Assessment on Efficacy and Safety of BAT2306 and Cosentyx® in Plaque Psoriasis Patients

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:
3. PASI ≥ 12,
4. IGA ≥ 3 (based on a scale of 0-4), and
5. BSA affected by chronic plaque-type psoriasis ≥ 10%
6. Candidates for systemic therapy, defined as having chronic plaque-type psoriasisconsidered inadequately controlled by:
7. topical treatment and/or
8. phototherapy and/or
9. previous systemic therapy.
10. Female patients of childbearing potential and male patients with a female partner ofchildbearing potential must be willing to use a highly effective contraceptiveprecaution throughout the study period and continuing for at least 20 weeks after thelast dose of study drug. See APPENDIX 1 for the acceptable highly effectivecontraceptive methods. Abstinence from heterosexual intercourse is accepted when thisis the usual lifestyle of the patient and must be continued for at least 20 weeksafter the last dose of study drug. A female patient is considered not of childbearingpotential when postmenopausal (at least 12 consecutive months without menses withoutan alternative medical cause) or surgically sterilized (hysterectomy, bilateralsalpingectomy, and bilateral oophorectomy).
11. If female of childbearing potential, patient should have a negative pregnancy testresult at screening and baseline visits.
12. Must be willing to provide written consent and to comply with the requirements of thestudy protocol.

Exclusion Criteria:

1. Have any forms of psoriasis at the time of the screening visit other than plaque-typesuch as erythrodermic psoriasis, pustular psoriasis, guttate psoriasis,medication-induced psoriasis or other skin conditions (e.g., eczema) that wouldinterfere with evaluations of the effect of investigational product on psoriasis.
2. Have previously received secukinumab, a biosimilar of secukinumab, or any drug thattargets interleukin-17 or the IL-17 receptor (eg, ixekizumab, brodalumab).
3. Weight > 120 kg.
4. Have received any monoclonal antibody-based biologic drugs for the treatment of PsO orPsA or with a potential effect on the study condition, other than those prohibited (see exclusion #2) within 5 half-lives or 6 months, whichever is longer, beforebaseline visit.
5. Have received non-monoclonal antibody biological drugs (eg, etanercept) for thetreatment of PsO or PsA within 12 weeks or 5 half-lives (whichever is longer) beforebaseline visit.
6. Have received topical therapies for the treatment of psoriasis (such ascorticosteroids, vitamin D analogs, retinoids, herbal or non-pharmacological topicalpreparations other than moisturizers or emollients) within 2 weeks before baselinevisit. And so on