Patients will be excluded from the study if they meet any of the following criteria:
 Have pustular, erythrodermic, and/or guttate forms of Ps.
 Have a history of drug-induced Ps.
 Had a clinically significant flare of Ps during the 12 weeks prior to baseline
(Week 0; Visit 2).
 Have received systemic nonbiologic Ps therapy (including, but not limited to,
oral psoralen and ultraviolet A [PUVA] light therapy; cyclosporine;
corticosteroids; methotrexate; oral retinoids; mycophenolate mofetil;
thioguanine; hydroxyurea; sirolimus; azathioprine; fumaric acid derivatives;
or 1, 25 dihydroxy vitamin D3 and analogues) or phototherapy (including
either oral and topical PUVA light therapy, ultraviolet B or self-treatment with
tanning beds or therapeutic sunbathing) within 4 weeks prior to baseline
(Week 0; Visit 2);
topical Ps treatment (including, but not limited to, corticosteroids,
anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene,
emollients and other nonprescription topical products containing urea,
>3% salicylic acid, or alpha- or beta-hydroxyl acids, and medicated shampoos
[for example those that contain >3% salicylic acid, corticosteroids, coal tar, or
vitamin D3 analogues]) within the previous 2 weeks prior to baseline
(Week 0; Visit 2)
Exceptions: Class 6 (mild, such as desonide) or Class 7 (least potent, such as
hydrocortisone) topical steroids will be permitted for use limited to the face,
axilla, and/or genitalia.
 Cannot avoid excessive sun exposure or use of tanning booths for at least
4 weeks prior to baseline (Week 0; Visit 2) and during the study.
 Have concurrent or recent use of any biologic agent within the following
washout periods: etanercept <28 days; infliximab, adalimumab, or alefacept
<60 days; golimumab <90 days; ustekinumab <8 months; rituximab or
efalizumab <12 months; or any other biologic agent <5 half-lives prior to
baseline (Week 0; Visit 2).
 Have ever received natalizumab or other agents that target alpha-4-integrin.
 Have previously completed or withdrawn from this study, participated in any
other study with ixekizumab, or have participated in any study investigating
other IL-17 antagonists.
 Have a known allergy or hypersensitivity to any biologic therapy that would
pose an unacceptable risk to the patient if participating in this study.
 Had a live vaccination within 12 weeks prior to baseline (Week 0; Visit 2), or
intend to have a live vaccination during the course of the study, or within
12 months of completing treatment in this study, or have participated in a
vaccine clinical study within 12 weeks prior to baseline. Investigators should
review the vaccination status of their patients and follow the local guidelines
for adult vaccination with nonlive vaccines intended to prevent infectious
disease prior to therapy.
(Note: Killed/Inactive or subunit vaccines are expected to be safe; however,
their efficacy with concomitant ixekizumab treatment is unknown.)
 Had a vaccination with Bacillus Calmette-Guérin (BCG) within 12 months
prior to baseline (Week 0; Visit 2), or intend to have a vaccination with BCG
during the course of the study, or within 12 months of completing treatment in
 Had any major surgery within 8 weeks prior to baseline (Week 0; Visit 2), or
will require such during the study that, in the opinion of the investigator in
consultation with Lilly or its designee, would pose an unacceptable risk to the
 Have current or a history of lymphoproliferative disease; or signs or
symptoms of lymphoproliferative disease; or have active or history of
(Note: Patients with successfully treated basal-cell carcinoma [no more than
3], squamous-cell carcinoma of the skin, or cervical carcinoma in situ, with no
evidence of recurrence within the 5 years prior to baseline [Week 0; Visit 2]
may participate in the study).
 Have presence of significant uncontrolled cerebrocardiovascular (for example,
myocardial infarction [MI], unstable angina, unstable arterial hypertension,
moderate-to-severe [New York Heart Association Class III/IV] heart failure,
or cerebrovascular accident [CVA]), respiratory, hepatic, renal,
gastrointestinal, endocrine, hematologic, neurologic or neuropsychiatric
disorders, or abnormal laboratory values at screening that, in the opinion of
the investigator, pose an unacceptable risk to the patient if participating in the
study or of interfering with the interpretation of data.
 Have a history of uncompensated heart failure, fluid overload, or MI, or
evidence of new-onset ischemic heart disease or other serious cardiac disease,
within 12 weeks prior to baseline (Week 0; Visit 2).
 Have presence of significant uncontrolled neuropsychiatric disorder, have
history of a suicide attempt, have a score of 3 on Item 12 (Thoughts of Death
or Suicide) of the Quick Inventory of Depressive Symptomatology – Self
Report (16 items) (QIDS-SR16) at screening (Visit 1) or baseline (Week 0;
Visit 2), or are clinically judged by the investigator to be at risk for suicide.
 Had a serious infection (for example, pneumonia, cellulitis), have been
hospitalized, or have received intravenous antibiotics for an infection, within
12 weeks prior to baseline (Week 0; Visit 2), or had a serious bone or joint
infection within 24 weeks prior to baseline, or have ever had an infection of
an artificial joint, or are immunocompromised to an extent such that
participation in the study would pose an unacceptable risk to the patient.
 Have or had an infection typical of an immunocompromised host, and/or that
occurs with increased incidence in an immunocompromised host (including,
but not limited to, Pneumocystis jirovecii pneumonia, histoplasmosis, or
coccidioidomycosis); or have a known immunodeficiency.
 Have or had a herpes zoster or any other clinically apparent varicella-zoster
virus infection within 12 weeks of baseline (Week 0; Visit 2).
 Have any other active or recent infection within 4 weeks of baseline (Week 0;
Visit 2) that, in the opinion of the investigator, would pose an unacceptable
risk to the patient if participating in the study; these patients may be
rescreened (1 time) 4 or more weeks after documented resolution of
 Have a body temperature ≥38°C (100.5°F) at baseline (Week 0; Visit 2); these
patients may be rescreened (1 time) ≥4 weeks after documented resolution of
 Have evidence or suspicion of active or latent TB (refer to Section 10.4.2.2 for
details on determining full TB exclusion criteria).
 Have uncontrolled arterial hypertension characterized by a systolic blood
pressure (BP) >160 mm Hg or diastolic BP >100 mm Hg.
(Note: Determined by 2 consecutive elevated readings. If an initial BP
reading exceeds this limit, the BP may be repeated once after the patient has
rested sitting for ≥10 minutes. If the repeat value is less than the criterion
limits, the second value may be accepted.)
 Are positive for human immunodeficiency virus serology (HIV), ie, positive
for human immunodeficiency virus antibody (HIVAb).
 Have evidence of or test positive for hepatitis B by any of the following
criteria: 1) positive for hepatitis B surface antigen (HBsAg+), 2) positive for
anti-hepatitis B core antibody (HBcAb+) and negative for anti-hepatitis B
surface antibody (HBsAb–), 3) positive for anti-hepatitis B core antibody
(HBcAb+) and positive for anti-hepatitis B surface antibody (HBsAb+) with a
concentration of HBsAb <200 mIU/mL, or 4) positive for anti-hepatitis B core
antibody, positive for anti-hepatitis B surface antibody (regardless of HBsAb
level), and positive for serum hepatitis B virus (HBV) DNA.
(Note: Patients who are negative for hepatitis B surface antigen (HBsAg–),
positive for anti-hepatitis B core antibody (HBcAb+), positive for antihepatitis
B surface antibody (HBsAb+) with a level of HBsAb ≥200 mIU/mL,
and negative for serum HBV DNA may participate in the study. Patients who
meet these criteria at screening will be identified by the central laboratory and
will be monitored during the study as detailed in Section 10.4.3.3.
 Have evidence of or test positive for hepatitis C virus (HCV). A positive test
for HCV is defined as: 1) positive for hepatitis C antibody (anti-HCV Ab),
and 2) positive via a confirmatory test for HCV (for example, HCV
polymerase chain reaction).
 Have clinical laboratory test results at screening that are outside the normal
reference range for the population and are considered clinically significant,
and/or have any of the following specific abnormalities:
[27a] Neutrophil count <1500 cells/L
[27b] Lymphocyte count <500 cells/L
[27c] Platelet count <100,000 cells/L
[27d] Aspartate aminotransferase (AST) or alanine aminotransferase
(ALT) >2.5 times the upper limit of normal (ULN)
[27e] Total white blood cell (WBC) count <3000 cells/L
[27f] Hemoglobin <8.5 g/dL (85.0 g/L) for male patients and <8.0 g/dL
(80 g/L) for female patients
[27g] Serum creatinine >2.0 mg/dL.
(Note: The AST and ALT may be repeated once within a week if the initial
response exceeds this limit, and the repeat value may be used to assess
eligibility. Other laboratory tests should not be repeated unless there is a
technical error or clinical reason to believe a result may be erroneous.)
 Have electrocardiogram (ECG) abnormalities that are considered clinically
significant and would pose an unacceptable risk to the patient if participating
in the study.
 Have allergy to rubber or latex.
 Have any other condition that precludes the patient from following and
completing the protocol, in the opinion of the investigator.
 Have donated more than 500 mL of blood within the last 4 weeks, or intend to
donate blood during the course of the study.
 Are women who are lactating or breastfeeding.
 Are investigator site personnel directly affiliated with this study and/or their
immediate families. Immediate family is defined as a spouse, parent, child, or
sibling, whether biological or legally adopted.
 Are Lilly employees or its designee.
 Are currently enrolled in, or discontinued from a clinical trial involving an
investigational product or nonapproved use of a drug or device, within the last
4 weeks or a period of at least of 5 half-lives of the last administration of the
drug, whichever is longer, or concurrently enrolled in any other type of
medical research judged not to be scientifically or medically compatible with