To Compare Pharmacokinetics, Efficacy, and Safety of CT-P17 With Humira in Patients With Moderate to Severe Chronic Plaque Psoriasis

Inclusion Criteria:

1. Patient is male or female aged 18 to 75 years old, both inclusive.

2. Patient has had a diagnosis of chronic plaque psoriasis for at least 24 weeks priorto the first administration of the study drug (Day 1).

3. Patient has stable moderate to severe plaque psoriasis with or without psoriaticarthritis at both Screening and at the time of the first administration of the studydrug (Day 1) as defined by:

• Psoriasis Area and Severity Index (PASI) score of 12 or greater and

• Static Physician's Global Assessment (sPGA) score of 3 or greater and

• Body Surface Area (BSA) affected by plaque psoriasis of 10% or greater.

4. Patient who is a candidate for systemic therapy or phototherapy.

5. Patient (or legal guardian, if applicable) is informed of the full nature andpurpose of the study, including possible risks and side effects, is able tocooperate with the investigator and is given ample time and opportunity to read andunderstand verbal and/or written instructions, and signs the written informedconsent form with date prior to participation in the study.

6. Female patient who is considered of childbearing potential (i.e., fertile, followingmenarche and until becoming post-menopausal unless permanently sterile) must agreeto use highly effective methods of contraception consistent with local regulationsduring the course of the study and at least 20 weeks following discontinuation ofstudy drug (excluding women who are not of childbearing potential). Examples includethe following:

7. Combined (estrogen and progestogen containing) or progestogen-only hormonalcontraceptives associated with inhibition of ovulation

8. Intrauterine device or intrauterine hormone-releasing system

9. True abstinence, when this is in line with the preferred and usual lifestyle ofthe patient. Periodic abstinence (e.g., calendar, ovulation, symptothermal,post-ovulation methods), declaration of abstinence for the duration of exposureto investigational drug, and withdrawal are not acceptable methods ofcontraception.

Male patient who is sexually active with a woman of childbearing potential must agree to use the highly effective method described as above or medically acceptable methods of contraception (e.g., male or female condom AND additional hormonal or barrier method by female partner) consistent with local regulations during the study and for 20 weeks following discontinuation of study drug. If patient or their partner has been surgically sterilized for less than 24 weeks prior to the date of informed consent form (ICF), they also must agree to use method(s) of contraception as described above. Postmenopausal female patients must have experienced their last menses more than 1 year prior to the date of ICF without an alternative medical cause to be classified as not of childbearing potential.

Exclusion Criteria:

1. Patient diagnosed with forms of psoriasis other than chronic plaque (e.g., pustular,erythrodermic or guttate psoriasis) or medication-induced psoriasis (e.g., new onsetor current exacerbation from beta-blockers, calcium channel inhibitors or lithium).

2. Patient who has previously received investigational or licensed product of tumornecrosis factor (TNF) α inhibitor for any purposes.

3. Patient who has prior exposure to 2 or more biologic agents considered by theinvestigator to affect the outcome of the study. Patient with 1 prior biologic agentwhich is not classified as TNF-α inhibitor (e.g., interleukin [IL]-17, IL-12/23,IL-23 blocker) can be enrolled after 5 half-lives prior to the first administrationof the study drug (Day 1).

4. Patient who has allergies to any of the excipients of study drug or materials ofdevice or any other murine and human proteins, or patient with a hypersensitivity toimmunoglobulin products.

5. Patient who currently has, or has a history of, any of the following infections:

6. A known infection with human immunodeficiency virus (HIV), hepatitis B orhepatitis C (active or carrier state) or syphilis. However, a patient with pasthepatitis B virus and/or hepatitis C virus is allowed if resolved.

7. Recurrent herpes zoster or other chronic or recurrent infection within 6 weeksprior to the first administration of the study drug (Day 1).

8. Past or current granulomatous infections or other severe or chronic infections (such as sepsis, abscess, opportunistic infections, or invasive fungalinfections such as histoplasmosis). A patient who has a past diagnosis withsufficient documentation of complete resolution of the infection can beenrolled in the study.

9. Acute infection requiring oral antibiotics within 2 weeks prior to the firstadministration of the study drug (Day 1) or a serious infection associated withhospitalization and/or which required parenteral injection of antibioticswithin 24 weeks before Day 1.

10. Patient who currently has, or has a history of, any of the following TB conditions:

11. Patient who has a history of TB or a current diagnosis of TB. A patient who hasa previous diagnosis of active TB cannot be enrolled in the study even if thereis sufficient documentation of complete resolution of active TB.

12. Patient who has had exposure to a person with active TB such as first-degreefamily members or co-workers.

13. Patient who has an indeterminate result for interferon-γ release assay (IGRA)or latent TB (defined as a positive result of IGRA with a negative examinationof chest X-ray) at Screening. A patient who has a previous diagnosis of latentTB cannot be enrolled despite sufficient documentation of prophylaxis. If theresult of the IGRA is indeterminate at Screening, 1 retest will be possibleduring the Screening period. If the repeated IGRA result is indeterminate againor positive, the patient will be excluded from the study. If the repeated IGRAresult is negative, the patient can be enrolled in the study.

14. Patient who has a medical condition including one or more of the following:

15. Classified as Class III obesity by WHO classification (body mass index≥40kg/m2)

16. Diabetes mellitus considered by the investigator to be clinically significantand uncontrolled, even after insulin treatment.

17. Uncontrolled hypertension (as defined by systolic blood pressure [BP] ≥160 mmHgor diastolic BP ≥100 mmHg).

18. Active ongoing inflammatory or autoimmune disease other than chronic plaquepsoriasis and psoriatic arthritis, that may confound the evaluation of theeffect of the study drug.

19. History of a known malignancy within the previous 5 years prior to the firstadministration of the study drug (Day 1) except completely excised and curedsquamous carcinoma of the uterine cervix in situ, cutaneous basal cellcarcinoma, or cutaneous squamous cell carcinoma.

20. New York Heart Association class III or IV heart failure, severe uncontrolledcardiac disease (unstable angina or clinically significant electrocardiogram [ECG] abnormalities), or myocardial infarction within 24 weeks prior to thefirst administration of the study drug (Day 1).

21. History of organ transplantation, including corneal graft/transplantation.

22. Any underlying condition (e.g., metabolic, hematologic, renal, hepatic,pulmonary, neurologic, endocrine, cardiac, infectious or gastrointestinal)that, in the opinion of the investigator significantly immunocompromises thepatient and/or places the patient at unacceptable risk for receiving animmunomodulatory therapy.

23. Pre-existing or recent-onset central or peripheral nervous system demyelinatingdisease, including multiple sclerosis, optic neuritis and Guillain-Barresyndrome.

24. Any other serious acute or chronic medical or psychiatric condition that couldincrease the risk associated with study participation or study drugadministration or that could interfere with the interpretation of studyresults.

25. History or evidence of any other clinically significant disorder, condition, ordisease that, in the opinion of the investigator, would pose a risk to patientsafety or interfere with the study evaluation, procedures, or completion.

26. Patient who has the following laboratory abnormalities:

27. Hemoglobin ≤8.0 g/dL (SI [Système International d'Unités] units: ≤80 g/L or 4.96 mmol/L).

28. Platelet count <75× 103 cells/µL (SI units: <75 × 109 cells/L).

29. Absolute neutrophil count <1.5 × 103 cells/µL (SI units: <1.5 × 109 cells/L).

30. Alanine aminotransferase or aspartate aminotransferase >3.0 × upper limit ofnormal (ULN).

31. Serum creatinine >1.5 × ULN or an estimated creatinine clearance level ≤50mL/min (by Cockcroft-Gault formula) (SI units: 0.84 mL/s).

32. Patient who has received or plans to receive any of following prohibited medicationsor treatments:

33. Topical treatment for psoriasis or any other skin condition (e.g.,corticosteroids, vitamin D analogues, pimecrolimus, retinoids, salicylvaseline,salicylic acid, lactic acid, tacrolimus, tar, urea, α-hydroxy or fruit acids)within 2 weeks prior to the first administration of the study drug (Day 1).However, low-potency topical corticosteroids (Class 6 or 7) applied to the faceand intertriginous areas are permitted during study participation to reducepatient's burden with a restriction of use within 12 hours prior to studyvisits requiring PASI or sPGA measures. Bland moisturizers/emollients notcontaining pharmacological active ingredients are permitted for treatment ofpsoriasis during study participation, but these should not be used within 12hours before study visits when efficacy assessments are going to be performed.

34. Ultraviolet A or B phototherapy (without oral psoralen) or psoralen withUltraviolet A photochemotherapy for the treatment of psoriasis within 4 weeksprior to the first administration of the study drug (Day 1).

35. Any systemic immunomodulating treatments (e.g., MTX, cyclosporine A,corticosteroids, cyclophosphamide, and other systemic nonbiologic therapies [e.g., apremilast, tofacitinib]) within 4 weeks prior to the firstadministration of the study drug (Day 1).

36. Any other investigational device or medical product within 4 weeks prior to thefirst administration of the study drug (Day 1) or 5 half-lives, whichever islonger.

37. Initiation or dose modification of drugs that may aggravate psoriasis (e.g.,beta-blockers, calcium channel blocker or lithium) within 4 weeks prior to thefirst administration of the study drug (Day 1). Patients who have been onstable dose without exacerbation of psoriasis for at least 4 weeks prior to thefirst administration of the study drug (Day 1) can be enrolled, however, thesame dose should remain throughout the study.

38. Patient who has received live or live-attenuated vaccine within 4 weeks prior to thefirst administration of the study drug (Day 1), or any planned live orlive-attenuated vaccination during the study period.

39. Herbal remedies that could affect the outcome of the study within 2 weeks prior tothe first administration of the study drug (Day 1).

40. Patient not willing to limit UV light exposure (e.g., sunbathing and/or the use oftanning devices) during the course of the study.

41. Patient with inability or unwillingness to undergo repeated venipuncture (e.g.,because of poor tolerability or lack of access to veins).

42. Female patient who is currently pregnant or breastfeeding, or plans to becomepregnant or breastfeed within 20 weeks of the last dose of study drug. Male patientwho is planning to donate sperm or father a child within 20 weeks of the last doseof study drug.

43. Patient who currently abuses alcohol or drugs or has a history of alcohol or drugabuse within 1 year from Screening.

44. Patient is vulnerable (e.g., employees of the study center or any other individualsinvolved with the conduct of the study, or immediate family members of suchindividuals, persons kept in prison, or other institutionalized persons by lawenforcement).

45. Patient who, in the opinion of their physician or the investigator, should notparticipate in the study.