Comparative Study of BAT2206 With Stelara® in Patients With Moderate to Severe Plaque Psoriasis

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.