Capable of giving informed consent and the consent must be obtained prior to any study related procedures
≥ 18 years at the time of consent; may be male or female
Diagnosis of plaque psoriasis ≥ 6 months prior to administration of study agent
Presence of moderate or severe psoriasis on the body other than the scalp
≥ 30% of scalp affected with erythema, induration and desquamation and s‐PGA score ≥ 4
Candidates for phototherapy or systemic treatment of psoriasis
Women of childbearing potential and all men must be using adequate birth control measures (e.g. abstinence, oral contraceptives, intrauterine device, barrier method with spermicide, or surgical sterilization) and must agree to continue use of such measures and not become pregnant or plan a pregnancy until 12 months after receiving the last injection of study agent
Be able to adhere to protocol requirements and study visit schedule
Must agree not to receive a live virus or live bacterial vaccination during the trial and 12 months after last study injection
Must agree not to receive a BCG vaccination during the trial and up to 12 months after the last injection
Must avoid prolonged sun exposure and avoid use of tanning booths or other ultraviolet light sources during the study
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Considered eligible according to the following TB screening criteria.
Have no history of latent or active TB prior to screening. An exception is made for participants currently receiving treatment for latent TB with no evidence of active TB, or who have a history of latent TB and documentation of having completed appropriate treatment for latent TB within 3 years prior to the first administration of study agent. It is the responsibility of the investigator to verify the adequacy of previous antituberculous treatment and provide appropriate documentation.
Have no signs or symptoms suggestive of active TB upon medical history or physical examination, or both.
Within 6 weeks prior to the first administration of study agent, have a negative QuantiFERON‐TB Gold test result.
Have a chest radiograph (both posterior‐anterior and lateral views), taken within 3 months prior to the first administration of study agent and read by a qualified radiologist, with no evidence of current, active TB or old, inactive TB.
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Have screening laboratory test results within the following parameters:
Heamoglobin > 10g/dL
White Blood Cells > 3.5 x 109/L
Neutrophils > 1.5 x 109/L
Platelets > 100 X109/L
Serum Creatinine < 1.5 mg/dL (or 133 micromol/L)
AST, ALT, and alkaline phosphatase levels must be within 1.5 times the upper limit of normal range for the laboratory conducting the test
Currently have non‐plaque forms of psoriasis (erythrodermic, guttate, or pustular)
Have current drug‐induced psoriasis
Presence of any skin conditions ( including scalp) other than psoriasis that would interfere with evaluations of the effect of study agents
Are pregnant, nursing, or planning pregnancy (both men and women) while enrolled in the study
Have used any therapeutic agent targeted at reducing IL‐12 and/or IL‐23, including but not limited to ustekinumab and ABT ‐874
Have used any investigational drug within the previous 4 weeks or 5 times the half‐life of the investigational agent, whichever is longer
Have used any investigational drug within the previous 3 months or 5 times the half‐life of the biological, whichever is longer
Have ever received natalizumab or other agents that target alpha‐4‐integrin
Have received phototherapy or any systemic medications/treatments that could affect psoriasis or s‐PGA/PASI evaluations (including but not limited to, oral or injectable corticosteroids, retinoids, 1, 25 dihydroxy vitamin D3 and analogues, psoralens, sulfasalazine, hydroxyurea, or fumaric acid derivatives) within 4 weeks of administration of study agent
Have used topical mediations/treatments that could affect psoriasis or s‐PGA/PASI evaluation ( e.g. corticosteroids , anthralin, calcipotriene, topical vitamin D derivatives, retinoids, tazarotene, methoxsalen, trimethyl psoralens) within 2 weeks of the first administration of study agent
Have used any systemic immunosuppressants (e.g. methotrexate, azathioprine, ciclosporin, 6‐thioguanine, mercaptopurine, mycophenolate, mofetil, hydroxyurea, and tacrolimus) within 4 weeks of the first administration of study agent
Are currently receiving lithium, anti‐malarials, or intramuscular gold, or have received lithium, anti‐malarials, or intramuscular gold, or have received lithium, anti‐malarials, or intramuscular gold within 4 weeks of the first administration of study agent
Have received within 3 months prior to the first injection a live virus or bacterial vaccination. Participants must agree not to receive a live virus or bacterial vaccination during the trial or up to 12 months after the last study agent injection
Have had a BCG vaccination within 12 months of screening. Participants must agree not to receive a BCG vaccination during the trial or up to 12 months after the last study agent injection
Have a history of chronic or recurrent infectious disease, including but not limited to chronic renal infection, chronic chest infections (e.g. bronchiectasis), recurrent urinary tract infections (recurrent pyelonephritis or chronic non‐remitting cystitis), or open, draining, or infected skin wounds or ulcers
Have or have had a serious infection (e.g. sepsis, pneumonia,or pyelonephritis) or have been hospitalised or received IV antibiotics for an infection during the 2 months prior to screening
Have a history of latent or active granulomatous infection, including histoplasmosis or coccidioidomycosis, prior to screening
Have persistently indeterminate (indeterminate on repeat sampling) QuantiFERON‐TB Gold test results
Have had a Bacille Calmette‐Guérin (BCG) vaccination within 12 months of screening
Have a chest radiograph within 3 months prior to the first administration of study agent that shows an abnormality suggestive of a malignancy or current active infection, including TB
Have had a non‐tuberculous mycobacterial infection or opportunistic infection (e.g. cytomegalovirus, pneumocystosis, aspergillosis) within 6 months prior to screening
Known to be infected with HIV, hepatitis B, or hepatitis C
Have current signs or symptoms of severe, progressive, or uncontrolled renal, hepatic, haematological, gastrointestinal, endocrine, pulmonary, cardiac, neurologic, cerebral, or psychiatric disease
Have a transplanted organ
Have a known history of lymphoproliferative disease, including lymphoma, or signs and symptoms suggestive of possible lymphoproliferative disease, such as lymphadenopathy and /or splenomegaly
Have a known malignancy or have a history of malignancy (with the exception of basal cell carcinoma, squamous cell carcinoma in situ of the skin or cervix that has been treated with no evidence of recurrence, or squamous cell carcinoma of the skin that has been treated with no evidence of recurrence within 5 years prior to the first administration of study agent)
Have been hospitalised in the past 3 years for asthma, ever required intubation for treatment of asthma, currently require oral corticosteroids for the treatment of asthma, or required more than one short‐term (< 2 weeks) course of oral corticosteroids for asthma within the previous year
Have undergone allergy immunotherapy previously for prevention of anaphylactic reactions
Have shown a previous immediate hypersensitivity response, including anaphylaxis, to an immunoglobulin product (e.g. plasma‐derived or recombinant monoclonal antibody).
Be known to have had a substance abuse (drug or alcohol) problem within the previous 12 months
Be participating in another trial using an investigational agent or procedure during participation in the trial
Use of tar shampoos within 14 days of first dose of study drug
Use of over‐the‐counter shampoos for scalp psoriasis will not be allowed during study
Use of topical corticosteroids or other topical agents for the treatment of psoriasis on the scalp will not be allowed during the study
