| Eligibility |
Inclusion Criteria:
1. Male or female = 18 years old with a diagnosis of plaque-type psoriasis for at least
24 weeks before screening.
2. Have moderate to severe plaque-type psoriasis as defined at screening and baseline by:
1. PASI = 12,
2. sPGA = 3, and
3. body surface area affected by chronic plaque-type psoriasis = 10%
3. Failed to respond to, or have a contraindication to, or is intolerant to other
systemic therapies including cyclosporine, methotrexate or psoralen and ultraviolet
(UV) A
4. Female patients of childbearing potential and male patients with a female partner of
childbearing potential must be willing to use a highly effective contraceptive
precaution throughout the study period and continuing for at least 15 weeks after the
last dose of study drug. See APPENDIX 1 for the acceptable highly effective
contraceptive methods. Abstinence from heterosexual intercourse is accepted when this
is the usual lifestyle of the patient and must be continued for at least 15 weeks
after the last dose of study drug. A female patient is considered not of childbearing
potential when postmenopausal (at least 12 consecutive months without menses without
an alternative medical cause) or surgically sterilized (hysterectomy, bilateral
salpingectomy, and bilateral oophorectomy).
5. If female of childbearing potential, patient should have a negative pregnancy test
result at screening and baseline visits.
6. Must be willing to provide written consent and to comply with the requirements of the
study protocol.
Exclusion Criteria:
1. Have any forms of psoriasis at the time of the screening visit other than plaque-type
such as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,
medication-induced psoriasis or other skin conditions (eg, eczema) that would
interfere with evaluations of the effect of investigational product on psoriasis.
2. Have previously received ustekinumab, a biosimilar of ustekinumab, or any drug that
targets interleukin-12 or interleukin-23.
3. Have received any biologic agents other than those prohibited (see exclusion #2)
within 12 weeks or 5 half-lives (whichever is longer) before the baseline visit.
4. Have received topical therapies for the treatment of psoriasis (such as
corticosteroids, vitamin D analogs, or retinoids) within 2 weeks before baseline
visit.
5. Have received UVA phototherapy (with or without oral psoralen), UVB phototherapy, any
systemic steroids or nonbiological drugs for the treatment of psoriasis within 4 weeks
before baseline visit
6. Have received any investigational drug within 8 weeks or 5 half-lives (whichever is
longer) before baseline visit
7. Have received any herbal remedies or traditional medicines used to treat psoriasis
within 4 weeks before baseline visit
8. History of allergy to the active substance or any of the excipients of study drugs, or
of hypersensitivity to latex.
9. History of invasive infection (eg, histoplasmosis, coccidioidomycosis, blastomycosis).
10. Presence of active infection at screening, history of infection requiring intravenous
antibiotics and/or hospitalization = 8 weeks before baseline visit or oral antibiotics
= 2 weeks before baseline visit. Minor fungal infections may be allowed.
11. Any recurrent bacterial, fungal, or viral infection that, (based on the investigator´s
clinical assessment), makes the patient unsuitable for the study, including
recurrent/disseminated herpes zoster.
12. Meet any of the following criteria relative to latent or active tuberculosis (TB)
infection.
13. Evidence of malignancy, lung infection, or abnormalities suggestive of active TB on
chest radiography (x-ray or computed tomography) performed within 12 weeks before the
screening visit or during the screening period.
14. Any history of malignancy or lymphoproliferative disease at any time, except curative
treatment for nonmelanoma skin cancer or resected carcinoma in situ of the cervix.
15. Have a transplanted organ/tissue or stem cell transplantation.
16. Have an underlying metabolic, hematologic, renal, hepatic, pulmonary, neurologic,
endocrine, cardiac, infectious, or gastrointestinal condition, which in the opinion of
the investigator places the patient at unacceptable risk.
17. Have a history of demyelinating diseases (including myelitis) or neurologic symptoms
suggestive of demyelinating disease.
18. Any major surgical procedure within 12 weeks of the baseline visit or planned during
the study.
19. History of clinically significant drug or alcohol abuse in the last 12 months as
judged by the investigator.
20. Pregnant or breastfeeding (lactating) women.
21. Patient is considered by the investigator, for any reason, to be an unsuitable
candidate for the study.
22. Patients participating in another investigational drug or device (a device is an
instrument, apparatus, implement, machine, contrivance, or implant, including a
component part or accessory intended for use in the diagnosis of disease or other
conditions, or in the cure, mitigation, treatment, or prevention of disease) trial or
planning on participating in another clinical trial during the course of the study.
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