18	19	14	81
Ethnicity (NIH/OMB)
Units: Subjects
Hispanic or Latino	5	5	7	4	4	25
Not Hispanic or Latino	22	23	23	25	24	117
Unknown or Not Reported	0	0	0	0	0	0
Race (NIH/OMB)
Units: Subjects
American Indian or Alaska Native	0	0	1	1	0	2
Asian	0	1	0	2	1	4
Native Hawaiian or Other Pacific Islander	0	0	0	0	0	0
Black or African American	2	0	1	2	2	7
White	25	27	28	24	25	129
More than one race	0	0	0	0	0	0
Unknown or Not Reported	0	0	0	0	0	0
Region of Enrollment
Units: Subjects
United States	27	27	29	28	28	139
Denmark	0	1	1	1	0	3
Baseline in Psoriasis Area and Severity Index (PASI)
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 (none) to 4 (very severe). Final PASI calculated as: 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 psoriasis) to 72(the most severe disease).
Units: units on a scale
arithmetic mean (standard deviation)	16.45 ( 5.26 )	19.18 ( 7.96 )	18.55 ( 4.94 )	17.2 ( 4.26 )	17.7 ( 6.21 )	-

End points

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Reporting group title

Placebo

Reporting group description

Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

10 mg ixekizumab

Reporting group description

Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

25 mg ixekizumab

Reporting group description

Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

75 mg ixekizumab

Reporting group description

Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

150 mg ixekizumab

Reporting group description

Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

120 mg/80 mg Total Ixekizumab

Reporting group description

Subject analysis set title

All Participants on Ixekizumab(10mg,25mg,75mg &150mg)

Subject analysis set type

Full analysis

Subject analysis set description

The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms. 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations. 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations Analysis Population Description (APD): All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

Primary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

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End point title

Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

End point description

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(none) to 4(very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: 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 psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Primary

End point timeframe

Week 12

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	26	28	30	29	28
Units: percentage of participants
number (not applicable)	7.7	28.6	76.7	82.8	82.1

PASI75_STATISTICAL_ANALYSIS_Placebo_vs_10 mg_Ixe

Comparison groups

Placebo v 10 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

= 0.079

Method

Fisher exact

Confidence interval

sides

2-sided

lower limit

upper limit

PASI75_STATISTICAL_ANALYSIS_Placebo_vs_25 mg Ixe

Comparison groups

Placebo v 25 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Fisher exact

Confidence interval

sides

2-sided

lower limit

upper limit

PASI75_STATISTICAL_ANALYSIS_Placebo_vs_75 mg Ixe

Comparison groups

Placebo v 75 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Fisher exact

Confidence interval

sides

2-sided

lower limit

upper limit

PASI75_STATISTICAL_ANALYSIS_Placebo_vs_150 mg Ixe

Comparison groups

Placebo v 150 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Fisher exact

Confidence interval

sides

2-sided

lower limit

upper limit

Primary: Percentage of PASI Improvement from Baseline to 12 Week endpoint

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End point title

Percentage of PASI Improvement from Baseline to 12 Week endpoint

End point 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(none) to 4(very severe). Each area is scored by itself and the scores were then combined for the final PASI. Final PASI calculated as: 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 psoriasis) to 72(the most severe disease).Least squares(LS) mean values were calculated using MMRM and controlled for baseline as a covariate,visit,treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. APD: All randomized participants who received at least 1 dose of study drug, had at least 1 post-baseline PASI assessment.

End point type

Primary

End point timeframe

Baseline to Week 12

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	23	27	29	29	26
Units: Percentage of improvement in PASI score
least squares mean (confidence interval 95%)	16.22 (4.44 to 28.01)	49.33 (38.25 to 60.41)	78.48 (67.67 to 89.29)	85.69 (74.87 to 96.5)	87.12 (75.94 to 98.29)

PASI_STATISTICAL_ANALYSIS_Placebo_vs_ 10 mg Ixe

Comparison groups

Placebo v 10 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Confidence interval

sides

2-sided

lower limit

upper limit

PASI_STATISTICAL_ANALYSIS_Placebo_vs_ 25 mg Ixe

Comparison groups

Placebo v 25 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Confidence interval

sides

2-sided

lower limit

upper limit

PASI_STATISTICAL_ANALYSIS_Placebo_vs_75 mg Ixe

Comparison groups

Placebo v 75 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Confidence interval

sides

2-sided

lower limit

upper limit

PASI_STATISTICAL_ANALYSIS_Placebo_vs_150 mg Ixe

Comparison groups

Placebo v 150 mg ixekizumab

Number of subjects included in analysis

Analysis specification

Pre-specified

Analysis type

superiority

P-value

< 0.001

Method

Mixed models analysis

Confidence interval

sides

2-sided

lower limit

upper limit

Secondary: Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12

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End point title

Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12

End point description

The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6 point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline. APD:All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Week 12

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	26	28	30	29	28
Units: percentage of participants
number (not applicable)	7.7	25	70	72.4	71.4

No statistical analyses for this end point

Secondary: Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks

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End point title

Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks

End point description

Treatment-emergent adverse events (TEAEs) are events which were not present at baseline or pre-existing conditions at baseline that worsened in severity following the start of treatment. A summary of other non-serious Adverse Events (AEs), and all Serious Adverse Events (SAE's), regardless of causality, is located in the Reported Adverse Events section. APD: All randomized participants who received at least 1 dose of study drug.

End point type

Secondary

End point timeframe

Baseline Up to 20 Weeks

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	27	28	30	29	28
Units: Participants
number (not applicable)	17	21	21	17	13

No statistical analyses for this end point

Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16

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End point title

Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16

End point description

The HADS is a 14-item, participant self-reported scale that consists of an anxiety scale and a depression scale, each with 7 items. Items are rated on a 4-point Likert-type scale ranging from 0 (low level of anxiety or depression) to 3 (high level of anxiety or depression). Each subscale score ranges from 0 to 21 with higher scores indicating greater symptom severity. The classification is defined: 0-7 normal, 8-10 Borderline, 11-21 Abnormal. LS mean was calculated using the analysis of covariance (ANCOVA) model including treatment as fixed effect and baseline as covariate. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	25	28	29	29	28
Units: units on a scale
least squares mean (standard error)
Anxiety	-0.86 ( 0.58 )	-1.97 ( 0.55 )	-2.1 ( 0.54 )	-2.17 ( 0.54 )	-2.81 ( 0.55 )
Depression	0.17 ( 0.54 )	-1.86 ( 0.51 )	-1.75 ( 0.51 )	-2.52 ( 0.51 )	-2.01 ( 0.51 )

No statistical analyses for this end point

Secondary: Change from Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16

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End point title

Change from Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16

End point description

The QIDS-SR16 is a self-administered, 16-item instrument in which a participant is asked to consider each statement as it relates to the way they have felt for the past 7 days. There is a 4-point scale for each item ranging from 0 (best) to 3 (worst). The 16 items are scored to give 9 individual 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), which are summed to give a single score ranging from 0 to 27, with higher scores denoting greater symptom severity. The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	24	27	26	27	25
Units: units on a scale
least squares mean (standard error)	-0.49 ( 0.56 )	-1.56 ( 0.52 )	-1.48 ( 0.53 )	-2.13 ( 0.52 )	-2.21 ( 0.54 )

No statistical analyses for this end point

Secondary: Change from Baseline in Patient Global Assessment (PatGA) at Week 12

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End point title

Change from Baseline in Patient Global Assessment (PatGA) at Week 12

End point description

The PatGA is a single-item self-reported instrument asking the participant to rate the severity of their psoriasis "today" by circling a number on the numeric rating scale from 0 (Clear = no psoriasis) to 5 (Severe = the worst their psoriasis has ever been). The LS Mean (no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Baseline, 12 Weeks

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	26	28	30	29	28
Units: units on a scale
least squares mean (standard error)	-0.6 ( 0.3 )	-1.1 ( 0.3 )	-2.3 ( 0.2 )	-2.9 ( 0.3 )	-2.5 ( 0.3 )

No statistical analyses for this end point

Secondary: Change from Baseline in Pain Visual Analog scale (VAS) at Week 12

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End point title

Change from Baseline in Pain Visual Analog scale (VAS) at Week 12

End point description

The pain VAS is a participant-administered single-item scale designed to measure current joint pain from psoriatic arthritis (PsA) using a 100- millimeter (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). A mixed effects model for repeated measures analysis was used. Least Squares (LS) Mean values were calculated using MMRM and were controlled for baseline as a covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with self-reported psoriatic arthritis at baseline were included in the analysis. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	4	7	11	8	8
Units: millimeter (mm)
least squares mean (confidence interval 95%)	3.87 (-20.9 to 28.64)	-4.32 (-23.05 to 14.41)	-19.36 (-34.31 to -4.4)	-21.24 (-37.89 to -4.58)	-34.24 (-51.83 to -16.66)

No statistical analyses for this end point

Secondary: Change from Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16

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End point title

Change from Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16

End point description

MOS-S provides a concise assessment of important dimensions of sleep, including initiation, maintenance, respiratory problems, quantity, perceived adequacy, and somnolence during the past 4 weeks. Scoring based on 7 subscales: sleep disturbance, snoring, awakened short of breath or with headache, sleep adequacy, and somnolence (range:0-100,with higher scores for more impairment); sleep quantity (range:0-24), and optimal sleep (yes:1, no:0). Six(6) and 9 item index measures of sleep disturbance were constructed to provide composite scores. Scores are transformed (actual raw score minus lowest possible score divided by possible raw score range * 100); total score range: 0 to 100; higher score = higher scores indicate greater problems with the attribute. The LS Mean (no multiplicity adjustments) was calculated using an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model.

End point type

Secondary

End point timeframe

Baseline, Week 16 APD:All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	25	28	29	29	28
Units: units on a scale
least squares mean (standard error)
Sleep Problems Index I	-0.05 ( 2.61 )	-5.35 ( 2.46 )	-8.78 ( 2.42 )	-7.97 ( 2.42 )	-2.38 ( 2.47 )
Sleep Problems Index II	0.21 ( 2.37 )	-6.42 ( 2.24 )	-9.23 ( 2.2 )	-8.43 ( 2.2 )	-2.48 ( 2.24 )
Sleep Adequacy	-2.83 ( 4.73 )	5.63 ( 4.47 )	11.35 ( 4.39 )	8.81 ( 4.39 )	-0.41 ( 4.48 )
Sleep Disturbance	-1.47 ( 3.27 )	-8.56 ( 3.1 )	-10.02 ( 3.03 )	-11.5 ( 3.04 )	-4.67 ( 3.09 )
Sleep Somnolence	1.12 ( 2.73 )	-2.32 ( 2.58 )	-7.14 ( 2.53 )	-5.8 ( 2.53 )	-0.76 ( 2.58 )
Snoring	-2.85 ( 4.22 )	-0.47 ( 3.94 )	2.94 ( 3.88 )	-3.24 ( 3.87 )	-3.81 ( 3.94 )
Sleep Short of Breath/headache	4.34 ( 3.1 )	-5.45 ( 2.92 )	-2.84 ( 2.87 )	-2.65 ( 2.87 )	-3.46 ( 2.91 )

No statistical analyses for this end point

Secondary: Number of Participants who received Medical Care measured by Medical Care Resource Utilization (PMRU))

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End point title

Number of Participants who received Medical Care measured by Medical Care Resource Utilization (PMRU))

End point description

The PMRU is a 3‑item participant-reported questionnaire on health care resource utilization due to psoriasis for physician/clinic visits, emergency room visits, and inpatient hospital admissions since the last study visit. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment.

End point type

Secondary

End point timeframe

Week 16

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	26	28	30	29	28
Units: participants
number (not applicable)
Week 16 - Office or Clinic(n=23,24,29,28,27)	1	0	0	1	3
Week 16 - Emergency Room(ER)(n=23, 24, 29, 28, 27)	0	0	0	0	1
Week 16 - Admitted thru ER (n=26,28,30,29,28)	0	0	0	0	0
Week 16 - Hospital Stay (n=26,28,30,29,28)	0	0	0	0	0

No statistical analyses for this end point

Secondary: Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16

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End point title

Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16

End point description

The WPAI questionnaire has six questions to assess whether the participant was currently employed (Q1); how many hours from work were missed due to problems associated with psoriasis (Q2) or any other reason (Q3); hours actually worked (Q4); degree that psoriasis affected productivity while working (Q5); and degree that psoriasis affected regular activities (Q6) over the past 7 days. Four separate overall scores were calculated, Absenteeism (work time missed) = (Q2/(Q2+Q4))*100, Presenteeism (impairment at work/reduced on-the-job effectiveness) = (Q5/10) *100, Work productivity loss(overall work impairment /absenteeism plus presenteeism) = (Q2/(Q2+Q4)+[(1-Q2/(Q2+Q4))x(Q5/10)]) * 100 and Activity Impairment = (Q6/10) * 100. Each score ranges from 0 to 100 with higher scores indicating greater impairment and less productivity ( worse outcomes). The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model.

End point type

Secondary

End point timeframe

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	26	28	30	29	28
Units: units on a scale
least squares mean (standard error)
Absenteeism (n=15,19,14,19,16)	-1.91 ( 1.88 )	0.71 ( 1.68 )	-0.83 ( 1.94 )	-2.64 ( 1.67 )	-1.96 ( 1.82 )
Presenteeism (n=15,20,16,19,16)	-3.38 ( 3.99 )	-0.99 ( 3.47 )	-4.59 ( 3.87 )	-14.48 ( 3.55 )	-10.69 ( 3.9 )
Work productivity loss (n=15,19,14,19,16)	-3.65 ( 4.3 )	1.74 ( 3.82 )	-4.65 ( 4.45 )	-14.76 ( 3.82 )	-11.12 ( 4.17 )
Activity Impairment (n=25,28,28,29,27)	-0.68 ( 4.19 )	-9.76 ( 3.96 )	-14.96 ( 3.95 )	-12.81 ( 3.9 )	-14.79 ( 4.03 )

No statistical analyses for this end point

Secondary: Change from Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16

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End point title

Change from Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16

End point description

The SF-36 is a participant-reported outcome measure evaluating participant's health status. It comprises 36 items covering 8 domains: physical functioning, role physical, role emotional, bodily pain, vitality, social functioning, mental health, and general health. Items are answered on Likert scales of varying lengths. The 8 domains are regrouped into the PCS and MCS scores. The summary scores range from 0 to 100, with higher scores indicating better levels of function and/or better health. The recall period was the past 4 weeks. The LS Mean was calculated using ANCOVA model including baseline as a covariate and treatment as fixed effect in the model. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	25	28	28	29	28
Units: units on a scale
least squares mean (standard error)
PCS	-1.22 ( 2.15 )	2.41 ( 2.03 )	1.95 ( 2.03 )	3.94 ( 2 )	5.72 ( 2.03 )
MCS	-0.56 ( 2.29 )	7.27 ( 2.19 )	5.16 ( 2.18 )	4.13 ( 2.13 )	4.15 ( 2.16 )

No statistical analyses for this end point

Secondary: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis at Week 12

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End point title

Change from Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis at Week 12

End point description

The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis (range from 0 [absence of psoriasis] to 4 [presence of psoriasis in all 4 quadrants]). Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160; higher scores indicate greater severity. If an individual toe or finger assessment was missing (not done), the average of the remaining measured digits was imputed and added to the sum. If <50% of the toes or finger assessments were missing, the imputation was performed. If >50% of the assessments were missing, then the sum of the scores was left as missing. LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects.

End point type

Secondary

End point timeframe

Baseline, Week 12 APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline nail involvement were included in the analysis.

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	14	13	10	10	10
Units: units on a scale
least squares mean (confidence interval 95%)	2.21 (-5.17 to 9.58)	-4.85 (-12.82 to 3.12)	-3.65 (-12.73 to 5.43)	-15.89 (-24.98 to -6.81)	-19.91 (-29 to -10.83)

No statistical analyses for this end point

Secondary: Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis at Week 12

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End point title

Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis at Week 12

End point description

The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with palmoplantar involvement were included in the analysis.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	1	4	4	2	2
Units: units on a scale
least squares mean (confidence interval 95%)	-1 (-10.3 to 8.3)	-6.4 (-12.3 to -0.5)	-4.6 (-10.3 to 1.2)	-3.4 (-11.5 to 4.8)	-12.8 (-20.9 to -4.7)

No statistical analyses for this end point

Secondary: Change from Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis at Week 12

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End point title

Change from Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis at Week 12

End point description

The PSSI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of scalp area involved. The PSSI score ranges from 0 to 72, with higher scores representing greater severity of scalp psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to unstructured. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Only participants with baseline scalp involvement were included in the analysis.

End point type

Secondary

End point timeframe

Baseline, Week 12

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	17	21	24	18	22
Units: units on a scale
least squares mean (confidence interval 95%)	-7.3 (-11.2 to -3.5)	-10.2 (-13.9 to -6.6)	-15.8 (-19.2 to -12.4)	-15 (-18.9 to -11)	-17.2 (-20.8 to -13.7)

No statistical analyses for this end point

Secondary: Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab from Baseline through 32 Weeks)

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End point title

Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab from Baseline through 32 Weeks)

End point description

The population pharmacokinetic (PK) modeling value for systemic clearance was based on data from week 1 to week 32 for all participants in all ixekizumab treatment arms. APD: All randomized participants who received at least 1 dose of study drug and had evaluable PK data.

End point type

Secondary

End point timeframe

Week 1, Week 2, Week 4, Week 6, Week 8, Week 12, Week 16, Week 20, Week 24, Week 28 and Week 32

End point values	All Participants on Ixekizumab(10mg,25mg,75mg &150mg)
Number of subjects analysed	115
Units: liters per hour (L/hr)
arithmetic mean (confidence interval 95%)	0.0177 (0.016 to 0.0199)

No statistical analyses for this end point

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16

End point description

The DLQI is a 10-item, participant-administered dermatology-specific questionnaire that assess health related quality of life that covers 6 domains including symptoms and feelings, daily activities, leisure, work and school, personal relationships, and treatment. The DLQI items response categories are scored 0 (not relevant) to 3 (very much) with a total score range of 0 to 30; higher scores indicate poor quality of life and a 5-point change from baseline is considered clinically relevant. The LS Mean(no multiplicity adjustments) are presented for each treatment versus placebo comparison at each visit and use an analysis of covariance (ANCOVA) model including baseline as a covariate and treatment as fixed effect in the model. APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Baseline, Week 16

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	25	28	29	29	28
Units: units on a scale
least squares mean (standard error)	-1.24 ( 0.97 )	-6.35 ( 0.92 )	-6.59 ( 0.9 )	-8.39 ( 0.9 )	-8.17 ( 0.92 )

No statistical analyses for this end point

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

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End point title

Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

End point description

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(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as: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 psoriasis) to 72(most severe disease).The LS mean are presented for each treatment versus placebo comparison at each visit and use ANCOVA model including baseline PASI covariate and treatment as fixed effect in the model.Results at Week 12 are summarized as Improvement in PASI which is defined as a reduction in the PASI calculated score at a visit as compared to the score calculated at the baseline visit.

End point type

Secondary

End point timeframe

Baseline, Week 12 APD: All randomized participants who received at least 1 dose of study drug and had at least 1 post-baseline PASI assessment. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	26	28	30	29	28
Units: units on a scale
least squares mean (standard error)	3.5 ( 1.21 )	8.2 ( 1.17 )	13.56 ( 1.12 )	14.99 ( 1.14 )	15.38 ( 1.16 )

No statistical analyses for this end point

Secondary: Percentage of Participants who achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)

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End point title

Percentage of Participants who achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)

End point description

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 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: 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 psoriasis) to 72 (the most severe disease). Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline.

End point type

Secondary

End point timeframe

Week 32 APD:Randomized participants who received at least 1 dose of drug, completed study treatment in Part A,achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32.LOCF was used to impute missing post-baseline values.

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	6	22	23	23	23
Units: percentage of participants
number (not applicable)	0	50	59.1	56.5	82.6

No statistical analyses for this end point

Secondary: Percentage of PASI Improvement from Baseline through 32 Weeks

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End point title

Percentage of PASI Improvement from Baseline through 32 Weeks

End point 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(none) to 4(very severe).Each area is scored by itself and the scores were then combined for the final PASI.Final PASI calculated as: 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 psoriasis) to 72(the most severe disease).Improvement in PASI is defined as improvement in the PASI calculated score at a visit as compared to the score calculated at the baseline visit. APD: All randomized participants who received at least 1 dose of study drug,completed study treatment in Part A,achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32.

End point type

Secondary

End point timeframe

Baseline Through 32 Weeks

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	0 ^[1]	4	16	18	21
Units: Percentage PASI improvement
arithmetic mean (standard deviation)	( )	80.55 ( 17.69 )	85.6 ( 12.74 )	85.16 ( 15.3 )	88.11 ( 11.35 )

Notes
[1] - Zero participants in the placebo arm had data.

No statistical analyses for this end point

Secondary: Percentage of Participants with a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) with at least a 2 point Improvement

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End point title

Percentage of Participants with a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) with at least a 2 point Improvement

End point description

The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline. APD: All randomized participants who received at least 1 dose of study drug, completed study treatment in Part A, achieved PASI 75 at Week 20 and who were followed for treatment durability up to Week 32. Last Observation Carried Forward (LOCF) was used to impute missing post-baseline values.

End point type

Secondary

End point timeframe

Week 32

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	0 ^[2]	6	22	23	23
Units: percentage of participants
number (not applicable)		33.3	45.5	47.8	65.2

Notes
[2] - Zero participants in the placebo arm had data.

No statistical analyses for this end point

Secondary: Percentage of Participants With Anti-Ixekizumab Antibodies

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End point title

Percentage of Participants With Anti-Ixekizumab Antibodies

End point description

Percentage of participants with treatment-emergent positive anti-ixekizumab antibodies was summarized by treatment 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%. APD: All randomized participants who received at least one dose of study drug and had a baseline and at least one post-baseline antibody assessment.

End point type

Secondary

End point timeframe

Baseline through Week 20

End point values	Placebo	10 mg ixekizumab	25 mg ixekizumab	75 mg ixekizumab	150 mg ixekizumab
Number of subjects analysed	25	24	30	29	27
Units: percentage of participants
number (not applicable)	4	54.2	40	17.2	22.2

No statistical analyses for this end point

Secondary: Percentage of Participants with Static Physician's Global Assessment (sPGA) of (0,1)

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End point title

Percentage of Participants with Static Physician's Global Assessment (sPGA) of (0,1)

End point description

The sPGA of psoriasis is scored on a 6-point scale, reflecting a global consideration of the erythema, induration, and scaling across all psoriatic lesions. Average erythema, induration, and scaling are scored separately over the whole body according to a 6-point severity scale (0 [clear] to 5 [severe]). The total score was calculated as average of the 3 severity scores and rounded to the nearest whole number score to determine the sPGA score and category (0=clear; 1=minimal; 2=mild; 3=moderate; 4=marked; 5 = severe). As defined by protocol, a responder is a participant who has a post-baseline sPGA score of '0' or a post-baseline score of '1' with at least a 2 point improvement from baseline. APD: All enrolled participants who had PASI 75 response at Week 20.

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	74
Units: percentage of participants
number (not applicable)	78.4

No statistical analyses for this end point

Secondary: Number of Treatment Emergent Adverse Events up to 344 Weeks

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End point title

Number of Treatment Emergent Adverse Events up to 344 Weeks

End point description

End point type

Secondary

End point timeframe

Baseline Up to 344 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	120
Units: Participants
number (not applicable)	105

No statistical analyses for this end point

Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS)

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End point title

Change from Baseline in Hospital Anxiety and Depression Scale (HADS)

End point description

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	74
Units: units on a scale
arithmetic mean (standard deviation)
Anxiety	-3 ( 3.4 )
Depression	-2.8 ( 3 )

No statistical analyses for this end point

Secondary: Number of Participants with Patient's Global Assessment of Disease Activity (PatGA)

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End point title

Number of Participants with Patient's Global Assessment of Disease Activity (PatGA)

End point description

End point type

Secondary

End point timeframe

Week 240

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	74
Units: Participants
number (not applicable)
Zero(Clear)	40
One	26
Two	4
Three	2
Four	2
Five(Severe)	0

No statistical analyses for this end point

Secondary: Change from Baseline in Pain Visual Analog scale (VAS)

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End point title

Change from Baseline in Pain Visual Analog scale (VAS)

End point description

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	24
Units: Millimeters (mm)
arithmetic mean (standard error)	-13.25 ( 32.34 )

No statistical analyses for this end point

Secondary: Change from Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis

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End point title

Change from Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis

End point description

The NAPSI is physician-rated and quantifies the severity of nail psoriasis by evaluating the presence or absence of psoriatic manifestations on the nail matrix and nail bed. Each finger nail is divided with imaginary lines into quadrants and scored for both nail matrix and nail bed psoriasis(range from 0[absence of psoriasis] to 4[presence of psoriasis in all 4 quadrants]).Participant's fingers and toes were evaluated and the sum of the scores was added resulting in a range of 0 to 160;higher scores indicate greater severity.If an individual toe or finger assessment was missing(not done),the average of the remaining measured digits was imputed and added to the sum.If <50% of the toes or finger assessments were missing,the imputation was performed.If >50% of the assessments were missing,then the sum of the scores was left as missing. Baseline is defined as the last available value prior to the first dose in Part A of the study. APD:Enrolled participants with baseline nail psoriasis.

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	32
Units: units on a scale
arithmetic mean (standard deviation)	-33.62 ( 30.48 )

No statistical analyses for this end point

Secondary: Change from Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis

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End point title

Change from Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis

End point description

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	56
Units: units on a scale
arithmetic mean (standard deviation)	-19.89 ( 13.68 )

No statistical analyses for this end point

Secondary: Change from Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis

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End point title

Change from Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis

End point description

The PPASI is a physician-assessed composite score derived from the summed scores for erythema, induration, and desquamation multiplied by a score for the extent of palm and sole area involvement. The PPASI score ranges from 0 to 72, with higher scores representing greater severity of palmoplantar psoriasis.LS mean was calculated using MMRM with baseline score as covariate, visit, treatment and visit by treatment interaction as fixed effects, with variance-covariance structure set to symmetric. APD: All enrolled participants with baseline palmoplantar psoriasis.

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	4
Units: units on a scale
arithmetic mean (standard deviation)	-9.1 ( 7.59 )

No statistical analyses for this end point

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

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End point title

Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

End point description

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 (none) to 4 (very severe). Each area is scored separately and the scores then combined for the final PASI. Final PASI calculated as: 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 psoriasis) to 72 (the most severe disease).Participants achieving PASI 75 were defined as having an improvement of ≥75% in the PASI score compared to baseline. APD: All enrolled participants who had PASI 75 response at Week 20.

End point type

Secondary

End point timeframe

Week 240

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	74
Units: percentage of participants
number (not applicable)	97.3

No statistical analyses for this end point

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI)

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End point title

Change from Baseline in Dermatology Life Quality Index (DLQI)

End point description

End point type

Secondary

End point timeframe

Baseline Up to 240 Weeks

End point values	120 mg/80 mg Total Ixekizumab
Number of subjects analysed	74
Units: units on a scale
arithmetic mean (standard deviation)	-9.2 ( 5.6 )

No statistical analyses for this end point

Adverse events

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Timeframe for reporting adverse events

Entire Study

Adverse event reporting additional description

Treatment durability refers to participants who had a PASI 75 response at Week 20 and remained in Part A of the study from Week 20-32 (treatment-free period). These participants moved to Part B of the study upon completion of Part A through Week 32 or upon loss of PASI75 response during the Part A treatment-free period.

Assessment type

Systematic

Dictionary name

MedDRA

Dictionary version

19.0

Reporting group title

Placebo Part A

Reporting group description

Part A: Placebo given on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

10mg LY2439821 Part A

Reporting group description

Part A: 10 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

25mg LY2439821 Part A

Reporting group description

Part A: 25 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

Post Treatment Safety Visits

Reporting group description

Participants who were followed due to neutropenia.

Reporting group title

150mg LY2439821 Part A

Reporting group description

Part A: 150 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Reporting group title

Treatment Durability Period

Reporting group description

Part A: Treatment durability/safety follow-up period:12 to 20 weeks.

Reporting group title

120 mg and 80 mg Total Ixekizumab

Reporting group description

Part B: (optional) 120 mg ixekizumab given SC Q4W. Subsequent to an amendment on May 2012, administration changed to 80 mg Q4W through Week 236.

Reporting group title

75mg LY2439821 Part A

Reporting group description

Part A: 75 mg ixekizumab given SC on weeks 0, 2, 4, 8, 12 and 16 for a total of six administrations.

Serious adverse events	Placebo Part A	10mg LY2439821 Part A	25mg LY2439821 Part A	Post Treatment Safety Visits	150mg LY2439821 Part A	Treatment Durability Period	120 mg and 80 mg Total Ixekizumab	75mg LY2439821 Part A
Total subjects affected by serious adverse events
subjects affected / exposed	1 / 27 (3.70%)	1 / 28 (3.57%)	1 / 30 (3.33%)	0 / 6 (0.00%)	0 / 28 (0.00%)	1 / 74 (1.35%)	24 / 120 (20.00%)	0 / 29 (0.00%)
number of deaths (all causes)	0	0	0	0	0	0	0	0
number of deaths resulting from adverse events	0	0	0	0	0	0	0	0
Neoplasms benign, malignant and unspecified (incl cysts and polyps)
invasive ductal breast carcinoma
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
non-small cell lung cancer metastatic
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
rectal adenocarcinoma
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
rectal adenoma
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
uterine leiomyoma
alternative dictionary used: MedDRA 19.0
subjects affected / exposed ^[1]	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 4 (0.00%)	0 / 14 (0.00%)	0 / 33 (0.00%)	1 / 50 (2.00%)	0 / 10 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Pregnancy, puerperium and perinatal conditions
abortion missed
alternative dictionary used: MedDRA 19.0
subjects affected / exposed ^[2]	0 / 13 (0.00%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 4 (0.00%)	0 / 14 (0.00%)	0 / 33 (0.00%)	1 / 50 (2.00%)	0 / 10 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Respiratory, thoracic and mediastinal disorders
breast cyst
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
dysmenorrhoea
alternative dictionary used: MedDRA 19.0
subjects affected / exposed ^[3]	1 / 13 (7.69%)	0 / 12 (0.00%)	0 / 12 (0.00%)	0 / 4 (0.00%)	0 / 14 (0.00%)	0 / 33 (0.00%)	0 / 50 (0.00%)	0 / 10 (0.00%)
occurrences causally related to treatment / all	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
dyspnoea
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
laryngeal oedema
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Psychiatric disorders
depression
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
suicide attempt
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Injury, poisoning and procedural complications
fall
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
fibula fracture
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
laceration
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
tibia fracture
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
wrist fracture
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Cardiac disorders
acute coronary syndrome
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
arteriosclerosis coronary artery
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
atrial fibrillation
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cardiac failure congestive
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
mitral valve prolapse
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 1	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Nervous system disorders
cerebrovascular accident
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Gastrointestinal disorders
pancreatitis acute
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Skin and subcutaneous tissue disorders
hidradenitis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Renal and urinary disorders
nephrolithiasis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	1 / 30 (3.33%)	0 / 6 (0.00%)	0 / 28 (0.00%)	1 / 74 (1.35%)	2 / 120 (1.67%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 1	0 / 0	0 / 0	0 / 1	0 / 3	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
urinary tract obstruction
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Musculoskeletal and connective tissue disorders
cervical spinal stenosis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
intervertebral disc protrusion
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Infections and infestations
abdominal abscess
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
cellulitis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	2 / 2	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
incision site infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
influenza
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
pyelonephritis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
soft tissue infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	1 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
wound infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0
Metabolism and nutrition disorders
diabetes mellitus inadequate control
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	1 / 120 (0.83%)	0 / 29 (0.00%)
occurrences causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 1	0 / 0
deaths causally related to treatment / all	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0	0 / 0

Notes
[1] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[2] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.
[3] - The number of subjects exposed to this adverse event is less than the total number of subjects exposed to this adverse event. These numbers are expected to be equal.
Justification: This event is gender specific, only occurring in male or female subjects. The number of subjects exposed has been adjusted accordingly.

Frequency threshold for reporting non-serious adverse events: 5%

Non-serious adverse events	Placebo Part A	10mg LY2439821 Part A	25mg LY2439821 Part A	Post Treatment Safety Visits	150mg LY2439821 Part A	Treatment Durability Period	120 mg and 80 mg Total Ixekizumab	75mg LY2439821 Part A
Total subjects affected by non serious adverse events
subjects affected / exposed	13 / 27 (48.15%)	15 / 28 (53.57%)	12 / 30 (40.00%)	1 / 6 (16.67%)	11 / 28 (39.29%)	11 / 74 (14.86%)	82 / 120 (68.33%)	10 / 29 (34.48%)
Injury, poisoning and procedural complications
laceration
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	1 / 28 (3.57%)	1 / 74 (1.35%)	3 / 120 (2.50%)	2 / 29 (6.90%)
occurrences all number	0	0	0	0	1	1	3	2
muscle strain
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	8 / 120 (6.67%)	1 / 29 (3.45%)
occurrences all number	0	0	0	0	0	0	11	1
Vascular disorders
hypertension
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	0 / 28 (0.00%)	1 / 30 (3.33%)	0 / 6 (0.00%)	1 / 28 (3.57%)	0 / 74 (0.00%)	7 / 120 (5.83%)	1 / 29 (3.45%)
occurrences all number	1	0	1	0	1	0	8	1
Nervous system disorders
dizziness
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	2 / 28 (7.14%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	0 / 120 (0.00%)	2 / 29 (6.90%)
occurrences all number	0	2	0	0	0	0	0	2
headache
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	4 / 28 (14.29%)	4 / 30 (13.33%)	0 / 6 (0.00%)	1 / 28 (3.57%)	3 / 74 (4.05%)	12 / 120 (10.00%)	1 / 29 (3.45%)
occurrences all number	1	7	11	0	1	3	20	1
General disorders and administration site conditions
injection site reaction
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	3 / 30 (10.00%)	0 / 6 (0.00%)	2 / 28 (7.14%)	0 / 74 (0.00%)	4 / 120 (3.33%)	1 / 29 (3.45%)
occurrences all number	0	0	4	0	3	0	17	1
peripheral swelling
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	2 / 27 (7.41%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	0 / 120 (0.00%)	0 / 29 (0.00%)
occurrences all number	3	0	0	0	0	0	0	0
Immune system disorders
hypersensitivity
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	1 / 28 (3.57%)	0 / 30 (0.00%)	1 / 6 (16.67%)	0 / 28 (0.00%)	0 / 74 (0.00%)	0 / 120 (0.00%)	0 / 29 (0.00%)
occurrences all number	1	1	0	2	0	0	0	0
Gastrointestinal disorders
diarrhoea
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	1 / 28 (3.57%)	0 / 74 (0.00%)	9 / 120 (7.50%)	1 / 29 (3.45%)
occurrences all number	0	1	0	0	1	0	13	1
nausea
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	5 / 120 (4.17%)	2 / 29 (6.90%)
occurrences all number	1	1	0	0	0	0	7	2
Respiratory, thoracic and mediastinal disorders
cough
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	5 / 120 (4.17%)	2 / 29 (6.90%)
occurrences all number	0	1	0	0	0	0	5	2
Skin and subcutaneous tissue disorders
dermatitis contact
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	1 / 30 (3.33%)	0 / 6 (0.00%)	2 / 28 (7.14%)	0 / 74 (0.00%)	8 / 120 (6.67%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	2	0	15	0
dry skin
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	2 / 28 (7.14%)	1 / 74 (1.35%)	0 / 120 (0.00%)	1 / 29 (3.45%)
occurrences all number	0	0	0	0	2	1	0	1
Musculoskeletal and connective tissue disorders
arthralgia
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	0 / 28 (0.00%)	1 / 30 (3.33%)	0 / 6 (0.00%)	0 / 28 (0.00%)	1 / 74 (1.35%)	7 / 120 (5.83%)	1 / 29 (3.45%)
occurrences all number	1	0	1	0	0	1	7	1
back pain
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	8 / 120 (6.67%)	0 / 29 (0.00%)
occurrences all number	0	1	0	0	0	0	8	0
psoriatic arthropathy
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	2 / 27 (7.41%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	6 / 120 (5.00%)	0 / 29 (0.00%)
occurrences all number	2	0	0	0	0	0	6	0
Infections and infestations
bronchitis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	10 / 120 (8.33%)	0 / 29 (0.00%)
occurrences all number	0	1	0	0	0	0	16	0
ear infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	2 / 28 (7.14%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	6 / 120 (5.00%)	0 / 29 (0.00%)
occurrences all number	0	2	0	0	0	0	6	0
influenza
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	0 / 28 (0.00%)	1 / 30 (3.33%)	0 / 6 (0.00%)	1 / 28 (3.57%)	1 / 74 (1.35%)	9 / 120 (7.50%)	0 / 29 (0.00%)
occurrences all number	0	0	1	0	1	1	10	0
nasopharyngitis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	5 / 27 (18.52%)	3 / 28 (10.71%)	3 / 30 (10.00%)	0 / 6 (0.00%)	4 / 28 (14.29%)	2 / 74 (2.70%)	29 / 120 (24.17%)	3 / 29 (10.34%)
occurrences all number	5	3	3	0	4	2	57	3
sinusitis
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	1 / 74 (1.35%)	17 / 120 (14.17%)	1 / 29 (3.45%)
occurrences all number	1	0	0	0	0	1	24	1
tooth infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	11 / 120 (9.17%)	1 / 29 (3.45%)
occurrences all number	0	1	0	0	0	0	12	1
upper respiratory tract infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	1 / 27 (3.70%)	1 / 28 (3.57%)	3 / 30 (10.00%)	0 / 6 (0.00%)	1 / 28 (3.57%)	0 / 74 (0.00%)	15 / 120 (12.50%)	1 / 29 (3.45%)
occurrences all number	1	1	3	0	1	0	21	1
urinary tract infection
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	0 / 27 (0.00%)	1 / 28 (3.57%)	1 / 30 (3.33%)	0 / 6 (0.00%)	1 / 28 (3.57%)	2 / 74 (2.70%)	13 / 120 (10.83%)	0 / 29 (0.00%)
occurrences all number	0	1	1	0	1	2	23	0
Metabolism and nutrition disorders
hypertriglyceridaemia
alternative dictionary used: MedDRA 19.0
subjects affected / exposed	2 / 27 (7.41%)	0 / 28 (0.00%)	0 / 30 (0.00%)	0 / 6 (0.00%)	0 / 28 (0.00%)	0 / 74 (0.00%)	3 / 120 (2.50%)	0 / 29 (0.00%)
occurrences all number	2	0	0	0	0	0	3	0

More information

Top of page

Were there any global substantial amendments to the protocol? Yes

13 May 2010

Protocol amendment a - The primary endpoint was changed to Week 12, updates to the inclusion criteria, and the addition of the sPGA scale with revisions to the secondary objective.

02 Sep 2010

Protocol amendment b - The overall study design and study objectives was revised to include an extended LY2439821 treatment period to provide long-term monitoring of safety and efficacy. As such, the double-blind treatment period of the original study design study was denoted as Part A, and an OLE period was added to the study as Part B.

15 May 2012

Protocol amendment c - Changed Part B dose to 80 mg ixekizumab Q4W to a dose strength and regimen that is consistent with the highest maintenance dose regimen being explored in Phase 3 clinical trials with ixekizumab.

17 Apr 2015

Protocol Amendment d - Was implemented to add an additional optional, open-label extended treatment period to Study RHAJ (Part C) where patients continued treatment with ixekizumab for up to 104 weeks, until ixekizumab has local commercial availability, or until study termination, whichever is soonest and discontinuation criteria was updated to align with ixekizumab Phase 3 protocols.

Were there any global interruptions to the trial? No

Limitations of the trial such as small numbers of subjects analysed or technical problems leading to unreliable data.

The study stopped prior to the completion of Part C per protocol due to commercial availability of Taltz (ixekizumab) in all countries participating in the study. This decision was per protocol and did not adversely impact the objects of the trial.

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Clinical trials

Clinical Trial Results: A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis

Trial information

Trial information

Subject disposition

Subject disposition

Baseline characteristics

Baseline characteristics

End points

End points

Primary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

Primary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

Primary: Percentage of PASI Improvement from Baseline to 12 Week endpoint

Primary: Percentage of PASI Improvement from Baseline to 12 Week endpoint

Secondary: Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12

Secondary: Percentage of Participants With a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) With at Least a 2 Point Improvement" at Week 12

Secondary: Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks

Secondary: Number of Participants With Treatment Emergent Adverse Events Up to 20 Weeks

Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16

Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS) Score at Week 16

Secondary: Change from Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16

Secondary: Change from Baseline in 16-Item Quick Inventory of Depressive Symptoms- Self Rated (QIDS-SR16) Total Score at Week 16

Secondary: Change from Baseline in Patient Global Assessment (PatGA) at Week 12

Secondary: Change from Baseline in Patient Global Assessment (PatGA) at Week 12

Secondary: Change from Baseline in Pain Visual Analog scale (VAS) at Week 12

Secondary: Change from Baseline in Pain Visual Analog scale (VAS) at Week 12

Secondary: Change from Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16

Secondary: Change from Baseline in Medical Outcomes Study Sleep Scale (MOS-S) at Week 16

Secondary: Number of Participants who received Medical Care measured by Medical Care Resource Utilization (PMRU))

Secondary: Number of Participants who received Medical Care measured by Medical Care Resource Utilization (PMRU))

Secondary: Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16

Secondary: Change from Baseline in Work Productivity and Activity Impairment Questionnaire (WPAI Q) at Week 16

Secondary: Change from Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16

Secondary: Change from Baseline in Medical Outcomes Study Short-Form 36 (SF-36) - Physical Component Score (PCS) and Mental Component Score (MCS) at Week 16

Secondary: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis at Week 12

Secondary: Change from Baseline in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis at Week 12

Secondary: Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis at Week 12

Secondary: Change from Baseline in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis at Week 12

Secondary: Change from Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis at Week 12

Secondary: Change from Baseline in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis at Week 12

Secondary: Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab from Baseline through 32 Weeks)

Secondary: Ixekizumab Systemic Clearance (CL) (Serum Concentrations of Ixekizumab from Baseline through 32 Weeks)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI) Total Score Total Score at Week 16

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

Secondary: Change From Baseline in Psoriasis Area and Severity Index (PASI) Score at Week 12

Secondary: Percentage of Participants who achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)

Secondary: Percentage of Participants who achieve a 75% Improvement in the Psoriasis Area and Severity Index (PASI 75)

Secondary: Percentage of PASI Improvement from Baseline through 32 Weeks

Secondary: Percentage of PASI Improvement from Baseline through 32 Weeks

Secondary: Percentage of Participants with a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) with at least a 2 point Improvement

Secondary: Percentage of Participants with a Static Physician's Global Assessment (sPGA) Score of Cleared (0) or Minimal (1) with at least a 2 point Improvement

Secondary: Percentage of Participants With Anti-Ixekizumab Antibodies

Secondary: Percentage of Participants With Anti-Ixekizumab Antibodies

Secondary: Percentage of Participants with Static Physician's Global Assessment (sPGA) of (0,1)

Secondary: Percentage of Participants with Static Physician's Global Assessment (sPGA) of (0,1)

Secondary: Number of Treatment Emergent Adverse Events up to 344 Weeks

Secondary: Number of Treatment Emergent Adverse Events up to 344 Weeks

Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS)

Secondary: Change from Baseline in Hospital Anxiety and Depression Scale (HADS)

Secondary: Number of Participants with Patient's Global Assessment of Disease Activity (PatGA)

Secondary: Number of Participants with Patient's Global Assessment of Disease Activity (PatGA)

Secondary: Change from Baseline in Pain Visual Analog scale (VAS)

Secondary: Change from Baseline in Pain Visual Analog scale (VAS)

Secondary: Change from Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis

Secondary: Change from Baseline up to 240 Weeks in Nail Psoriasis Severity Index (NAPSI) in Participants with Nail Psoriasis

Secondary: Change from Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis

Secondary: Change from Baseline up to 240 Weeks in Scalp Psoriasis Severity Index (PSSI) in Participants with Scalp Psoriasis

Secondary: Change from Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis

Secondary: Change from Baseline up to 240 Weeks in Palmoplantar Psoriasis Severity Index (PPASI) in Participants with Palmoplantar Psoriasis

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

Secondary: Percentage of Participants Achieving Psoriasis Area and Severity Index ≥75% (PASI 75) Improvement

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI)

Secondary: Change from Baseline in Dermatology Life Quality Index (DLQI)

Adverse events

Adverse events

More information

Substantial protocol amendments (globally)

Interruptions (globally)

Limitations and caveats

Clinical Trial Results:
A Dose-Ranging And Efficacy Study of LY2439821 (An Anti-IL-17 Antibody) In Patients With Moderate-To-Severe Psoriasis